MANABE HIV 2010 - GLOBE Network · Kiryandongo Kamwezi KIhihi Aboke Apac Aduku Aber Buwenge Mukujju Mulanda Bugembe ... • QA/QC for 45 Districts by 2013. Impact: JUMP …

Field ExperiencesAccordia Global Health Foundation,

Infectious Diseases Institute

September 17, 2010

Accordia Global Health Foundation

• Bring together global resources to

fight infectious disease in Africa

• Strengthen in-country capabilities to

offer health training, research,

prevention, and care

• Create evidence-based models that

are immediately relevant in resource-

limited settings and can be replicated

throughout Africa

Infectious Diseases Institute

• Established in 2004

• Public Private Partnership (Makerere

University owned NGO) with major

support from Pfizer

• 3 major programs: Research,

Training, Prevention Care Treatment

• CAP certified core laboratory

• Translational diagnostics laboratory

The Continuum: Diagnostics Research to Practice

Research (Rapid, POC, new

products)

Clondiag CD4Urinary LAM

TB Diagnostics

Impact(On-site

supervision)

Monitoring & evaluation

Rx consistent with national policy

Core Lab Validation

Validation against other known

approved test

Testing methodology (sequential vs

parallel)

Quality Management Plan

(QA/QC)Sustainability

Outcomes(Field

Implementation)

Team approach to malaria case management

Rational use of lab testing

Diagnosis based medical

management (rational drug use)Accountability for

outcomes (surveillance & data

management)

Research: PIMA CD4 Point-of Care Testing

• Absolute CD4 in whole blood

• Cartridge: integrated capillary for

5 µl blood, dried reagents

• Disposable, no instrument contact

with blood

• Portable size, battery pack

Diagnostic Research Trial at IDI

• Venous PIMA vs

venous FACScaliber

• PIMA consistently

slightly lower, but

good agreement

(Passing-Bablok)

Diagnostic Research Trial at IDI• Capillary PIMA vs

venous FACScaliber

• PIMA consistently

slightly lower, outliers

(Passing-Bablok)

• Method correlation 0.93

• Mean bias -68.5 cell/µL

ranging from -12.2 (for

the 0-200 cell/µL

range) to -121.7 cell/µL

(for the >500 cell/µL

range)


• Capillary PIMA vs venous PIMA (Bland Altman)


• Capillary PIMA vs

venous PIMA

• Capillary PIMA with

more frequent

outliers (Passing-

Bablok)

• Led to modification

of the EDTA and

capillary part of the

cartridge

Lateral Flow Urinary LAM TB Diagnostic

• Results in 25 minutes

• ELISA results promising in smear(-), HIV(+),

CD4<200 cells/µl (problematic population)

• Urine based, non-invasive

• Room temperature storage, easy transport

• Individualized foil strip packaging

• Inbuilt procedural control

Research: Urinary LAM Test Procedure

• 500 TB suspects

diagnostic trial just initiated

at IDI

• Broad definition of TB

suspect in HIV(+) (fever,

weight loss)

• Comparison to ELISA LAM

and TB sputum and blood

culture gold standards

The Continuum: Research to Practice


products)


TB Diagnostics

Impact(On-site

supervision)



Core Lab Validation


approved test


parallel)



Outcomes(Field

Implementation)






management)

• Makerere University-Johns Hopkins University

collaboration since 1989

• Supports clinical trials

• College of American Pathologists certified as well

as UK NEQAS, VQA

• 40 qualified professionals

• Validation of all tests offered on test menu

MU-JHU Clinical Core Lab

• Parallel vs sequential HIV rapid testing

• Validation of all tests offered on test menu

• Maintains a high QA/QC standard with continuous

quality improvement

• Sustainable model for high quality lab testing

– Cost per test includes technical cost, reagent, supply

chain, management, QA/QC, and capital replacement

– Not for profit


Elbireer et al. Lab Medicine 2010 41:429-433


MLO Lab of the Year 2010: First Runner Up



products)


TB Diagnostics

Impact(On-site

supervision)



Core Lab Validation


approved test


parallel)



Outcomes(Field

Implementation)






management)

Outcomes: Joint Ugandan Malaria Program

• Accordia initiative with financial

support from ExxonMobil

• Partnership beginning 2006

– IDI, Uganda Malaria Surveillance Project

(UMSP), MU-UCSF malaria Research

collaboration, National Malaria control

program of Ministry of Health

JUMP

• Integrated management

• On-site training

• Team approach (clinicians, lab and records staff)

• Training on smear microscopy and rapid diagnostic

tests for fever

• Test diagnosis-based targeted treatment

• Avoids misdiagnosis, overuse of antimalarials, and

delays in treatment of other illnesses

Akokoro

Omugo

KasambyaIganga

WalukubaKyenjojo

Kabale

Nagongera

Kiryandongo

Kamwezi

KIhihi

Aboke

Apac

Aduku

Aber

BuwengeMukujju

Mulanda

Bugembe

Ogur

Amac

AlebtongAnyeke

Orum

Kibalinga & Butawata HCII

Wakitaka & Megamaga

Paya & Kisoko HCW

KisoroDistrict HCW

Rukungiri District HCIIs

OliAdumi

Aroi

NebbiPakwach

St Paul

Kilembe

Exxon Cascade IMM sitesExxon RDT sites

Exxon IMM Sites trained at IDI

PMI IMM Sites trained at IDI

IDRC RDT sitesWHO RDT sites

The whole district

The whole districtWas trained The whole

district was trained



products)


TB Diagnostics

Impact(On-site

supervision)



Core Lab Validation


approved test


parallel)



Outcomes(Field

Implementation)






management)

Impact: JUMP On-Site Follow-Up

• Developed a monitoring and evaluation system that

demonstrates the impact of training and capacity

building on improved case management for malaria at

health facility level

• Improved surveillance systems and data collection in

the target health facilities.

• QA/QC for 45 Districts by 2013


Indicator Baseline 6 wks ARR(CI) 12 wks ARR(CI)

Proper Hx 20% 42% 1.41

(0.48-2.35)

60% 2.71

(1.54-3.88)

Proper PE 18% 57% 1.94

(1.18-2.71)

82% 3.28

(2.30-4.26)

Correct Dx 47% 96% 3.41

(2.03-4.78)

97% 3.66

(2.05-5.26)

C/W Nat’l

Policy

42% 86% 2.27

(1.51-3.05)

92% 2.96

(1.94-3.97)

Adequate pt

education

17% 83% 4.36

(2.71-6.02)

87% 4.68

(2.92-6.44)


Indicator Baseline 6 wks 12 wks

%BS prepared correctly 22% 67% 63%

%BS read correctly 49% 71% 70%

%(+)BS read correctly 49% 71% 70%

%(-)BS read correctly 72% 77% 91%

Ssekabira Am J Trop Med Hyg, Dec 2008; 79: 826 - 833

Impact of RDT training intervention

on antimalarial prescribing

*Generalized estimating equations controlling for history of fever and age, adjustment for repeated measures on the same day.

Site

Relative change in proportion of

patients prescribed antimalarialAntimalarial

doses saved per

1000 patientsRR (95% CI)* p-value

Mubende 0.32 (0.29 – 0.36) <0.001 420

Jinja 0.44 (0.39 – 0.50) <0.001 358

Tororo 0.73 (0.70 – 0.77) <0.001 183

Conclusions: Diagnostics Research to Practice

• Accordia Global Health Foundation through the IDI has

participated in the continuum of diagnostics from

research, clinical core lab validation and field

implementation.

• Innovative post-training on-site supervision has led to

sustainable, high quality testing that influences clinical

decision making

• Has moved empiric algorithm-based treatment to rapid

test-confirmed diagnoses with targeted treatment

Acknowledgements

• IDI /Accordia

• Alex Coutinho, ED IDI

• Carol Spahn, ED Accordia

• Lydia Mpanga Sebuyira

• Umaru Ssekabira

• Kelly Willis

• MU-JHU Core laboratory

• Clondiag – Ralf Lalburger

• TB-CDRC – Jerrold Ellner, Susan Dorman

Documents

MANABE HIV 2010 - GLOBE Network · Kiryandongo Kamwezi KIhihi Aboke Apac Aduku Aber Buwenge Mukujju Mulanda Bugembe ... • QA/QC for 45 Districts by 2013. Impact: JUMP …