Translating Research into Policy: Rapid Diagnostic Tests (RDTs) for Malaria in Uganda

Helen Counihan

Malaria Consortium

June 2007

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Malaria Consortium in UgandaMalaria Consortium is: An implementing agency Works mainly in partnership with National Control

Programmes and at international policy level Has the Africa Regional Office and many

programmes in Uganda

Objective:This presentation is on work on RDTs in Uganda to

demonstrate process of translating research into policy

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Introduction: Malaria diagnosis There is need for accurate diagnosis with advent of

artemisinin-based combination therapies (ACTs) for malaria: cost, resistance, quality of care

Diagnostic methods Clinical: over-treatment, missing true diagnosis Microscopy: infrastructure, training, quality

assurance, still gold standard Rapid diagnostic tests: quick, relatively easy

All 3 methods have limitations, need to understand when and where to use each one

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Introduction: types of Rapid Diagnostic Test (RDT) HRP2 (histidine-rich protein II) pLDH (Plasmodium lactate dehydrogenase)

Strengths/weaknesses: HRP2 is very heat stable but cannot diagnose non-

falciparum species and has prolonged positivity after successful treatment which can last weeks –

pLDH generally less heat stable but returns to negative rapidly after treatment

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RDTs in Uganda: need for research Uganda has areas of varying malaria

endemicity from very high to low transmission, predominantly P. falciparum

Most research on RDTs done in Asia and South America

Both HRP2 and pLDH tests are available in Uganda with very little regulation

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RDTs in Uganda: Communication vacuum

National Malaria Control Programme (NMCP) started developing policy for RDT use in late 2006 but without using evidence from Uganda

Many research studies already completed in Uganda but results do not always reach NMCP

Evidence on RDTs from Uganda:1. Epicentre/MSF studiesMbarara 2002: 5 different RDTs, all HRP2,

found Paracheck best

Mbarara 2005: 4 different RDTs,

3 pLDH and 1 HRP2 (Paracheck),

pLDH test (Carestart) equal in sensitivity and

specificity to Paracheck but returned to negative much more rapidly

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2. Uganda Malaria Surveillance Project (UMSP): Study on RDTs (2006-7) Evaluation of different diagnostic methods for

malaria 1000 consecutive patients at each of 7 UMSP

sites Blood smear for expert microscopy HRP2 RDT - Paracheck pLDH RDT – Parabank Blood collected on filter paper for PCR

Gold standard expert microscopy corrected by PCR for P. falciparum

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UMSP Study Results: PPV

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• Microscopy and pLDH: PPV excellent for all ages at all the sites

• HRP2: PPV poor at lowest transmission site but pretty good at other sites

• Compared to other tests, HRP2 will give positive results in a few more patients who don’t have malaria

• Microscopy and pLDH: NPV worsens with ↑ transmission and younger ages

• HRP2: NPV excellent for all ages at all the sites

• Compared to HRP2, microscopy and pLDH miss an increasing number of sub-patent parasitemia cases according to age and transmission intensity

UMSP Study Results: NPV

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3. Malaria Consortium (MC) Study - ongoing Response to question from NMCP re most suitable

test for Uganda Discussed requirements with NMCP, performed a

situation analysis including availability, cost, suitability and ease-of-use

Assessed a HRP2 test ICT (SA) in Soroti, holoendemic area

Measured sensitivity and specificity compared to microscopy

Currently assessing prolonged positivity

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MC Study Results

Result Below 5yr (%)n=163

Above 5 yr(%)n=194

Sensitivity (true +Ve) 98 98

Specificity (true –Ve) 54 74

PPV 78 50

NPV 94 99

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What to do with this information? What does it mean? What choices need to be made? The MC became aware that NMCP needed to be

informed of the research results on RDTs The MC organised a workshop with WHO with

international experts, researchers and MoH Two days in Kampala, including presentations and

discussions on research in Uganda and other countries

Resulting in specific recommendations for Uganda as requested by NMCP

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Key recommendations for Uganda1. HRP2 based tests recommended for

Uganda

2. Modify policy framework to promote parasitological-based diagnosis for >5s and appropriate management of negative results

3. Training and guidelines with job aids in place before introduction of RDTs

4. Implementation phased starting in low-to-moderate transmission areas in health posts and health centres without microscopy

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Key recommendations for Uganda (cont)

5. Community sensitisation about RDTs needed

6. Initiation of community level use of RDTs piloted for feasibility, safety and acceptability

7. National Drug Authority responsible for quality assurance

8. Operational research to continue

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Lessons learnt on research into policy Important to develop policies that are evidence-

based Need to have good communication between

researchers and policy-makers (and researcher and researcher!)

NMCPs should be involved in research choices at beginning

Resources big influence on policy - research on cost-effectiveness vital

Once policy is set there is a need for ongoing research to ensure best quality practice

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