Reducing malaria transmission in forest-going mobile and migrant populations in Lao PDR and Cambodia: protocol for stepped-wedge cluster-randomised controlled trial

Win Htike, Win Han Oo, Thet Lynn, Lun Sovanda, Paul A Agius, May Chan Oo, Naw Hkawng Galau, Kaung Myat Thu, Aung Khine Zaw, Ei Phyu Htwe, Julia C Cutts, Ellen A Kearney, Nick Scott, Katherine O'Flaherty, Bangyuan Wang, Boualam Khamlome, Phoutnalong Vilay, Sovannaroth Siv, Freya J I Fowkes, Win Htike, Win Han Oo, Thet Lynn, Lun Sovanda, Paul A Agius, May Chan Oo, Naw Hkawng Galau, Kaung Myat Thu, Aung Khine Zaw, Ei Phyu Htwe, Julia C Cutts, Ellen A Kearney, Nick Scott, Katherine O'Flaherty, Bangyuan Wang, Boualam Khamlome, Phoutnalong Vilay, Sovannaroth Siv, Freya J I Fowkes

Abstract

Background: Countries of the Greater Mekong Sub-region aim to achieve malaria elimination by 2030. In the region, malaria is concentrated in high-risk areas and populations such as forest-going mobile and migrant populations (MMPs). However, routine protective measures such as long-lasting insecticidal nets do not prevent all infectious bites in these high-risk populations. Evidence for the effectiveness of a personal protection package tailored to forest-going MMPs which is acceptable, feasible, and cost-effective for reducing malaria transmission is required to inform the malaria elimination toolkit in the region.

Methods: A personal protection package consisting of long-lasting insecticidal hammock net, insect repellent and health communication pamphlet was developed in consultation with relevant implementing partners from Cambodia and Lao PDR. An open stepped-wedge cluster-randomised controlled trial will be conducted over a period of 12 months in a minimum of 488 villages (~ 428 in Lao PDR and ~ 60 in Cambodia) to evaluate the effectiveness of the personal protection package. Villages will be randomised into 11 blocks, with blocks transitioned in random order from control to intervention states at monthly intervals, following a 1-month baseline period. The primary outcome of the trial is the prevalence of Plasmodium spp. infection diagnosed by rapid diagnostic test. Difference in prevalence of malaria infection will be estimated across intervention and control periods using generalized linear mixed modelling. Nested within the stepped-wedge cluster-randomised controlled trial is a mixed-methods study to explore the acceptability of the personal protection package, feasibility of implementing a personal protection package as a vector control intervention, and knowledge, attitude and practice of MMPs regarding malaria prevention; and cost-analysis to determine the cost-effectiveness of implementing a personal protection package.

Discussion: This study, using a rigorous design and mixed-methods methodology, will evaluate whether a personal protection package can reduce residual malaria transmission among forest-going MMPs in Cambodia and Lao PDR. It will also measure implementation research outcomes such as effectiveness of the intervention package, cost-effectiveness, acceptability, and feasibility, in order to inform potential national and regional policy. Trial registration This trial was prospectively registered on ClinicalTrials.gov (NCT05117567) on 11th November 2021.

Keywords: Community-delivered intervention; Elimination; Falciparum; Malaria; Migrant; Prevention; Vector; Vivax.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Map of the study areas (Map generated using the tmap package in R version 3.6.1 using base maps from the GADM database of Global Administrative Areas, version 2.8. URL: www.gadm.org)
Fig. 2
Fig. 2
Timeline for stepwise implementation of the personal protection package in the selected villages

References

    1. World Health Organization . World Malaria Report 2014. Geneva: World Health Organization; 2014.
    1. World Health Organization . World Malaria Report 2021. Geneva: World Health Organization; 2021.
    1. Win Han Oo Hoban E, Gold L, Kyu Kyu T, Thazin L, Aung T, Fowkes FJI: Community demand for comprehensive primary health care from malaria volunteers in South-East Myanmar: a qualitative study. Malar J. 2021;20(1):19. doi: 10.1186/s12936-020-03555-4.
    1. World Health Organization . Eliminating Malaria in the Greater Mekong Subregion: United to End a Deadly Disease. Geneva: World Health Organization; 2016.
    1. World Health Organization: Countries of the Greater Mekong are stepping up to end malaria. In: WHO’s Mekong Malaria Elimination Programme. vol. WHO’s Mekong Malaria Elimination Programme. Geneva: World Health Organization; 2018: 16.
    1. World Health Organization . Strategy for malaria elimination in the Greater Mekong Subregion: 2015–2030. Manila: WHO Regional Office for the Western Pacific; 2015.
    1. World Health Organization. Countries of the Greater Mekong zero in on falciparum malaria; 2019.
    1. Nofal SD, Peto TJ, Adhikari B, Tripura R, Callery J, Bui TM, von Seidlein L, Pell C. How can interventions that target forest-goers be tailored to accelerate malaria elimination in the Greater Mekong Subregion? A systematic review of the qualitative literature. Malar J. 2019;18(1):32–32. doi: 10.1186/s12936-019-2666-5.
    1. Guyant P, Canavati SE, Chea N, Ly P, Whittaker MA, Roca-Feltrer A, Yeung S. Malaria and the mobile and migrant population in Cambodia: a population movement framework to inform strategies for malaria control and elimination. Malar J. 2015;14:252. doi: 10.1186/s12936-015-0773-5.
    1. World Health Organization. Population mobility and malaria. New Delhi: World Health Organization, Regional Office for South-East Asia; 2017.
    1. National Malaria Control Programme. National Strategic Plan for Malaria Elimination (2021–2025): Department of Public Health. Ministry of Health and Sports: Republic of the Union of Myanmar; 2019
    1. Center for Malaria Parasitology and Entomology. National Strategic Plan for Malaria Control and Elimination 2016–2020. Vientiane Capital, Lao PDR: Ministry of Health; 2016.
    1. National Center for Parasitology Entomology and Malaria Control. The National Strategic Plan For Elimination of Malaria in the Kingdom of Cambodia 2011–2025. Phnom Penh, Cambodia: Ministry of Health; 2011.
    1. Hii J, Rueda LM. Malaria vectors in the Greater Mekong Subregion: overview of malaria vectors and remaining challenges. Southeast Asian J Trop Med Public Health. 2013;44:73–165.
    1. Williams YA, Tusting LS, Hocini S, Graves PM, Killeen GF, Kleinschmidt I, Okumu FO, Feachem RGA, Tatarsky A, Gosling RD. Expanding the vector control toolbox for malaria elimination: a systematic review of the evidence. Adv Parasitol. 2018;99:345–379. doi: 10.1016/bs.apar.2018.01.003.
    1. Agius PA, Cutts JC, Han W, Thi A, Flaherty K, Zayar K, Kyaw TH, Poe AP, Mon TM, Nyi ZN, et al. Evaluation of the effectiveness of topical repellent distributed by village health volunteer networks against Plasmodium spp. infection in Myanmar: A stepped-wedge cluster randomised trial. PLoS Med. 2020;17(8):e1003177. doi: 10.1371/journal.pmed.1003177.
    1. Thang ND, Erhart A, Speybroeck N, Xa NX, Thanh NN, Ky PV, le Hung X, le Thuan K, Coosemans M, D'Alessandro U. Long-Lasting Insecticidal Hammocks for controlling forest malaria: a community-based trial in a rural area of central Vietnam. PLoS ONE. 2009;4(10):e7369. doi: 10.1371/journal.pone.0007369.
    1. Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011;38(2):65–76. doi: 10.1007/s10488-010-0319-7.
    1. O'Flaherty K, Oo WH, Zaloumis SG, Cutts JC, Aung KZ, Thein MM, Drew DR, Razook Z, Barry AE, Parischa N, et al. Community-based molecular and serological surveillance of subclinical malaria in Myanmar. BMC Med. 2021;19(1):121. doi: 10.1186/s12916-021-01993-8.
    1. Lautu-Gumal D, Razook Z, Koleala T, Nate E, McEwen S, Timbi D, Hetzel MW, Lavu E, Tefuarani N, Makita L, et al. Surveillance of molecular markers of Plasmodium falciparum artemisinin resistance (kelch13 mutations) in Papua New Guinea between 2016 and 2018. Int J Parasitol Drugs Drug Resist. 2021;16:188–193. doi: 10.1016/j.ijpddr.2021.06.004.
    1. Williams GS, Mweya C, Stewart L, Mtove G, Reyburn H, Cook J, Corran PH, Riley EM, Drakeley CJ. Immunophoretic rapid diagnostic tests as a source of immunoglobulins for estimating malaria sero-prevalence and transmission intensity. Malar J. 2009;8:168. doi: 10.1186/1475-2875-8-168.
    1. Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M. The PRECIS-2 tool: designing trials that are fit for purpose. BMJ : British Medical Journal. 2015;350:h2147. doi: 10.1136/bmj.h2147.
    1. Brown CA, Lilford RJ. The stepped wedge trial design: a systematic review. BMC Med Res Methodol. 2006;6(1):54. doi: 10.1186/1471-2288-6-54.
    1. Haines TP, Hemming K. Stepped-wedge cluster-randomised trials: level of evidence, feasibility and reporting. J Physiother. 2018;64(1):63–66. doi: 10.1016/j.jphys.2017.11.008.
    1. Hemming K, Taljaard M. Reflection on modern methods: when is a stepped-wedge cluster randomized trial a good study design choice? Int J Epidemiol. 2020;49(3):1043–1052. doi: 10.1093/ije/dyaa077.
    1. Hemming K, Taljaard M, Grimshaw J. Introducing the new CONSORT extension for stepped-wedge cluster randomised trials. Trials. 2019;20(1):68. doi: 10.1186/s13063-018-3116-3.
    1. Woertman W, Hoop E, Moerbeek M, Zuidema SU, Gerritsen DL, Teerenstra S. Stepped wedge designs could reduce the required sample size in cluster randomized trials. J Clin Epidemiol. 2013;66(7):752–758. doi: 10.1016/j.jclinepi.2013.01.009.

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