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Malaria treatment: no place like home
Opinion
Malaria treatment: no place like home Franco Pagnoni Special Programme for Research and Training in Tropical Diseases, World Health Organization, 20 Avenue Appia, CH 1211 Geneva 27, Switzerland
If the United Nations Millennium Development Goals are to be met, there is a need to improve access to effective antimalarial treatment where the burden of malaria is highest. Health facilities are often bypassed by communities, and inappropriate and poor-quality self-medication is common. The home management of malaria (HMM) strategy has been shown to have an effect on malaria morbidity and mortality in the chloroquine era, but several evidence gaps remain to be filled to confirm its value in the era of artemisinin-based combination therapies. Nevertheless, if a substantial reduction of the malaria burden is to be achieved, access to effective medicines has to be vastly improved, and in most of sub-Saharan Africa, this will have to be through HMM.
ment, delivered at home by caregivers (mostly mothers) soon after the appearance of symptoms, will result in a reduction in malaria morbidity and mortality [9] with a very low cost–effectiveness ratio [10,11]. However, although HMM has been promoted by WHO as a cornerstone of malaria control in Africa [1], researchers and policy-makers have not yet reached a full consensus on this strategy. This article will illustrate the potential of HMM and discuss the issues it raises. Although some evidence gaps remain to be addressed through operational research, scaling-up of HMM should not be delayed, and HMM should be regarded as a key public health strategy to expand coverage of effective antimalarial treatment and, thus, reduce the burden of the disease.
Current inadequacy of the African health system Malaria is a curable disease: prompt treatment with effective antimalarial therapy is a cornerstone of malaria control in sub-Saharan Africa [1]. However, in many areas, the capacity of the institutional health system to deliver a service of acceptable quality is limited by factors that include the lack of geographical access to health centres, inadequacy of health-care infrastructure and staffing, scarcity of affordable drugs and the poor performance of health personnel [2–5]. This is particularly evident in remote, rural areas in sub-Saharan Africa, where transmission of malaria is highest and where the majority of people at risk live. None of these factors has improved over the past decade. In spite of the important increase of resources from which health systems have benefited – external aid to low-income countries rose from US$ 6 billion in 2000 to US$ 16 billion in 2006, and government health expenditure per person in sub-Saharan Africa has increased by 30% since 2000 [6,7] – health facilities in the public sector remain underused and access to adequate care is still low among poor, underserved populations in most countries in sub-Saharan Africa [8]. As a result, the burden imposed by malaria is still intolerably high. The home management of malaria (HMM) strategy was developed by the World Health Organization (WHO), based largely on studies supported by the Special Programme for Research and Training on Tropical Diseases (TDR) [1], to alleviate this situation and improve access to life-saving medicines for people suffering from malaria. The strategy – originally designed for the treatment of children under the age of five years living in highly endemic rural areas in Africa, where a majority of fever cases can be presumed to be due to Plasmodium falciparum malaria – is based on the assumption that adequate treat-
HMM: improving treatment at home Faced with the inadequacy of the health system, many people seek to resolve their health problems at the household or village level, without recourse to formally trained health professionals, particularly for disease episodes perceived as mild [4]. A high proportion of presumed malaria episodes are treated at home, and self-medication is common. However, the treatment administered at home is often suboptimal in dosage and quality [12,13]; this is known to have harmful effects on the outcome of severe malaria [14] and to be an important factor in the selection of drug-resistant parasites [15,16]. HMM builds on the common practice of home treatment, with the aim of improving self-medication at household level.
Corresponding author: Pagnoni, F. ([email protected]).
HMM: the package HMM comprises three fundamental pillars: (i) the selection and training of community members as community medicine distributors (CMDs) to correctly dispense antimalarial medicines; (ii) an information, education and communication campaign to sensitize caregivers to the importance of adhering to the correct treatment schedule; and (iii) making effective antimalarial medicines available in every village, close to home, in unit-dosed and userfriendly blister packages. Whereas HMM is today a well-established term, use of the word ‘home’ has been, at times, misunderstood. The HMM strategy does not imply keeping antimalarial medicines at home, waiting for a disease episode to occur. Rather, ‘home’ means ‘close to home’, underlying the concept that antimalarial medicines must be available in the close vicinity, to avoid caregivers walking long distances to health facilities. Medicines are kept by trained CMDs, ready to be delivered on request to caregivers of sick children, accompanied by usage instructions and appropriate counselling (Figure 1). Also, ‘close to home’ includes
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Figure 1. Counselling and distribution of antimalarial drugs by a CMD. After having examined the child, a trained CMD in Ejisu-Juaben District, Ghana, discusses with the child’s mother how the antimalarial drugs should be used, including the importance of adhering to the treatment regimen. ß WHO/TDR/Franco Pagnoni.
the concept that antimalarial medicines must be available to households at an affordable cost, limiting the need for out-of-pocket expenses [17]. Thus, HMM aims to improve access to treatment both geographically and socioeconomically. Evidence gaps in HMM The impact of HMM on malaria mortality and severe morbidity was demonstrated in the late 1990s and early 2000 with the use of chloroquine. In Ethiopia, a programme to provide home treatment for malaria reduced all-cause mortality by 40% and malaria-specific mortality by 70% [18]; in Burkina Faso, prompt treatment of children with uncomplicated malaria with pre-packaged antimalarial drugs reduced progression to severe malaria by 25–50% [17,19]. Hopkins et al. [20], in a review of the impact of HMM on health outcomes, underlined the narrowness of the evidence base for HMM in Africa, particularly regarding use of artemisinin-based combination therapy (ACT). This is entirely correct; the few available studies all used chloroquine. The effect of HMM on malaria morbidity and mortality needs to be confirmed with use of ACT, possibly in different epidemiological settings, to inform policymakers about HMM as a large-scale malaria control intervention in endemic countries. However, the results of the review should not be considered as evidence against HMM because all three studies with mortality end-points that failed to show a positive impact were carried out in the 1980s and did not use pre-packaged antimalarial drugs, which are a key element in the HMM strategy. Several other evidence gaps need to be filled to confirm the validity of HMM in the era of ACT. Research groups, 116
including the ACT Consortium (http://www.lshtm.ac.uk/ news/2008/gatesfunding.html) and TDR (http://www. who.int/tdr/svc/research/antimalarial-policy-access) have launched studies to fill these gaps and address the concerns raised by some experts about the use of ACT in HMM [21–23]. The first evidence gap to be filled concerns the feasibility and acceptability of integrating ACT into the HMM strategy. Evidence for this has been provided in recent years, first from a pilot study in Ghana [24] and then from a multicentre study in four African sites supported by TDR [25]. These studies have shown that (i) CMDs are able to dispense ACT correctly (on average, 98% of the time); (ii) most caregivers adhere to treatment instructions in terms of dose, duration and promptness of care (on average, 77% of the time); and (iii) once HMM is made available to caregivers, a large proportion of sick children are treated through HMM (on average, 59%). The main findings of the multicentre study are summarized in Table 1. Another knowledge gap regards the effectiveness of ACT used in HMM. In this respect, encouraging data have been provided by another multicentre study in three subSaharan Africa sites supported by TDR [26]. The study showed PCR-adjusted cure rates of greater than 90% in all sites (varying from 90.9% in Nigeria to 97.2% in Uganda), thus adding to the evidence base for HMM as a public health strategy. Other important evidence gaps need to be addressed to support the much-needed expansion of access to effective antimalarial treatment through community-based medicine distribution [20,27]. These include conclusive demonstration of the safety and effectiveness of ACT used under
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Table 1. Feasibility and acceptability of ACT use in HMM in four African sitesa
Total number of febrile episodes in children less than five years of age treated with ACT by CMDs (from CMD registers) Number (%) correctly dosed Number of children with a fever episode in the previous two weeks (from household survey) Number (%) of episodes treated with ACT from a CMD (coverage) Number (%) correctly treated – dose and duration Number (%) treated promptly – receiving first dose on the same or next day Number (%) treated correctly and promptly
Totals
Ejisu-Juaben Ho District, Badeku and District, Ghana Ojoku/Ajia Ghana Districts, Nigeria 4522 3958 1044
Bugiri and Iganga Districts, Uganda 11 039
4473 (99%) 428
3900 (98%) 124
1019 (98%) 551
10 671 (97%) 20 063 (98%) 1087 2190
289 (68%) 281 (97%) 259 (90%)
93 (75%) 69 (74%) 89 (96%)
288 (52%) 256 (89%) 278 (97%)
619 (57%) 490 (79%) 531 (86%)
1289 (59%) 1096 (85%) 1157 (90%)
252 (87%)
69 (74%)
231 (80%)
438 (71%)
990 (77%)
20 563
a
Data from Ref. [25].
‘real-life’ conditions (which is particularly important for ACT to be available as an over-the-counter drug), the possibility of incorporating rapid diagnostic testing to avoid widespread presumptive use of ACT, the expansion of HMM to urban areas to take into account rapid urbanization in sub-Saharan Africa, the use of incentives to maintain CMDs’ performance and the engagement of the private sector in community-based medicine distribution. Improving malaria diagnosis to limit overuse of antimalarial medicines seems to be increasingly necessary because there is mounting evidence that malaria incidence is decreasing in areas with traditionally high levels because of effective control interventions [28] and because these interventions are being scaled up to decrease transmission in many parts of Africa [29]. A particular concern is that overuse of ACT, often without parasitological confirmation, could facilitate the appearance of parasite resistance to these precious medicines. Related to this, as previously mentioned, exposure to subtherapeutic drug levels is a major factor in the selection of resistant parasites [15,16]. In this respect, the high level of adherence to the correct treatment schedule by caregivers documented in a multicountry study [25] provides some reassurance. Further reassurance could come from the incorporation of rapid diagnostic testing in the HMM strategy. Many research groups have started studies on these topics, including the ACT Consortium, the Malaria Clinical Trials Alliance (http://www.indepth-network.net/mcta/mctaindex.htm), the Medicines for Malaria Venture Access Initiative (http://www.mmv.org/rubrique.php3?id_rubrique=142), the Malaria Consortium (http://www.malariaconsortium.org), the Clinton Foundation (http:// www.clintonfoundation.org/what-we-do/clinton-hiv-aidsinitiative/our-approach/access-programs/malaria), various academic groups and TDR. Some studies have been completed only recently and many are still under way. However, while fully recognizing the need to expand the evidence base for HMM in Africa, the current evidence enables HMM to move forwards, addressing knowledge gaps during implementation, rather than delaying the introduction of new interventions to those in need. HMM and the private sector Recently, the engagement of the private sector, formal and informal, to improve access to effective antimalarial treatment has been largely advocated because it is known that a
considerable proportion of the population in both urban and rural areas purchases drugs in the private sector [30]. Financing mechanisms, such as the Affordable Medicines Facility for Malaria (http://www.rbm.who.int/globalsubsidytaskforce.html), are under development to make effective antimalarial medicines available at affordable prices through the private sector, both formal and informal. HMM is usually considered to be a strategy belonging to the public sphere, however imprecise this classification might be, but there cannot be a truly considerable improvement of access to antimalarial medicines without a substantial engagement of the private sector. However, the risk is that the private sector and HMM delivery systems could compete, with one eventually prevailing over the other. It is crucial to avoid this happening. In fact, there is a need to leverage both distribution mechanisms, particularly in remote rural areas, where the distinction between a private medicine vendor and a CMD becomes very subtle. Strategies for medicine delivery through the private sector and HMM should be designed so that they are complementary to each other because the best use of all resources is necessary to improve access to effective medicines. In this respect, developing mechanisms to provide CMDs with adequate remuneration for their work and ensuring some uniformity of working conditions and incentives for all medicine providers at community level – public and private – is of crucial importance. Integrating HMM in the health system Addressing these evidence gaps in the implementation of HMM is a huge challenge for researchers working on HMM. In addition, advocates of HMM face strategic challenges. Until now, with only a few exceptions (e.g. Uganda and Rwanda), HMM has mostly been implemented at no higher than the district level. A key issue is whether HMM can be scaled up to large populations while maintaining sufficient quality and the desired impact [31]. Large-scale, continent-wide adoption of HMM would have substantial economic and public health implications, and some experts have raised concerns that it could divert resources from other public health programmes and investment in health facilities that could result in a similar, if not higher, impact on health outcomes (U. d’Alessandro, personal communication). Research in Tanzania has indicated that strengthening of peripheral health facilities has huge potential to improve health and survival at household level [32]. How117
Opinion ever, the contribution of community health workers to achieve child survival goals has also been documented [33], and there is a clear potential for integrating the service delivery system of HMM with that of other childhood diseases (e.g. pneumonia or diarrhoea) or malaria prophylaxis (e.g. intermittent preventive treatment for children). The value of community-directed interventions to provide treatment for a variety of diseases, including malaria, at the community level has been reaffirmed recently [34]. Furthermore, prioritizing the community level has been suggested as a means of reducing inequity by preferentially reaching the poorest [33,35,36], a key public health objective. Of the five dimensions of access proposed by Obrist et al. [37] – availability, accessibility, affordability, adequacy and acceptability – it would seem that HMM has the potential to surpass facility-based services in four of them, with only availability of the commodities facing similar challenges. Thus, the role of HMM in the public health context can be viewed in a different light. Health-facility-based and community-based care are strategically complementary and operationally closely linked. HMM should by no means be seen as an alternative case-management option to treatment in formal health facilities but rather should be seen as an extension of case management in health facilities, to reach users who cannot appropriately be served by the formal health system. Patients with symptoms of severe disease need to be referred to the nearest health facility and treated there, taking into account any treatment they received in the community. The quality of the relationship with the formal health services – in terms of management, supervision and coordination – is known to be an important factor that influences impact and sustainability of community-based interventions [33]. Recent research has also indicated that by reducing the workload in health facilities, HMM might contribute to an overall increase of performance at the health-facility level [38]. It would, thus, seem reasonable that the effort to fight malaria involves all levels of health care and a variety of providers, from public health facilities to community-based interventions to the private sector [39]. The two-pronged strategy of both strengthening the formal health system and expanding community-based management of malaria will require a considerable increase in investment, in terms of human and financial resources and operational organization. However, the magnitude and urgency of the malaria disease burden – with an estimated 881 000 malaria deaths in 2006 and a child death caused by malaria every 30s [40] – leaves the governments in subSaharan Africa and the donor community with no other choice. Concluding remarks HMM is facing important technical and strategic challenges. Furthermore, malaria epidemiology varies across Africa and could vary even more in the future as a result of modern malaria control interventions. Addressing these challenges will require appropriately designed implementation of research and adequate funds. HMM, like any other public health intervention, will need to evolve and possibly be tailored to local conditions. Nonetheless, 118
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expanding the health-care delivery system through community-based providers is a key factor in achieving and maintaining over time the universal coverage envisaged in the Global Malaria Action Plan to move towards malaria elimination [41]. Given the conditions in the majority of malaria-endemic countries, it would be wholly unrealistic to expect that the United Nations Millennium Development Goals of reducing childhood mortality and halting malaria incidence will be achieved unless access to effective medicines is vastly improved, and in most of subSaharan Africa, this will have to be through HMM. References 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 Kager, P.A. (2002) Malaria control: constraints and opportunities. Trop. Med. Int. Health 7, 1042–1046 3 Moerman, F. et al. (2003) The contribution of health-care services to a sound and sustainable malaria-control policy. Lancet Infect. Dis. 3, 99– 102 4 Foster, S. (1995) Treatment of malaria outside the formal health services. J. Trop. Med. Hyg. 98, 29–34 5 Wiseman, V. et al. (2008) Determinants of provider choice for malaria treatment: experiences from The Gambia. Soc. Sci. Med. 67, 487–496 6 Evans, D. (2008) Getting the Right Resources the Right Way. Presentation at the Geneva Health Forum, 2008 (http:// www.genevahealthforum.org/ghf08/files/presentations/ Plenary%20Sessions/PL05-3_Evans,%20D.pdf) 7 Snow, R.W. et al. (2008) International funding for malaria control in relation to populations at risk of stable Plasmodium falciparum transmission. PLoS Med. 5, e142 (10.1371/journal.pmed.0050142) 8 Haddad, S. et al. (2006) Learning from health system reforms: lessons from Burkina Faso. Trop. Med. Int. Health 11, 1889–1897 9 Greenwood, B.M. et al. (1991) Why do some African children develop severe malaria? Parasitol. Today 7, 277–281 10 Goodman, C.A. et al. (2006) The cost-effectiveness of improving malaria home management: shopkeeper training in rural Kenya. Health Policy Plan. 21, 275–288 10.1093/heapol/czl011 11 Onwujekwe, O. et al. (2007) Feasibility of a community health worker strategy for providing near and appropriate treatment of malaria in southeast Nigeria: an analysis of activities, costs and outcomes. Acta Trop. 101, 95–105 12 The´ra, M.A. et al. (2000) Child malaria treatment practices among mothers in thedistrict of Yanfolila, Sikasso region. Mali. Trop. Med. Int. Health 12, 876–881 13 Hamel, M.J. et al. (2001) Malaria control in Bungoma District, Kenya: a survey of home treatment of children with fever, bednet use and attendance at antenatal clinics. Bull. World Health Organ. 79, 1014–1023 14 Orimadegun, A.E. et al. (2008) Early home treatment of childhood fevers with ineffective antimalarials is deleterious in the outcome of severe malaria. Malar. J. 7, 143 15 Wernsdorfer, W.H. (1991) The development and spread of drugresistant malaria. Parasitol. Today 7, 297–303 16 White, N.J. (2004) Antimalarial drug resistance. J. Clin. Invest. 113, 1084–1092 17 Pagnoni, F. et al. (1997) A community-based programme to provide prompt and adequate treatment of presumptive malaria in children. Trans. R. Soc. Trop. Med. Hyg. 91, 512–517 18 Kidane, G. and Morrow, R.H. (2000) Teaching mothers to provide home treatment of malaria in Tigray, Ethiopia: a randomised trial. Lancet 356, 550–555 19 Sirima, S.B. et al. (2003) Early treatment of childhood fevers with prepackaged antimalarial drugs in the home reduces severe malaria morbidity in Burkina Faso. Trop. Med. Int. Health 8, 133–139 20 Hopkins, H. et al. (2007) Impact of home-based management of malaria on health outcomes in Africa: a systematic review of the evidence. Malar. J. 6, 134
Opinion 21 d’Alessandro, U. et al. (2005) Should artemisinin-based combination treatment be used in the home-based management of malaria? Trop. Med. Int. Health 10, 1–2 22 Charlwood, D. (2004) The paradox of home management of malaria with artemisinin combinations. Trends Parasitol. 20, 405–406 23 Depoortere, E. et al. (2005) Efficacy and effectiveness of the combination of sulfadoxine/pyrimethamine and a 3-day course of artesunate for the treatment of uncomplicated falciparum malaria in a refugee settlement in Zambia. Trop. Med. Int. Health 10, 139–145 24 Chinbuah, M.A. et al. (2006) Feasibility and acceptability of the use of artemether-lumefantrine in the home-management of uncomplicated malaria in children 6–59 months old in Ghana. Trop. Med. Int. Health 11, 1003–1016 25 Ajayi, I.O. et al. (2008) Feasibility and acceptability of artemisininbased combination therapy for the home management of malaria in four African sites. Malar. J. 7, 6 26 Ajayi, I.O. et al. (2008) Effectiveness of artemisinin-based combination therapy used in the context of home management of malaria: a report from three study sites in sub-Saharan Africa. Malar. J. 7, 190 27 Pagnoni, F. et al. (2005) Artemisinin-based combination treatment in home-based management of malaria. Trop. Med. Int. Health 10, 621– 622 28 O’Meara, W.P. et al. (2008) Effect of a fall in malaria transmission on morbidity and mortality in Kilifi, Kenya. Lancet 372, 1555–1562 29 Hay, S. et al. (2008) Measuring malaria endemicity from intense to interrupted transmission. Lancet Infect. Dis. 8, 369–378 30 Yeung, S. and White, N.J. (2005) How do patients use antimalarial drugs: a review of the evidence. Trop. Med. Int. Health 10, 121–138 31 WHO/TDR (2004) Scaling-up Home-based Management of Malaria. From Research to Implementation. World Health Organization/ Special Programme for Research and Training in Tropical Diseases,
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WHO/HTM/MAL/2004.1096; TDR/IDE/HMM/04.1 (http://whqlibdoc. who.int/hq/2004/WHO_HTM_MAL_2004.1096.pdf) Armstrong Schellenberg, J.R. (2008) Health and survival of young children in southern Tanzania. BMC Public Health 8, 194 Haines, A. et al. (2007) Achieving child survival goals: potential contribution of community health workers. Lancet 369, 2121–2131 TDR (2008) Community-Directed Interventions for Major Health Problems in Africa. A Multi-Country Study. Final Report. World Health Organization/Special Programme for Research and Training in Tropical Diseases (http://www.who.int/tdr/publications/tdrresearch-publications/community-directed-interventions-healthproblems/pdf/cdi_report_08.pdf) Masanja, H. et al. (2005) Impact of integrated management of childhood illness on inequalities in child health in rural Tanzania. Health Policy Plan. 20 (Suppl. 1), i77–i84 Nathan, R. et al. (2004) Mosquito nets and the poor: can social marketing redress inequities in access? Trop. Med. Int. Health 9, 1121–1126 Obrist, B. et al. (2007) Access to health care in contexts of livelihood insecurity: a framework for analysis and action. PLoS Med. 4, 1584– 1588 Tiono, A.B. et al. (2008) Implementation of home-based management of malaria in children reduces the work load for peripheral health facilities in a rural district of Burkina Faso. Malar. J. 7, 201 Deressa, W. et al. (2008) Malaria-related health-seeking behaviour and challenges for care providers in rural Ethiopia: implications for control. J. Biosoc. Sci. 40, 115–135 WHO (2008) World Malaria Report 2008. World Health Organization, WHO/HTM/GMP/2008.1 (http://www.who.int/malaria/ wmr2008/malaria2008.pdf) Roll Back Malaria Partnership (2008) The Global Malaria Action Plan (http://rbm.who.int/gmap/gmap.pdf)
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Malaria treatment: no place like home Franco Pagnoni Special Programme for Research and Training in Tropical Diseases, World Health Organization, 20 Avenue Appia, CH 1211 Geneva 27, Switzerland
If the United Nations Millennium Development Goals are to be met, there is a need to improve access to effective antimalarial treatment where the burden of malaria is highest. Health facilities are often bypassed by communities, and inappropriate and poor-quality self-medication is common. The home management of malaria (HMM) strategy has been shown to have an effect on malaria morbidity and mortality in the chloroquine era, but several evidence gaps remain to be filled to confirm its value in the era of artemisinin-based combination therapies. Nevertheless, if a substantial reduction of the malaria burden is to be achieved, access to effective medicines has to be vastly improved, and in most of sub-Saharan Africa, this will have to be through HMM.
ment, delivered at home by caregivers (mostly mothers) soon after the appearance of symptoms, will result in a reduction in malaria morbidity and mortality [9] with a very low cost–effectiveness ratio [10,11]. However, although HMM has been promoted by WHO as a cornerstone of malaria control in Africa [1], researchers and policy-makers have not yet reached a full consensus on this strategy. This article will illustrate the potential of HMM and discuss the issues it raises. Although some evidence gaps remain to be addressed through operational research, scaling-up of HMM should not be delayed, and HMM should be regarded as a key public health strategy to expand coverage of effective antimalarial treatment and, thus, reduce the burden of the disease.
Current inadequacy of the African health system Malaria is a curable disease: prompt treatment with effective antimalarial therapy is a cornerstone of malaria control in sub-Saharan Africa [1]. However, in many areas, the capacity of the institutional health system to deliver a service of acceptable quality is limited by factors that include the lack of geographical access to health centres, inadequacy of health-care infrastructure and staffing, scarcity of affordable drugs and the poor performance of health personnel [2–5]. This is particularly evident in remote, rural areas in sub-Saharan Africa, where transmission of malaria is highest and where the majority of people at risk live. None of these factors has improved over the past decade. In spite of the important increase of resources from which health systems have benefited – external aid to low-income countries rose from US$ 6 billion in 2000 to US$ 16 billion in 2006, and government health expenditure per person in sub-Saharan Africa has increased by 30% since 2000 [6,7] – health facilities in the public sector remain underused and access to adequate care is still low among poor, underserved populations in most countries in sub-Saharan Africa [8]. As a result, the burden imposed by malaria is still intolerably high. The home management of malaria (HMM) strategy was developed by the World Health Organization (WHO), based largely on studies supported by the Special Programme for Research and Training on Tropical Diseases (TDR) [1], to alleviate this situation and improve access to life-saving medicines for people suffering from malaria. The strategy – originally designed for the treatment of children under the age of five years living in highly endemic rural areas in Africa, where a majority of fever cases can be presumed to be due to Plasmodium falciparum malaria – is based on the assumption that adequate treat-
HMM: improving treatment at home Faced with the inadequacy of the health system, many people seek to resolve their health problems at the household or village level, without recourse to formally trained health professionals, particularly for disease episodes perceived as mild [4]. A high proportion of presumed malaria episodes are treated at home, and self-medication is common. However, the treatment administered at home is often suboptimal in dosage and quality [12,13]; this is known to have harmful effects on the outcome of severe malaria [14] and to be an important factor in the selection of drug-resistant parasites [15,16]. HMM builds on the common practice of home treatment, with the aim of improving self-medication at household level.
Corresponding author: Pagnoni, F. ([email protected]).
HMM: the package HMM comprises three fundamental pillars: (i) the selection and training of community members as community medicine distributors (CMDs) to correctly dispense antimalarial medicines; (ii) an information, education and communication campaign to sensitize caregivers to the importance of adhering to the correct treatment schedule; and (iii) making effective antimalarial medicines available in every village, close to home, in unit-dosed and userfriendly blister packages. Whereas HMM is today a well-established term, use of the word ‘home’ has been, at times, misunderstood. The HMM strategy does not imply keeping antimalarial medicines at home, waiting for a disease episode to occur. Rather, ‘home’ means ‘close to home’, underlying the concept that antimalarial medicines must be available in the close vicinity, to avoid caregivers walking long distances to health facilities. Medicines are kept by trained CMDs, ready to be delivered on request to caregivers of sick children, accompanied by usage instructions and appropriate counselling (Figure 1). Also, ‘close to home’ includes
1471-4922/$ – see front matter ß 2008 Elsevier Ltd. All rights reserved. doi:10.1016/j.pt.2008.12.003 Available online 23 January 2009
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Figure 1. Counselling and distribution of antimalarial drugs by a CMD. After having examined the child, a trained CMD in Ejisu-Juaben District, Ghana, discusses with the child’s mother how the antimalarial drugs should be used, including the importance of adhering to the treatment regimen. ß WHO/TDR/Franco Pagnoni.
the concept that antimalarial medicines must be available to households at an affordable cost, limiting the need for out-of-pocket expenses [17]. Thus, HMM aims to improve access to treatment both geographically and socioeconomically. Evidence gaps in HMM The impact of HMM on malaria mortality and severe morbidity was demonstrated in the late 1990s and early 2000 with the use of chloroquine. In Ethiopia, a programme to provide home treatment for malaria reduced all-cause mortality by 40% and malaria-specific mortality by 70% [18]; in Burkina Faso, prompt treatment of children with uncomplicated malaria with pre-packaged antimalarial drugs reduced progression to severe malaria by 25–50% [17,19]. Hopkins et al. [20], in a review of the impact of HMM on health outcomes, underlined the narrowness of the evidence base for HMM in Africa, particularly regarding use of artemisinin-based combination therapy (ACT). This is entirely correct; the few available studies all used chloroquine. The effect of HMM on malaria morbidity and mortality needs to be confirmed with use of ACT, possibly in different epidemiological settings, to inform policymakers about HMM as a large-scale malaria control intervention in endemic countries. However, the results of the review should not be considered as evidence against HMM because all three studies with mortality end-points that failed to show a positive impact were carried out in the 1980s and did not use pre-packaged antimalarial drugs, which are a key element in the HMM strategy. Several other evidence gaps need to be filled to confirm the validity of HMM in the era of ACT. Research groups, 116
including the ACT Consortium (http://www.lshtm.ac.uk/ news/2008/gatesfunding.html) and TDR (http://www. who.int/tdr/svc/research/antimalarial-policy-access) have launched studies to fill these gaps and address the concerns raised by some experts about the use of ACT in HMM [21–23]. The first evidence gap to be filled concerns the feasibility and acceptability of integrating ACT into the HMM strategy. Evidence for this has been provided in recent years, first from a pilot study in Ghana [24] and then from a multicentre study in four African sites supported by TDR [25]. These studies have shown that (i) CMDs are able to dispense ACT correctly (on average, 98% of the time); (ii) most caregivers adhere to treatment instructions in terms of dose, duration and promptness of care (on average, 77% of the time); and (iii) once HMM is made available to caregivers, a large proportion of sick children are treated through HMM (on average, 59%). The main findings of the multicentre study are summarized in Table 1. Another knowledge gap regards the effectiveness of ACT used in HMM. In this respect, encouraging data have been provided by another multicentre study in three subSaharan Africa sites supported by TDR [26]. The study showed PCR-adjusted cure rates of greater than 90% in all sites (varying from 90.9% in Nigeria to 97.2% in Uganda), thus adding to the evidence base for HMM as a public health strategy. Other important evidence gaps need to be addressed to support the much-needed expansion of access to effective antimalarial treatment through community-based medicine distribution [20,27]. These include conclusive demonstration of the safety and effectiveness of ACT used under
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Table 1. Feasibility and acceptability of ACT use in HMM in four African sitesa
Total number of febrile episodes in children less than five years of age treated with ACT by CMDs (from CMD registers) Number (%) correctly dosed Number of children with a fever episode in the previous two weeks (from household survey) Number (%) of episodes treated with ACT from a CMD (coverage) Number (%) correctly treated – dose and duration Number (%) treated promptly – receiving first dose on the same or next day Number (%) treated correctly and promptly
Totals
Ejisu-Juaben Ho District, Badeku and District, Ghana Ojoku/Ajia Ghana Districts, Nigeria 4522 3958 1044
Bugiri and Iganga Districts, Uganda 11 039
4473 (99%) 428
3900 (98%) 124
1019 (98%) 551
10 671 (97%) 20 063 (98%) 1087 2190
289 (68%) 281 (97%) 259 (90%)
93 (75%) 69 (74%) 89 (96%)
288 (52%) 256 (89%) 278 (97%)
619 (57%) 490 (79%) 531 (86%)
1289 (59%) 1096 (85%) 1157 (90%)
252 (87%)
69 (74%)
231 (80%)
438 (71%)
990 (77%)
20 563
a
Data from Ref. [25].
‘real-life’ conditions (which is particularly important for ACT to be available as an over-the-counter drug), the possibility of incorporating rapid diagnostic testing to avoid widespread presumptive use of ACT, the expansion of HMM to urban areas to take into account rapid urbanization in sub-Saharan Africa, the use of incentives to maintain CMDs’ performance and the engagement of the private sector in community-based medicine distribution. Improving malaria diagnosis to limit overuse of antimalarial medicines seems to be increasingly necessary because there is mounting evidence that malaria incidence is decreasing in areas with traditionally high levels because of effective control interventions [28] and because these interventions are being scaled up to decrease transmission in many parts of Africa [29]. A particular concern is that overuse of ACT, often without parasitological confirmation, could facilitate the appearance of parasite resistance to these precious medicines. Related to this, as previously mentioned, exposure to subtherapeutic drug levels is a major factor in the selection of resistant parasites [15,16]. In this respect, the high level of adherence to the correct treatment schedule by caregivers documented in a multicountry study [25] provides some reassurance. Further reassurance could come from the incorporation of rapid diagnostic testing in the HMM strategy. Many research groups have started studies on these topics, including the ACT Consortium, the Malaria Clinical Trials Alliance (http://www.indepth-network.net/mcta/mctaindex.htm), the Medicines for Malaria Venture Access Initiative (http://www.mmv.org/rubrique.php3?id_rubrique=142), the Malaria Consortium (http://www.malariaconsortium.org), the Clinton Foundation (http:// www.clintonfoundation.org/what-we-do/clinton-hiv-aidsinitiative/our-approach/access-programs/malaria), various academic groups and TDR. Some studies have been completed only recently and many are still under way. However, while fully recognizing the need to expand the evidence base for HMM in Africa, the current evidence enables HMM to move forwards, addressing knowledge gaps during implementation, rather than delaying the introduction of new interventions to those in need. HMM and the private sector Recently, the engagement of the private sector, formal and informal, to improve access to effective antimalarial treatment has been largely advocated because it is known that a
considerable proportion of the population in both urban and rural areas purchases drugs in the private sector [30]. Financing mechanisms, such as the Affordable Medicines Facility for Malaria (http://www.rbm.who.int/globalsubsidytaskforce.html), are under development to make effective antimalarial medicines available at affordable prices through the private sector, both formal and informal. HMM is usually considered to be a strategy belonging to the public sphere, however imprecise this classification might be, but there cannot be a truly considerable improvement of access to antimalarial medicines without a substantial engagement of the private sector. However, the risk is that the private sector and HMM delivery systems could compete, with one eventually prevailing over the other. It is crucial to avoid this happening. In fact, there is a need to leverage both distribution mechanisms, particularly in remote rural areas, where the distinction between a private medicine vendor and a CMD becomes very subtle. Strategies for medicine delivery through the private sector and HMM should be designed so that they are complementary to each other because the best use of all resources is necessary to improve access to effective medicines. In this respect, developing mechanisms to provide CMDs with adequate remuneration for their work and ensuring some uniformity of working conditions and incentives for all medicine providers at community level – public and private – is of crucial importance. Integrating HMM in the health system Addressing these evidence gaps in the implementation of HMM is a huge challenge for researchers working on HMM. In addition, advocates of HMM face strategic challenges. Until now, with only a few exceptions (e.g. Uganda and Rwanda), HMM has mostly been implemented at no higher than the district level. A key issue is whether HMM can be scaled up to large populations while maintaining sufficient quality and the desired impact [31]. Large-scale, continent-wide adoption of HMM would have substantial economic and public health implications, and some experts have raised concerns that it could divert resources from other public health programmes and investment in health facilities that could result in a similar, if not higher, impact on health outcomes (U. d’Alessandro, personal communication). Research in Tanzania has indicated that strengthening of peripheral health facilities has huge potential to improve health and survival at household level [32]. How117
Opinion ever, the contribution of community health workers to achieve child survival goals has also been documented [33], and there is a clear potential for integrating the service delivery system of HMM with that of other childhood diseases (e.g. pneumonia or diarrhoea) or malaria prophylaxis (e.g. intermittent preventive treatment for children). The value of community-directed interventions to provide treatment for a variety of diseases, including malaria, at the community level has been reaffirmed recently [34]. Furthermore, prioritizing the community level has been suggested as a means of reducing inequity by preferentially reaching the poorest [33,35,36], a key public health objective. Of the five dimensions of access proposed by Obrist et al. [37] – availability, accessibility, affordability, adequacy and acceptability – it would seem that HMM has the potential to surpass facility-based services in four of them, with only availability of the commodities facing similar challenges. Thus, the role of HMM in the public health context can be viewed in a different light. Health-facility-based and community-based care are strategically complementary and operationally closely linked. HMM should by no means be seen as an alternative case-management option to treatment in formal health facilities but rather should be seen as an extension of case management in health facilities, to reach users who cannot appropriately be served by the formal health system. Patients with symptoms of severe disease need to be referred to the nearest health facility and treated there, taking into account any treatment they received in the community. The quality of the relationship with the formal health services – in terms of management, supervision and coordination – is known to be an important factor that influences impact and sustainability of community-based interventions [33]. Recent research has also indicated that by reducing the workload in health facilities, HMM might contribute to an overall increase of performance at the health-facility level [38]. It would, thus, seem reasonable that the effort to fight malaria involves all levels of health care and a variety of providers, from public health facilities to community-based interventions to the private sector [39]. The two-pronged strategy of both strengthening the formal health system and expanding community-based management of malaria will require a considerable increase in investment, in terms of human and financial resources and operational organization. However, the magnitude and urgency of the malaria disease burden – with an estimated 881 000 malaria deaths in 2006 and a child death caused by malaria every 30s [40] – leaves the governments in subSaharan Africa and the donor community with no other choice. Concluding remarks HMM is facing important technical and strategic challenges. Furthermore, malaria epidemiology varies across Africa and could vary even more in the future as a result of modern malaria control interventions. Addressing these challenges will require appropriately designed implementation of research and adequate funds. HMM, like any other public health intervention, will need to evolve and possibly be tailored to local conditions. Nonetheless, 118
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expanding the health-care delivery system through community-based providers is a key factor in achieving and maintaining over time the universal coverage envisaged in the Global Malaria Action Plan to move towards malaria elimination [41]. Given the conditions in the majority of malaria-endemic countries, it would be wholly unrealistic to expect that the United Nations Millennium Development Goals of reducing childhood mortality and halting malaria incidence will be achieved unless access to effective medicines is vastly improved, and in most of subSaharan Africa, this will have to be through HMM. References 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 Kager, P.A. (2002) Malaria control: constraints and opportunities. Trop. Med. Int. Health 7, 1042–1046 3 Moerman, F. et al. (2003) The contribution of health-care services to a sound and sustainable malaria-control policy. Lancet Infect. Dis. 3, 99– 102 4 Foster, S. (1995) Treatment of malaria outside the formal health services. J. Trop. Med. Hyg. 98, 29–34 5 Wiseman, V. et al. (2008) Determinants of provider choice for malaria treatment: experiences from The Gambia. Soc. Sci. Med. 67, 487–496 6 Evans, D. (2008) Getting the Right Resources the Right Way. Presentation at the Geneva Health Forum, 2008 (http:// www.genevahealthforum.org/ghf08/files/presentations/ Plenary%20Sessions/PL05-3_Evans,%20D.pdf) 7 Snow, R.W. et al. (2008) International funding for malaria control in relation to populations at risk of stable Plasmodium falciparum transmission. PLoS Med. 5, e142 (10.1371/journal.pmed.0050142) 8 Haddad, S. et al. (2006) Learning from health system reforms: lessons from Burkina Faso. Trop. Med. Int. Health 11, 1889–1897 9 Greenwood, B.M. et al. (1991) Why do some African children develop severe malaria? Parasitol. Today 7, 277–281 10 Goodman, C.A. et al. (2006) The cost-effectiveness of improving malaria home management: shopkeeper training in rural Kenya. Health Policy Plan. 21, 275–288 10.1093/heapol/czl011 11 Onwujekwe, O. et al. (2007) Feasibility of a community health worker strategy for providing near and appropriate treatment of malaria in southeast Nigeria: an analysis of activities, costs and outcomes. Acta Trop. 101, 95–105 12 The´ra, M.A. et al. (2000) Child malaria treatment practices among mothers in thedistrict of Yanfolila, Sikasso region. Mali. Trop. Med. Int. Health 12, 876–881 13 Hamel, M.J. et al. (2001) Malaria control in Bungoma District, Kenya: a survey of home treatment of children with fever, bednet use and attendance at antenatal clinics. Bull. World Health Organ. 79, 1014–1023 14 Orimadegun, A.E. et al. (2008) Early home treatment of childhood fevers with ineffective antimalarials is deleterious in the outcome of severe malaria. Malar. J. 7, 143 15 Wernsdorfer, W.H. (1991) The development and spread of drugresistant malaria. Parasitol. Today 7, 297–303 16 White, N.J. (2004) Antimalarial drug resistance. J. Clin. Invest. 113, 1084–1092 17 Pagnoni, F. et al. (1997) A community-based programme to provide prompt and adequate treatment of presumptive malaria in children. Trans. R. Soc. Trop. Med. Hyg. 91, 512–517 18 Kidane, G. and Morrow, R.H. (2000) Teaching mothers to provide home treatment of malaria in Tigray, Ethiopia: a randomised trial. Lancet 356, 550–555 19 Sirima, S.B. et al. (2003) Early treatment of childhood fevers with prepackaged antimalarial drugs in the home reduces severe malaria morbidity in Burkina Faso. Trop. Med. Int. Health 8, 133–139 20 Hopkins, H. et al. (2007) Impact of home-based management of malaria on health outcomes in Africa: a systematic review of the evidence. Malar. J. 6, 134
Opinion 21 d’Alessandro, U. et al. (2005) Should artemisinin-based combination treatment be used in the home-based management of malaria? Trop. Med. Int. Health 10, 1–2 22 Charlwood, D. (2004) The paradox of home management of malaria with artemisinin combinations. Trends Parasitol. 20, 405–406 23 Depoortere, E. et al. (2005) Efficacy and effectiveness of the combination of sulfadoxine/pyrimethamine and a 3-day course of artesunate for the treatment of uncomplicated falciparum malaria in a refugee settlement in Zambia. Trop. Med. Int. Health 10, 139–145 24 Chinbuah, M.A. et al. (2006) Feasibility and acceptability of the use of artemether-lumefantrine in the home-management of uncomplicated malaria in children 6–59 months old in Ghana. Trop. Med. Int. Health 11, 1003–1016 25 Ajayi, I.O. et al. (2008) Feasibility and acceptability of artemisininbased combination therapy for the home management of malaria in four African sites. Malar. J. 7, 6 26 Ajayi, I.O. et al. (2008) Effectiveness of artemisinin-based combination therapy used in the context of home management of malaria: a report from three study sites in sub-Saharan Africa. Malar. J. 7, 190 27 Pagnoni, F. et al. (2005) Artemisinin-based combination treatment in home-based management of malaria. Trop. Med. Int. Health 10, 621– 622 28 O’Meara, W.P. et al. (2008) Effect of a fall in malaria transmission on morbidity and mortality in Kilifi, Kenya. Lancet 372, 1555–1562 29 Hay, S. et al. (2008) Measuring malaria endemicity from intense to interrupted transmission. Lancet Infect. Dis. 8, 369–378 30 Yeung, S. and White, N.J. (2005) How do patients use antimalarial drugs: a review of the evidence. Trop. Med. Int. Health 10, 121–138 31 WHO/TDR (2004) Scaling-up Home-based Management of Malaria. From Research to Implementation. World Health Organization/ Special Programme for Research and Training in Tropical Diseases,
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