Reactive community-based self-administered treatment against residual malaria transmission: study protocol for a randomized controlled trial

Joseph Okebe, Joan Muela Ribera, Julie Balen, Fatou Jaiteh, Yoriko Masunaga, Davis Nwakanma, John Bradley, Shunmay Yeung, Koen Peeters Grietens, Umberto D'Alessandro, Joseph Okebe, Joan Muela Ribera, Julie Balen, Fatou Jaiteh, Yoriko Masunaga, Davis Nwakanma, John Bradley, Shunmay Yeung, Koen Peeters Grietens, Umberto D'Alessandro

Abstract

Background: Systematic treatment of all individuals living in the same compound of a clinical malaria case may clear asymptomatic infections and possibly reduce malaria transmission, where this is focal. High and sustained coverage is extremely important and requires active community engagement. This study explores a community-based approach to treating malaria case contacts.

Methods/design: This is a cluster-randomized trial to determine whether, in low-transmission areas, treating individuals living in the same compound of a clinical malaria case with dihydroartemisinin-piperaquine can reduce parasite carriage and thus residual malaria transmission. Treatment will be administered through the local health system with the approach of encouraging community participation designed and monitored through formative research. The trial goal is to show that this approach can reduce in intervention villages the prevalence of Plasmodium falciparum infection toward the end of the malaria transmission season.

Discussion: Adherence and cooperation of the local communities are critical for the success of mass treatment campaigns aimed at reducing malaria transmission. By exploring community perceptions of the changing trends in malaria burden, existing health systems, and reaction to self-administered treatment, this study will develop and adapt a model for community engagement toward malaria elimination that is cost-effective and fits within the existing health system.

Trial registration: Clinical trials.gov, NCT02878200 . Registered on 25 August 2016.

Keywords: Community; Formative research; Plasmodium falciparum; Prevalence; Reactive case treatment.

Conflict of interest statement

Ethics approval and consent to participate

The study has been approved by the Gambia Government/MRC Joint Ethics Committee (SCC 1488, 20 July 2016). Information about the trial, approved by the local ethics committee, will be delivered to potential study participants in their preferred local language by trained members of the study team. Participants or compounds retain the right to withdraw participation at any point in the course of the trial without prejudice to the quality of health that they are entitled to receive from the VHW or health facility. Consent to participate, receive DP, and have blood sampled has been obtained from residents of villages.

Consent for publication

All authors reviewed the final draft of the manuscript and agreed on the content and format for publication.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Timeline for project activities
Fig. 2
Fig. 2
Village selection and randomization into trial arms
Fig. 3
Fig. 3
Schematic describing activities in the trial arms following identification of a malaria case
Fig. 4
Fig. 4
Table showing schedule for enrollment, interventions, assessments, analysis, and dissemination of results

References

    1. Bousema T, Drakeley C. Epidemiology and infectivity of Plasmodium falciparum and Plasmodium vivax gametocytes in relation to malaria control and elimination. Clin Microbiol Rev. 2011;24:377–410. doi: 10.1128/CMR.00051-10.
    1. Global Malaria Programme . The role of mass drug administration, mass screening and treatment, and focal screening and treatment for malaria. Geneva: World Health Organization; 2015.
    1. Poirot E, Skarbinski J, Sinclair D, Kachur SP, Slutsker L, Hwang J. Mass drug administration for malaria. Cochrane Database Syst Rev. 2013;12:CD008846.
    1. Kern SE, Tiono AB, Makanga M, Gbadoé AD, Premji Z, Gaye O, Sagara I, Ubben D, Cousin M, Oladiran F, et al. Community screening and treatment of asymptomatic carriers of Plasmodium falciparum with artemether-lumefantrine to reduce malaria disease burden: a modelling and simulation analysis. Malar J. 2011;10:210. doi: 10.1186/1475-2875-10-210.
    1. Stresman GH, Kamanga A, Moono P, Hamapumbu H, Mharakurwa S, Kobayashi T, Moss WJ, Shiff C. A method of active case detection to target reservoirs of asymptomatic malaria and gametocyte carriers in a rural area in Southern Province, Zambia. Malar J. 2010;9:265.
    1. Sturrock HJ, Novotny JM, Kunene S, Dlamini S, Zulu Z, Cohen JM, Hsiang MS, Greenhouse B, Gosling RD. Reactive case detection for malaria elimination: real-life experience from an ongoing program in Swaziland. PLoS One. 2013;8:e63830. doi: 10.1371/journal.pone.0063830.
    1. Littrell M, Sow GD, Ngom A, Ba M, Mboup BM, Dieye Y, Mutombo B, Earle D, Steketee RW. Case investigation and reactive case detection for malaria elimination in northern Senegal. Malar J. 2013;12:331. doi: 10.1186/1475-2875-12-331.
    1. Hustedt J, Canavati SE, Rang C, Ashton RA, Khim N, Berne L, Kim S, Sovannaroth S, Ly P, Ménard D, et al. Reactive case-detection of malaria in Pailin Province, Western Cambodia: lessons from a year-long evaluation in a pre-elimination setting. Malar J. 2016;15:132. doi: 10.1186/s12936-016-1191-z.
    1. Searle KM, Hamapumbu H, Lubinda J, Shields TM, Pinchoff J, Kobayashi T, Stevenson JC, Bridges DJ, Larsen DA, Thuma PE, Moss WJ. Evaluation of the operational challenges in implementing reactive screen-and-treat and implications of reactive case detection strategies for malaria elimination in a region of low transmission in southern Zambia. Malar J. 2016;15:412. doi: 10.1186/s12936-016-1460-x.
    1. Smith Gueye C, Sanders KC, Galappaththy GN, Rundi C, Tobgay T, Sovannaroth S, Gao Q, Surya A, Thakur GD, Baquilod M, et al. Active case detection for malaria elimination: a survey among Asia Pacific countries. Malar J. 2013;12:358. doi: 10.1186/1475-2875-12-358.
    1. Tiono AB, Ouedraogo A, Ogutu B, Diarra A, Coulibaly S, Gansane A, Sirima SB, O’Neil G, Mukhopadhyay A, Hamed K. A controlled, parallel, cluster-randomized trial of community-wide screening and treatment of asymptomatic carriers of Plasmodium falciparum in Burkina Faso. Malar J. 2013;12:79. doi: 10.1186/1475-2875-12-79.
    1. Ceesay SJ, Casals-Pascual C, Erskine J, Anya SE, Duah NO, Fulford AJ, Sesay SS, Abubakar I, Dunyo S, Sey O, et al. Changes in malaria indices between 1999 and 2007 in The Gambia: a retrospective analysis. Lancet. 2008;372:1545–1554. doi: 10.1016/S0140-6736(08)61654-2.
    1. van den Hoogen LL, Griffin JT, Cook J, Sepulveda N, Corran P, Conway DJ, Milligan P, Affara M, Allen SJ, Proietti C, et al. Serology describes a profile of declining malaria transmission in Farafenni, The Gambia. Malar J. 2015;14:416. doi: 10.1186/s12936-015-0939-1.
    1. World Health Organization (WHO) Global Malaria Programme. World malaria report 2015. Geneva: WHO; 2015. .
    1. Tynan A, Atkinson JA, Toaliu H, Taleo G, Fitzgerald L, Whittaker M, Riley I, Schubert M, Vallely A. Community participation for malaria elimination in Tafea Province, Vanuatu: Part II. Social and cultural aspects of treatment-seeking behaviour. Malar J. 2011;10:204. doi: 10.1186/1475-2875-10-204.
    1. Atkinson JAM, Fitzgerald L, Toaliu H, Taleo G, Tynan A, Whittaker M, Riley I, Vallely A. Community participation for malaria elimination in Tafea Province, Vanuatu: Part I. Maintaining motivation for prevention practices in the context of disappearing disease. Malar J. 2010;9:93. doi: 10.1186/1475-2875-9-93.
    1. Kirby MJ, Ameh D, Bottomley C, Green C, Jawara M, Milligan PJ, Snell PC, Conway DJ, Lindsay SW. Effect of two different house screening interventions on exposure to malaria vectors and on anaemia in children in The Gambia: a randomised controlled trial. Lancet. 2009;374:998–1009. doi: 10.1016/S0140-6736(09)60871-0.
    1. Oriero EC, Okebe J, Jacobs J, Van Geertruyden JP, Nwakanma D, D’Alessandro U. Diagnostic performance of a novel loop-mediated isothermal amplification (LAMP) assay targeting the apicoplast genome for malaria diagnosis in a field setting in sub-Saharan Africa. Malar J. 2015;14:396. doi: 10.1186/s12936-015-0926-6.
    1. World Health Organization (WHO) Guidelines for the treatment of malaria. 3. Geneva: WHO; 2015.
    1. Mwesigwa J, Okebe J, Affara M, Di Tanna GL, Nwakanma D, Janha O, Opondo K, Grietens KP, Achan J, D’Alessandro U. On-going malaria transmission in The Gambia despite high coverage of control interventions: a nationwide cross-sectional survey. Malar J. 2015;14:314. doi: 10.1186/s12936-015-0829-6.
    1. Pinder M, Jawara M, Jarju LB, Salami K, Jeffries D, Adiamoh M, Bojang K, Correa S, Kandeh B, Kaur H, et al. Efficacy of indoor residual spraying with dichlorodiphenyltrichloroethane against malaria in Gambian communities with high usage of long-lasting insecticidal mosquito nets: a cluster-randomised controlled trial. Lancet. 2015;385:1436–1446. doi: 10.1016/S0140-6736(14)61007-2.
    1. Carter BR, Hood K. Balance algorithm for cluster randomized trials. BMC Med Res Methodol. 2008;8:65. doi: 10.1186/1471-2288-8-65.
    1. Raab GM, Butcher I. Balance in cluster randomized trials. Stat Med. 2001;20:351–365. doi: 10.1002/1097-0258(20010215)20:3<351::AID-SIM797>;2-C.
    1. Hofmann N, Mwingira F, Shekalaghe S, Robinson LJ, Mueller I, Felger I. Ultra-sensitive detection of Plasmodium falciparum by amplification of multi-copy subtelomeric targets. PLoS Med. 2015;12:e1001788. doi: 10.1371/journal.pmed.1001788.
    1. Daniels R, Ndiaye D, Wall M, McKinney J, Sene PD, Sabeti PC, Volkman SK, Mboup S, Wirth DF. Rapid, field-deployable method for genotyping and discovery of single-nucleotide polymorphisms associated with drug resistance in Plasmodium falciparum. Antimicrob Agents Chemother. 2012;56:2976–2986. doi: 10.1128/AAC.05737-11.
    1. Lindblade KA, Steinhardt L, Samuels A, Kachur SP, Slutsker L. The silent threat: asymptomatic parasitemia and malaria transmission. Expert Rev Anti Infect Ther. 2013;11:623–639. doi: 10.1586/eri.13.45.
    1. Newby G, Hwang J, Koita K, Chen I, Greenwood B, von Seidlein L, Shanks GD, Slutsker L, Kachur SP, Wegbreit J, et al. Review of mass drug administration for malaria and its operational challenges. Am J Trop Med Hyg. 2015;93:125–134. doi: 10.4269/ajtmh.14-0254.
    1. von Seidlein L, Dondorp A. Fighting fire with fire: mass antimalarial drug administrations in an era of antimalarial resistance. Expert Rev Anti Infect Ther. 2015;13:715–730. doi: 10.1586/14787210.2015.1031744.
    1. Strachan CE, Kana M, Martin S, Dada J, Wandera N, Marasciulo M, Counihan H, Kolawole M, Babale T, Hamade P, et al. The use of formative research to inform the design of a seasonal malaria chemoprevention intervention in northern Nigeria. Malar J. 2016;15:474. doi: 10.1186/s12936-016-1526-9.
    1. Tine RC, Ndiaye P, Ndour CT, Faye B, Ndiaye JL, Sylla K, Ndiaye M, Cisse B, Sow D, Magnussen P, et al. Acceptability by community health workers in Senegal of combining community case management of malaria and seasonal malaria chemoprevention. Malar J. 2013;12:467. doi: 10.1186/1475-2875-12-467.
    1. Kaneko A, Taleo G, Kalkoa M, Yamar S, Kobayakawa T, Bjorkman A. Malaria eradication on islands. Lancet. 2000;356:1560–1564. doi: 10.1016/S0140-6736(00)03127-5.
    1. Dial NJ, Ceesay SJ, Gosling RD, D’Alessandro U, Baltzell KA. A qualitative study to assess community barriers to malaria mass drug administration trials in The Gambia. Malar J. 2014;13:47. doi: 10.1186/1475-2875-13-47.
    1. Dierickx S, Gryseels C, Mwesigwa J, O’Neill S, Bannister-Tyrell M, Ronse M, Jaiteh F, Gerrets R, D’Alessandro U, Grietens KP. Factors associated with non-participation and non-adherence in directly observed mass drug administration for malaria in The Gambia. PLoS One. 2016;11:e0148627. doi: 10.1371/journal.pone.0148627.
    1. Rutherford ME, Dockerty JD, Jasseh M, Howie SR, Herbison P, Jeffries DJ, Leach M, Stevens W, Mulholland K, Adegbola RA, Hill PC. Access to health care and mortality of children under 5 years of age in The Gambia: a case-control study. Bull World Health Organ. 2009;87:216–224. doi: 10.2471/BLT.08.052175.

Source: PubMed

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

3
Abonner