Expanding Access to Treatment Through Community-Health Worker Initiatives: Trends and Implications

1. Expanding Access To Treatment Through Community-health worker Initiatives:An update on evolving trends George Jagoe, Global Access TeamMedicines for Malaria Venture A Presentation to The All-Party Parliamentary Group on Malaria and Neglected Tropical Diseases (APPMG)November 10, 2009

2. 10 second reminder about MMV – our portfolio of drugs in discovery and development in 3Q 2009

3. What are the implications of expanding community-based management of malaria as improved treatments become available? • Why It Matters 1: • “Current evidence suggests that most of those who need the drugs do not get them.” • “It is essential that as much effort is put into investigating new ways of delivering drugs to those who need them, as has gone into developing the drugs in the first place.” • “At present, in much of Africa, it is possible to target most activities (eg HMM) to children under five years of age and pregnant women.” • In most countries, HBMF is still in early stages of planning / implementation as a malaria case management strategy • We believe there is a lack of comprehensive knowledge about existing and planned HBMF activities at the country level • There is general uncertainty about the potential to integrate new therapy options and formulations into HBMF programs 1 Malar J. 2008; 7(Suppl 1): S7. Published online 2008 December 11. doi: 10.1186/1475-2875-7-S1-S7.PMCID: PMC2604871 Deployment of ACT antimalarials for treatment of malaria: challenges and opportunities Christopher JM Whitty,1 Clare Chandler,1,2 Evelyn Ansah,3 Toby Leslie,1,4 and Sarah G Staedke1,5

4. HBMF is a bridge to expand access and increasingly to deliver quality ACTs HBMF Basics • Strategy developed by WHO based on studies supported by TDR – first published by WHO in 20051 • Concept: Community workers/volunteers deliver antimalarials to families directly in the home • Goal: improve access to life-saving medicines for people who currently lack adequate access • Intended target population: children <5 living in highly endemic rural areas in Africa, where most fevers can be presumed to be P. falciparum • Guiding assumption: Effective treatment, delivered at home by caregivers soon after symptoms appear, will reduce malaria morbidity and mortality with a very low cost–effectiveness ratio2 1 WHO (2005) The roll back malaria strategy for improving access to treatment through home management of malaria. World Health Organization, WHO/HTM/MAL/2005.1101 (http://whqlibdoc.who.int/hq/2005/WHO_HTM_MAL_2005.1101.pdf) 2 Pagnoni, Franco. “Malaria Treatment: No place like home”. Trends in Parasitology Vol.25 No.3, 2008.

5. HBMF has advanced through a series of research and pilots, and the approach continues to evolve Evolution of HBMF Programs and Research Focus CQ pilots ACT pilots RDT pilots Inclusion in ICCM Beginning in mid-2000’s Beginning in 2007-2008 Gaining focus in 2009-2010 1998 - 2003 Best-known: Burkina Faso, Ghana, Nigeria, Uganda E.g., Sudan, Zambia 17 countries (PSI/TDR, others) • Goal: • Evaluate the process by which HBMF can be effectively implemented in rural settings • Goal: • Determine whether ACTs can be appropriately distributed and used within existing HBMF structures • Goal: • Assess RDT quality • Determine whether CHWs can effectively utilize RDTs to distinguish cases requiring ACT treatment • Challenges identified: • Lack of compelling product • Community acceptance (esp. in absence of treatments for negative test results) • Potential for many false positives in endemic areas • Goal: • Integrate CHW-delivered community health activities • Provide range of treatments for all major childhood diseases • Challenges identified: • Lack of plan for expanding CHW training and managing drug supply • Should CHWs be trusted to manage multiple resistance-prone therapies (including antibiotics)? • Challenges identified: • Need for community buy-in • Importance of prepacking • CHW incentive structures and attrition rates • Need for simple training materials and re-training on ACTs CQ = chloroquine; ACT = artemisinin-based combination therapy; RDT = rapid diagnostic test; ICCM = integrated community case management

6. We are advocating for a country database of HBMF tracking – the seed has been planted

7. This data should track… • HBMF status classification • Details on HBMF programs/efforts • HBMF policy status • Context of HBMF programs – including use of RDTs and integration with IMCI • Key HBMF players (i.e., funders and implementers) • Current malaria treatment guidelines • Country demographics (e.g., % of population <5, % in rural areas) • Malaria incidence and burden (total incidence, incidence in >5, %<5 affected) • Government malaria expenditure (total and per-case) • Notes on resistance • Global Fund grants received (and amounts for HBMF, where available) • Notes on supply chain and private sector (where available) • Notes on CHW incentives (where available)

8. As of 2009, most countries have included HBMF in their national malaria control strategic plans However, the status of existing and planned HBMF initiatives is highly variable across countries, with few having achieved significant scale to date Some HBMF efforts discussed or planned* Some HBMF implementation No known HBMF efforts or plans to date HBMF using ACTs – pilot stages HBMF using ACTs – scaling up HBMF using ACTs + RDTs – pilot stages HMM using ACTs + RDTs – scaling up Status of HBMF Program Implementation Mauritania Mali Eritrea Senegal Niger Sudan Chad Djibouti Gambia Nigeria Guinea Bissau Somalia South Sudan Ethiopia CAR Cameroon Guinea BurkinaFaso Uganda Benin Kenya SierraLeone Rwanda Gabon DR Congo Burundi Congo Ghana Tanzania Liberia Zanzibar Togo Malawi Coted’Ivoire Comoros Angola Eq. Guinea Zambia Mozambique Madagascar Mauritius Namibia AL is current 1st line treatment in national guidelines Botswana Swaziland * E.g., mention in NMCP plan, request for funds in recent round of Global Fund or PMI (but details of implementation not known) Zimbabwe South Africa Lesotho Note: Refer to file “HBMF Countries database_Sept09.xls” for details and full citations.

9. HBMF appears to be a promising access mechanism, but efforts to scale up have been slow Success Stories Barriers to Scaling Up • The most successful HBMF programs have been established in countries that have simultaneously improved their other malaria control efforts • E.g., Zambia has built up traditional health facilities in parallel with a strong HBMF initiative • HBMF pilot research has demonstrated that CHWs can deliver correct treatment1 • Insufficient drug supply • E.g., due to Global Fund grant delays • Inability to retain and guide CHWs (motivation / incentives; supervision; monitoring) • Resulting training backlog • Lack of quality of care data in HBMF setting Result = scaling up process takes years and multiple rounds of funding 1 For example: Ajayi IO et al 2008; Tiono AB et al 2008

10. There are also questions about long-term HBMF viability Objections to HBMF • HBMF is a risky and wasteful approach to malaria control • Accelerates resistance due to lack of proper use / adherence • Wastes drug due to lack of diagnostic tool availability • HBMF cannot be scaled up • Long timelines, insufficient CHW retention will prevent programs from attaining substantial reach • HBMF may not be equally appropriate in all settings • Recently published evidence against use in urban areas1 • HBMF should be viewed as a stopgap measure • In the long run, countries should move AWAY from HBMF and toward the building of sustainable health infrastructure Addressing Objections • Pagnoni studies already suggest high adherence rates (84-94%); however, these were pilots • Future studies could compare compliance rates for treatment provided at home vs. in public health facilities • RDTs can be incorporated into HBMF strategy (will require more evidence) • HBMF should be applied in a targeted manner and is primarily appropriate for rural villages without alternative means of access to care 1 Staedke SG et al. “Home management of malaria with artemether-lumefantrine compared with standard care in urban Ugandan children: a randomised controlled trial.” Lancet. 2009 May 9;373(9675):1623-31. Epub 2009 Apr 9

11. Though some questions remain to be answered, HBMF is likely to be key to access going forward Outstanding Questions • Should RDTs be incorporated into home-based management? • Are HBMF efforts duplicating the work of ICCM programs? If so, how can they be integrated? • How can CHWs be appropriately motivated and rewarded for their work? • How (if at all) should HBMF programs address adult malaria cases? • How should funding and efforts to support HBMF be targeted – based on establishing health equity or health impact?

12. Acknowledgements Thanks to all the individuals who participated in this research, and to our research associate Susan Bobulsky who carried the ball on this effort! References: • World Bank programs • UNICEF programs • Ministry of Health websites • PMI country operating plans (2006-2009) • Global Fund proposals (Rounds 1-8) • WHO publications • UNICEF: Naawa Sipilanyambe • SFH: Uzo Gilpin • World Bank: Noel Chisaka • USAID: Larry Barat • UNICEF: Angus Spiers (planned) • WHO: Peter Olumese, Philipe Vanstraete • RBM: Richard Carr, Betty Udom, Jan Van Erps • WHO/TDR: Franco Pagnoni • WHO Pediatric Meds List: Suzanne Hill