Malaria rapid testing by community health workers is effective and safe for targeting malaria treatment: randomised cross-over trial in Tanzania

Marycelina Mubi, Annika Janson, Marian Warsame, Andreas Mårtensson, Karin Källander, Max G Petzold, Billy Ngasala, Gloria Maganga, Lars L Gustafsson, Amos Massele, Göran Tomson, Zul Premji, Anders Björkman, Marycelina Mubi, Annika Janson, Marian Warsame, Andreas Mårtensson, Karin Källander, Max G Petzold, Billy Ngasala, Gloria Maganga, Lars L Gustafsson, Amos Massele, Göran Tomson, Zul Premji, Anders Björkman

Abstract

Background: Early diagnosis and prompt, effective treatment of uncomplicated malaria is critical to prevent severe disease, death and malaria transmission. We assessed the impact of rapid malaria diagnostic tests (RDTs) by community health workers (CHWs) on provision of artemisinin-based combination therapy (ACT) and health outcome in fever patients.

Methodology/principal findings: Twenty-two CHWs from five villages in Kibaha District, a high-malaria transmission area in Coast Region, Tanzania, were trained to manage uncomplicated malaria using RDT aided diagnosis or clinical diagnosis (CD) only. Each CHW was randomly assigned to use either RDT or CD the first week and thereafter alternating weekly. Primary outcome was provision of ACT and main secondary outcomes were referral rates and health status by days 3 and 7. The CHWs enrolled 2930 fever patients during five months of whom 1988 (67.8%) presented within 24 hours of fever onset. ACT was provided to 775 of 1457 (53.2%) patients during RDT weeks and to 1422 of 1473 (96.5%) patients during CD weeks (Odds Ratio (OR) 0.039, 95% CI 0.029-0.053). The CHWs adhered to the RDT results in 1411 of 1457 (96.8%, 95% CI 95.8-97.6) patients. More patients were referred on inclusion day during RDT weeks (10.0%) compared to CD weeks (1.6%). Referral during days 1-7 and perceived non-recovery on days 3 and 7 were also more common after RDT aided diagnosis. However, no fatal or severe malaria occurred among 682 patients in the RDT group who were not treated with ACT, supporting the safety of withholding ACT to RDT negative patients.

Conclusions/significance: RDTs in the hands of CHWs may safely improve early and well-targeted ACT treatment in malaria patients at community level in Africa.

Trial registration: ClinicalTrials.gov NCT00301015.

Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

Figures

Figure 1. Flow of patients through the…
Figure 1. Flow of patients through the study.

References

    1. WHO. World Malaria Report. 2008. Available: Accessed 2011, May 13th.
    1. Bhattarai A, Ali AS, Kachur SP, Mårtensson A, Abbas AK, et al. Impact of artemisinin-based combination therapy and insecticide treated nets on malaria burden in Zanzibar. PLoS Medicine. 2007;4:e309.
    1. WHO 2004. Scaling up home-based management of malaria: From research to implementation. WHO/HTM/MAL/2004.1096; TDR/IDE/HMM/04.1 Available: Accessed 2011, May 13th.
    1. WHO. Guidelines for treatment of malaria. Second edition. WHO 2010 ISBN 97892 154 7925. Available:/// . Accessed 2011, May 13th.
    1. Ajayi IO, Browne EN, Garshong B, Bateganya F, Yusuf B. Feasibility and acceptability of artemisinin–based combination therapy for the home management of malaria in four African sites. Malar J. 2008;Jan 8;7:6.
    1. Ajayi IO, Falade CO, Bamgboye EA, Odulola AM, Kale OO. Assessment of a treatment guideline to improve home management of malaria in children in rural south-west Nigeria. Malar J. 2008;Jan 29;7:24.
    1. NMCP. National guidelines for malaria diagnosis and treatment. Ministry of Health and Social Welfare, United Republic of Tanzania and National Malaria Control Programme; 2006.
    1. Dondorp AM, Nosten F, Yi P, Das D, Phyo AP. Artemisinin resistance in Plasmodium falciparum malaria. N Engl J Med. 2009;Jul30;361:455–67.
    1. Sisowath C, Strömberg J, Mårtensson A, Msellem M, Obondo C, et al. In vivo selection of Plasmodium falciparum pfmdr1 86N coding alleles by artemether-lumefantrine (Coartem). J Infect Dis. 2005;191:1014–7.
    1. Cho-Min-Naing, Gatton ML. Performance appraisal of rapid on-site malaria diagnosis (ICT malaria Pf/Pv test) in relation to human resources at village level in Myanmar. Acta Trop. 2002;81:13–9.
    1. Wongsrichanalai C, Barcus MJ, Muth S, Sutamihardja A, Wernsdorfer WH. A review of malaria diagnostic tools: microscopy and rapid diagnostic test (RDT). Am J Trop Med Hyg. 2007;77:119–27.
    1. Hanscheid T. Diagnosis of malaria: a review of alternatives to conventional microscopy. Clin Lab Haematol. 1999;21:235–45.
    1. Moody A. Rapid diagnostic tests for malaria parasites. Clin Microbiol Rev. 2002;15:66–78.
    1. Bell D, Wongsrichanalai C, Barnwell JW. Ensuring quality and access for malaria diagnosis: how can it be achieved? Nat Rev Microbiol. 2006;4:682–95.
    1. Lubell Y, Reyburn H, Mbakilwa H, Mwangi R, Chonya S, et al. The impact of response to the results of diagnostic tests for malaria: cost-benefit analysis. BMJ. 2008;336:202–5.
    1. Nicastri E, Bevilacqua N, Sane Schepisi M, Paglia MG, Meschi S, et al. Accuracy of malaria diagnosis by microscopy, rapid diagnostic test, and PCR methods and evidence of antimalarial overprescription in non-severe febrile patients in two Tanzanian hospitals. Am J Trop Med Hyg. 2009;80:712–7.
    1. Rafael ME, Taylor T, Magill A, Lim YW, Girosi F, et al. Reducing the burden of childhood malaria in Africa: the role of improved diagnosis. Nature. 2006;444(Suppl 1):39–48.
    1. Hamer DH, Ndhlovu M, Zurovac D, Fox M, Yeboah-Antwi K, et al. Improved diagnostic testing and malaria treatment practices in Zambia. JAMA. 2007;297:2227–31.
    1. Reyburn H, Mbakilwa H, Mwangi R, Mwerinde O, Olomi, et al. Rapid diagnostic tests compared with malaria microscopy for guiding outpatient treatment of febrile illness in Tanzania: randomised trial. BMJ. 2007;334:403.
    1. Bisoffi Z, Sirima BS, Angheben A, Lodesani C, Gobbi F, et al. Rapid malaria diagnostic tests vs. clinical management of malaria in rural Burkina Faso: safety and effect on clinical decisions. A randomized trial. Trop Med Int Health. 2009;May;14(5):491–8.
    1. Ansah EK, Narh-Bana S, Epokor M, Akanpigbiam S, Quartey AA, et al. Rapid testing for malaria in settings where microscopy is available and peripheral clinics where only presumptive treatment is available: a randomised controlled trial in Ghana. BMJ. 2010;340:c930.
    1. Msellem MI, Mårtensson A, Rotllant G, Bhattarai A, Strömberg J, et al. Influence of rapid malaria diagnostic tests on treatment and health outcome in fever patients, Zanzibar: a crossover validation study. PLoS Med. 2009;Apr 28;6(4):e1000063.
    1. Skarbinski J, Ouma PO, Causer LM, Kariuki SK, Barnwell JW. Effect of malaria rapid diagnostic tests on the management of uncomplicated malaria with artemether-lumefantrine in Kenya: a cluster randomized trial. Am J Trop Med Hyg. 2009;80:919–26.
    1. English M, Reyburn H, Goodman C, Snow RW. Abandoning presumptive antimalarial treatment for febrile children aged less than five years–a case of running before we can walk? PLoS Med. 2009;6(1):e1000015.
    1. D'Acremont V, Lengeler C, Mshinda H, Mtasiwa D, Tanner M, et al. Time to move from presumptive malaria treatment to laboratory-confirmed diagnosis and treatment in African children with fever. PLoS Med. 2009;6;6(1):e252.
    1. D'Acremont V, Malila A, Swai N, Tillya M, Kahama-Maro R. Withholding antimalarials in febrile children who have a negative result for a rapid diagnostic test. Clin Infect Dis. 2010;51:506–11.
    1. Björkman A, Mårtensson A. Risks and benefits of targeted malaria treatment based on rapid diagnostic test results. Clin Infect Dis. 2010;51:512–4.
    1. Premji Z, Minjas JN, Shiff CJ. Laboratory diagnosis of malaria by village health workers using the rapid manual ParaSight-F test. Trans R Soc Trop Med Hyg. 1994;88:418.
    1. Yeboah-Antwi K, Pilingana P, Macleod WB, Semrau K, Siazeele K. Community Case Management of Fever Due to Malaria and Pneumonia in Children Under Five in Zambia: A Cluster Randomized Controlled Trial. PLoS Med. 2010;7(9):e1000340.
    1. Kerry SM, Bland JM. The intracluster correlation coefficient in cluster randomisation. BMJ. 1998;316(7142):1455.
    1. Haines A, Sanders D, Lehmann U, Rowe AK, Lawn JE. Achieving child survival goals: potential contribution of community health workers. Lancet. 2007;369:2121–31.
    1. Chinbuah AM, Gyapong JO, Pagnoni F, Wellington EK, Gyapong M. 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. 2006;11:1003–16.
    1. Gitonga CW, Amin AA, Ajanga A, Kangwana BB, Noor AM, Snow RW. The use of artemether-lumefantrine by febrile children following national implementation of a revised drug policy in Kenya. Trop Med Int Health. 2008;13:487–94.
    1. WHO 2005. Resolution WHA 58.2. Malaria control, Fifty-eighth World Health Assembly, Resolutions and Decisions Annex. Available: . Accessed 2009, May 15.
    1. National Bureau of Statistics, Dar es Salaam, Tanzania MEASURE DHS, ICF Macro Calverton, Maryland USA, August 2010; Tanzania Demographic and Health Survey 2010, preliminary report.
    1. Al-Taiar A, Jaffar S, Assabri A, Al-Habori M, Azazy A, et al. Who develops severe malaria? Impact of access to healthcare, socio-economic and environmental factors on children in Yemen: a case-control study. Trop Med Int Health. 2008;13:762–70.
    1. Kidane G, Morrow RH. Teaching mothers to provide home treatment of malaria in Tigray, Ethiopia: a randomised trial. Lancet. 2000;356:550–5.
    1. Binka FN, Bawah AA, Phillips JF, Hogdson A, Adjuik M, et al. Rapid achievement of the child survival millennium development goal: evidence from the Navrongo experiment in Northern Ghana. Trop Med Int Health. 2007;12:578–83.
    1. Hopkins H, Talisuna A, Whitty CJ, Staedke SG. Impact of home-based management of malaria on health outcomes in Africa: a systematic review of the evidence. Malar J. 2007;6:134.
    1. Swarthout TD, Counihan H, Senga RK, van den Broek I. Paracheck-Pf accuracy and recently treated Plasmodium falciparum infections: is there a risk of over-diagnosis? Malar J. 2007;6:58.
    1. Kyabayinze DJ, Tibenderana JK, Odong GW, Rwakimari JB, Counihan H. Operational accuracy and comparative persistent antigenicity of HRP2 rapid diagnostic tests for Plasmodium falciparum malaria in a hyperendemic region of Uganda. Malar J. 2008;29:221.
    1. Houzé S, Boly MD, Le Bras J, Deloron P, Faucher JF. PfHRP2 and PfLDH antigen detection for monitoring the efficacy of artemisinin-based combination therapy (ACT) in the treatment of uncomplicated falciparum malaria. Malar J. 2009;8:211.
    1. Hopkins H, Bebell L, Kambale W, Dokomajilar C, Rosenthal PJ, et al. Rapid diagnostic tests for malaria at sites of varying transmission intensity in Uganda. J Infect Dis. 2008;197:510–8.
    1. Willcox ML, Sanogo F, Graz B, Forster M, Dakouo F, et al. Rapid diagnostic tests for the home-based management of malaria, in a high-transmission area. Ann Trop Med Parasitol. 2009;103(1):3–16.
    1. McMorrow ML, Masanja MI, Abdulla SM, Kahigwa E, Kachur SP. Challenges in routine implementation and quality control of rapid diagnostic tests for malaria–Rufiji District, Tanzania. Am J Trop Med Hyg. 2008;79:385–90.
    1. Chanda P, Castillo-Riquelme M, Masiye F. Cost-effectiveness analysis of the available strategies for diagnosing malaria in outpatient clinics in Zambia. Cost Eff Resour Alloc. 2009;7:5.

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