The Johns Hopkins University,Bloomberg School of Public Health

Health Research Challenge for ImpactCooperative Agreement

with the

United States Agency for International DevelopmentGHS-A-00-09-00004-00

Final Project ReportOctober 1, 2009 – September 30, 2016

Robert E. Black, MD, MPHPrincipal Investigator

This report was made possible through support provided by the Office of Health, Infectious Diseases, and Nutrition, Global Health Bureau, U.S. Agency for International Development, under the terms of Award No. GHS-A-00-09-00004-00, Health Research Challenge for Impact Cooperative Agreement. The opinions expressed herein are those of the author(s) and do not necessarily reflect the views of the U.S. Agency for International Development.

TABLE OF CONTENTS

TABLE OF CONTENTS........................................................................................................................................1EXECUTIVE SUMMARY.....................................................................................................................................3RESEARCH IN ASIA.............................................................................................................................................5

Determining the Burden of Maternal Ill Health and Death and its Programmatic Implications in Rural Bangladesh Dissemination...................................................................................................................................5Chlorhexidine (CHX) Main Trial Dissemination................................................................................................6Analysis of Outcomes Related to Short Inter-Pregnancy Intervals (IPI) in Projahnmo I and II (Sylhet and Mirzapur).............................................................................................................................................................7Safety and Efficacy of Simplified Antibiotic Regimens for Outpatient Treatment of Suspected Severe Infections in Neonates and Young Infants (SAT)...............................................................................................8Implementation research (IR) to support Bangladesh MOHFW to implement its recent policy of management of clinically suspected serious infections (CSSI) in young infants in two rural sub-districts of Bangladesh.....9Support for Improved Functioning of the Planning Wing and Other Departments of MOHFW, Bangladesh. 12Operations Research to improve the quality and coverage of services provided at community clinics in Bangladesh.........................................................................................................................................................13Best practices, capacity-building and leadership for Maternal, Neonatal and Child Health, Family Planning and Nutrition Programs in Bangladesh..............................................................................................................13Technical Assistance Bangladesh Maternal Mortality and Morbidity Survey (BMMS)..................................14Repeat Reproductive Age Mortality Study (RAMOS II) in Afghanistan.........................................................15Systematic Documentation of Community-oriented Approaches to Improve Recognition of and Appropriate Care Seeking for Newborn and/or Maternal Complications in Sarlahi District, Nepal....................................16

RESEARCH IN AFRICA......................................................................................................................................17Monitoring, Documentation and Evaluation of an Integrated Maternal and Newborn Health Care Program in Morogoro Region, Tanzania..............................................................................................................................18A Learning Agenda for the Development of Community Based Programs in Tanzania: Towards the Development of a Community Health Worker (CHW) Cadre..........................................................................19A Verbal/Social Autopsy Study to Improve Estimates of the Causes and Determinants of Neonatal and Child Mortality in Nigeria...........................................................................................................................................23The Care and Treatment of Severe Pneumonia in HIV-exposed and Infected Children in Zambia.................25Development and Testing of Evidence-based Mental Health Treatment for Affected Youth – Zambia..........25Sanitation Hygiene Infant Nutrition Efficacy (SHINE) Sub-study – Zimbabwe..............................................27Planning Activity for Confronting the Burden of Child Injury in Ethiopia......................................................29

GLOBAL RESEARCH.........................................................................................................................................30Child Injury Experts Meeting............................................................................................................................30Assessing the Impact of Health Interventions for Non-communicable Diseases and Injuries in Low and Middle Income Countries: A user-friendly model.............................................................................................31Implementation Research and Delivery Science (IRDS)..................................................................................32

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Community-based Approaches to Improving Reproductive, Maternal, Neonatal and Child Health Supplement Publication.........................................................................................................................................................34

ADDITIONAL SUPPORT FOR ADMINISTRATIVE EFFORTS......................................................................34HRCI Administrative Core................................................................................................................................35

APPENDIX: PUBLICATIONS AND MANUSCRIPTS IN PREPARATION (as of September 30, 2016)........36

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EXECUTIVE SUMMARY

The aim of Health Research Challenge for Impact (HRCI) Cooperative Agreement (CA) was to accelerate the development and introduction of new, feasible, culturally acceptable, low cost, preventive and curative interventions for the main causes of maternal, newborn and child (MNC) deaths. To achieve this aim, the Department of International Health at the Johns Hopkins Bloomberg School of Public Health (JHBSPH) established a partnership that included the field presence and experience of Save the Children and leading research institutions in both Africa and Asia. These have included The Muhimbili University of Health and Allied Science in Tanzania (MUHAS), International Centre for Diarrhoeal Disease Research in Bangladesh (ICDDR,B), Shimantik in Bangladesh, and the National Population Commission of Nigeria, among others.

The work conducted under the auspices of the HRCI was organized into four linked components: three research areas (intervention research, program approach research and tools/measurement research) and a cross-cutting component dedicated to accelerating progress along the research to use (HARP) continuum under which the cooperative agreement was developed. This framework highlights the importance of conducting research with an eye toward national and international policy change and program implementation.

Since 2009, USAID investment in research through the Health Research Challenge for Impact (HRCI) partnership has resulted in several key advancements in maternal, newborn and child survival and has served as a key component in efforts to move along the research to practice continuum. The project has provided global leadership and the generation of robust evidence across a broad geographic and contextual scope.

HRCI played a strong leadership role in advancements in newborn health along the HARP continuum. This included leadership in the dissemination of results from three large chlorhexidine trials which led the WHO to revise its umbilical cord care recommendation for high mortality settings and which in turn has led to global scale up of chlorhexidine umbilical cord care. HRCI also supported a randomized clinical trial on the safety and efficacy of simplified antibiotic regimens for outpatient treatment of suspected severe infections in neonates and young infants (SAT). Based on the findings of this study and findings of two similar trials, the WHO revised global guidelines for the management of

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Research to Use

Internal USAID priority setting

& reviewHRCD

Research on Interventions• Safety• Efficacy

Research on program approaches• Synergies &

antagonisms • Effectiveness • Efficiency• Feasibility• Acceptability

Tools & measurement• Coverage• Impact• Projections

Strategies to accelerate translation of research findings into sound MNC programs

HRCI Aim: To accelerate the development and introduction of new feasible preventive and curative interventions for the main causes of maternal, newborn and child deaths.”

possible severe bacterial infections in young infants. HRCI subsequently supported implementation research to assist the Government of Bangladesh in implementing its adapted national guidelines for management of young infant infections, and to provide lessons learned to other countries looking to adapt and scale up their guidelines.

HRCI has also led the expansion of research into new geographical regions and areas of focus within maternal, newborn and child health. This had included a multiple methods reproductive age mortality study in Afghanistan, a Verbal and Social Autopsy (VASA) study in Nigeria, development and testing of evidence-based mental health treatment for affected youth in Zambia, associations with exposure to aflatoxin in relation to birth outcomes in Zimbabwe, and assessment of the burden of child injury in Ethiopia.

Finally, HRCI has focused heavily on capacity building in target countries. Over the course of the HRCI agreement, researchers from JHSPH and MUHAS supported the Tanzanian Ministry of Health and Social Welfare and its Task Force on Community Health Workers (CHWs) in their efforts to develop a national cadre of CHWs that will best serve the needs of people in the Tanzania. Another project, ‘Best Practices, Capacity-Building and Leadership for Maternal, Neonatal and Child Health, Family Planning and Nutrition Programs in Bangladesh,’ focused on building capacity for public health leadership and promoting local best practices.

This final report presents an abbreviated description of each of the funded studies/activities under the HRCI, highlighting findings and implications for policy and program implementation. It is organized by study country/region plus other global activities studies and other administrative and technical support. In addition to the main text, Appendix A includes a list of publications and manuscripts in various stages of preparation, organized by study.

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RESEARCH IN ASIA

The work of the HRCI built on the large portfolio of research undertaken in Bangladesh under the Global Research Activity (GRA) CA which included five main randomized controlled trials (Projahnmo-1, Projahmo-2, Chlorhexidine Cleansing, Simplified Antibiotic Treatment, and Thermal Care) along with their accompanying efforts (i.e. maternal interventions sub-study in Projahnmo-1, formative research on Chlorhexidine, Chlorhexidine Operations Research (OR), and Sepsis OR proposal development). Dissemination and write-up of several studies was completed during the life of HRCI. The Simplified Antibiotic Treatment trial which began under GRA was completed in 2014 and led into an implementation research study to support Bangladesh MOHFW to implement its recent policy of management of clinically suspected serious infections (CSSI). Additional efforts were undertaken to support the Bangladesh health sector and develop in-country research and leadership capacity. Outside of Bangladesh, the Repeat Reproductive Age Mortality Study (RAMOS II) was completed in Afghanistan and research on community-oriented approaches to improve recognition of and appropriate care seeking for newborn and/or maternal complications was undertaken in Nepal as part of a larger study led by TRAction.

Determining the Burden of Maternal Ill Health and Death and its Programmatic Implications in Rural Bangladesh Dissemination

Study Overview: The study entitled “Determining the burden of maternal ill health and death and its programmatic implications in rural Bangladesh” was funded under USAID’s GRA CA from May 2006 to September 2009. The study was implemented in Matlab, Bangladesh, using both quantitative and qualitative research methods, to investigate the following:

• Women who suffer severe obstetric complications are at risk of suffering from further physical, social, mental consequences or death compared to those with normal deliveries with no complication.

• Women who suffer from poor pregnancy outcomes (e.g., stillbirths, early neonatal death) are at risk of suffering from further physical, social, mental consequences or death compared to those with normal deliveries with no complication.

• A child of a mother suffering from severe maternal complications is at higher risk of death, poorer growth and development than those of women without such consequences.

• Families of women who have suffered severe maternal complications (and/or poor pregnancy outcomes) are at higher risk of dissolution, violence, and/or impoverishment.

The dissemination event occurred after the close of the GRA CA on November 11 and 12, 2009 and was funded by HRCI. On November 11, 2009 a working group meeting with selected experts from the government, NGO and private sectors gathered to share the study findings and set policy recommendations. On the following day the results were disseminated among the wider audience (about 100 participants) including policy makers, program managers, researchers and professionals. It was decided that the recommendations from the study will be further discussed among the group of maternal health experts and policy makers for consideration for policy formulations. The study resulted in a number of peer reviewed publications, including a special journal issue “Maternal Morbidity, Disability and their consequences: Neglected Agenda in Maternal Health” in the Journal of Health, Population and Nutrition.

Partners:ICDDR,B

Main Findings and Implications: The prospective study was conducted to assess the effect of severe obstetric morbidities on short-term physical,

psychological, and economic consequences on the life of women, their children and other family members and also the effect of mothers’ severe obstetric complications on child development. Based on the findings, the study recommends:

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o Facility delivery to ensure good outcomes for both mother and newborn at delivery and beyond. There is also suggestion to improve the quality of intrapartum care in both public and private facilities. To monitor quality of care in facilities, a uniform standardized record keeping system is also required amongst both public and private facilities.

o Testing different counseling models for families and communities where there is a perinatal death to lessen depression, blame and emotional violence.

o That financial protection is needed for the poorest to encourage use of facilities for delivery and prevent families being impoverished. It also suggests that demand side financing should be expanded conditional on evaluation. For long-term there should be more policy options.

o That programs addressing pre-pregnancy and antenatal counseling on early childhood development should be given priority.

The retrospective study was conducted using the Health and Demographic surveillance System (HDSS) and the other safe motherhood data sources in Matlab (during 1882 and 2005) to assess the effect of maternal death on survival and education of children.

o The study finds that infant mortality is about eight times higher in the case of a maternal death. It also confirms if a mother dies in the first five years of life, eight of ten children under five years of age are likely to die. Children who lose their mother are also likely to have less education as compared to their counterpart. This finding has strong advocacy message that mother’s death carries double burden.

Qualitative studies were also conducted to understand the short- and long-term social consequences of maternal morbidities.

o People in rural Matlab often failed to understand the severity of short- and long-term pregnancy-related morbidities and did not k now where to seek care for their problems. As a result, their health problems were often overlooked and remained untreated, frequently leading to severe social consequences for women. To avoid pregnancy-related morbidities proper referral mechanisms with functional emergency obstetric and gynecological care need to be made accessible to rural communities. Awareness raising campaigns should be developed to disseminate information on potential complications during and after delivery, and the importance of obtaining timely treatment for physical and psychological consequences associated with these conditions. Doctors and health workers should be accountable to the community in terms of explaining the reasons for doing a c-section and the potential consequences.

Chlorhexidine (CHX) Main Trial Dissemination

Study Overview: Three large CHX trials were conducted in Bangladesh, Nepal and Pakistan. Two of them, in Bangladesh and Nepal, were conducted by Johns Hopkins Department of International Health. Two of these trials were funded by USAID and the other one was funded by NIH. After these trials were completed, USAID/HRCI supported a joint analysis of all investigators from all three sites in Baltimore and a pooled analysis was done showing a 23% reduction in neonatal mortality. HRCI also funded dissemination efforts with other partners, including a dissemination meeting, Chlorhexidine for Umbilical Cord Care: Evidence Base and the Way Forward Dissemination Workshop that was held in Nepalgunj, Nepal on September 15-16, 2011.

Partners:PATHSaving Newborn Lives – Save the ChildrenMCHIP

Main Findings and Implications: Results of all three trials were presented at the dissemination workshop in Nepal in 2011. Over 70 participants

attended, including representatives from governments and NGOs from over 7 countries.

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The overall results of the meeting demonstrated that there is sufficient evidence to recommend inclusion of 4% chlorhexidine cord cleansing as a strategy to reduce neonatal mortality in settings where poor hygiene and high neonatal mortality are issues.

Applying 4% CHX immediately after cord cutting proved most effective in reducing neonatal mortality and omphalitis.

The reduction of neonatal mortality in the three countries varied from 20% to 38%. The demonstrated reduction in omphalitis ranged from 24% to 75%. Based on these trial results, in 2012, WHO revised its umbilical cord care recommendation for high mortality

settings. The new guideline recommends that newborn umbilical cord should be cleansed with CHX To support scale up of CHX umbilical cord care, a global Chlorhexidine Working Group was established. The

Working Group has worked with ministries of health, manufacturers, and regulatory authorities in Sub-Saharan Africa and South Asia to select appropriate supply strategies to ensure sustainable availability of quality chlorhexidine for umbilical cord care.

The working group also supported ministries of health and other key stakeholders in priority countries to develop country-driven policies, clinical guidelines as well as program designs for sustainable introduction and scale up of the chlorhexidine product in newborn care programs.

Now, over 25 countries are exploring or implementing chlorhexidine for umbilical cord care. Of these, ten countries are engaged in scale up and another nine are piloting use of the product or aligning policy for product introduction

o Introduction/scale up: DRC, Ethiopia, Kenya, Liberia, Madagascar, Malawi, Mozambique, Nepal, Nigeria and Pakistan.

o Pilot/Policy alignment: Afghanistan, Bangladesh, Ghana, Haiti, India, Mali, Niger, Uganda and Zambiao Expressed interest: Angola, Benin, Burkina Faso, Cameroon, Cote d’Ivoire, Myanmar, Senegal, Sierra

Leone

Analysis of Outcomes Related to Short Inter-Pregnancy Intervals (IPI) in Projahnmo I and II (Sylhet and Mirzapur)

Study Overview: This study was a secondary data analysis of studies conducted in Bangladesh by the Projahnmo Study Group which is a research partnership of Johns Hopkins University with Bangladeshi institutions. The data were drawn from a study known as ‘Projahnmo I’ which was a community-based, cluster randomized trial that was conducted in the Sylhet district of Bangladesh. The aim of the original study was to evaluate the effect of an integrated maternal and newborn care program on neonatal mortality. The trial had 3 arms including a comparison area with usual care; a home-based care arm where trained community health workers (CHWs) made home visits to provide counselling during pregnancy and the immediate post-partum period; and a community care arm where health promotion was conducted through group sessions. Each arm was made up of 8 clusters of population sizes around 20,000. In the analysis of the parent trial, we used data from the endline survey conducted in 2006 to determine whether interventions resulted in changes in neonatal mortality rates and maternal and newborn care practices. These data were also used for the present study.

The secondary analysis of this data set was conducted to examine the association of birth interval with birth outcomes using pregnancy histories and outcome data that occurred between 2003 and 2005 among married women aged 15-49 years in Sylhet, Bangladesh. The data included 49,544 pregnancy outcomes from 36,560 mothers. Reported adverse pregnancy outcomes were spontaneous abortion, stillbirth and neonatal death. Logistic regression models with robust standard errors were applied to account for within-mother clustering of outcomes and adjusted for previous pregnancy outcomes, child- and mother-level factors, and household socioeconomic status (SES) derived from household-level socio-economic variables.

Partners:Projahnmo/ Johns Hopkins University-Bangladesh ICDDR,B

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Main Findings and Implications: The shortest inter outcome interval (IOI) (<18 months) was associated with increased risks for spontaneous

abortion, stillbirth, and neonatal death [Adjusted Odds Ratios (AOR) (95% confidence intervals): 3.33 (2.89, 3.82), 1.48 (1.24, 1.78) and 1.46 (1.23, 1.74), respectively]; compared to the 35-59 months IOI. The IOI of 18-24 months was also associated with an increased risk for spontaneous abortion. The longest IOI, 60+ months, was associated with an increased risk for stillbirth [AOR: 1.35 (1.08, 1.68)]. A population attributable risk fraction analysis indicated that waiting at least 9 months (i.e. IOI>18 months) before becoming pregnant again, would reduce spontaneous abortions by 24%, stillbirths by 9%, and neonatal death by 8%.

This findings reconfirms the earlier findings based on observational data that short birth intervals are associated with increased risk of several adverse perinatal outcomes. We recommend that MNH programs should consider systematically integrating FP as it benefits from early and sustained FP use, reduced risk of short birth intervals, and improve birth outcomes.

Johns Hopkins University and its partners recently completed a quasi-experiment with USAID funds to evaluate the feasibility and impact of integrating post-partum family planning with a community based MNH program and demonstrated that integration is feasible and that the integrated package led to about a 20% increased cumulative probability of modern method adoption through the 36 months postpartum period, preventing pregnancies that have the highest risk for both mother and newborn health. It led to a 19% reduction of the probability of shorter birth intervals and 21% lower risk of preterm birth (unpublished data). These findings are of substantial public health importacet. Johns Hopkins University is exploring funding to support scale up of this intervention.

Post-HRCI PlansA manuscript is being revised and is planning to be submitted to a journal in late 2016.

Safety and Efficacy of Simplified Antibiotic Regimens for Outpatient Treatment of Suspected Severe Infections in Neonates and Young Infants (SAT)

Study Overview: Severe infections remain one of the leading causes of neonatal deaths worldwide. Possible severe bacterial infection is diagnosed in young infants (aged 0-59 days) according to the presence of one or more of the following clinical signs: stopped feeding well, movements only on stimulation, severe chest in-drawing, temperature below 35.5oC, and temperature 38oC or above. The recommended treatment is hospital admission with 7-10 days of injectable antibiotic therapy. In low- and middle-income countries, barriers to hospital care lead to delayed, inadequate, or no treatment for many young infants. We aimed to identify effective alternative antibiotic regimens to expand treatment options for situations where hospital admission is not possible. To this end, we conducted a randomized, open-label, equivalence trial in four urban hospitals and one rural field site of Bangladesh to determine whether two alternative antibiotic regimens with reduced numbers of injectable antibiotics combined with oral antibiotics used as outpatient treatment had similar efficacy and safety to the standard regimen involving 14 injections, procaine penicillin and gentamicin daily for 7 days. We randomly assigned infants who showed at least one clinical sign of severe, but not critical, infection, whose parents refused hospital admission, to one of the three treatment regimens. We stratified randomization by study site and age (<7 days or 7-59 days) using computer-generated randomization sequences. The standard treatment was intramuscular procaine benzylpenicillin and gentamicin once per day for 7 days (group A). The alternative regimens were intramuscular gentamicin once per day and oral amoxicillin twice per day for 7 days (group B) or intramuscular procaine benzylpenicillin and gentamicin once per day for 2 days, then oral amoxicillin twice per day for 5 days (group C). The primary outcome was treatment failure within 7 days after enrolment. Assessors of treatment failure were masked to treatment allocation. Primary analysis was per protocol. We used a pre-specified similarity margin of 5% to assess equivalence between regimens.

Partners:Saving Newborn Lives program of Save the Children Federation, Inc.

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Bill and Melinda Gates FoundationChild Health Research FoundationHospital for Sick ChildrenShimantik

Main Findings and Implications: Between July 1, 2009, and June 30, 2013, 2490 young infants were recruited into the trial, about 830 infants in

assigned to each treatment group. 2367 (95%) infants fulfilled per-protocol criteria. 78 (10%) of 795 per-protocol infants had treatment failure in group A compared with 65 (8%) of 782 infants in group B (risk difference -1.5%, 95% CI -4.3 to 1.3) and 64 (8%) of 790 infants in group C (-1.7%, -4.5 to 1.1). In group A, 14 (2%) infants died before day 15, compared with 12 (2%) infants in group B and 12 (2%) infants in group C. Non-fatal relapse rates were similar in all three groups (12 [2%] infants in group A vs 13 [2%] infants in group B and 10 [1%] infants in group C).

These results suggest that the two alternative antibiotic regimens for outpatient treatment of clinical signs of severe infection in young infants whose parents refused hospital admission are as efficacious as the standard regimen. This finding could increase treatment options in resource-poor settings when referral care is not available or acceptable.

Based on the findings of this study and findings of two similar trials conducted, one in three countries of Africa and the other in Pakistan, the WHO revised global guidelines for the management of possible severe bacterial infections in young infants. The Government of Bangladesh (GoB) has adapted the updated WHO guideline in its national guidelines for management of young infant infections to allow for young infants with possible severe bacterial infections to be treated by providers at outpatient facilities. This policy provides an opportunity to expand treatment services to many infants and families in the case that hospital treatment is not affordable or accessible. The WHO is planning global scale-up in the near future.

Capacity Building Activities Findings from this study were translated to a new global guideline set forth by WHO. This guideline was adapted by the Ministry of Health and Family Welfare (MOH&FW) of the GoB. Several partners including Johns Hopkins University have been providing technical support to the MOHFW to implement initially in three districts of Bangladesh. These partners are also providing evaluation and implementation research support. Please find additional information on the Capacity Building Activities described in the next section on Implementation research (IR) to support Bangladesh MOHFW to implement its recent policy of management of clinically suspected serious infections (CSSI) in young infants in two rural sub-districts of Bangladesh.

Implementation research (IR) to support Bangladesh MOHFW to implement its recent policy of management of clinically suspected serious infections (CSSI) in young infants in two rural sub-districts of Bangladesh

Study Overview: Based on the results of the simplified antibiotic therapy trial for management of young infant infections conducted by our group in Bangladesh (known as Projahnmo) and a similar trial in Africa, the Ministry of Health and Family Welfare (MOH&FW) of the Government of Bangladesh (GoB) has developed new guidelines for management of young infant infections at the union level health facilities. During the first year of implementation, the Projahnmo study group worked closely with the MOH&FW to help operationalize and implement the new guidelines and has designed and initiated an implementation research study in selected districts to document the early implementation challenges and solutions to facilitate scale-up across the country. The primary aim was to support local MOH&FW officials in selected unions of two rural districts to effectively implement the newly developed guidelines for management of infections in young infants (0-59 days old) at the union level health facilities by providing assistance in planning, training, strengthening MIS, monitoring, documenting program learning, and identify and address key operational issues.

Specific objectives of the implementation research are:

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1. To examine feasibility of implementation of the newly developed infection management guidelines in young infants at the union-level health facilities through outpatient services

2. To assess the acceptability of infection management services delivered as outpatients at union-level health facilities among the parents and families of young infants

3. To measure caregiver knowledge and coverage of infection management for young infants 4. To assess the compliance of the families to the referral advice and new treatment regimen for young infant

infections delivered at the union-level health facilities 5. To document the safety of the injectable antibiotic therapies delivered at union level facilities as per

national guidelines for infants classified as clinical severe infection (CSI) who refuse referral advice6. To identify the enabling and hindering factors, and strategies to address barriers to the implementation of

the national guidelines for management of infections of young infants at the union level health facilities

The Projahnmo research team is responsible for providing implementation support to the MOH&FW and carrying out the program evaluation in the Sylhet district unions. The MaMoni program will be responsible for providing technical support to the MOH&FW in Lakshmipur and will support the Projahnmo study group as Projahnmo leads evaluation efforts in this study area.

Partners:Johns Hopkins University, Bangladesh (JHU-B)’s research partnership (Projahnmo) with Bangladesh MoH&FW and Bangladeshi NGOs, including Center for Sustainable Development and Research (CSDR) and Shimantik, led the implementation support and evaluation in Sylhet. Projahnmo also worked in partnership with the implementation lead, MaMoni Health Systems Strengthening (HSS) project, to conduct the evaluation in Lakhmipur. In Kushtia, Saving Newborn Lives, Save the Children is supporting implementation and icddr,b is leading the evaluation efforts during the first year of implementation and have a longer study period (Figure 1).

Main Findings and Implications: Some key study findings and recommendations for the first and second round of data collection (October 2015

through May 2016) are presented by relevant study themes including service readiness, maternal knowledge and care-seeking, UH&FWC utilization, case management and follow-up, and record keeping and supervision.

o Service availability and facility readiness: Assessments identified some gaps related to service availability and service readiness at the UH&FWCs. Routine systems were not fully in place to supply PSBI drugs and equipment so project inputs facilitated the supply of these items to study area UH&FWCs. Inadequate infrastructure including lack of clean water supply and intermittent electricity in some UH&FWCs was also a challenge for service delivery. Further strengthening of the infrastructure at these first-level facilities and streamlining of the drug and equipment supply are needed to ensure consistency among facilities, and feasibility and fidelity of the implementation of the new guidelines. Additionally, there was the challenge of providers and services being unavailable at the UH&FWC on non-working days, either for new patients or for patients who returned for their 2nd day injection. All the study area UH&FWCs had a SACMO posted at the start of study initiation. However, human resource

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Figure 1. Map of Bangladesh highlighting the 3 study areas

vacancies in UH&FWCs nationwide present another challenge; if no SACMO is posted at a clinic, there is no provision for training another provider in the new guidelines affecting uninterrupted service availability.

o Demand for treatment: Another challenge to implementation of the new guidelines is the variable demand for treatment at the UH&FWCs among caregivers of young infants. Care-seeking for young infant illness from government facilities was generally low in this context. There are both formal and informal providers from whom caregivers seek care for their infants. Initial findings suggest care-seeking by caregivers of young infants in Sylhet and Lakshmipur is low. Furthermore, UH&FWC utilization varied by union in both Sylhet and Lakshmipur, which health workers attributed, in part, to the location of facilities and the strength of the relationship between the SACMO and community. Data collected from caregivers of young infants indicated that perceptions of illness severity, cost, and availability of transportation and distance to the health facility were important determinants of care-seeking for young infant illness. One possible strategy to increase care-seeking at the clinics is to expand community mobilization and behavior change communication to increase recognition of infant illness as well as awareness that young infants should be brought to UH&FWCs when illness is identified. The GoB may also explore options to involve the private sector in the care provision, however, mechanisms will need to be developed to ensure quality of care and access to population not able to pay for services.

o Referral and follow-up of young infants classified as Clinical Severe Infection (CSI): Compliance to referral and follow-up of young infants classified as CSI to ensure adherence to care by return visit to the UH&FWC on day 2 of treatment for the second injection remained challenging. SACMOs also reported that the day 4 follow-up phone calls added both a time and financial burden to them. SACMOs felt that a phone call was not an adequate method for assessing a sick infant. Many SACMOs reported that they requested families to return for day 4 follow-up rather than rely on a phone call. Although the number of families that return on day 4 was not recorded, SACMOs reported that many families returned to the UH&FWC for the day 4 visit. The study team also identified challenges with follow-up visit in the community on the last day of treatment. Family Planning Inspectors (FPI), the providers responsible for the day 8 follow-up visit, have not been provided basic equipment to assess temperature and respiratory rate and have limited clinical training. Additionally, transportation was reported as a barrier to day 8 FPI follow-up visits required at the homes of sick infants.

o Record keeping with sick young infant register: Adequate record keeping also remained a challenge. The current register does not have space for writing presenting complaints reported by the caregivers by the service providers. This may be solved with a revisions to the structure of the newborn register. Additionally, some service providers marked multiple classifications in the register or did not mark any classification at all. Sometimes day 4 follow-up findings were not recorded in the registers. These issues may indicate the need for additional training and adjustment of sick young infant register.

o Supervision: Finally, there were challenges with routine supervision, which according to the data, appeared to be infrequent or nonexistent in study area UH&FWCs. While supervisors were trained on the guidelines, SACMOs report that the content of supervision visits focused on record keeping, with limited opportunities for assessing and building clinical skills of SACMOs.

Based on this study’s findings, we recommend that the study partners and Ministry of Health and Family Welfare consider the following:

o Strengthen infrastructure in UH&FWCs and streamline channels for supply of PSBI drugs and equipment to the union level facilities

o Improve awareness and demand for services at the UH&FWC through strengthening community mobilization activities utilizing existing MoH&FW community health workers

o Provide training to SACMOs on counseling for successful referral and follow-up with mother and family members

o Discuss with partners and policymakers about considering a day 4 follow-up visit in lieu of phone callo Revise register and review registrar data in monthly meetings as opportunities to identify skills gaps and

coach SACMOs

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Capacity Building Activities During this start-up period, Projahnmo and MaMoni provided technical assistance to the MOH&FW to improve the capacity of Union Health & Family Welfare Centers (UH & FWC) by strengthening infrastructure and logistics management, and providing training to the service providers in the updated guidelines for infection management in young infants. Community awareness building activities were designed and implemented using exiting health personnel in the community at the household level as well as by organizing community group orientation.

Post-HRCI PlansThe study ended prematurely because the funding mechanism ended. The lessons learned were valuable to the MOH&FW, however, continuation of this study for another year would have provided adequate lessons for successful implementation and guidance for national scale up. The investigative team applied for USAID’s BAA addendum # 2. If funded, that may allow us the opportunity to provide additional support to Bangladesh MOH&FW to national scale up and support other countries with implementation and scale up.

Support for Improved Functioning of the Planning Wing and Other Departments of MOHFW, Bangladesh

Study Overview: The Ministry of Health and Family Welfare (MOHFW), Government of Bangladesh is overseeing and directing the five-year Health, Population, Nutrition Sector Development Program (HPNSDP) 2011-2016. The HPNSDP is based on a Sector-Wide Approach (SWAp) and aims to improve access to and utilization of an Essential Services Package (ESP) for the poor, reduce maternal mortality and morbidity, and ensure continued improvements in maternal and child health and family planning. USAID contributed $40 million for five years to support HPNSDP as a single donor trust fund, through an agreement with the World Bank. The Planning Wing (PW) of the MOHFW is responsible for monitoring and manages the implementation of the HPNSDP and promote evidence-based decision making.

Building capacity at the PW and other relevant departments of MOHFW is a sustainable investment to enhance its capacity to manage and monitor HPNSDP, periodically review progress, and identify corrective actions, program modifications and improvements. USAID had particular interest in strengthening the PW and other related agencies by enhancing its monitoring capacity through a Performance Monitoring Plan (PMP) for HPNSDP, establishing the Technical Support Team for the Programme Management and Monitoring Unit (PMMU) in the Planning Wing and the strengthening of the routine health information system to ensure reliable and on-time data for program management and tracking progress.

ICDDR,B was funded through HRCI to provide support for the improved functioning of the PW and identifying priority issues for maternal, newborn and child health and developing evidence-based policy guidance brief for the guidance of the Ministry. This included administrative and logistical support, organization of several workshops/events on key topics of interest to HPNSDP, organization of participation of GoB policy makers in global symposiums/conferences, and producing policy discussion papers.

Partners:Ministry of Health and Family Welfare (MOHFW)ICDDR,B

Main Findings and Implications: Administrative and logistical support was provided to the PW and PMMU of MOHFW, including support in

organizing workshops at national and regional levels and during annual review of the sector program. Three policy discussion papers were produced:

o Utilization of the private sector for maternal care in urban settings of Bangladesho Averting maternal deaths in Bangladesh: How to achieve post MDG maternal mortality targets by 2030?o Averting Neonatal Deaths in Bangladesh: Progress and Challenges for Achieving Neonatal Mortality

Targets by 2030

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Operations Research to improve the quality and coverage of services provided at community clinics in Bangladesh

Study Overview: Revitalization of the community health care initiative in Bangladesh is associated with major changes in all domains of the health system – service delivery, workforce, information systems, equipment and supplies, financing and governance. Evaluations focused on the specific aspects of health system are common; however, evaluation of complete health systems is less common in general. The revitalization of community clinics (CC) provided a rare and important opportunity to evaluate and help improve the effect of a program that is associated with large scale restructuring of health systems.

With funding from USAID’s Bangladesh mission, JHSPH and ICDDR,B began conducting an operation research project to identify interventions to improve the performance of community clinics (CC) in Bangladesh. The team drafted Bangladesh context specific protocols, manuals and instruments, received ethical approval to collect data, and completed household listing and mapping for a baseline assessment. However work on this project was terminated in July 2011 and the operations research study was unable to be completed. Funds were expended for the initial phases of this work which were completed.

Partners:Ministry of Health and Family Welfare (MOHFW)ICDDR,BCenter for Sustainable Development and Research (CSDR)HLSP

Best practices, capacity-building and leadership for Maternal, Neonatal and Child Health, Family Planning and Nutrition Programs in Bangladesh

Study Overview: The goal of the ‘Best Practices, Capacity-Building and Leadership for Maternal, Neonatal and Child Health, Family Planning and Nutrition Programs in Bangladesh’ project was to contribute to the continuing improvement in maternal and child health in Bangladesh by building capacity for public health leadership and promoting local best practices through two linked components.

The objective of the first component was to develop and offer a course on strategic leadership to build the leadership capacity of district (and select subdistrict) managers in health and family planning. The course was offered through a partnership with Save the Children – Bangladesh and Bangabandhu Sheikh Mujib Medical University (BSMMU) in Dhaka.

The objective of the second component was to identify and profile examples of good practices within MNCH-FP-N to serve as sources of “lessons learned” that can be helpful to the Government of Bangladesh’s implementation of the health sector strategy as well other stakeholders and NGOs. The profiles promote worthwhile leadership and management practices and/or health and family planning programs that have a demonstrated impact through the programs’ own monitoring and evaluation results, and are incorporated as case study examples in the SLMTP course curriculum.

Partners:Save the Children – BangladeshBangabandhu Sheikh Mujib Medical University (BSMMU)Organizations profiled for best practices: LAMB Rural Health and Development, World Renew, CARE Bangladesh, Development Organisation of the Rural Poor (DORP), Jhenaidah Sadar Hospital

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Main Findings and Implications: Given the success of the training program, it could be considered to expand the training program and fully

incorporate a mentorship component to district and upazila level health and family planning managers in the public, private or non-government organization (NGO) sectors. This could help to strengthen the leadership and management capacity of this important group of professionals engaged in developing and implementing key programs in the field maternal, neonatal and child health, family planning and nutrition in Bangladesh.

An evaluation of the training program has been proposed, in order to demonstrate evidence of the training’s effectiveness. This would provide further justification for the Government/Ministry of Health and Family Planning to consider taking the ownership of this strategic leadership training program, and this training can be offered on an ongoing basis under the In Service Training (IST) Program. This can also be considered to be included in Foundation training.

We highlighted best practices addressing major causes of neonatal morbidity and mortality (KMC), gaps in maternal care coverage (community skilled birth attendants), bottom-up health systems strengthening (budget reviews and people’s institutions), and quality of facility-based care.

The best practices component attempted to diffuse lessons learned by profiling real world successful programs, operating in routine conditions, and paying particular attention to the keys for success.

Capacity Building Activities Strategic Leadership and Management Training Program for District and Upazila Managers in Health & Family Planning (SLMTP) was developed. Through this program, country contextualized course manuals for both the participants and the facilitators were developed. A group of in-country facilitators were identified and trained through Training of Trainers. A total of 93 district and upazila managers participated in this training program. Also, a guideline for mentorship was developed through this program.

For best practices, secondary and primary data collected on the five programs were used to write case study profiles, which were collated and published in a full color 80-page booklet, Lessons from the Ground: A Collection of Case Studies, heavily enhanced with professional photographs of the profiled programs. Each profile contains descriptive information about the highlighted program, mention of positive changes resulting from the program, “keys to success” of the program, recommendations, and contact information for the implementing organization. The results were shared with stakeholders at a meeting in Dhaka, 31 May 2015. Videos of the profiles were also produced and are available on YouTube.

Post-HRCI PlansResearchers would be happy to develop programs for expansion of the SLMTP program and mentorship component throughout the country with possible funding support.

Technical Assistance Bangladesh Maternal Mortality and Morbidity Survey (BMMS)

Study Overview: Reducing maternal mortality is a priority health target in Bangladesh. The Government of Bangladesh (GoB) conducted the first Bangladesh Maternal Mortality and Morbidity Survey in 2001 (BMMS 2001). The BMMS 2001 aimed to estimate the level of maternal mortality and proportion of maternal deaths due to different causes to inform decision-making in maternal health. The second BMMS was conducted in 2010 to track progress in reducing maternal mortality over a decade from 2001 to 2010. The third BMMS is now being planned for 2016, with an additional objective of collecting data on maternal morbidity across life-span consequences. With funding from HRCI, Dr. Saifuddin Ahmed provided technical consultation to the BMMS team for collecting and validating data on chronic maternal morbidity conditions, namely obstetric fistula and pelvic organ prolapse. The purpose of consultation was to provide specialized expertise for unbiased measurement of maternal morbidity at population level in Bangladesh using survey data.

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Partners:Government of BangladeshThe MEASURE Evaluation Project

Main Findings and Implications: Dr. Ahmed worked with the survey team to review draft questionnaires and advise on questionnaire content

particularly as related to obstetric fistula (OF) and pelvic organ prolapse (POP). He also advised on sample size requirements and study design for measuring OF and POP at population level.

The BMMS survey instruments and sampling plan were finalized following this consultation, training on morbidity validation occurred in July 2016 and fielding of the survey began in August 2016.

Repeat Reproductive Age Mortality Study (RAMOS II) in Afghanistan

Study Overview: In 2002, a reproductive age mortality survey (RAMOS I) was conducted by the Afghanistan MoPH, the US Centers for Disease Control and Prevention and UNICEF in four districts of Afghanistan. The districts were selected to reflect an urban to rural/remote continuum: urban - Kabul City, Kabul province; semi-rural - Alisheng, Laghman province; rural - Maiwand, Kandahar; and rural remote - Ragh, Badakshan. The study found that all indicators of mortality risk were among the highest recorded globally, increasing substantially with remoteness. Maternal deaths exceeded every other cause of death among women of reproductive age except in Kabul. Of the women who died, 75% of their infants also died and none had accessed a skilled attendant in the two remote areas – Ragh and Maiwand.

These study findings initiated a strong response from the Afghan MoPH and the international humanitarian aid community. Enhancement of maternal and child health services became a major priority area and the focus of nearly a decade of health strategies and policies. In an effort to identify changes in mortality rates in the same geographic areas over time the MoPH and stakeholders approved a repeat of the RAMOS I study using the same two-stage survey methodology, as well as qualitative data collection to assess contextual influences affecting maternal mortality decline.

Data collection tools for RAMOS II built upon those used in 2002 to ensure comparability but included additional questions to explore equity, care seeking, and other domains of interest thought to affect health outcomes. Security considerations affected data collection and quality in Alisheng, Laghman and quantitative data collection was suspended before fully complete in the interest of safety. In total, quantitative data collection was only fully completed in Kabul City, Kabul and Ragh, Badakshan. The survey was completed among 27,000 households in Kabul City and Ragh district in Badakshan province – a sample size calculated to measure a decline of up to 25% in maternal mortality. Kabul and Ragh represent extremes of urban and rural contexts.

The qualitative component of the study, conducted in all four RAMOS I study districts, included both interviews and focus groups. All qualitative interviews and discussions used a semi-structured interview guide that was specific to level (national/community), position, and in the case of focus groups, sex, of the participant. Interviews with health officials and service providers were designed to collect information about how the availability and quality of services has changed since the RAMOS I study was conducted, the capacity to address obstetric complications at district and provincial health facilities, and the challenges faced in providing maternal health services at each of these levels.

Partners:Afghanistan Ministry of Public Health (MoPH)Central Statistics Office of AfghanistanJhpiego

Main Findings and Implications:

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The study results indicate that statistically significant improvements in maternal and newborn mortality risk have occurred, but also evidence of great disparity between urban and rural settings.

All estimates of maternal mortality show evidence of decline in both Kabul and Badakshan, although only one measure, the maternal mortality rate, reached statistical significance in Kabul City.

o In Kabul, the MMRatio declined from 418 deaths per 100,000 live births in 2002 to 166 in 2011, a decline of approximately 60.2%. The maternal mortality rate (MMRate) declined from 0.7 deaths per 1000 women of reproductive age to 0.2 deaths, a statistically significant decline of approximately 75%. The adult lifetime risk of maternal death, which measures the proportion of women who reach age 12 who will die before age 49 from maternal causes, declined from 1 in 42 in 2002 to 1 in 149 in 2012. The proportion of deaths to women of reproductive age did not change significantly.

o In Badakshan, the maternal mortality ratio, maternal mortality rate, and the lifetime risk of maternal death all declined by statically significant margins. The MMR declined by 89%, from 6507 deaths per 100,000 live births in 2002 to 713 deaths in 2002 while the MMRate declined by 87%. In 2002, approximately 1 in 3 adult women in Badakshan were estimated to die of maternal causes; by 2011 this proportion decreased to 1 in 19. The proportion of deaths due to maternal causes in Badakshan fell from 65% in 2002 to 42% in 2011.

Comparison of changes in maternal mortality across study districts suggests that despite noteworthy improvements, substantial disparities between urban and rural areas persist and more must be done to reduce maternal mortality in all areas of the country. Qualitative findings further illustrate the disparities in access and quality of maternal health care across Afghanistan, and need for particular attention maternal health needs in remote and insecure areas. Greater focus on inequities within the Afghan population is imperative to continue to achieve global goals for maternal mortality prevention.

While great strides have been made to increase the maternal health workforce through midwifery education programs and to introduce innovative models for increasing the reach of health services in remote areas of Afghanistan, there is a need for critical review of the contexts where maternal health has and has not improved and for reconsideration of how best meet the needs of the women in these areas.

The evidence of the declines and the program inputs considered to have contributed to this are being used by the MoPH and may provide information for other countries struggling with very high death rates, and in complex settings. However, greater focus on inequities is necessary in Afghanistan and elsewhere.

The results of this study have been submitted to the Lancet Global Health and an additional paper focusing on the child mortality results and costs for health care services is being prepared for submission to another high impact journal.

Capacity Building Activities Numerous Afghans, primarily women were trained in quantitative and qualitative data collection methods and logistics.

Systematic Documentation of Community-oriented Approaches to Improve Recognition of and Appropriate Care Seeking for Newborn and/or Maternal Complications in Sarlahi District, Nepal

Study Overview: Skilled and timely care before, during and after childbirth can save the lives of women and newborn babies from preventable and treatable causes. There are many real and perceived barriers to accessing care, particularly for women in rural areas of low-income countries. Delays in receiving appropriate care can be important for many conditions, but delays of even a few hours in addressing an obstetrical emergency around the time of birth or the onset of sepsis in a neonate can be significant. In rural Nepal, reasons for low usage of free maternal and newborn health facilities remains unclear, and persist despite health policy and programs that have aimed to remove financial and access- to- care barriers to services at primary health care facilities. Understanding care seeking practices and what drives decisions (both facilitators and barriers) at family and at community levels for maternal and newborn complications is crucial. This study aims to assess how women and caretakers identify maternal/newborn complications and the factors behind decision-

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making to seek care, along with an assessment of the quality of maternal and newborn care received at birthing centers and its influence on care seeking behavior and practices in rural Nepal.

The study is currently ongoing and is being conducted at an existing study site in the Sarlahi district of Nepal. The district is located in the central terai and is a predominantly rural area with a population density of 1,900 people per square mile. The Nepal Nutrition Intervention Project – Sarlahi (NNIPS) project has been conducting research in the area since 1989. The NNIPS study site is active in 34 of the village development committees (VDCs) in the district (about 1/3 of the district) and has extensive information about the households in these VDCs. A mix-methods approach is used and the study is nested within an ongoing large community randomized trial on newborn oil massage comparing sunflower seed oil and mustard oil. The following three data collection methods are used:

1. Collection of 32 qualitative rendering of an illness event (complicated maternal and newborn events and few maternal and newborn deaths) by those who had the illness along with those who witnessed the event through in-depth interviews and small group interviews.

2. Collection of quantitative data on recognition of danger signs and decision to seek care through survey questionnaire among approximately 5000 pregnant women enrolled in an ongoing newborn oil massage parent trial.

3. Collection of quantitative data on the quality of maternal and newborn care provided in the 24 birthing centers in the study district through health facility audit to determine the availability of trained staff, equipment and supplies and through health worker interviews to assess their knowledge and training.

Partners:Nepal Nutrition Intervention Project – Sarlahi (NNIPS)

Main Findings and Implications: The data collection is ongoing and hence the key findings will be published once data is analyzed. The information we gain from the qualitative interviews and quantitative survey will help us understand the care seeking process for ill mothers and babies, which could help inform areas of improvement in early recognition and proper care seeking practices for maternal and newborn complications for future pregnant woman and babies in the community. The study findings may also help inform the government on delays in seeking care for serious illness in mothers and newborn babies and areas that need to be addressed in order to improve access and utilization of maternal and newborn care services in rural Nepal.

The information we gain from the health worker interviews will help to understand the health workers’ training, experience and knowledge on maternal and newborn health care. The health facility audit will also indicate the existing facilities available in these birthing centers and areas of improvement in order to provide better quality of care. The study findings may help inform the government on gaps and areas of improvement in health worker skillset and knowledge and health facility infrastructure/equipment for better quality care in birthing centers in rural Nepal.

Post-HRCI PlansThe data collection for all three components of the study has been completed and the quantitative data cleaning and qualitative data translations is underway. Data analysis, synthesis and reporting writing will occur post 9/30/2016. It is anticipated that a final report to USAID and dissemination of the research findings will occur in early 2017.

RESEARCH IN AFRICA

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One of the largest efforts under HRCI was an ongoing collaboration that was developed with The Muhimbili University of Health and Allied Science (MUHAS) in Tanzania. This work including the evaluation of an integrated maternal and newborn health care program in the Morogoro Region as well as support of the MOHSW and the newly created CHW task force in the scale-up of a national CHW cadre, along with associated research. Another large effort, a verbal and social autopsy (VASA) study in Nigeria was co-funded with the Child Health Epidemiology Reference Group (CHERG). Additional research included 2 studies in Zambia: 1) Care and treatment of severe pneumonia in HIV-exposed and infected Children and 2) Development and testing of evidence-based mental health treatment for affected youth; a nutrition study in Zimbabwe and planning activities for confronting the burden of child injury in Ethiopia.

Monitoring, Documentation and Evaluation of an Integrated Maternal and Newborn Health Care Program in Morogoro Region, Tanzania

Study Overview: The goal of the Morogoro Evaluation Project (MEP) was to significantly improve maternal, newborn and child health outcomes in Tanzania by identifying optimal strategies for integration of maternal newborn and child health interventions with attention to both HIV positive and negative mothers and infants and implementation and sustained delivery through evidence-based, cost-effective, culturally acceptable strategies. The MEP accomplished this through monitoring, evaluation, and documentation of the implementation processes and outcomes of the integrated MNCH intervention package in Morogoro Region, Tanzania and providing timely feedback on access, coverage, quality, and continuity of essential MNCH interventions to partners including the Ministry of Health and Social Welfare and Jhpiego/Tanzania. A step wise evaluation framework was used to attain this goal.

During the first year of the evaluation (2011-2012), JHSPH and MUHAS team conducted baseline assessments of the coverage of maternal, newborn, and child health services in Morogoro, Tanzania and examined a number of contextual factors. Data were collected through a survey of 1,900 recently-delivered women (RDWs), a survey of existing community health workers, and qualitative interviews with recently delivered women (RDW), family members, community leaders, and community health workers (CHWs). Primary objectives of the survey were to assess baseline MNCH care utilization among RDW, the capacity for and quality of maternal and newborn services at the community and in the facility, and the barriers for accessing health care services.

During Year 2 (2012-2013), the evaluation team focused on the facility level interventions to assess the facility preparedness, level on integration of MNCH/HIV care and quality and continuity of care through collection of qualitative and quantitative data in 18 Morogoro facilities. Of these facilities, 9 received training in the integrated program while the remaining 9 facilities did not received the intervention. Specifically, PNC services were assessed through observations of PNC service delivery, exit interviews with clients, and provider interviews.

In 2013 the MOHSW and Jhpiego rolled out the integrated program at the community level in Morogoro. The evaluation for Year 3 (2013-2014) focused on assessing CHW program implementation, including costs, strengths and limitations of the current model of health promotion and counseling by CHWs, and community and program support systems for CHWs. The evaluation team used a mixed-methods approach to assess the community component through a quantitative survey of 228 CHWs, a time-motion assessment of 33 CHWs; in-depth interviews with CHWs, CHW supervisors, health committee members, and district and regional managers; and focus group discussions with CHWs, RDW, and home-based care providers.

Partners:The Muhimbili University of Health and Allied Science (MUHAS)Tanzanian Ministry of Health and Social Welfare (MoHSW) Jhpiego

Main Findings and Implications:

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The study identified many challenges notably, a weak community program which was based on community volunteers, inadequate quality of care in both facilities and at the community level, and a large dropout from the continuum of care. Given weak MNCH community program, improving quality and continuity of care were major challenges.

Based on the evaluation findings, findings of other studies and program learnings, Tanzania MOHSW decided to develop an integrated MNCH-HIV/AIDS community program which will utilize paid health workers. To this end, MOHSW developed a CHW Task Force, developed policy guidelines, curriculum for CHWs and started recruiting paid CHWs

Lessons Learned: Reasons to integrate interventions at point of delivery include:1. Impact - Adding interventions directed against one problem increases the impact on a second problem; 2. Quality and Continuity of Care– Integrated services can be more comprehensive, and seamless service

delivery can affect client perceptions of quality; 3. Efficiency – Integrated services can save time and money for both clients and service providers, and

eliminate the need to access multiple systems of care; and 4. Normalization - Integrating HIV care into routine services can decrease stigma associated with disease (if

done well).

Capacity Building Activities Throughout this evaluation, ongoing sharing of findings with MOHSW in Tanzania, Jhpiego, MUHAS, and other partners occurred. MUHAS and JHU organized annual dissemination workshops in Dar es Salaam which brought together over 100 professionals working in MNCH and HIV/AIDS to share learnings and jointly develop implementation strategies. Group work happened to identify issues, understand programmatic challenges related to implementation, and develop strategies to address the challenges. Some of these strategies were adapted by the Ministry of Health in the larger program.

A Learning Agenda for the Development of Community Based Programs in Tanzania: Towards the Development of a Community Health Worker (CHW) Cadre

Study Overview: The primary aim of this project was to support the Tanzanian Ministry of Health, Community Development, Gender, Elderly, & Children (MoHCDGEC) and it’s Task Force on Community Health Workers (Task Force) in their efforts to develop a national cadre of community health worker (CHW) program that will best serve the needs of people in the United Republic of Tanzania (Tanzania). A secondary aim is to collaborate with, and support, the MOHSW and its partner organizations implementing HIV programs in Tanzania, in their efforts to reduce dropouts from the continuum of care and scale up community-based programs. To achieve these aims, the following specific objectives were proposed:

1. Collect relevant information and develop a knowledge base on a variety of ongoing CHW programs to help MOHSW and its Task Force understand the current CHW programs landscape and develop a more harmonized, community-based approach to preventive and promotive care.

2. Analyze the loss to follow-up data collected by the National AIDS Control Program (NACP) in MOHSW and partner organizations supported by The President's Emergency Plan For AIDS Relief (PEPFAR) to examine the extent of, and reasons for, loss to follow-up with the view of developing integrated facility-community implementation strategies intended to improve retention of HIV-positive mothers and testing/treatment of children.

3. Provide evaluation and implementation research support to MOHSW and partner organizations to scale up their community-based programs in light of the findings by Objective 1 and 2.

The components of this study included: 1) Mapping of CHW programs in Tanzania, 2) Stakeholder analysis, 3) A discrete choice experiment, 4) Case Study of an innovative integrated CHW model, and 5) CHW Recruitment and Selection.

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Partners:The Muhimbili University of Health and Allied Science (MUHAS)Tanzanian Ministry of Health and Social Welfare (MoHSW)

Main Findings and Implications:

1) Mapping of CHW Programs in Tanzania The mapping exercise provided detail on the structure of CHW programs in Tanzania as well as an overview of

the diversity of training and CHW skills related to each program. The following are key lessons learned based on the results of the mapping exercise:

o Both males and females can effectively work at community level as CHWs. o Only 20 % of existing CHWs will satisfy age and education criteria for government service.o A large number of CHWs will have to be trained nationally as many villages do not have any CHWs

operating in communitieso There are more than 10 form-4 levers who are not currently employed available in each village

indicating that government will be able to find form-4 educated CHWs from each village in these regions though current data do not provide bifurcation of available form-4 levers on sex.

o More than three fourth of the CHWs have received training on MNCH, HIV/AIDS, Malaria, Nutrition and Family Planning. About 80% of existing CHWs are trained on more than 4 thematic areas hence do have basic knowledge on these topics and can be used by government as community educator and mobilizers to support selected CHWs.

o Majority of existing CHWs are working as health educators and providing information to community on their thematic area of work while less than 20% of CHWs are involved in service provision like FP and malaria.

o Majority of existing CHWs are working on voluntary basis (84.3%). The envisaged national cadre will require a minimum of form-4 education and will be trained on a

comprehensive package that includes health promotion, prevention, and selected curative components. In the future, the government would like to collect information on CHWs performance under the new integrated

scheme and using a modified data collection tool on periodic basis to capture information on new CHWs and building software under the HRIS to regularly monitor performance of new CHWS.

The MoHSW should mandate different partners and donors to follow the government criteria for selection of new CHWs in areas where CHWs under the government scheme are not yet available. MoHSW should mandate the partners to use government CHWs to implement their programs by providing additional training rather than building parallel systems of CHWs.

It is important to build up the training curriculum with material based on country disease burden and health priorities for the training of newly recruited CHWs and ensure that all selected CHW candidates complete the training before deployment at village level.

A standard equipment and instrument set should be determined along with necessary logistics and commodities for new CHWs based on their job roles and responsibilities and establish effective logistic supply systems for replenishment of these logistics and commodities at regular basis.

2) Stakeholder Analysis A stakeholder analysis (SA) was conducted to help the Ministry and the CHW Task Force, USAID and other

funders, implementing partners, and civil society organizations (CSO) understand the perspectives of the key stakeholders on existing CHW services and development of a national CHW cadre. The analysis identified key actors in CHW services in Tanzania and delineated prospects for policy and programmatic change. This analysis helped to define stakeholder engagement, power dynamics within and between stakeholders, and facilitative strategies and prohibitive barriers to change in what and how CBHC services are delivered, financed and regulated.

The analysis concluded that there is need to raise greater awareness among stakeholders of the vision and specific policy plans of the Ministry with regard to a national CHW cadre.

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The MUHAS-JHU team recommended that the Ministry should:o 1) Increase avenues for greater stakeholder engagement by coordinating with donors and other

stakeholders in policy development and implementation; o 2) Launch and update a website on national CHW policy developments; o 3) Ensure the participation of different partners in an effort to stimulate a plan for transitioning existing

trained CHWs into the formalized national cadre; and o 4) Work with donors and development partners to operationalize the training and deployment of CHWs.

3) Discrete Choice Experiments Discrete choice experiments (DCE) were conducted on CHWs and community governing structures to provide an

understanding of their preferences. The DCE involved key individuals such as patients, clients, health workers, and structures such as village health committees, local government authorities, health management teams and NGOs. Preferences were stated in regard to hypothetical alternative scenarios or sets of services. The answers were used to assess whether preferences are significantly influenced by the specific attribute, and to assess their relative importance. This was expected to allow planners and decision-makers to better consider the desirability and potential feasibility of different program design options.

The findings from the CHW DCE led to the following recommendations:o Prospective CHWs should be selected by community governing structures and should be trained on a

comprehensive package of health services.o Trained CHWs should be paid a fixed and recurring wage.o The Ministry should establish a clear accountability system that targets supervisory mechanisms at both

the health facility level and local governing structures. The analysis of the DCE results also identified preferences for how to design governance of CBHC programs and

the relative importance of different attributes.

4) Case Study of Integrated HIV-MNCH CHW Model The overall aim of this case study was to characterize the implications of establishing an integrated HIV-MNCH

CHW program. Specifically, the MUHAS-JHU team conducted a sequential mixed methods case study of an existing home-based care (HBC) CHW program that provided services such as HIV treatment adherence counseling and support and follow up tracking after missed appointments. The program subsequently trained about two thirds of the existing HBC providers on the Ministry’s approved 3-week MNCH curriculum, thereby establishing an integrated HBC-MNCH CHW model.

The case study explored the perspectives of community level implementation actors on acceptance, adoption, and feasibility of the integrated HBC-MNCH model and examined whether the integrated HBC-MNCH model resulted in any change in the number and type of household-level visits conducted by CHWs and changes in facility utilization before and after role expansion to integrate HIV and MNCH activities at the community level.

The study used in-depth interviews, monthly summary data on HIV, monthly summary data on MNCH, HBC demographic data and quarterly ART reports and routinely collected facility-based MNCH data to answer the research questions. Information obtained from this innovative CHW programmatic model is expected to provide evidence to inform the decision making organs of the Ministry during the rollout of the national cadres.

Preliminary qualitative findings with regard to role expansion from HIV to MNCH suggest: o Task prioritization: Most HBC-MNCH CHWs and their supervisors stated they did not prioritize either HIV

or MNCH tasks – they felt both services were equally important to provide to the community members. However, some HBC-MNCH CHWs expressed a clear prioritization of MNCH services, either to create attention and awareness among community members that a new service related to MNCH was available, they viewed MNCH as more important to provide to the community given the frequent occurrence of maternal deaths, and/or they realized there was “nothing new” with regard to HIV service provision as they have been providing those services for years.

o Balancing two scopes of work: Many CHWs spoke of a devising a timetable whereby they devoted one to two days per week to HIV services and two to three days per week to MNCH services. Of note, the CHW’s mental model of organizing service delivery suggests early-on they may have compartmentalized

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HIV and MNCH tasks, rather than integrating them. Further analysis of the qualitative data will explore this theme in greater detail, but the structure of the program design with two separate HIV and MNCH facility-based supervisors may have contributed to CHW mental models of siloed service delivery.

o Expanded workloads: The majority of HBC-MNCH CHWs enjoyed working across both HIV and MNCH domains. However, some HBC-MNCH CHWs stated a specific preference to focus on just one scope of practice, either HIV or MNCH, in large part because the workload was too heavy to manage both sets of services. In addition to the qualitative findings, analysis of the quantitative data will help understand whether the HBCs were actually able to balance the HIV and MNCH workloads.

Quantitative data is currently being analyzed; therefore, recommendations are pending the final analysis and interpretation based on assessing both qualitative and quantitative findings. Full results and recommendations will be shared with the Ministry and stakeholders as soon as available.

5) CHW Recruitment & Selection CHW-LAP provided implementation research support to the Ministry for the recruitment and selection phases of

the CHW trainees for the CBHP. The main objective was to describe CHW recruitment and selection processes in two regions (Simiyu and Morogoro) of Tanzania in order to identify strengths, gaps and challenges faced by the implementers as well as the potential trainees and to assess adherence to guidelines issued by the Ministry. These findings will support refinement of future CHW recruitment and selection processes for the national rollout in Tanzania.

Various stakeholders, including applicants for the CHW training positions, local government authorities and Council Health Management Team (CHMT) members, were surveyed about the CHW recruitment and selection processes in their locality.

Findings showed a high level of awareness about the CBHP among stakeholders in both regions. Different communication channels were used to inform the communities about the program. Applicants followed different application processes to apply for the training. Lack of internet services and low computer literacy were the main bottlenecks during the application process. Involvement of LGAs in recruitment and selection of applicants was limited particularly in Morogoro region.

Key recommendations emerging from the Implementation research findings included:o The Ministry and LGAs should continue with their efforts to disseminate information about CBHP to the

general population and eligible candidates. They should revise the guidelines to specify criteria to be used by LGAs to recommend applicants for CHW selection.

o Ministry should continue to support implementation research in the various components of the CHW program to allow early program adjustments.

Capacity Building ActivitiesThe entire project may be viewed as a capacity building project. The team supported the MoHCDGEC to create a CHW task force in Tanzania. Researchers helped to do the initial formative research and landscaping for the project, sharing information to inform the task force. These findings were used in the design of the CHW program. The team also facilitated the development of the curriculum and training materials for the CHW cadre. Now with the MoHCDGEC and MUHAS implementation research and case studies are being conducted in support of extending their program.

Post-HRCI PlansDuring the project life time we learned about the existing CHW programs and managed to generate information to support the Ministry in developing the new multipurpose CHW cadre. However the work of CHW-LAP remains unfinished since the CBHP is still in its early phases of implementation. The first class of CHW trainees will graduate in November 2016. The next CHW recruitment phase is already underway and their training will need to be assessed for quality, content and the skills acquired. Deployment dynamics of the graduating classes need thorough assessment to determine the proportions returning to their original villages, how they fit into communities, who will be their employers etc. Therefore, it is hoped that implementation research to assist the Ministry will continue in order to ensure that: 1) The training institutions have adequate capacity to undertake the proposed training, 2) The training is taking place according to the curriculum and facilitator guides, 3) Student welfare is being addressed, and 4) The deployment

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process is monitored so that qualifying graduates return to their communities to serve them and that they are well remunerated by the district councils.

A Verbal/Social Autopsy Study to Improve Estimates of the Causes and Determinants of Neonatal and Child Mortality in Nigeria

Study Overview: The Nigeria Verbal/Social Autopsy (VASA) study was a national study of the causes and determinants of neonatal (0-27 days) and child (1-59 months) deaths in Nigeria. The study conducted a VASA interview of a random sample of one under-five death per household of all under-five deaths in the prior five years identified by the 2013 Nigeria Demographic and Health Survey (DHS). Field workers who had served as DHS interviewers were trained (TOI) by trainers from the study partners who in turn had been trained (TOT) and were then assisted during the TOI by the JHU investigators. The field work was conducted over a 2-month period, resulting in 2,944 interviews conducted of the 3,254 attempted. Of the 2,944, 164 were determined by the VASA interview to be stillbirths, yielding a total of 723 and 2,057 interviews of, respectively, neonatal and child deaths. The JHU investigators conducted the first round of data analysis, shared these findings with the study partners, and then held a data analysis workshop in Baltimore with the partners to conduct additional analyzes, interpret the findings, draw preliminary conclusions and recommendations, and draft the study report. A second workshop was held in Nigeria to strengthen the Ministry of Health’s participation in drawing the study’s conclusions and recommendations, following which a national dissemination meeting was held under the leadership of the study partners. Following the dissemination meeting, a consensus meeting was held with the Ministry of Health, National Bureau of Statistics, National Population Commission, USAID, WHO, UNICEF and other stakeholders to reach consensus of which data should be considered Nigeria’s official data on the causes of neonatal and child death.

Partners:Nigeria National Population Commission (NPC)Ministry of Health and Social Welfare (MOH)National Bureau of Statistics (NBS)

Main Findings and Implications: The study findings show that there is low coverage of key interventions along the continuum of care and that

progress needs to be accelerated to increase coverage of interventions and service delivery channels. More than two-thirds of women who recognized they had a labor/delivery complication (the most important

risk factor for neonatal mortality) that started at home did not seek formal care, so it will be important to prioritize and promote good recognition and early care seeking for the most common labor/delivery complications.

Nearly two-thirds of caregivers of deceased newborns did not seek care for the fatal neonatal illnesses (primarily birth asphyxia and severe infection). Therefore, it is recommended to implement maternal care by midwives and neonatal care by CHEWs and possibly by JCHEWs within the community for effective and timely intervention.

A high proportion of deaths among 1-59 month old children are caused by malaria, pneumonia and diarrhea. The government should make an effort to increase awareness of community based management of uncomplicated malaria, pneumonia and diarrhea and the need for prompt and facilitated referral from the community to health facilities for complicated cases. Specifically, CHEWs could be trained in assessment, management and referral of children with malaria, pneumonia and diarrhea.

Inaccessibility to health facilities for maternal and child care is a large issue. The main constraints to care-seeking are the lack of transportation, distance, and the costs for transport and care at the health facilities. Measures to overcome the constraints may include: a) implementing universal health insurance and/or free health care services for children under age 5 years, b) advocating and campaigning at the community level to sensitize and create awareness of the community based health insurance schemes for maternal, neonatal and

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child health services, and c) taking inter-sectoral action to improve the availability and accessibility of public transportation.

More than 80% of deceased neonates and children that reached and left the first health care provider alive in the community and at health facilities were not referred. However, of those that were referred, the caregivers of half of the referred neonates and 84% of the referred children accepted the referral. This indicates that referral systems need to be strengthened. The VASA study did not identify what actions are needed to strengthen the referral system, therefore, a study should be conducted of community-level providers (CHEWs and JCHEWs) and at first-level facilities to examine the referral rates of severely ill neonates and children and possible associated factors, including conducting exit interviews of caregivers.

Capacity Building Activities A two-week Training of Trainers was conducted in Abuja, Nigeria. This included participants from NPC, MOH and NBS who were trained to train interviewers and supervisors for the VASA study. Also, a two week VASA data analysis workshop was conducted in Baltimore. This workshop included participants from NPC and MOH and provided assistance with conducting analysis and interpreting findings from the study.

Post-HRCI PlansA paper writing workshop with the participation of the JHU investigators, national (NPC and MOH) and international (USAID) study partners took place on August 29-September 2 in London, UK. Tables and figures of five selected papers (list below) were examined, discussed and refined by the group. Outlines and working drafts of the text were substantially produced for the selected papers. Following the workshop, the draft papers are being worked on by lead authors and the group aims to complete and submit to one or more international peer-reviewed journals by the end of 2016.

The list of selected papers for the workshop is below: 1. Knowing the number but neglecting the cause; Direct estimates of cause-specific proportions of under-five

deaths in the Northern and Southern regions of Nigeria by verbal autopsy.2. How fast did newborns die in Nigeria from 2009-2013- A time from birth-to-death analysis using Verbal /

Social Autopsy data3. Case-control study with propensity score matching to assess differentials in MNCH indicators of deceased

and living newborns in Nigeria.4. Social Autopsy study identifies the determinants of neonatal mortality in (the Northern and Southern

regions of) Nigeria.5. Social Autopsy study identifies the determinants of young child mortality in (the Northern and Southern

regions of) Nigeria.

Additional papers/titles have been discussed during the workshop. The group decided to further work on developing these manuscripts during the first quarter of 2017, with tentative submission to journals by June 2017.

1. How fast did 1-59 months old die in Nigeria from 2009-2013- A time from birth-to-death analysis using Verbal / Social Autopsy data

2. Case-control study with propensity score matching to assess differentials in child health indicators of deceased and living children in Nigeria

3. Modelling fatal illness duration (from illness onset to death) among neonatal deaths using the 2014 Nigerian Verbal and Social Autopsy data

4. Modelling fatal illness duration (from illness onset to death) among children 1-59 months old deaths using the 2014 Nigerian Verbal and Social Autopsy data

5. Care seeking competing event history analysis for neonatal deaths in Nigeria 2009-20136. Care seeking competing event history children 1-59 months old deaths in Nigeria 2009-20137. Verbal and Social Autopsy Study in Nigeria: A policy paper from the perspective of an International Partner

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We are planning to release the Nigeria VASA data to the public on the USAID website (https://www.usaid.gov/data) and the JHU-IIP website as soon as the first five papers (that resulted from discussions at the workshop above mentioned) are published..

The Care and Treatment of Severe Pneumonia in HIV-exposed and Infected Children in Zambia

Study Overview: Pneumonia is the leading infectious cause of death in children. HIV-exposed and infected children are particularly susceptible to pneumonia but little information exists on the likelihood of and risk factors for mortality among hospitalized children with pneumonia. To address the gaps in knowledge, this study, nested within the Pneumonia Etiology Research for Child Health (PERCH) project, is evaluating treatment outcomes for severe and very severe pneumonia among hospitalized children enrolled at the site in Lusaka, Zambia. The PERCH project is a multi-center, case-control study conducted in seven countries to determine the etiology of severe and very severe pneumonia among hospitalized children younger than five years of age.

This PERCH Zambia study was conducted at the University Teaching Hospital in Lusaka, Zambia from October 2011 to March 2014 among children one month to five years of age with severe pneumonia. Preliminary data from the PERCH site in Zambia indicated that there was little standardization of care of pneumonia in hospitalized children. To standardize and improve the care and management of these children, this sub-study developed, implemented, and evaluated a clinical guidance tool based on the WHO recommendations, including best practices specific to HIV-infected and exposed children. In March 2013, a clinical guidance tool was implemented to standardize and improve care. In-hospital mortality pre- and post-implementation was compared. In total, 443 children were enrolled in the pre-intervention period and 250 in the post-intervention period

Partners:Boston UniversityZambia Center for Applied Health Research and Development (ZCAHRD)University of Zambia, School of Medicine

Main Findings and Implications: Overall, 18.2% of children died during hospitalization, with 44% of deaths occurring within the first 24 hours

after admission. Mortality was associated with HIV infection status, pneumonia severity, and weight-for-height z-score. Despite improving and standardizing the care received, the clinical guidance tool did not significantly reduce

mortality (relative risk: 0.89; 95% CI: 0.65, 1.23). This is in part because almost half of the deaths occurred within 24 hours of hospitalization, too early for the tool to have an impact.

The tool appeared to be more effective among HIV-exposed but uninfected children and children younger than 6 months of age.

The clinical guidance tool was well-accepted by clinical and study staff, easy to use, and succeeded in standardizing and improving care. Further research is needed to determine if similar interventions can improve treatment outcomes and should be implemented on a larger scale.

Efforts to educate new mothers on the signs and symptoms of pneumonia and to improve the referral system may improve care seeking behaviors and ultimately outcomes. Further research is needed on the feasibility of implementing the clinical guidance tool in routine clinical practice, outside a study setting.

Development and Testing of Evidence-based Mental Health Treatment for Affected Youth – Zambia

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Study Overview: Trauma has been identified as a major issue that affects children and adolescents in Lusaka, Zambia. Trauma and its related symptoms impact a child’s ability to function, increases the likelihood of problems in adulthood, and may lead to an increase in HIV risk behaviors. Our objective was to test the effectiveness of a mental health treatment that addresses trauma and its related symptoms in children and adolescents.

A two-arm randomized controlled trial of Trauma Focused Cognitive Behavioral Therapy (TFCBT) was conducted in five community settings in Lusaka, Zambia. Children between the ages of 5 and 18 years who experienced at least one traumatic event and reported significant symptoms (score of 38 or above on the PTSD-RI) were enrolled from five community sites and randomized to TF-CBT or a treatment as usual (TAU) control condition. Post assessments were completed 4 to 5 months following baseline assessment. Outcomes were measured using locally adapted and validated versions of the Post Traumatic Stress Disorder Reaction Index (PTSD-RI) and a locally developed function scale. Secondary outcomes included HIV risk behaviors and parental report on child’s symptoms and functioning.

Children randomized to the treatment arm received 10-16 weekly sessions of TF-CBT. TF-CBT is an evidence-based treatment developed in the U.S. for use with children and adolescents between the ages of 5 and18 who have experienced a traumatic event and subsequent symptoms. The treatment has previously been adapted for use in Zambia by our team.

Partners:Serenity Harm Reduction Programme, Zambia (SHARPZ)Zambia Ministry of Health

Main Findings and Implications: Baseline assessments were completed by 298 children and adolescents. All participants who were eligible

(n=257) agreed to participate in the trial. Of the 257, 131 were randomly assigned to TF-CBT and 126 to the control group. There was a statistically significantly larger decrease from baseline to post-assessment in average trauma score (p<.0001) and average functioning impairment score (p<.0001) among the TF-CBT group compared to the wait-list control group. The effect size, calculated using Cohen’s d statistic, was 2.41 for trauma symptoms and 0.32 for functional impairment.

TF-CBT was officially put into the country’s recommended treatment policy. TF-CBT has shown to be an effective treatment for trauma symptomtology in children and adolescents, as

delivered by lay counselors who are under supervision. The high interest from control cases suggests that there is acceptability and interest within the community. The challenges and lessons learned are largely focused on implementation constructs. Overall, given the effectiveness of TF-CBT, we recommend that it be scaled-up and integrated into services. Zambia would benefit from future evaluations on implementation variables such as who are the providers best served to deliver TF-CBT, what infrastructures could integrate TF-CBT, and the sustainability within different delivery systems.

It is also recommended that stakeholders such as the Ministry of Health and funders operating in Zambia consider supporting or encouraging the use of TF-CBT over non-evaluated programs commonly used for orphans and vulnerable children (OVC). If there is a program of interest or one believed to be effective, it would be beneficial to compare it to TF-CBT to better understand for whom, when, and how these treatments potentially help various populations.

In an effort to move from research-to-use, one specific recommendation is that Zambia should train a wider number of providers as studies are showing that most individuals do not have full time hours to dedicate to providing mental health treatment. These providers could be across a number of infrastructures to best capture children and families who may be in need. We believe counselors are well placed in schools, but would also recommend that services be provided within the school year and account for holiday leave time as this was one of our challenges. It is the current recommendation of agencies like the WHO to integrate mental health care into primary care settings. We believe this is another location where counselors would be valuable. It will be

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important to carefully examine how implementation in these settings would work due to challenges around having counselor time and space at the clinics.

Another recommendation for Zambia is to evaluate how to grow locally based TF-CBT trainers to help with the ongoing training and sustainability over time of these services. Since the process to develop trainers in such an evidence-based treatment has not been determined, it is recommended that Zambia undertake this with a strong Monitoring and Evaluation component to assure the fidelity, effectiveness and acceptability remain intact.

An additional lesson learned was that TF-CBT was effectively integrated into a variety of settings that were all able to serve families and children effectively despite some implementation challenges (e.g., time, space). Parental participation may be challenging with an OVC population given the demands on caregivers and multiple children so treatments should be flexible with their involvement and offer options. It was critical that TF-CBT was a treatment that is effective despite limited caregiver involvement. The greatest lesson learned is that many of those trained have other duties and so it is important to consider in who one trains, and make plans with organizations about how much time could be dedicated to mental health provision.

Capacity Building Activities 11 SHARPZ staff members (including data entry specialists, assessors, and M&E officers) in Zambia were trained

in: 1) education on mental health and trauma, 2) information and practice on child and youth interviewing skills, 3) a close review of study assessment tools and how to administer them, 4) appropriate administration of assessment measures and informed consent 5) training on how to handle high risk cases, such as suicide, 6) research ethics and 7) detailed information about the study design, implementation, monitoring and evaluation plan, and 8) appropriate procedures for data collection and management.

20 lay counselors were trained in TF-CBT. Training and supervision of the counselors was based on the apprenticeship model developed by Dr. Murray and colleagues. Training occurred during a two-week live training led by US-based expert trainers. The training was multi-faceted and covered the following topics: 1) an outline of the implementation plan of the study, 2) a background of evidenced based treatments for traumatized children and trauma and related mental health symptoms, 3) a complete overview of ethical issues and responsibilities, 4) an in-depth protocol on handling of high risk cases including protocol for suicidal/homicidal ideation, 5) training and practice on the eight components of TF-CBT which include Psycho-education, Relaxation, Affective Modulation, Cognitive Processing, Trauma Narrative, Cognitive Reprocessing, Co-joint Session and Enhancing Skills, and 6) a review of cultural issues including how to integrate HIV education and HIV risk prevention into each component. The training was done through a variety of methods including didactic explanations, demonstration role-plays and small-group role-plays.

Post-HRCI PlansAll primary study activities have been completed. One additional manuscript based on data collected from the study is in preparation and should be published by the end of 2016.

Sanitation Hygiene Infant Nutrition Efficacy (SHINE) Sub-study – Zimbabwe

Study Overview: Aflatoxins are toxic secondary metabolites of Aspergillus species that contaminate staple foods such as maize and groundnuts. Aflatoxin exposure during pregnancy has been associated with poor birth outcomes in limited scale surveys in Sub-Saharan Africa. The Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial, is a large cluster-randomized community-based trial in Zimbabwe investigating the effects of a nutrition and hygiene intervention on early child growth. HRCI supported a sub-study within the larger SHINE trial to characterize pregnancy exposure to multiple mycotoxins and its relation to birth outcomes in SHINE. The over-arching hypothesis is that AF exposure, alone or in combination with FUM and DON, is an important cause of adverse birth outcomes globally.

The specific aims of the study were as follows:

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To describe the prevalence and severity of multiple mycotoxin exposures in a large representative sample of pregnant women in rural Zimbabwe.

To characterize the relationship between maternal serum aflatoxin-albumin concentration during pregnancy and adverse birth outcomes preterm birth, low birth weight (LBW), small-for-gestational age (SGA) and short-for-gestational age in HIV-negative mothers. Pregnancy loss will also be explored as an outcome variable, but with less robust statistical power.

To explore the joint exposures of FUM, DON and AF in relation to risk of preterm birth.

The study utilized a prospective cohort design to capture the relationship between AF exposure and multiple adverse birth outcomes, namely miscarriage, stillbirth, preterm birth, low birthweight and poor fetal growth (measured as small-for-gestational age (SGA) and short-for-gestational age (short-for-GA)). A nested case-control study was also conducted focusing specifically on preterm birth to explore the hypothesis that co-exposure to FUM and DON interacts with the effects of AF to increase the probability of preterm birth.

This sub-study will generate novel knowledge about the burden of multiple mycotoxins (AF, FUM, DON) during pregnancy and the potential contribution of mycotoxin exposure to adverse birth outcomes. The long-term goal is to understand the effect of mycotoxin exposure on maternal and child health in Zimbabwe and by doing so, to inform the development of more effective child health interventions and food safety policy globally.

Partners:Zvitambo Institute for Maternal and Child Health ResearchZimbabwe Food and Nutrition CouncilZimbabwe Ministry of Health and ChildcareCornell UniversityUniversity of MarylandUniversity of Muenster

Main Findings and Implications: AFM1 was detected in 30% of samples (median of exposed, 162.5 pg AFM1/mg creatinine; range 30-6046 pg

AFM1/mg). In multivariable ordinal logistic models, geographical location (p<0.001), seasonality (p<0.001) and dietary practices (p= 0.011) were significant predictors of urinary AFM1.

We hypothesize that one mechanism by which aflatoxin exposure during pregnancy could lead to adverse birth outcomes may be through aflatoxin-induced immunomodulation and enteropathy leading to systemic inflammation. There were significant differences across quartiles of aflatoxin exposure for CRP, but not for other demographic variables or other biomarkers. Fractional polynomial analysis revealed potentially non-linear relationships between aflatoxin exposure and CRP and stool AAT but not for plasma AAT nor fecal myeloperoxidase, indicating that aflatoxin may be associated with certain pathways to systemic and mucosal inflammation in a dose-dependent fashion.

This is the largest aflatoxin biomarker survey conducted in Zimbabwe, and has demonstrated frequent exposure in pregnant women with clear temporal and spatial variability in aflatoxin biomarker levels. Such data will support our understanding of critical developmental periods during pregnancy.

These results suggest that aflatoxin exposure may contribute to the complex milieu of inflammation during pregnancy. Given the high prevalence of aflatoxin exposure and inflammation and the potential negative impacts during the critical period of pregnancy, future research in the context of adverse birth outcomes is warranted.

The preliminary study results have been shared with the Ministry of Health and Childcare in Zimbabwe and have spurred discussion over implications for food safety policy. These results suggest that it is critical to incorporate considerations of aflatoxin-prone foods and conditions favoring aflatoxin accumulation into food security programs and public health policy to adequately address the nutritional food safety and security of rural populations, particularly pregnant women and children.

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Capacity Building Activities This study has built capacity to measure exposure to aflatoxin in Harare, Zimbabwe at the Zvitambo laboratory. In addition, through the course of the study investigators built collaborations with research groups at the University of Muenster, JHU and University of Maryland to enhance global capacity to measure exposure to multiple mycotoxins in humans.

Post-HRCI PlansAdditional funding was secured from NIH to continue this study. There are plans to complete measurement of mycotoxins in serum and urine in 2017. It is anticipated that full study results will be available by mid-2017.

Planning Activity for Confronting the Burden of Child Injury in Ethiopia

Study Overview: Ethiopia appears to have a high burden of injuries and child injuries with 68,948 total injury deaths in 2012, 13,002 of which were among children under 5 years and 9,267 among children 5-14 years old. Injury is a leading cause of death among children, with 16% of all deaths among the 5 – 14 year olds are due to injuries. Injuries account for more deaths than the vaccine preventable childhood-cluster diseases, including Pertussis, Diphtheria, Measles and Tetanus. (WHO, 2014)

It is therefore important for the health sector to pay attention to addressing the burden of injuries among children. This is consistent with the aim of holistic child health and child survival. An initial focus on children under five years old may leverage existing resources for child survival targeted to this age group.

This research was initiated in order to conduct a situation analysis and scoping study to assess: The current true burden of child injuries in Ethiopia Defining specific risk factors and the epidemiology of the burden especially for <5 years olds Understanding what is being done and by whom Defining the gaps for research and action

The objectives of this activity are to conduct an initial country assessment of the burden of child injuries in Ethiopia and to develop a proposal for the implementation of a child injury prevention package in Ethiopia. It is hoped that the collection of this evidence around child injuries will help to position injury higher on the national agenda for child health in Ethiopia.

Partners:Johns Hopkins International Injury Research UnitEthiopian Ministry of HealthAddis Ababa UniversityEthiopian Central Agency of StatisticsSt. Paul Hospital

Main Findings and Implications: The large burden of injury deaths among children in Ethiopia makes it important for stakeholders to pay

attention and take immediate actions to address the burden of injuries among children in Ethiopia. Stakeholder engagement is important to mobilize opinion and investments around child injuries in the country. Delivered outputs include a policy brief, Burden of Child Injuries report, and scientific paper on child injuries in

Ethiopia As a follow-up to the findings from the situation analysis, a national stakeholder conference on child injuries was

convened in Addis Ababa on September 6-7, 2016. The multi-stakeholder meeting was timely for raising awareness, creating a collective understanding of the magnitude of the problem, identifying knowledge gaps, and developing solutions by consensus.

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The meeting identified 3 packaged programs for large-scale implementation and research in Ethiopia:o 1) Home injury risk assessment and safety education in Ethiopia; o 2) An integrated home-school intervention package to prevent child road traffic injuries; and o 3) Comprehensive package of interventions for drowning prevention among under-five and school-age

children in Ethiopia Additional recommendations that emerged from the meeting include:

o Need to conduct both population-based and health facility-based studies and establish surveillance systems to describe the risk factors of child unintentional injuries in Ethiopia.

o Develop and test locally-based interventions that respond to specific risk factors particular to the Ethiopian context using multiple delivery platforms (including community level, school-based programs, and health facility-based programs).

o Integrate child injury prevention into broader FMOH comprehensive child health programs and strengthen the health system to address child injuries at the primary, secondary, and tertiary levels.

o Design and roll out a multi-sectoral child injury prevention policy and plan of action, involve key sectors including health, education, agriculture, transport, academia, and hospitals.

Post-HRCI PlanTo work with USAID and Ethiopian partners (including the Ministry of Health) to implement the meeting recommendations and conduct a large-scale implementation research study around identified package of interventions for child injuries

GLOBAL RESEARCH

Prior to the child injury work conducted in Ethiopia, the HRCI team from Johns Hopkins International Injury Research Unit, along with IIP and USAID organized a workshop on Child injuries in low and middle income countries (LMICs). Additionally, research was conducted to assess the impact of health interventions for non-communicable diseases and injuries in LMICs. Another global priority led by the HRCI team has involved further pushing the agenda for Implementation Research and Delivery Science (IRDS) through expert meetings, working groups and development of a Lancet Series. Finally, HRCI supported the publication of a journal supplement on Community-based Approaches to Improving Reproductive, Maternal, Neonatal and Child Health.

Child Injury Experts Meeting

Study Overview: On May 21 – 22, 2014, the United States Agency for International Development (USAID), the Johns Hopkins International Injury Research Unit (JH-IIRU) and the Institute of International Programs (IIP) jointly organized a workshop on “Child injuries in low and middle income countries” in Baltimore, MD, USA. The meeting was sponsored under the Health Research Challenge for Impact (HRCI) agreement between USAID and the Johns Hopkins Bloomberg School of Public Health. The overall goal of the workshop was to identify knowledge gaps in unintentional childhood injuries for five major injury mechanisms – road traffic injuries, drowning, burns, falls and poisoning – and to explore opportunities for addressing this burden. More than 40 child injury and child health experts from diverse disciplines, sectors and LMICs attended this workshop.

Partners:Johns Hopkins International Injury Research Unit

Main Findings and Implications: Five major themes emerged from the workshop around child injuries:

1. That interdisciplinary and inter-sectoral engagement are important;30

2. More information with higher quality on epidemiology and risk factors of child injuries in LMICs is still needed;

3. There is a need to define and engage in opportunities for conducting new studies on child injury prevention interventions in LMICs;

4. There is a need to start the process of defining and implementing a “package” of child injury interventions for LMICs; and

5. A “political map” for child injury prevention is needed. The workshop was successful in highlighting both the lack of knowledge and potential pathways for short- and

long-term investments in addressing the burden of child unintentional injuries in LMICs. Some of the recommendations that emerged from this meeting include steps to:

1. Promote engagement between child health and child injury groups so that they can learn from each other,

2. Develop new data sources to support the burden of diseases and the epidemiology of child injuries in LMICs,

3. Update the 2008 WHO/UNICEF World Report on Child Injuries Prevention,4. Conduct a systematic review on child injury and intervention effectiveness from LMICs,5. Develop and test a “package of interventions” for child injury in a few low and middle income countries 6. And conduct a global review of policies and plans for child injury prevention.

Assessing the Impact of Health Interventions for Non-communicable Diseases and Injuries in Low and Middle Income Countries: A user-friendly model

Study Overview: According to the Global Burden of Disease (GBD 2010 update) chronic diseases and injuries account for more than 75% of all deaths in the world. In May 2012, the World Health Assembly committed to a target of reducing premature deaths from non-communicable diseases (NCDs – including cardiovascular diseases, diabetes, cancer and chronic respiratory diseases) by 25% by 2025. USAID’s Bureau for Global Health acknowledged that the world’s epidemiology is constantly evolving and that noncommunicable diseases and injuries (NCDIs) now represent urgent and growing global public health and development concerns.

USAID commissioned Johns Hopkins under HRCI to build Excel-based analytical models to capture the burden of NCDIs and how the burden is affected by selected interventions in four low- and middle- income countries (Bangladesh, Cambodia, Guatemala and Kenya). The analytical model was designed to produce baseline estimates of the burden of disease of chronic conditions and injuries and subsequently, to forecast the changes in such burden with specific interventions over time under transparent and explicit assumptions. This tool will support domestic and international policy-makers attempting to improve the allocation of scarce resources and will provide them with the ability to understand alternative scenarios as they attempt to estimate the impact of interventions in order to maximize technical and allocative efficiency.

The conceptual model followed the WHO Global Monitoring Framework. The model was designed to be modular and allow the addition of new diseases and conditions to extend the scope of the model. The analytical models created are able to provide estimates of deaths and DALYs averted by interventions addressing tobacco taxation, diabetes education, seatbelt use and speed reduction in the four target countries. They also predict the changes in such burden over time under transparent and explicit assumptions.

Main Findings and Implications: Four excel-based tools were created (one for each intervention), based on the following criteria:

o The tool must be user-friendlyo The tool must be transparent on the calculations and its assumptions

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o The tool must allow policy-makers to modify the parameters and to input their own data, when available.

o The tool must allow policy-makers to explore different plausible scenarios.o The tool must produce ready-to-use graphic and table outputs.

Each of the tools provides policy-makers with the following measurable outcomes, where applicable:o Lives saved per year and average cost per life savedo Years of life saved per year and average cost per year of life savedo DALYs averted per year and average cost per DALY avertedo Sensitivity analysis with levels of uncertainty set by the policy-maker.o Graphic visualization of all outcomes.

The tobacco taxation tool was made to help policymakers estimate the effect of hypothetical tobacco tax changes on consumption and mortality in their countries.

The diabetes education model incorporates data at baseline from the targeted population as well as results from various studies to estimate the effect of different types of educational interventions on diabetes prevalence and mortality to help policymakers determine the best use of their funds.

The road safety model predicts the impact of interventions on two specific risk factors for road injuries: seatbelt enforcement and speed reduction.

This tool will improve the allocation of scarce resources and will provide them with the ability to understand alternative scenarios as they attempt to estimate the impact of interventions in order to maximize technical and allocative efficiency. The analytical model also allows the specification of alternative scenarios in order to give policy makers the chance to conduct sensitivity analyses.

Post-HRCI PlansA second phase for the project was proposed, but to date has not received funding support. Proposed additions in this phase include augmenting the model to include dynamic changes in population, changes in economic conditions, and additional behavioral adjustments in behavior as consequence of the selected interventions. It was also envisioned that a full comparative risk assessment methodology would be developed that assesses the multiple health impacts of risk factors and policy interventions. For instance, the use of cookstoves impacts both injuries and a full range of cardiovascular diseases. Additionally, the model could be expanded to include additional interventions. The analytical model would be translated from an Excel-based format to a web-based software to allow for broader use, easy and visual manipulation, and transparency. It would focus on the three key objectives of the WHO Global Monitoring Framework: Surveillance and Monitoring, Prevention and Management, based on the outcome, exposure and health systems targets agreed upon.

Implementation Research and Delivery Science (IRDS)

Study Overview: This work involved active participation in “The Collaboration for Implementation Research and Delivery Science” consisting of USAID, WHO’s Alliance for Health Policy and Systems Research (AHPSR), the World Bank, the TRACTION Project, and other stakeholders to support the development of IRDS. The JHU team has actively participated with the administrative team in a number of areas, including: 1) Jointly convening and facilitating meetings to build consensus about defining the field and key steps to be taken; 2) Supporting work on developing a Lancet Series, including authoring two of the papers; 3) Supporting the development of case studies and materials for promoting IRDS.

Implementation Research and Delivery Science Field Building - The convening activities included a set of structured and consultative international meetings which aimed to bring together different IRDS players to identify problems and opportunities related to IRDS, build consensus in describing the field, showcase useful examples and develop priorities for action. This series of meetings include: Developing and finalizing the Guide “Implementation Research in Health: A Practical Guide (Geneva, 2012); consultations on the priorities for statement on IRDS (Washington, April 2014 & Accra, July 2014); launch of the “Statement on Advancing

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Implementation Research and Delivery Science” at the Health Systems Global Conference (Cape Town, October 2014); and two Lancet series writing workshops (Washington, November, 2015 and Montreux April, 2016).

Lancet Series on IRDS - JHU led the conceptualization and negotiations to obtain a Lancet series on IRDS, and collaborated on facilitating the preparation meetings and the drafting of four papers.

Systematic Review of IRDS papers in LMICs (paper 4 in the Lancet series) - A systematic review of SCOPUS database was conducted to identify peer-reviewed literature on implementation research and delivery science (IRDS) in low- and middle-income countries (LMICs). The review covered the period of 1998-2014 and identified 7,066 records. Title and abstract screening were conducted to identify publications that were research or evaluations conducted in health or public health in an LMIC addressing an implementation issue. This screening reduced the number of records to 1,596, which were then abstracted for a number of relevant fields. Descriptive analyses were conducted along with an in-depth qualitative review of 17 articles identified as potential exemplars of IRDS publications. These findings have formed the basis for a paper being written for the upcoming Lancet series on IRDS.

Supporting the development of Case Studies and Materials for IRDS - This work was done through participation on the ad hoc inter-agency committee supporting IRDS, and by supporting a graduate student (Arielle Mancuso) to work at WHO Alliance for Health Policy and Systems Research (AHPSR) to help prepare case studies materials and protocols. Summary materials on IRDS have been produced through WHO, as well as case studies protocols, a call for case studies, and draft case studies on the application of IRDS. These will be curated at the WHO AHPSR website, and with presentations at the Vancouver Global Health Systems Symposium.

Partners:WHO’s Alliance for Health Policy and Systems Research (AHPSR)The World BankUSAID’s TRAction Project

Main Findings and Implications: IRDS field building activities led to The Cape Town Statement on Advancing Implementation and Delivery

Science: http://www.healthsystemsglobal.org/the-irds-statement/. They also produced two publications in collaboration with AHPSR which serve to define the field of implementation research and orient researchers to developments in this area of science. This also led to the development of the forthcoming Lancet series on IRDS and the development of case studies and symposium sessions at the Vancouver Global Health Systems Symposium.

The key messages of the Lancet Series on IRDS are: o IRDS offers the opportunity to improve people’s health and build responsive health systems. It does this

by generating timely evidence to take proven solutions to scale sustainably in different contexts. The value proposition of IRDS is the new opportunity to improve people’s health

o IRDS involves the use of a wide range of disciplines, scientific methods and principles to develop real-time solutions that are responsive to the problems of implementation of health policies, programs, and interventions; from testing their feasibility and acceptance to their coverage, equity, efficiency, scale, and sustainability. IRDS draws on diverse disciplines to solved implementation problems in real time

o IRDS is dependent on trusted partnerships and collaboration involving communities, researchers, implementers, and policymakers across the research cycle in the co-production and use of knowledge and evidence to strengthen implementation and improve outcomes. IRDS involves a collaborative approach and a central role for implementers

o IRDS offers new ways to stimulate organizational and systems changes by improving responsiveness to stakeholder needs. Embedding research within programs and health systems is one approach that can greatly facilitate change and improvement. IRDS embedded within programs can stimulate learning within organizations and be more responsive to stakeholders knowledge demands

o IRDS requires changes in organizational cultures and incentives’ structures in research/academic institutions, funding agencies, policymaking bodies, and community and implementing organizations. Successful IRDS requires culture changes and new incentives

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Key findings from the systematic review of IRDS papers in LMICs show:o Thirty-six percent of the 603 papers included for quantitative analysis were published in 2012; the

number of publications over a 17 years review period (between 1998 and 2014) increased significantly, by an average of 1.2 percentage point per year [95% CI (0.5, 1.9), p-value 0.003].

o The top 7 countries of origin for publication were India (n = 52), China (n = 42), South Africa (n = 42), Uganda (n = 32), Kenya (n= 24), Ethiopia (n = 22), and Ghana (n = 19).

o The main IRDS objective was evaluation of an intervention or strategy in subject areas around maternal, neonatal and child health; health systems; and HIV. Less than 5% of papers addressed other IRDS objectives (e.g. scale up, sustainability).

o Less than 30% of the studies were conducted under real world conditions. Few studies measured both internal and external contextual factors. Less than 10% of papers described measurement of changes in implementation variables. Only 25% of the papers included both an implementation variable and outcomes of intervention/program effectiveness.

o Research methods were evenly split among qualitative, quantitative, and mixed methods. Only 11 papers reported research designs suggested as suitable for IRDS, such as implementation-effectiveness trial. The qualitative assessment confirmed that contextual factors were only being partially reported, most studies did not document any deviations from planned protocol, and while IRDS studies were reporting who was conducting the implementation, this description only focused on the front-line implementers without describing the overarching institutions supporting activities.

Post-HRCI PlansThe Lancet Series is expected to be completed by the end of 2016. In connection with the HRCI led systematic review, there are plans to prepare an accessible database of IRDS research. The case study work, when complete, will be curated at the WHO AHPSR website. Presentations from this IRDS work are planned at the Vancouver Global Health Systems Symposium.

Community-based Approaches to Improving Reproductive, Maternal, Neonatal and Child Health Supplement Publication

Study Overview: In FY 2014, MCHIP provided a small amount of support to JHSPH to write a review of the MCHIP and Child Survival and Health Grants Program experience in community-based programming. As part of this work, a literature review of community-based approaches to improving reproductive, maternal, neonatal and child health was requested. Drafts of this review were completed at this time, led by JHSPH faculty member Henry Perry, along with Jim Ricca (MCSP) and Jean Sack (Jhpiego informationalist). This comprehensive RMNCH review covers broad findings from the literature, including literature reviews, meta-analyses, programmatic experiences (including approaches to community engagement and experiences with large-scale CHW programs) whose health outcomes are not necessarily assessed, and country-level experiences in improving community-based RMNCH. HRCI has provided funds to publish this review as a journal supplement, “Community-based Approaches to Improving Reproductive, Maternal, Neonatal and Child Health: A Review of the Evidence to Inform Sustainable Country-level Programming,” in The Journal of Health, Population and Nutrition.

Partners:Maternal and Child Survival Program (MCSP)

Main Findings and Implications: The journal supplement is expected to be finalized late 2016.

ADDITIONAL SUPPORT FOR ADMINISTRATIVE EFFORTS

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Finally, the HRCI Cooperative Agreement has a core administrative budget which is described briefly below.

HRCI Administrative Core The HRCI Administrative Core budget provided for the general management of the Cooperative Agreement, including salary for the Director, Deputy Director, Program and Financial Managers, and Budget Analysts. The HRCI website, which is hosted within the main website of the JHSPH Institute for International Programs website, (http://www.jhsph.edu/research/centers-and-institutes/institute-for-international-programs/current-projects/health-research-challenge-for-impact/) was developed utilizing these funds.

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APPENDIX: PUBLICATIONS AND MANUSCRIPTS IN PREPARATION (as of September 30, 2016)

“Determining the Burden of Maternal Ill Health and Death and its Programmatic Implications in Rural Bangladesh”

Stanton ME, Brandes N. “A New Perspective on Maternal Ill-health and Its Consequences”. Journal of Health, Population, and Nutrition. 2012;30(2):121-123.

Koblinsky M, Chowdhury ME, Moran A, Ronsmans C. “Maternal Morbidity and Disability and Their Consequences: Neglected Agenda in Maternal Health”. Journal of Health, Population, and Nutrition. 2012;30(2):124-130.

Huda FA, Ahmed A, Dasgupta SK, et al. “Profile of Maternal and Foetal Complications during Labour and Delivery among Women Giving Birth in Hospitals in Matlab and Chandpur, Bangladesh”. Journal of Health, Population, and Nutrition. 2012;30(2):131-142.

Ferdous J, Ahmed A, Dasgupta SK, et al. “Occurrence and Determinants of Postpartum Maternal Morbidities and Disabilities among Women in Matlab, Bangladesh”. Journal of Health, Population, and Nutrition. 2012;30(2):143-158.

Khan R, Blum LS, Sultana M, Bilkis S, Koblinsky M. “An Examination of Women Experiencing Obstetric Complications Requiring Emergency Care: Perceptions and Sociocultural Consequences of Caesarean Sections in Bangladesh”. Journal of Health, Population, and Nutrition. 2012;30(2):159-171.

Gausia K, Ryder D, Ali M, Fisher C, Moran A, Koblinsky M. “Obstetric Complications and Psychological Well-being: Experiences of Bangladeshi Women during Pregnancy and Childbirth”. Journal of Health, Population, and Nutrition. 2012;30(2):172-180.

Naved RT, Blum LS, Chowdhury S, Khan R, Bilkis S, Koblinsky M. “Violence against Women with Chronic Maternal Disabilities in Rural Bangladesh”. Journal of Health, Population, and Nutrition. 2012;30(2):181-192.

Hamadani JD, Tofail F, Hilaly A, et al. “Association of Postpartum Maternal Morbidities with Children’s Mental, Psychomotor and Language Development in Rural Bangladesh”. Journal of Health, Population, and Nutrition. 2012;30(2):193-204.

Hoque ME, Powell-Jackson T, Dasgupta SK, Chowdhury ME, Koblinsky M. “Costs of Maternal Health-related Complications in Bangladesh”. Journal of Health, Population, and Nutrition. 2012;30(2):205-212.

Iyengar K. Early Postpartum Maternal Morbidity among Rural Women of Rajasthan, India: A Community-based Study. Journal of Health, Population, and Nutrition. 2012;30(2):213-225.

Iyengar K, Yadav R, Sen S. Consequences of Maternal Complications in Women’s Lives in the First Postpartum Year: A Prospective Cohort Study. Journal of Health, Population, and Nutrition. 2012;30(2):226-240.

Gausia, K., Moran, A. C., Ali, M., Ryder, D., Fisher, C., & Koblinsky, M. “Psychological and social consequences among mothers suffering from perinatal loss: perspective from a low income country”. BMC public health. 2011; 11(1), 1.

Powell Jackson T, Hoque M.E. "Economic consequences of maternal illness in rural Bangladesh." Health economics 21.7 (2012): ‐796-810.

Chlorhexidine (CHX) Main Trial Dissemination

Mullany LC, El Arifeen S, Winch PJ, Shah R, Mannan I, Rahman SM, Rahman MR, Darmstadt GL, Ahmed S, Santosham M, Black RE, Baqui AH. ”Impact of 4.0% chlorhexidine cleansing of the umbilical cord on mortality and omphalitis among newborns of Sylhet, Bangladesh: design of a community-based cluster randomized trial.”BMC Pediatr. 2009 Oct 21;9:67. PMCID: PMC2770449

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Mullany LC, Saha SK, Shah R, Islam MS, Rahman M, Islam M, Talukder RR, El Arifeen S, Darmstadt GL, Baqui AH. ”Impact of 4.0% Chlorhexidine Cord Cleansing on the Bacteriological Profile of the Newborn Umbilical Stump in Rural Sylhet District, Bangladesh: A Community-Based, Cluster-Randomized Trial.” Pediatr Infect Dis J. 2012 May;31(5):444-50. PubMed PMID: 22510992.

Arifeen SE, Mullany LC, Shah R, Mannan I, Rahman SM, Talukder MRR, Begum N, Al-Kabir A, Darmstadt GL, Santosham M, Black RE, Baqui AH. ”The effect of cord cleansing with chlorhexidine on neonatal mortality in rural Bangladesh: a community-based, cluster-randomised trial.” Lancet. 2012 Mar 17; 379(9820):1022-8. Epub 2012 Feb 8. PubMed PMID: 22322124.

Mullany LC, Shah R, El Arifeen S, Mannan I, Winch PJ, Hill A, Darmstadt GL, Baqui AH. “Chlorhexidine cleansing of the umbilical cord and separation time: a cluster-randomized trial.” Pediatrics. 2013;131(4):708-15. Epub 2013/03/20. doi: 10.1542/peds.2012-2951. PubMed PMID: 23509175.

Imdad A, Mullany LC, Baqui AH, El Arifeen S, Tielsch JM, Khatry SK, Shah R, Cousens S, Black RE, Bhutta ZA. “The effect of umbilical cord cleansing with chlorhexidine on omphalitis and neonatal mortality in community settings in developing countries: a meta-analysis.” BMC Public Health. 2013; 13 Suppl 3:S15.doi: 10.1186/1471-2458-13-S3-S15. Epub 2013 Sep 17, PubMed PMID: 24564621

Alam MA, Ali NA, Sultana N, Mullany LC, Teela KC, Khan NU, Baqui AH, El Arifeen S, Mannan I, Darmstadt GL, Winch PJ. Newborn umbilical cord and skin care in Sylhet District, Bangladesh: implications for the promotion of umbilical cord cleansing with topical chlorhexidine. J Perinatol. 2008 Dec;28 Suppl 2:S61-8. doi: 10.1038/jp.2008.164.

Safety and Efficacy of Simplified Antibiotic Regimens for Outpatient Treatment of Suspected Severe Infections in Neonates and Young Infants (SAT)

Zaidi AK, Baqui AH, Qazi SA, Bahl R, Saha S, Ayede AI, Adejuyigbe EA, Engmann C, Esamai F, Tshefu AK, Wammanda RD, Falade AG, Odebiyi A, Gisore P, Longombe AL, Agala WN, Tikmani SS, AS UA, Brandes N, Roth DE, Darmstadt GL. ”Scientific rationale for study design of community-based simplified antibiotic therapy trials in newborns and young infants with clinically diagnosed severe infections or fast breathing in South Asia and sub-Saharan Africa.” The Pediatric infectious disease journal. 2013;32(9 Suppl 1):S7-11. Epub 2013/10/18. doi: 10.1097/INF.0b013e31829ff5fc. PubMed PMID: 23945577.

Wall SN, Mazzeo CI, Adejuyigbe EA, Ayede AI, Bahl R, Baqui AH, Blackwelder WC, Brandes N, Darmstadt GL, Esamai F, Hibberd PL, Jacobs M, Klein JO, Mwinga K, Rollins NC, Saloojee H, Tshefu AK, Wammanda RD, Zaidi AK, Qazi SA. ”Ensuring quality in AFRINEST and SATT: clinical standardization and monitoring.” The Pediatric infectious disease journal. 2013;32(9 Suppl 1):S39-45. Epub 2013/10/18. doi: 10.1097/INF.0b013e31829ff801. PubMed PMID: 23945575.

Esamai F, Tshefu AK, Ayede AI, Adejuyigbe EA, Wammanda RD, Baqui AH, Zaidi, AK, Saha S, Rollins NC, Wall S, Brandes N, Engmann C, Darmstadt G, Qazi SA, Bahl R. “Ongoing trials of simplified antibiotic regimens for the treatment of serious infections in young infants in South Asia and sub-Saharan Africa: implications for policy.” The Pediatric infectious disease journal. 2013;32(9 Suppl 1):S46-9. Epub 2013/10/18. doi: 10.1097/INF.0b013e31829ff941. PubMed PMID: 23945576.

Baqui AH, Saha SK, Ahmed AS, Shahidullah M, Quasem I, Roth DE, Williams E, Mitra D, Shamsuzzaman AK, Ahmed W, Mullany LC, Cousens S, Wall S, Brandes N, Black RE. “Safety and efficacy of simplified antibiotic regimens for outpatient treatment of serious infection in neonates and young infants 0-59 days of age in Bangladesh: design of a randomized controlled trial.” The Pediatric infectious disease journal. 2013;32(9 Suppl 1):S12-8. Epub 2013/10/18. doi: 10.1097/INF.0b013e31829ff790. PubMed PMID: 23945570.

Chan GJ, Stuart EA, Zaman M, Mahmud AA, Baqui AH, Black RE. The effect of intrapartum antibiotics on early-onset neonatal sepsis in Dhaka, Bangladesh: a propensity score matched analysis. BMC Pediatr. 2014 Apr 17; 14:104. doi: 10.1186/1471-2431-14-104.

Baqui AH, Saha SK, Ahmed ASMNU, Shahidullah M, Quasem I, Roth DE, Samsuzzaman AKM, Ahmed W, Tabib SMSB, Mitra DK, Begum N, Islam M, Moin MI, Mullany LC, Cousens S, Arifeen SE, Wall S, Brandes N, Santosham M, Black RE. ”Safety and Efficacy of alternate Antibiotic Regimens for Outpatient Treatment of Suspected Serious Infections in Neonates and Young Infants in Bangladesh: A Randomized Controlled Trial.” Lancet Global Health, 2015 May;3(5):e279-87

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Repeat Reproductive Age Mortality Study (RAMOS II) in Afghanistan

Tappis, H. Koblinsky M, Winch PJ, Turkmani S, Bartlett L. Context Matters: Successes and challenges of intrapartum care scale up in four districts in Afghanistan. Glob Public health 2016;11(4):387-406

Bartlett L, LeFevre A, Zimmerman L, Ataullah Saeedzai S, Torkamani S, Zabih W, Tappis H, Becker S, Winch P, Koblinsky M, Javed Rahmanzai A. Maternal mortality declines while striking inequities exist: Results of the Afghanistan RAMOS II study. (Under revision for Lancet GH)

TZ MEP Evaluation - Monitoring, Documentation and Evaluation of an Integrated Maternal and Newborn Health Care Program in Morogoro Region, Tanzania

Callaghan-Koru JA, McMahon SA, Chebet JJ, Kilewo C, Frumence G, Gupta S, Stevenson R, Lipingu C, Baqui AH, Winch PJ. A qualitative exploration of health workers' and clients' perceptions of barriers to completing four antenatal care visits in Morogoro Region, Tanzania. Health Policy Plan. 2016 Apr 26. pii: czw034. [Epub ahead of print]

LeFevre AE, Mpembeni R, Chitama D, George AS, Mohan D, Urassa DP, Gupta S, Feldhaus I, Pereira A, Kilewo C, Chebet JJ, Cooper CM, Besana G, Lutale H, Bishanga D, Mtete E, Semu H,Baqui AH, Killewo J, Winch PJ. Profile, knowledge, and work patterns of a cadre of maternal, newborn, and child health CHWs focusing on preventive and promotive services in Morogoro Region, Tanzania. Hum Resour Health. 2015 Dec 24;13:98. doi: 10.1186/s12960-015-0086-3.

An SJ, George AS, LeFevre AE, Mpembeni R, Mosha I, Mohan D, Yang A, Chebet J, Lipingu C,Baqui AH, Killewo J, Winch PJ, Kilewo C. Supply-side dimensions and dynamics of integrating HIV testing and counselling into routine antenatal care: a facility assessment from Morogoro Region, Tanzania. BMC Health Serv Res. 2015 Oct 4;15:451. doi: 10.1186/s12913-015-1111-x.

Feldhaus I, Silverman M, LeFevre AE, Mpembeni R, Mosha I, Chitama D, Mohan D, Chebet JJ, Urassa D, Kilewo C, Plotkin M, Besana G, Semu H, Baqui AH, Winch PJ, Killewo J, George AS. Equally able, but unequally accepted: Gender differentials and experiences of community health volunteers promoting maternal, newborn, and child health in Morogoro Region, Tanzania. Int J Equity Health. 2015 Aug 25;14:70. doi: 10.1186/s12939-015-0201-z.

Mpembeni RN, Bhatnagar A, LeFevre A, Chitama D, Urassa DP, Kilewo C, Mdee RM, Semu H, Winch PJ, Killewo J, Baqui AH, George A. Motivation and satisfaction among community health workers in Morogoro Region, Tanzania: nuanced needs and varied ambitions. Hum Resour Health. 2015 Jun 5;13:44. doi: 10.1186/s12960-015-0035-1.

An SJ, George AS, LeFevre A, Mpembeni R, Mosha I, Mohan D, Yang A, Chebet J, Lipingu C, Killewo J, Winch P, Baqui AH, Kilewo C. Program synergies and social relations: implications of integrating HIV testing and counselling into maternal health care on care seeking. BMC Public Health. 2015 Jan 21;15:24. doi: 10.1186/s12889-014-1336-3.

Mohan D, Gupta S, LeFevre A, Bazant E, Killewo J, Baqui AH. Determinants of postnatal care use at health facilities in rural Tanzania: multilevel analysis of a household survey. BMC Pregnancy Childbirth. 2015 Oct 30;15:282. doi: 10.1186/s12884-015-0717-7.

Roberton T, Applegate J, Lefevre A et al. Initial experiences and innovations in supervising community health workers for maternal, newborn, and child health in Morogoro region, Tanzania. Human Resources for Health 2015; 13. DOI:10.1186/s12960-015-0010-x.

Urassa D, LeFevre A, George A, et al. Influence of age on community health worker’s knowledge and service provision for maternal, newborn, and child health in Morogoro region, Tanzania. East African Journal of Public Health 2015. 12(1):964.

McMahon S, Mohan D, LeFevre A, et al. “You should go so that others can come”; the role of facilities in determining an early departure after childbirth in Morogoro Region, Tanzania. BMC Pregnancy and Childbirth 2015; 15: 328. DOI:10.1186/s12884-015-0763-1

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Gupta S, Yamada G, Mpembeni R, Frumence G, Callaghan-Koru JA, Stevenson R, Brandes N,Baqui AH. Factors associated with four or more antenatal care visits and its decline among pregnant women in Tanzania between 1999 and 2010. PLoS One. 2014 Jul 18;9(7):e101893. doi: 10.1371/journal.pone.0101893. eCollection 2014.

McMahon S, George A, Chebet J, Mosha I, Mpembeni R, Winch P. Experiences of and responses to disrespectful maternity care and abuse during childbirth; a qualitative study with women and men in Morogoro Region, Tanzania. BMC Pregnancy Childbirth 2014; 14: 268. doi:10.1186/1471-2393-14-268

Greenspan J, McMahon S, Chebet J, Mpunga M, Urassa D, Winch P. Sources of community health worker motivation: a qualitative study in Morogoro Region, Tanzania. Human Resources for Health. 2013;11(1):52. doi:10.1186/1478-4491-11-52.

The Care and Treatment of Severe Pneumonia in HIV-exposed and Infected Children in Zambia

Sutcliffe CG, Thea DM, Seidenberg P, Chipeta J, Mwyanayanda L, Duncan J, Mwale M. Mulindwa J, Mwenechenya M, Izadnegahdar R, Moss WJ. A clinical guidance tool to improve the care of children hospitalized with severe pneumonia in Lusaka, Zambia. BMC Pediatr. 2016;16:136.

Development and Testing of Evidence-based Mental Health Treatment for Affected Youth - Zambia

Murray, L.K., Skavenski-van Wyk, S.S., Kane, J.C., Mayeya, J., Dorsey, S., Cohen, J.A., Michalopoulos, L., Imasiku, M., & Bolton, P. (2015). Effectiveness of Trauma Focused Cognitive Behavioral Therapy Among Trauma-Affected Children in Lusaka, Zambia: A Randomized Clinical Trial. JAMA Pediatrics, 169(8): 761-9.

Kane, J.C., Murray, L.K., Cohen, J., Dorsey, S., van Wyk, S.S., Henderson, J.G., Imasiku, M., Mayeya, J., & Bolton, P. (in press). Moderators of treatment response to trauma-focused cognitive behavioral therapy among youth in Zambia. Journal of Child Psychology and Psychiatry.

Sanitation Hygiene Infant Nutrition Efficacy (SHINE) Sub-study – Zimbabwe

Smith LE, Prendergast AJ, Turner P, Mbuya MN, Mutasa K, Kembo G, Stoltzfus RJ and the SHINE Trial Group. The potential role of mycotoxins as a contributor to stunting in the SHINE Trial. Clinical and Infectious Diseases 2015. 71 Suppl 7: S733-7.

Implementation Research Delivery Science Meeting, Working Group and Lancet Series

Peters, DH, Tran, NT, Adam, T. 2013. Implementation Research in Health: A Practical Guide. World Health Organization. Geneva: World Health Organization (In collaboration with AHPSR)

Peters DH, Adam T, Alonge O, Agyepong IA, Tran N. Implementation research: What it is and how to do it. BMJ 2013; 347:f6753. (In collaboration with AHPSR)

PUBLICATIONS FROM PREVIOUS GRA WORK PUBLISHED BY HRCI (Projahnmo-1 and 2)

Shah R, Mullany LC, Darmstadt GL, Mannan I, Rahman SM, Talukder RR, Applegate JA, Begum N, Mitra D, Arifeen SE, Baqui AH; ProjAHNMo Study Group in Bangladesh. Incidence and risk factors of preterm birth in a rural Bangladeshi cohort. BMC Pediatr. 2014 Apr 24;14:112. doi: 10.1186/1471-2431-14-112.

Lehnertz NB, Alam A, Ali NA, Henry EG, Williams EK, Rahman SM, Ahmed S, El Arifeen S, Baqui AH, Winch PJ. Local understandings 39

and current barriers to optimal birth intervals among recently delivered women in Sylhet District, Bangladesh.Int Health. 2013 Dec;5(4):266-72. doi: 10.1093/inthealth/iht031. Epub 2013 Nov 18.

LeFevre AE, Shillcutt SD, Waters HR, Haider S, El Arifeen S, Mannan I, Seraji HR, Shah R, Darmstadt GL, Wall SN, Williams EK, Black RE, Santosham M, Baqui AH; Projahnmo Study Group.Economic evaluation of neonatal care packages in a cluster-randomized controlled trial in Sylhet, Bangladesh. Bull World Health Organ. 2013 Oct 1;91(10):736-45. doi: 10.2471/BLT.12.117127. Epub 2013 Jul 12.

Nonyane BA, Williams EK, Blauvelt C, Shah MR, Darmstadt GL, Moulton L, Baqui AH. Clustering of neonatal deaths in Bangladesh: results from the Projahnmo studies. Paediatr Perinat Epidemiol. 2013 Mar;27(2):165-71. doi: 10.1111/ppe.12032.

Shillcutt SD, Lefevre AE, Lee AC, Baqui AH, Black RE, Darmstadt GL. Forecasting burden of long-term disability from neonatal conditions: results from the Projahnmo I trial, Sylhet, Bangladesh. Health Policy Plan. 2013 Jul;28(4):435-52. doi: 10.1093/heapol/czs075. Epub 2012 Sep 23.

Choi Y, El Arifeen S, Mannan I, Rahman SM, Bari S, Darmstadt GL, Black RE, Baqui AH; Projahnmo Study Group. Can mothers recognize neonatal illness correctly? Comparison of maternal report and assessment by community health workers in rural Bangladesh. Trop Med Int Health. 2010 Jun;15(6):743-53. doi: 10.1111/j.1365-3156.2010.02532.x. Epub 2010 Apr 6.

Baqui AH, Arifeen SE, Rosen HE, Mannan I, Rahman SM, Al-Mahmud AB, Hossain D, Das MK, Begum N, Ahmed S, Santosham M, Black RE, Darmstadt GL; Projahnmo Study Group. Community-based validation of assessment of newborn illnesses by trained community health workers in Sylhet district of Bangladesh. Trop Med Int Health. 2009 Dec;14(12):1448-56. doi: 10.1111/j.1365-3156.2009.02397.x. Epub 2009 Oct 5.

Baqui AH, Rosen HE, Lee AC, Applegate JA, El Arifeen S, Rahman SM, Begum N, Shah R, Darmstadt GL, Black RE. Preterm birth and neonatal mortality in a rural Bangladeshi cohort: implications for health programs. J Perinatol. 2013 Dec;33(12):977-81. doi: 10.1038/jp.2013.91. Epub 2013 Aug 15.

Mannan I, Choi Y, Coutinho AJ, Chowdhury AI, Rahman SM, Seraji HR, Bari S, Shah R, Winch PJ, El Arifeen S, Darmstadt GL, Baqui AH. Vulnerability of newborns to environmental factors: findings from community based surveillance data in Bangladesh. Int J Environ Res Public Health. 2011 Aug;8(8):3437-52. doi: 10.3390/ijerph8083437. Epub 2011 Aug 22.

Baqui AH, Choi Y, Williams EK, Arifeen SE, Mannan I, Darmstadt GL, Black RE. Levels, timing, and etiology of stillbirths in Sylhet district of Bangladesh. BMC Pregnancy Childbirth. 2011 Apr 1;11:25. doi: 10.1186/1471-2393-11-25.

Shah R, Munos MK, Winch PJ, Mullany LC, Mannan I, Rahman SM, Rahman R, Hossain D, El Arifeen S, Baqui AH. Community-based health workers achieve high coverage in neonatal intervention trials: a case study from Sylhet, Bangladesh. J Health Popul Nutr. 2010 Dec;28(6):610-8.

Schiffman J, Darmstadt GL, Agarwal S, Baqui AH. Community-based intervention packages for improving perinatal health in developing countries: a review of the evidence. Semin Perinatol. 2010 Dec;34(6):462-76. doi: 10.1053/j.semperi.2010.09.008. Review.

Rahman SM, Ali NA, Jennings L, Seraji MH, Mannan I, Shah R, Al-Mahmud AB, Bari S, Hossain D, Das MK, Baqui AH, El Arifeen S, Winch PJ. Factors affecting recruitment and retention of community health workers in a newborn care intervention in Bangladesh. Hum Resour Health. 2010 May 3;8:12. doi: 10.1186/1478-4491-8-12.

Baqui AH, Arifeen SE, Williams EK, Ahmed S, Mannan I, Rahman SM, Begum N, Seraji HR, Winch PJ, Santosham M, Black RE, Darmstadt GL. Effectiveness of home-based management of newborn infections by community health workers in rural Bangladesh. Pediatr Infect Dis J. 2009 Apr;28(4):304-10. doi: 10.1097/INF.0b013e31819069e8.

Baqui AH, Williams E, El-Arifeen S, Applegate JA, Mannan I, Begum N, Rahman SM, Ahmed S, Black RE, Darmstadt GL. Effect of community-based newborn care on cause-specific neonatal mortality in Sylhet district, Bangladesh: findings of a cluster-randomized controlled trial. Journal of Perinatology 2015 5 Nov. doi:10.1038/jp.2015.139

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