Reducing Malaria Transmission in Forest-going Mobile and Migrant Populations in Myanmar
NCT ID: NCT05025761
Last Updated: 2021-11-04
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
1200 participants
INTERVENTIONAL
2022-01-01
2022-06-30
Brief Summary
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Detailed Description
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The study will be implemented between July 2021 (M1) to June 2022 (M12). The personal protection package for MMPs will be implemented sequentially in a minimum of 100 villages serviced by an ICMV. The villages will be grouped into 11 blocks of 9 villages, with each block transitioned from control phase (before introduction of the personal protection package) to intervention phase (after introduction of the personal protection package) at monthly intervals in random order. This follows an initial one-month baseline period at the start of the study period where all villages will not be exposed to the personal protection package exclusively.
For this proposed stepped-wedge cluster randomized controlled study, it is estimated that approximately 30 RDTs per month will be tested in each study site (village/worksite) and there will be 36,000 MMP tests over 12 months in 100 villages/worksites. It will be undertaken yielding a relative minimum detectable difference of 40% in odds of RDT-detectable malaria infection (assuming a village intraclass correlation \[ICC\]= 0.42 \[6\]; 5% significance; 80% power and 1% RDT malaria prevalence).
For the stepped-wedged cluster randomized trial, both descriptive and primary outcome trial analyses will be performed. In both analyses, sampling weights will be derived and applied in analyses where village selection probabilities are not equal - possible if the achieved number of villages sampled across townships varies. Furthermore, cluster robust standard errors will be used in all descriptive analyses given the complex sampling design. Differences in prevalence of malaria infections will be estimated across intervention and control periods using generalized linear mixed modelling (e.g. logit link function and binomial distribution).
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 (DEET), Insecticide-treated clothes (ITC), and mobile and migrant population-tailored behavioural change communication (BCC) package
Personal protection package
The personal protection package will be distributed to mobile and migrant peoples in each village according to the stepped wedge design.
Control
No personal protection package
No interventions assigned to this group
Interventions
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Personal protection package
The personal protection package will be distributed to mobile and migrant peoples in each village according to the stepped wedge design.
Eligibility Criteria
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Inclusion Criteria
* Presence of ICMV networks managed by NMCP and HPA
* High malaria burden
* High MMP activities
* Available budget
* Currently living in the selected villages/ worksites
* Being any of the following types of workers: 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
* Aged 18 years and over
• Participants selected purposively from the same cohort of MMPs who have received the personal protection package during the study period
* Aged over 18 years
* From different levels of NMCP, EHOs and HPA
* Basic health staff such as Public Health Supervisors, Midwives, Health Assistants, Township Health Officers and focal person from Township VBDC/NMCP offices
* Health staff from ethnic health organizations such as medics, doctors and nurses
* Health staff from HPA such as field supervisor, field office manager, technical officer
• ICMV participants will be selected purposively from the ICMVs actively working in the selected villages.
Exclusion Criteria
* The township is not under the administration of NMCP or HPA
* The township has an ongoing armed conflict at the time of sampling
* The location of the township is not geographically or politically feasible for the NMCP or HPA staff to conduct regular supervision visits
* 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 ICMVs actively working in the village
* The village has a government health facility for malaria services
* The village has an ICMV program operated by any organizations other than NMCP or HPA
18 Years
ALL
Yes
Sponsors
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Health Poverty Action
OTHER
National Malaria Control Program, Myanmar
OTHER_GOV
Macfarlane Burnet Institute for Medical Research and Public Health Ltd
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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260/21_forest_Myanmar
Identifier Type: -
Identifier Source: org_study_id