A Presentation to The All-Party Parliamentary Group on Malaria

and Neglected Tropical Diseases (APPMG)

November 10, 2009

Expanding Access To Treatment Through Community-health

worker Initiatives:

An update on evolving trends

George Jagoe, Global Access TeamMedicines for Malaria Venture

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

What are the implications of expanding community-based management of malaria as improved treatments become available?

o In most countries, HBMF is still in early stages of planning / implementation as a malaria case management strategy

o We believe there is a lack of comprehensive knowledge about existing and planned HBMF activities at the country level

o 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

Why It Matters 1:

o “Current evidence suggests that most of those who need the drugs do not get them.”

o “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.”

o “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.”

HBMF is a bridge to expand access and increasingly to deliver quality ACTs

• 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

HBMF Basics

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.

HBMF has advanced through a series of research and pilots, and the approach continues to evolve

CQ pilots

ACT pilots

RDT pilots

Inclusion in ICCM

Evolution of HBMF Programs and Research Focus

• 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)?

1998 - 2003Beginning in mid-2000’s

Beginning in 2007-2008

Gaining focus in 2009-2010

CQ = chloroquine; ACT = artemisinin-based combination therapy; RDT = rapid diagnostic test; ICCM = integrated community case management

• 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

Best-known: Burkina Faso, Ghana, Nigeria, Uganda E.g., Sudan, Zambia 17 countries (PSI/TDR, others)

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

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)

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*

HBMF using ACTs – pilot stages

HMM using ACTs + RDTs – scaling up

Malawi

Some HBMF implementation

HBMF using ACTs – scaling up

Status of HBMF Program ImplementationNiger

Ghana

Ethiopia

KenyaUganda

Tanzania

ZambiaAngola

Namibia

South Africa

Mali

BurkinaFaso

Moz

ambi

que

Senegal

Zimbabwe

Botswana

DR Congo

Somalia

SudanChad

CAR

Gabon

Congo

Cameroon

Nigeria

BeninGuinea

SierraLeone

Liberia

Coted’Ivoire

TogoM

adag

asca

r

Zanzibar

Gambia

Rwanda

Mauritania

South Sudan

Eq. Guinea

Guinea Bissau

No known HBMF efforts or plans to date

* E.g., mention in NMCP plan, request for funds in recent round of Global Fund or PMI (but details of implementation not known)

Burundi

AL is current 1st line treatment in national guidelines

Comoros

HBMF using ACTs + RDTs – pilot stages

Djibouti

Eritrea

Mauritius

Swaziland

Lesotho

Note: Refer to file “HBMF Countries database_Sept09.xls” for details and full citations.

HBMF appears to be a promising access mechanism, but efforts to scale up have been slow

• 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

Success Stories Barriers to Scaling Up

1 For example: Ajayi IO et al 2008; Tiono AB et al 2008

Result = scaling up process takes years and multiple

rounds of funding

There are also questions about long-term HBMF viability

• 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

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

Objections to HBMF

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

Though some questions remain to be answered, HBMF is likely to be key to access going forward

• 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?

Outstanding Questions

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!

Activities Sources

Desk research

Interviews and discussions

Conference presentations

• 6th Annual ECTMIH (Verona, Italy)

• PMI country operating plans (2006-2009)• Global Fund proposals (Rounds 1-8)• WHO publications

• World Bank programs• UNICEF programs• Ministry of Health websites

• WHO: Peter Olumese, Philipe Vanstraete• RBM: Richard Carr, Betty Udom, Jan Van

Erps• WHO/TDR: Franco Pagnoni• WHO Pediatric Meds List: Suzanne Hill

• UNICEF: Naawa Sipilanyambe• SFH: Uzo Gilpin• World Bank: Noel Chisaka• USAID: Larry Barat• UNICEF: Angus Spiers (planned)

References: