Reducing Malaria Transmission in Forest-going Mobile and Migrant Populations in Lao PDR and Cambodia
NCT ID: NCT05117567
Last Updated: 2021-11-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
5868 participants
INTERVENTIONAL
2021-12-01
2022-06-30
Brief Summary
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Detailed Description
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The open stepped-wedge cluster-randomised controlled trial, randomized at the volunteer level (i.e. the volunteer and the village / workplaces they service), will be implemented between July 2021 to June 2022. The personal protection package for MMPs will be implemented sequentially in a minimum of \~488 villages serviced by approximately \~488 VMWs (\~428 in Lao PDR and \~60 in Cambodia). Villages from each country will be randomised into 11 ordered blocks, with blocks transitioned from control (no personal protection package) to intervention (distribution of personal protection package) states at monthly intervals (10 blocks of 44 villages for the first 10 steps and a block of 48 villages transitioned at the last step). This follows an initial baseline control period of one-month at the start of the study
Approximately 11 RDTs per month will be undertaken in each study site (village/ worksite). Given the design we estimate that the study has power to detect a relative minimum detectable difference of 34% (OR = 0.66) in odds of RDT-detectable malaria infection due to the intervention (assuming a village intraclass correlation \[ICC\]= 0.42; 5% significance; 90% power and 1% RDT malaria prevalence).
For the stepped-wedged cluster randomized trial, both descriptive and primary outcome trial analyses will be performed. Using Stata version 15, differences in prevalence of Plasmodium spp. infections will be estimated across intervention and control periods using generalized linear mixed modelling (e.g. logit link function and binomial distribution) with crossed random effects for village and time, and intervention state, time and seasonality estimated as independent fixed factors. Temporal and spatial trends of Plasmodium spp. infections will also be explored including analysis of the effectiveness of the intervention across the study period. We will also explore any village-specific heterogeneity in effect by specifying a random effect for the intervention. Generalised linear mixed modelling will be extended to include model terms for country (main and interaction effects), and these will used to assess the extent of country-specific heterogeneity in intervention effect. The same approach will be used to assess risk group-specific heterogeneity (MMP, forest-goer, villager) in intervention effect.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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Personal protection package
A personal protection package that includes Long-lasting insecticidal hammock net (LLIHN), insect repellent (Icaridin), and mobile and migrant population-tailored behavioural change communication (BCC) package
Personal protection package
A personal protection package that includes Long-lasting insecticidal hammock net (LLIHN), insect repellent (Icaridin), and MMP-tailored behavioural change communication (BCC) package
Control
No personal protection package
No interventions assigned to this group
Interventions
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Personal protection package
A personal protection package that includes Long-lasting insecticidal hammock net (LLIHN), insect repellent (Icaridin), and MMP-tailored behavioural change communication (BCC) package
Eligibility Criteria
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Inclusion Criteria
* Traditional slash-and-burn and paddy field farming communities visiting their forest farms (commonly ethnic minority groups)
* Seasonal agricultural laborers
* Forest workers in the informal sector (hunters, small-scale gem/gold miners, people gathering forest products (precious timber, construction timber, rattan/bamboo)
* Transient or mobile camp residents associated with commercial projects (road/pipeline construction, large-scale logging, deep seaport projects, etc.)
* Formal and informal cross-border migrant workers
For qualitative research component, local health stakeholders meeting the following criteria will be eligible:
* Aged 18 years and over
* The local health stakeholders such as health centre staff, Operational District Malaria Supervisor (ODMS), and Provincial Malaria Supervisor (PMS), and basic health staff such as malaria unit staff in health centres, midwives, health assistants, district health officers and district focal person from CMPE and CNM
* Health staff members from HPA and Lao malaria community service organisations
Exclusion:
A village will be excluded from the study if:
The village has an VHV/VMW program operated by any organizations other than CMPE, CNM, HPA, malaria CSOs in Lao PDR The village has no malaria cases or API less than 1 in any of the past three years (2018 - 2020) The village has no MMPs The village has no VHV/VMW The village has a government health facility for provision of malaria services
18 Years
ALL
Yes
Sponsors
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Health Poverty Action
OTHER
Centre of Malariology Parasitology and Entomology, Department of Communicable Diseases Control, Ministry of Health, Lao PDR
UNKNOWN
National Centre for Parasitology, Entomology and Malaria Control, Cambodia
OTHER
Macfarlane Burnet Institute for Medical Research and Public Health Ltd
OTHER
Responsible Party
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Central Contacts
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References
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Gabaldon Figueira JC, Wagah MG, Adipo LB, Wanjiku C, Maia MF. Topical repellents for malaria prevention. Cochrane Database Syst Rev. 2023 Aug 21;8(8):CD015422. doi: 10.1002/14651858.CD015422.pub2.
Htike W, Oo WH, Lynn T, Sovanda L, Agius PA, Oo MC, Galau NH, Thu KM, Zaw AK, Htwe EP, Cutts JC, Kearney EA, Scott N, O'Flaherty K, Wang B, Khamlome B, Vilay P, Siv S, Fowkes FJI. Reducing malaria transmission in forest-going mobile and migrant populations in Lao PDR and Cambodia: protocol for stepped-wedge cluster-randomised controlled trial. BMC Infect Dis. 2022 Sep 24;22(1):747. doi: 10.1186/s12879-022-07724-5.
Other Identifiers
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388/21_forest_Cambodia_Laos
Identifier Type: -
Identifier Source: org_study_id