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

1. Translating Research into Policy: Rapid Diagnostic Tests (RDTs) for Malaria in Uganda Helen Counihan Malaria Consortium June 2007

2. Malaria Consortium in Uganda Malaria 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

3. 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

4. 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

5. 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

6. 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

7. Evidence on RDTs from Uganda:1. Epicentre/MSF studies Mbarara 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

8. 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

9. UMSP Study Results: PPV • 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

10. UMSP Study Results: NPV • 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

11. 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

12. MC Study Results

13. 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

14. Key recommendations for Uganda • HRP2 based tests recommended for Uganda • Modify policy framework to promote parasitological-based diagnosis for >5s and appropriate management of negative results • Training and guidelines with job aids in place before introduction of RDTs • Implementation phased starting in low-to-moderate transmission areas in health posts and health centres without microscopy

15. Key recommendations for Uganda (cont) • Community sensitisation about RDTs needed • Initiation of community level use of RDTs piloted for feasibility, safety and acceptability • National Drug Authority responsible for quality assurance • Operational research to continue

16. 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