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

There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

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

Supplementary Information

The online version contains supplementary material available at 10.1186/s12879-022-07724-5.

Related collections

Most cited references 21

Record: found
Abstract: found
Article: not found

Outcomes for Implementation Research: Conceptual Distinctions, Measurement Challenges, and Research Agenda

Enola Proctor, Hiie Silmere, Ramesh Raghavan … (2010)

An unresolved issue in the field of implementation research is how to conceptualize and evaluate successful implementation. This paper advances the concept of “implementation outcomes” distinct from service system and clinical treatment outcomes. This paper proposes a heuristic, working “taxonomy” of eight conceptually distinct implementation outcomes—acceptability, adoption, appropriateness, feasibility, fidelity, implementation cost, penetration, and sustainability—along with their nominal definitions. We propose a two-pronged agenda for research on implementation outcomes. Conceptualizing and measuring implementation outcomes will advance understanding of implementation processes, enhance efficiency in implementation research, and pave the way for studies of the comparative effectiveness of implementation strategies.

0 comments Cited 1767 times – based on 0 reviews      Review now

Bookmark

Record: found
Abstract: not found
Article: not found

The PRECIS-2 tool: designing trials that are fit for purpose.

Kirsty Loudon, Shaun Treweek, Frank Sullivan … (2015)

0 comments Cited 504 times – based on 0 reviews      Review now

Bookmark

Record: found
Abstract: found
Article: not found

Stepped wedge designs could reduce the required sample size in cluster randomized trials.

Willem Woertman, Esther de Hoop, Mirjam Moerbeek … (2013)

The stepped wedge design is increasingly being used in cluster randomized trials (CRTs). However, there is not much information available about the design and analysis strategies for these kinds of trials. Approaches to sample size and power calculations have been provided, but a simple sample size formula is lacking. Therefore, our aim is to provide a sample size formula for cluster randomized stepped wedge designs. We derived a design effect (sample size correction factor) that can be used to estimate the required sample size for stepped wedge designs. Furthermore, we compared the required sample size for the stepped wedge design with a parallel group and analysis of covariance (ANCOVA) design. Our formula corrects for clustering as well as for the design. Apart from the cluster size and intracluster correlation, the design effect depends on choices of the number of steps, the number of baseline measurements, and the number of measurements between steps. The stepped wedge design requires a substantial smaller sample size than a parallel group and ANCOVA design. For CRTs, the stepped wedge design is far more efficient than the parallel group and ANCOVA design in terms of sample size. Copyright © 2013 Elsevier Inc. All rights reserved.

0 comments Cited 143 times – based on 0 reviews      Review now

Bookmark

All references

Author and article information

Contributors

Win Htike:

ORCID: http://orcid.org/0000-0003-2820-477X

win.htike@burnet.edu.au

Freya J. I. Fowkes: freya.fowkes@burnet.edu.au

Journal

Journal ID (nlm-ta): BMC Infect Dis

Journal ID (iso-abbrev): BMC Infect Dis

Title: BMC Infectious Diseases

Publisher: BioMed Central (London )

ISSN (Electronic): 1471-2334

Publication date (Electronic): 24 September 2022

Publication date PMC-release: 24 September 2022

Publication date Collection: 2022

Volume: 22

Electronic Location Identifier: 747

Affiliations

[1 ]GRID grid.1056.2, ISNI 0000 0001 2224 8486, Disease Elimination Program, Burnet Institute, ; 85 Commercial Road, Melbourne, VIC 3004 Australia

[2 ]Health Poverty Action, London, UK

[3 ]GRID grid.1002.3, ISNI 0000 0004 1936 7857, Department of Epidemiology and Preventive Medicine, , Monash University, ; Melbourne, VIC Australia

[4 ]GRID grid.1008.9, ISNI 0000 0001 2179 088X, Melbourne School of Population and Global Health, , University of Melbourne, ; Melbourne, VIC Australia

[5 ]GRID grid.1008.9, ISNI 0000 0001 2179 088X, Department of Medicine at the Doherty Institute, , University of Melbourne, ; Melbourne, Australia

[6 ]GRID grid.415768.9, ISNI 0000 0004 8340 2282, Center of Malariology Parasitology and Entomology, , Ministry of Health, ; Vientiane, Lao PDR

[7 ]National Center for Parasitology Entomology and Malaria Control, Ministry of Health, Phnom Penh, Cambodia

Author information

Win Htike http://orcid.org/0000-0003-2820-477X

Article

Publisher ID: 7724

DOI: 10.1186/s12879-022-07724-5

PMC ID: 9509546

SO-VID: 3ee26a93-ddf0-4fe7-a80c-00c685e17be3

License:

Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.