Feasibility and acceptability of artemisinin-based combination therapy for the home management of malaria in four African sites

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Abstract

Background

The Home Management of Malaria (HMM) strategy was developed using chloroquine, a now obsolete drug, which has been replaced by artemisinin-based combination therapy (ACT) in health facility settings. Incorporation of ACT in HMM would greatly expand access to effective antimalarial therapy by the populations living in underserved areas in malaria endemic countries. The feasibility and acceptability of incorporating ACT in HMM needs to be evaluated.

Methods

A multi-country study was performed in four district-size sites in Ghana (two sites), Nigeria and Uganda, with populations ranging between 38,000 and 60,000. Community medicine distributors (CMDs) were trained in each village to dispense pre-packaged ACT to febrile children aged 6–59 months, after exclusion of danger signs. A community mobilization campaign accompanied the programme. Artesunate-amodiaquine (AA) was used in Ghana and artemether-lumefantrine (AL) in Nigeria and Uganda. Harmonized qualitative and quantitative data collection methods were used to evaluate CMD performance, caregiver adherence and treatment coverage of febrile children with ACTs obtained from CMDs.

Results

Some 20,000 fever episodes in young children were treated with ACT by CMDs across the four study sites. Cross-sectional surveys identified 2,190 children with fever in the two preceding weeks, of whom 1,289 (59%) were reported to have received ACT from a CMD. Coverage varied from 52% in Nigeria to 75% in Ho District, Ghana. Coverage rates did not appear to vary greatly with the age of the child or with the educational level of the caregiver. A very high proportion of children were reported to have received the first dose on the day of onset or the next day in all four sites (range 86–97%, average 90%). The proportion of children correctly treated in terms of dose and duration was also high (range 74–97%, average 85%). Overall, the proportion of febrile children who received prompt treatment and the correct dose for the assigned duration of treatment ranged from 71% to 87% (average 77%). Almost all caregivers perceived ACT to be effective, and no severe adverse events were reported.

Conclusion

ACTs can be successfully integrated into the HMM strategy.

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Most cited references 22

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Teaching mothers to provide home treatment of malaria in Tigray, Ethiopia: a randomised trial.

Gary R. Morrow, Asmeret G Kidane (2000)

No satisfactory strategy for reducing high child mortality from malaria has yet been established in tropical Africa. We compared the effect on under-5 mortality of teaching mothers to promptly provide antimalarials to their sick children at home, with the present community health worker approach. Of 37 tabias (cluster of villages) in two districts with hyperendemic to holoendemic malaria, tabias reported to have the highest malaria morbidity were selected. A census was done which included a maternity history to determine under-5 mortality. Tabias (population 70,506) were paired according to under-5 mortality rates. One tabia from each pair was allocated by random number to an intervention group and the other was allocated to the control group. In the intervention tabias, mother coordinators were trained to teach other local mothers to recognise symptoms of malaria in their children and to promptly give chloroquine. In both intervention and control tabias, all births and deaths of under-5s were recorded monthly. From January to December 1997, 190 of 6383 (29.8 per 1000) children under-5 died in the intervention tabias compared with 366 of 7294 (50.2 per 1000) in the control tabias. Under-5 mortality was reduced by 40% in the intervention localities (95% CI from 29.2-50.6; paired t test, p<0.003). For every third child who died, a structured verbal autopsy was undertaken to ascribe cause of mortality as consistent with malaria or possible malaria, or not consistent with malaria. Of the 190 verbal autopsies, 13 (19%) of 70 in the intervention tabias were consistent with possible malaria compared with 68 (57%) of 120 in the control tabias. A major reduction in under-5 mortality can be achieved in holoendemic malaria areas through training local mother coordinators to teach mothers to give under-5 children antimalarial drugs.

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Amodiaquine alone, amodiaquine+sulfadoxine-pyrimethamine, amodiaquine+artesunate, and artemether-lumefantrine for outpatient treatment of malaria in Tanzanian children: a four-arm randomised effectiveness trial.

Theonest K. Mutabingwa, Devota Anthony, Archie Heller … (2005)

Many countries in Africa are considering a change to combination treatment for falciparum malaria because of the increase in drug resistance. However, there are few effectiveness data for these combinations. Our aim was to study the effectiveness of three drug combinations that have proven efficacious in east Africa compared with amodiaquine monotherapy. We undertook a randomised trial of antimalarial drug combinations for children (aged 4-59 months) with uncomplicated malaria in Muheza, Tanzania, an area with a high prevalence of resistance to sulfadoxine-pyrimethamine and chloroquine. Children were randomly allocated 3 days of amodiaquine (n=270), amodiaquine +sulfadoxine-pyrimethamine (n=507), or amodiaquine+artesunate (n=515), or a 3-day six-dose regimen of artemether-lumefantrine (n=519). Drugs were taken orally, at home, unobserved by medical staff. The primary endpoint was parasitological failure by day 14 assessed blind to treatment allocation. Secondary endpoints included day 28 follow-up and gametocyte carriage. Analysis was by intention to treat. Of 3158 children screened, 1811 were randomly assigned treatment and 1717 (95%) reached the 14-day follow-up. The amodiaquine group was stopped early by the data and safety monitoring board. By day 14, the parasitological failure rates were 103 of 248 (42%) for amodiaquine, 97 of 476 (20%) for amodiaquine+sulfadoxine-pyrimethamine, 54 of 491 (11%) for amodiaquine+artesunate, and seven of 502 (1%) for artemether-lumefantrine. By day 28, the parasitological failure rates were 182 of 239 (76%), 282 of 476 (61%), 193 of 472 (40%), and 103 of 485 (21%), respectively. The difference between individual treatment groups and the next best treatment combination was significant (p<0.001) in every case. Recrudescence rates by day 28, after correction by genotyping, were 48.4%, 34.5%, 11.2%, and 2.8%, respectively. The study shows how few the options are for treating malaria where there is already a high level of resistance to sulfadoxine-pyrimethamine and amodiaquine. The WHO-packaged six-dose regimen of artemether-lumefantrine is effective taken unsupervised, although cost is a major limitation.

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Artemisinin-based combination therapies (ACTs): best hope for malaria treatment but inaccessible to the needy!

T Mutabingwa (2005)

Artemisinin-based combination therapies (ACTs) are the best anti-malarial drugs available now. Artemisinin enhances efficacy and has the potential of lowering the rate at which resistance emerges and spreads. Under low transmission intensity, ACTs have an additional public health benefit of reducing the overall malaria transmission and studies are urgently needed to investigate modalities of attaining similar benefits under high transmission. Despite being recommended by WHO since 2001, overall deployment of ACT has been slow. Limiting factors are high cost, limited knowledge and public awareness on the concept of combination therapy (CT) and ACT in particular, limited knowledge on safety of ACTs in pregnancy, operational issue such as inappropriate drug use, lack of suitable drug formulations, lack of post-marketing surveillance (PMS) systems, and the imbalance between demand and supply. Through concerted efforts of multilateral organizations, the local scientific community with involvement of policy-makers progress has been on several fonts leading to improved ACT uptake rates in the last 2 years. Of 43 countries that had adopted ACT by February 2005, 18 (42%) adopted the policy in 2004. Preference to co-formulated Coartem has led to a surge in its demand with consequent shortage. Alternative ways for increased production of ACTs are urgently needed otherwise most policies will remain adopted on paper. Despite limitations, opportunities are opening up for effective malaria control. Insecticides, insecticide-treated nets (ITNs) and ACTs are proven efficacious controls available that should be accessed by many. Substantial funding is now available for biomedical malaria research and for policy implementation. While the Global Fund is the financial engine behind the scaling up of ACT uptake, delays in cash flow after grant approval has led to many countries adopting ACT in 2004 but only few (nine) implementing it. Clear policies on granted funds and minimal politics within funding agencies might improve the situation. Increased interest in drug development together with the public and private sector partnership have led to new anti-malarials, some less expensive and therefore affordable by poor malaria endemic countries. Dihydroartemisinin-piperaquine (Artekin) has a cost advantage over other ACTs (USD 1 for an adult treatment) making it a potential best candidate for deployment in Africa. Part of available funds should be invested into capacity building and strengthening (personnel, resources and infrastructure) of institutions in malaria endemic countries. This will create enabling environment and a critical mass of scientists and public health experts to spearhead ACT policy implementation. Active involvement of scientists from malaria endemic countries in recent International Scientific Forums like the Malaria in Pregnancy Working Group and the Consortium on ACT Implementation is the best way forward to emulate.

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Author and article information

Journal

Journal ID (nlm-ta): Malar J

Title: Malaria Journal

Publisher: BioMed Central

ISSN (Electronic): 1475-2875

Publication date Collection: 2008

Publication date (Electronic): 8 January 2008

Volume: 7

Page: 6

Affiliations

[1 ]Malaria Research Laboratories, Institute of Medical Research and Training, College of Medicine, University of Ibadan, Nigeria

[2 ]Department of Community Health, School of Medical Sciences, KNUST, Kumasi, Ghana

[3 ]Health Research Unit, Ghana Health Service, Accra, Ghana

[4 ]Department of Sociology, Makerere University, Kampala, Uganda

[5 ]Institute for Development Studies, College of Humanities and Social Studies, University of Nairobi, Nairobi, Kenya

[6 ]Infectious Diseases Epidemiology Unit, London School of Hygiene and Tropical Medicine, London, UK

[7 ]Implementation Research & Methods Unit, UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR), Geneva, Switzerland

Article

Publisher ID: 1475-2875-7-6

DOI: 10.1186/1475-2875-7-6

PMC ID: 2254635

PubMed ID: 18182114

SO-VID: 51b55bea-3465-4d2d-b0e5-6d1fac822080

License:

This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Feasibility and acceptability of artemisinin-based combination therapy for the home management of malaria in four African sites

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Most cited references 22

Teaching mothers to provide home treatment of malaria in Tigray, Ethiopia: a randomised trial.

Amodiaquine alone, amodiaquine+sulfadoxine-pyrimethamine, amodiaquine+artesunate, and artemether-lumefantrine for outpatient treatment of malaria in Tanzanian children: a four-arm randomised effectiveness trial.

Artemisinin-based combination therapies (ACTs): best hope for malaria treatment but inaccessible to the needy!

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