1

Effectiveness of Decentralized Program Planning and Management in Improving Age

Appropriate Immunizations in a Rural Area of India

Abstract Objective: To study the effectiveness of planning and management interventions in improving

age appropriate immunization.

Methods: All 4336 children aged <18 month and 5213 children born during July 2005 to

December 2006 were enrolled from Khizrabad Block of Yamunanagar District in India.

Operational bottlenecks were evaluated by review of plans, staffing and stock position, and

condition of cold chain; observations of a sample of immunization sessions, and interview of

parents and health providers. An intervention package was evolved with community-based

volunteers as a pivotal strategy. Mean age at administration of DPT doses served as indicator of

age appropriate immunization. Chi square, t test and ANOVA were used to test statistical

differences before and after the interventions and for comparison with reference population.

Findings: Staff shortage, non-adherence to micro-plans and vaccine stock outs were the major

causes of delayed immunization. After intervention, coverage of third dose of DPT at the age of

6 month was significantly higher among post-intervention cohorts (70%) compared to pre-

intervention (62%). The mean age at administration of 1st, 2nd, and 3rd dose of DPT declined by

17, 21 and 34 days respectively in intervention area whereas no change occurred in hospitalized

children from non-intervention blocks. This corresponds to 21%, 16% and 18% decline over

baseline in mean age at administration of DPT1, 2 and 3 respectively in intervention area.

Conclusions: Better program planning and management can improve immunization

performance. Government of India’s decentralization policy for hiring of contractual staff and

2

community-based volunteers called Accredited Social Health Activists (ASHAs) is likely to

enhance age-appropriate immunization.

Key-words: immunization, age-appropriate, community volunteer, program management

3

Introduction

Communicable diseases kill more than 14 million people annually, predominantly in

developing world1. As of now, measles, pertussis and tetanus are the leading causes of disability

adjusted life years lost among childhood diseases2. Thirty million cases and 888,000 deaths

occur worldwide annually due to measles, of which 85% occur in South East Asia and Africa

regions3. Diphtheria too, has the potential to cause outbreaks especially in countries with low

vaccination coverage 4.

Despite the availability of safe and effective vaccines, the coverage of immunization

against six vaccine preventable diseases has remained variable in different regions of India5.

Beside the emphasis on enhancing the coverage for immunization, there is a need to administer

vaccines at the correct age as per the national immunization schedule to provide protection from

disease at the high risk age6. Numerous studies have documented immunization coverage and

recommended several strategies to enhance the coverage7-12. However, there have been limited

intervention studies to administer vaccines at appropriate age13. Present study was conducted

primarily to identify program interventions that can overcome operational barriers and improve

age-appropriate immunizations.

4

Materials and methods

Study area

This study was conducted in Khizrabad rural Community Development Block of

Yamunanagar district in Haryana state (India) from July 2005 to December 2006. Study district

was purposely chosen as immunization coverage for all currently administered vaccines at one

year of age was 78% 14, which was considered to be adequate coverage for introduction of Hib

vaccine. Out of the four blocks in this district, Khizrabad block was chosen since its geographic

location facilitated better patient access to study hospitals. The study was part of an Indian

Council of Medical Research and Johns Hopkins University Bloomberg School of Public Health

funded pilot project for studying the feasibility of estimating the preventable burden of

haemophilus influenzae type b (Hib) meningitis and pneumonia in India. A written informed

consent was taken from parents of all children who were enrolled in the study. The study was

approved by the Institutional Review Board of the Johns Hopkins University, Baltimore, USA

and the Institute Ethics Committee of Post Graduate Institute of Medical Education and

Research, Chandigarh, India.

In India, Primary Health Care system comprises of a Community Health Center (CHC) to

provide specialist services to 100,000 population while a Primary Health Centre (PHC) provides

preventive, curative, and promotive health care services to 30,000 population. PHC has 5-6

subcentres, each covering a population of 5000, where preventive, promotive and basic medical

care for minor illnesses are provided by multipurpose health workers male [MPHW(M)] and

female [MPHW(F)]. The study block had a network of one CHC, three PHCs and 25 sub centers

to provide health care to a population of 170,000 in 204 villages. Beside the staff of health

services, 155 primary child care workers (anganwadi) of the Integrated Child Development

5

Services Scheme were also available at village level (one for 1000 population) who also mobilize

community for nutritional and health interventions.

Planning, implementation and monitoring of immunization services in Yamunanagar

district is decentralized upto PHC level. The vaccines are stored for a period of three months at

district headquarters from where supplies are sent to CHC and PHCs which have facilities for

storage of vaccines for one month. Outreach sessions are held only once a week (conventionally

on a wednesday) by the subcentres in villages (at anganwadis) where vaccine storage equipment

is not available15. National immunization schedule in India envisages administration of one dose

of BCG at birth to 6 weeks and three doses of DPT and OPV at 6, 10 and 14 weeks respectively,

and measles vaccine is delivered at 9 months of age15.

Situational analysis

Completeness of enrollment of eligible children at subcentre level was ascertained by

comparing the births registered by MPHW(F) during April 2004-March 2005 with children

registered by a trained Community Volunteer (CV) in the corresponding period. This

comparison was done in 13 (52%) subcentres which had the same MPHW(F) working in that

subcentre for 2 consecutive years. Completeness of registration by CVs was validated by field

supervisors in 10% of the randomly selected households.

The study investigators supervised one outreach session in villages at each of the 25

subcentres using standard WHO supervisory checklist to identify problems in planning,

implementation and monitoring of immunization services16. Mothers of 527 children who had

dropped out after the first dose of DPT vaccine, i.e., had not turned up in the next session (one

month after the previous dose) were interviewed to ascertain the reasons for dropout. All the

MPHWs (F) in the block were interviewed to assess the number of sessions held during the

6

preceding month as against the planned number of sessions. Reasons for not holding a session on

the planned date and venue were assessed. Cold chain and vaccine logistics system was also

reviewed.

Intervention package

The results of situational analysis were discussed with district health authorities, CHC

and PHC medical officers and MPHW(F) in separate meetings. A strategy for improving

immunization program was jointly worked out (Table 1). Presence of CV as a community

mobilizer was designed as a pivotal part of the overall strategy. Twenty five CVs were recruited

at subcentre level who had minimum tenth grade education and were paid Rs.1000/- (US $25) 17

every month as honorarium for the part-time work. MPHW(F) were recruited on contract for

filling the vacant positions at subcentres. Additionally part-time vaccinators were hired to

supplement immunization activity at subcentre which had a vacancy due to transfer or temporary

absence of the MPHW(F) on a vaccination day. Comprehensive microplans at PHC level were

prepared describing the date, venue, vaccinator, number of clients, vaccine requirement, and

vaccine delivery mechanism for each session. Continuing education sessions were held for

doctors, health workers and anganwadi workers at PHC level highlighting the benefits of age

appropriate immunization. The investigators participated in the monthly review meetings of

program officers and PHC medical officers at district level, where previous month’s

immunization progress was presented and operational problems resolved.

Data collection

Community volunteers enrolled all children who were less than 18 months of age, maintained

log of pregnant women and prospectively enrolled all live births also during the study period

among permanent residents of the block. Past immunization status was recorded for children less

7

than 18 months of age at the time of initial enrolment. Subsequently, CVs recorded

immunization dates prospectively whenever children were vaccinated in the immunization

sessions. These records were submitted as a part of the weekly report. Each child was followed

up till 18 months age and a follow-up form was filled at attainment of the age of 24 months

wherein date for vaccines administered after enrolment were recorded again based on mother’s

recall. Follow-up form was used to test the accuracy of records collected by community

volunteer on a prospective basis. Discordance in data was verified and correct record was then

agreed upon by the field supervisors. Five full time field supervisors were recruited and posted at

PHC level for supervision of CVs. The immunization data of children of less than two years of

age who were admitted to 15 pediatric private and government hospitals from the entire district

was recorded by medical officers as a part of the pneumonia and meningitis surveillance activity.

A total of 4336 children under 18 months were registered at the start of the study and

5213 children were registered prospectively at births during the study period. Majority (99.3%)

of the mothers consented to participate in the study. Overall 1st, 2nd, and 3rd dose of DPT were

administered prospectively to 4810, 4775 and 4730 children during the study. A total of 814

children were admitted in the study hospitals from remaining blocks of Yamunanagar district.

According to their parent’s reports 1st, 2nd, 3rd dose of DPT had been administered to 477, 377

and 294 of them respectively.

Data Analysis

Enrolment and follow-up forms were scanned and converted to electronic format in Epi

Info (version 3.0) statistical software for analysis. Overall effectiveness of interventions was

assessed by comparing immunization coverage of children who had already started or completed

their immunization schedule at the time of enrolment in the study (pre-intervention cohort)

8

reflecting past performance of immunization program versus new births who were enrolled in the

study period before the start of scheduled immunization (post intervention cohort) reflecting the

impact of interventions. Mean of age (days) at the time of administration of different DPT doses

and mean gap (in days) between the DPT doses were compared between the two enrolment

cohorts described above. Similar analysis was done in hospitalized children from all the blocks

except the study block. They were divided into two groups, i.e. children who received

immunization before or after July 2005 (the date of introduction of interventions in the study

block). Chi square test and t-test were used for testing statistical significance of difference

between categorical and continuous variables respectively in the two groups.

The immunization data from weekly reports of CVs were also analyzed for six quarterly

immunization cohorts from July 2005 to December 2006. ANOVA test was used to test the

significance of trend of means over six quarters of the study period. Age-specific coverage of

DPT3 was also calculated in different enrolment cohorts, i.e., children enrolled before and after

receiving 1st dose of DPT.

9

Results

Though nearly 92% children had received third dose of DPT by the age of 12 months, but

only 19% received it by 4 month of age; the age by which every child should have receive it as

per the universal immunization schedule of India. Hence, a situational analysis was conducted to

identify operational barriers that need to be overcome to improve the age-appropriate

immunization coverage.

Operational Problems in the Delivery of Immunization Services

On an average MPHW(F) did not register 7.5% of the births. The percentage of missed

births was less in villages which had an anganwadi centre (0.5%) than those without it (17.2%).

Coverage of birth registration in villages was inversely related to distance from subcentre with

percentage of missed births ranging from 0.02% in subcentre villages or villages within 2 km

from the subcentre village to 9.5% in villages which were 2 to 5 km from subcentre and 8.2% in

villages which were more than 5 km away from the subcentre.

A review of vaccine logistics revealed that ice-lined refrigerators (ILR) and deep freezers

(DF) were not functional in two out of the four PHCs. Only one month requirement of vaccine

could be stocked at the district store due to inadequate storage space. Overall requirement of

ILRs and DFs in the district for storage of three month stock was deficient by 20%. There was

stockout of DPT vaccine during two months in the preceding year (2004-05) at district level.

Updated and comprehensive microplans were not available in PHCs. Sixteen (13.9%)

sessions planned during the preceding month were not held. Major reasons for 16 missed

sessions included monthly staff meeting at PHC scheduled on a day meant for immunization

(50%), vacant post of MPHW(F) (25%), decision taken by MPHW(F) to skip session while

another 12.5% sessions were not held as MPHW(F) was either on leave or away on training and

10

there was no one to replace her. Among sessions held, 23 (23.2%) sessions were not held on the

planned day. Reasons for 527 children who dropped out one month after DPT-1 included: ‘child

not at home on day of immunization’ (47.3%), ‘child not vaccinated due to minor illness’

(27.3%), ‘mother busy and nobody to bring the child to session’ (7%) and ‘session not held’ on

that day (4.6%). Among remaining 14% cases either vaccine was not available in the session or

mother had no information of session being held on that day.

Review of the situation led to the development and implementation of an intervention

package by the district health authorities which addressed the above mentioned operation

barriers. These interventions were found to be effective in improving the age-appropriate in the

study block.

Effectiveness of immunization program management interventions

The coverage of DPT 3rd dose by the age of 4, 6, and 9 month was significantly higher

among post-intervention enrolment cohort (22%, 70%, and 88%) compared to the pre-

intervention cohort (19%, 62%, and 85%) (p<0.001) with insignificant coverage at 12 months.

Statistically significant trend was observed in the lowering of the mean age of 1st, 2nd, and

3rd dose of DPT administration from first quarter of the study period (July-September 2005) to

the sixth quarter (October-December 2006) (p< 0.0001) (Table 2, Figure 1). The mean age at

administration of 1st, 2nd, and 3rd dose of DPT declined by 17, 21 and 34 days respectively in

intervention area whereas children admitted to study hospitals from rest of the district did not

show this trend. Mean age for DPT1 in hospitalized controls varied from 65.8 days to 68.9 days

from first to sixth immunization cohort, while it varied from 94.3 days to 129.7 days and 129.4

days to 121.7 days for DPT 2 and DPT3 respectively during the corresponding period.

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Discussion

Immunization program in the study area was being monitored by assessment of coverage

of fully immunized children at one year of age. Periodic immunization evaluation surveys also

utilize this crude indicator to evaluate the overall performance of routine immunization

program18-20. The emphasis on coverage at one year of age is what drives the work of health

workers and medical officers. This was also evident in the present study area where the coverage

of 3rd dose of DPT was 92% at the age of 12 months but the coverage at 4 month was very low.

Benefits are greater if a child gets immunization at appropriate age especially so for

Haemophilus influenzae ‘b’ (Hib) and Pneumococcal vaccines. Governments are now including

these newer vaccines in their program, therefore, age-appropriate coverage should be made a

benchmark for assessment of the performance of immunization programs.

Major operational lacunae in the immunization programs are related to program

planning and management. The study findings demonstrate that better micro-planning along with

a responsive management information system (MIS) can improve program performance

significantly. Utilizing the data generated from routine MIS, the performance of program was

reviewed in monthly meetings at PHC, CHC and district level for finding solutions that can work

in the local conditions. MIS was used for actions rather than just for data transmission.

Higher than the expected workload also impede program implementation. The average

subcentre in the study area catered to a population of 6800, way above the national norm of

5000, with 12 (48%) subcentres having more than 8000 population. To compound the problem

further, there is shortage of MPHW(F). These findings are in conformity to another local study

21. Hiring of MPHW(F) on contract for subcentres to fill vacant posts, and employment of

additional vaccinators and community volunteers on part-time basis was possible due to the

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decentralization and delegation of powers of recruitment at district level under the Reproductive

and Child Health II program 22. A related issue which also deserves mention is strengthening of

infrastructure for storage of vaccines and cold chain. This assumes greater importance as

Government of India intends to introduce newer vaccines such as Hib and Hep B.

Under-registration of births appears to be one of the reasons for the gap found in reported

and evaluated coverage of routine immunization services in various studies23-24. Birth registration

can be improved further by universalization of ICDS program in all areas and better intersectoral

coordination with anganwadi workers 25. This was evident in the present study with nearly

complete birth registration by MPHW(F) in villages which had an anganwadi.

Majority of the studies conducted for documenting immunization performance have

focused on overall coverage 7-12. We could not find any published research which estimated age

appropriate immunization coverage except one in grey literature 13. Many authors have however

tried to emphasize the importance of immunizing children for better protection against

pertussis26, measles 27 and haemophilus influenzae type ‘b’ 28.

Substantial drop outs occur after first dose for multi-dose vaccines (like DPT). Another

study from Delhi found similar magnitude of dropout from first to third dose of DPT with the

major reason being lack of information about the session29. This requires a major shift in the

behaviour change communication messages from ‘universal coverage’ to ‘universal timely

coverage’ for clients and in continuing education of health workers.

The study highlights several operational barriers that impede delivery of immunization at

appropriate ages in a developing country setting. However, as evident from the study, effective

tracking by community level workers, improved planning and monitoring of the program can

significantly improve age-appropriate immunization coverage (Table 2).

13

It is often difficult to conduct double blind randomized control trials for finding the

effectiveness of program management interventions. Before and after comparison in an

intervention area and a reference area can provide reasonable assurance about the validity of the

findings. However, it is difficult to find a comparable reference population and even if one finds

a comparable population, ethics committees find it hard to justify spending money only on data

collection in an area where interventions are not planned. Hence, this study utilized

immunization data from hospitalized children as a reference population rather than community

controls from rest of the district. Parents of children admitted in hospitals are likely to be having

better health seeking behaviour. This was reflected in overall better immunization coverage at

baseline in these children than in the children of the study area. However, the age at which

vaccines were administration in study area became lower after the intervention whereas no such

change was observed in the hospitalized children from the reference (non-intervention) area.

There was no difference in the health infrastructure, health indicators, socio-demographic

characteristics of people living in the study area and rest of the district. Absence of any

significant change in timeliness of immunization in the children who were hospitalized from rest

of the district adds strength to the validity of the study findings. The interventions were planned

and implemented within the health infrastructure, therefore, the possibility of replication in

similar settings in other areas is higher. Moreover, there was hardly any chance of selection bias

in this study as only a few parents (0.7%) had refused participation.

Although the mean age for administration of 2nd and 3rd dose of DPT was lowered by

several weeks but the age for 1st DPT dose did not register a significant change among new

births cohort (post-intervention group). The delay in administration of 1st dose is due to a strong

cultural practice in the study area; pregnant women go to their parental house for delivering the

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first baby and return when the baby is about two month old. Health workers usually administer

vaccine only to the resident population for avoiding the drop out. A policy decision at the state

level is required so that irrespective of place of residence clients can access immunization at

place of migration also. Mothers should also be encouraged to get the child vaccinated wherever

the baby is delivered. It was difficult to administer the vaccine at the age specified in the

immunization schedule because outreach immunization sessions are held only once a month in

each village, which if missed, pushes up the age for initiation and subsequent immunization by

another month. The real impact of program interventions could be seen only in the sixth

immunization cohorts since all interventions could not be administered at a single point of time.

Complete implementation of intervention package was possible only in the third quarter of the

starting year (table 1).

This study was conducted in an area which had overall high rates of immunization

coverage by 12 months of age. Hence, similar results may not be achieved in areas which have

low immunization coverage rates. However, this does not preclude that the planning and

management intervention evolved in this study are not applicable to other areas, we believe that

these interventions would lead to enhanced immunization coverage first, followed by improved

timeliness. This is supported by WHO/UNICEF Global Immunisation and Vision Strategies

(GIVS) which recommend similar interventions 30 in both low and high income settings 31-33

This study demonstrates that decentralized planning and management improves program

performance which has major policy implications for various health programs. The role played

by CVs assumes importance considering the innovative cadre of Accredited Social Health

Activists (ASHA) introduced in India under the National Rural Health Mission (NRHM) 34. The

educational qualification and roles of these village-based volunteers are similar to that of CVs in

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the present study. There is a renewed interest worldwide in the potential contribution which

community-based health workers can make in programs related to child survival 35. Their role is

especially pertinent where human resources are most lacking. Community-based workers are a

feasible and cost effective option and have the potential of reducing inequity by preferentially

reaching the poorest 36.

This study also has a major bearing on Government of India’s recent health sector

reforms of decentralization and devolution of administrative and financial powers under NRHM;

which provide flexibility at the district level and below for hiring staff on contract including

MPHW(F) and ASHA to meet demand for services. Local village level people can also be hired

to transport vaccine from the place of storage to the venue of outreach immunization session.

These recent initiatives are likely to increase overall and age-appropriate immunization coverage.

16

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Table 1: Timeline of interventions for strengthening age appropriate immunization coverage

Time period Interventions

June 2005 Community Volunteers and Field Supervisors recruitment and training

August-October 2005 Trainings and continuing education for medical officers of Primary Health Centers (PHCs), and Multi-Purpose Health Workers (MPHWs) and Anganwadi Workers (AWWs)

September-October 2005 Situational analysis of immunization program

November 2005 Feedback of results to district health authorities, PHC and subcentre staff. Action plan drawn through participatory planning approach

November 2005-May2006 Micro-planning at PHC level

Intensive monitoring of immunization program

Monthly feedback of performance

December 2005 Recruitment of additional female MPHWs and vaccinators by district health authorities to fill vacant positions

21

Table 2: Trend of age appropriate immunization with intervention package in six quarterly immunization cohorts Time period

Children immunized Mean age in days (SD) Mean days gap between DPT doses (SD)

DPT1 DPT2 DPT3

DPT1*

DPT2* DPT3* DPT1-2*

DPT2-3*

Jul-Sep 2005

919 754 766 82.5 (58.4) 129.9 (66.9)

190.3 (86.2)

52.5 (39.4)

65.6 (54.8)

Oct-Dec 2005

1155 1107 1035 79 (62.6) 129.2 (69.6)

191.2 (91.2)

50.2 (40.2)

57.5 (51.1)

Jan-Mar 2006

978 1096 1174 71.4 (59.1) 123.3 (81.8)

164.3 (90.2)

42.3 (43.3)

55.5 (39.4)

Apr-Jun 2006

761 789 813 68.8 (44.4) 116.9 (69.7)

169.6 (89.6)

50 (49.6)

51.9 (41.1)

Jul-Sep 2006

822 822 888 73.4 (55.6) 121.9 (58.8)

175.9 (82.9)

50.4 (38.8)

52.9 (47.9)

Oct-Dec 2006

1035 979 855 65.2 (33.2) 108.5 (52)

156.1 (63.3)

43.4 (37.2)

42.3 (27.2)

* p < 0.0001 (trend)

22

Figure 1: Age appropriate coverage for DPT doses in six quarterly immunization cohorts

30

40

50

60

70

80

Jul-Sep'05 Oct-Dec'05 Jan-Mar'06 Apr-Jun'06 Jul-Sep'06 Oct-Dec'06

Immunization cohort

DP

T d

ose

co

vera

ge (

%)

Birth-DPT1 gap <60 days* DPT1-2 gap <35 days* DPT2-3 gap <35 days*

* p (trend)< 0.0001