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Answering key questions on malaria drug delivery: 8 years of research


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Presentation by David Schellenberg
Director, ACT Consortium
Professor of Malaria & International Health at London School of Hygiene & Tropical Medicine

Published in: Healthcare
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Answering key questions on malaria drug delivery: 8 years of research

  1. 1. Prof David Schellenberg London School of Hygiene & Tropical Medicine
  2. 2. Prof David Schellenberg London School of Hygiene & Tropical Medicine
  3. 3. Prof David Schellenberg London School of Hygiene & Tropical Medicine
  4. 4. The ACT Consortium Goal: Develop and evaluate mechanisms to improve ACT delivery ACCESS TARGETING SAFETY QUALITY Formative research, cluster randomised trials, cohort and descriptive studies, impact evaluations, economic and anthropological studiesACT Consortium 2007-2016 25 projects 10 countries 20+ institutions What is ACT? •Artemisinin-based Combination Treatment •The recommended treatment for uncomplicated malaria caused by Plasmodium falciparum
  5. 5. ACT now for a malaria-free world
  6. 6. 6 Access to ACT among African children <5 years with confirmed malaria WHO World Malaria Report 2014
  7. 7. Getting ACTs to people who need them Appropriate diagnostic strategies are needed wherever patients seek care
  8. 8. The Private Sector Pharmacies, shops, mobile street vendors Most malaria treatments are obtained from the private sector in some countries • Eg DRC 85%, Nigeria 95% • Nigeria + DRC had 1/3 of all African malaria cases in 2006 Subsidies for ACTs can enhance access • E.g. novel financing mechanisms such as the Affordable Medicines Facility for malaria (AMFm)
  9. 9. A Balancing Act ACCESS TARGETING
  10. 10. 10 Targeting of ACTs Private retail sector, Tanzania Briggs M et al (2014) PLoS ONE 9(4): e94074. Fever patients attending private retail outlets in Tanzania • 70% of those infected did not get ACTs • 80% of those receiving ACTs were not infected
  11. 11. 11 The need for targeting ACTs: Tanzanian Health Facilities Low prevalence (Mbeya) Medium prevalence (Mwanza) No diagnostic testing Medium prevalence (Mtwara)
  12. 12. 12 The Goal
  13. 13. 13 Rapid Diagnostic Tests (RDTs) Point of care diagnostic No laboratory or electricity needed, minimum training Based on antigen capture: 2 main types • HRP-2 – persists (weeks) after cure • LDH – negative ~2 days after cure
  14. 14. Access & Targeting Studies 1. UGANDA Public health facilities (part of HF ‘enhancement’ trial) 2.+3. UGANDA HBMF Drug shops (comparing with no RDT) 4. TANZANIA Public health facilities (Observing MoH scale-up) 7. ZANZIBAR Public health facilities (observational) 6. AFGHANISTAN Public health facilities (IRT & cluster trials of RDT vs standard care) 9. TANZANIA Public health facilities (+peer group training; patient intervention) 8. GHANA Public health facilities (observational safety & health outcomes) 15. GHANA Public health facilities (IRT RDT vs standard) 5a. CAMEROON Public health facilities (enhanced training) 5b. NIGERIA Public & Private (enhanced training; community intervention) IRT = Individually Randomised Trial
  15. 15. Ugandan community health workers, RDTs & ACTs Control group: Symptom-based diagnosis Intervention group: RDT-guided treatment High Transmission Low Transmission no ACT
  16. 16. 16 Antibiotic prescription by RDT result RDTs available Positive Negative Not tested * * * 0 10 20 30 40 50 60 70 80 90 100 Percentage RDT arms Positive 0 10 20 30 40 50 60 70 80 90 100 Percentage RDT arms Negative 0 10 20 30 40 50 60 70 80 90 100 Percentage RDT arms Not tested
  17. 17. Mapping causes of non-malaria febrile illness in malaria-endemic areas A collaboration with WWARN/Oxford and several other partners
  18. 18. 18 ACT Consortium research: Our 25 studies in 10 countries address ACT: Access Targeting Safety Quality
  19. 19. Drug Safety Individual trials are often insufficiently powered to detect rare side effects With widespread programmatic implementation of ACTs, need to consolidate safety profiles ACT Consortium studies sought to address questions on: •High-risk groups including children subjected to repeat dosing •Safety in people with HIV, including those on anti-retrovirals
  20. 20. Data Capture Tools • Formative research to develop a range of tools – Non-clinician & clinicians – Active follow-up & spontaneous reports – Adults & children
  21. 21. Data flow in drug safety repository Signal Detection (Data Mining Tool) Centralised Safety Database ADR repository Additional Participant data I D SAEs/AEs Data Entry Additional denominator data Liverpool SG/CSP DSR Liverpool Send electronically or by fax on continuous basis Descriptive analysis & signal investigation/ confirmation Batch Data Upload at pre-defined intervals ACT Ex Com m Assessment for causality, severity, coding (MedDRA, WHO) Research sites (direct or via PV co- ordinator) Conversion of trial files to compatible file format Data output (emerging signals) DSMB s PIs Reports Dissemination DSMB/ Sponsor No new safety concerns have been identified Safety repository is available for wider use
  22. 22. Future work on drug safety Online resource for pharmacovigilance work in collaboration with The Global Health Network (TGHN) •Link to safety reports and tools from ACT Consortium and other sites with open-access material relevant for global community •Invite experts for interviews, topical discussions •Survey membership to inform further resources Website launch planned for May 2016 • Review training opportunities & identify eLearning needs, for collaborative development
  23. 23. 23 ACT Consortium research: Our 25 studies in 10 countries address ACT: Access Targeting Safety Quality
  24. 24. Fake antimalarials? Can health professionals and patients assume that the medicines that they are prescribing and taking are of good quality?
  25. 25. 10,000 packets of ACTs 3 independent laboratories 6 endemic countries RESULTS Country (date of sampling) Brands Falsified Substandard Rwanda (2008) 1 0 found 6.2% Cambodia (2010) 21 0 found 31.3% Ghana-Kintampo (2011) 31 0 found 37.0% Tanzania (2010) 37 0 found 12.0% Tanzania (2011) 46 0 found 2.2% Nigeria-Enugu Metropolis (2013) 131 1.2% 6.6% Nigeria-Ilorin city (2013) 77 0.8% 7.7% Equatorial Guinea-Bioko Island (2014) 142 7.4% 1.6%
  26. 26. Distribution of Active Pharmaceutical Ingredients (APIs) in ACTs in Tanzania Compared with stated amount, one or more APIs outside 85-115% for 12.1% samples (30.6% outside 90-110%) %ofantimalarials Active Pharmaceutical Ingredient (%) Am J Trop Med Hyg 2015: doi:10.4269/ajtmh.14-0544
  27. 27. Process Evaluations in Operational Research If a strategy doesn’t work, make sure the evaluation can show where it broke down. If it does work, identify components critical to success! A B L A C K B O X
  28. 28. 29 RESOURCES ●Resources in English, French and Portuguese
  29. 29. 30 Please send questions & comments to #actdiagnosis @ACTconsortium
  30. 30. Our multidisciplinary teams developed, piloted, delivered & evaluated training resources… …now available to those responsible for developing health communication & training about malaria diagnosis & treatment
  31. 31. Listening to Your Audience: Qualitative Research in Malaria Interventions Dr Clare Chandler