Clinical trial NCT05025761: Reducing Malaria Transmission in Forest-going Mobile and Migrant Populations in Myanmar
Official title: A Personal Protection Package for Reducing Malaria Transmission in Forest-going Mobile and Migrant Populations in Myanmar: A Stepped-wedge Trial With Nested Mixed-methods Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Plasmodium Falciparum Infection
Keywords: malaria
prevention
vector
migrant
elimination
vivax
falciparum
community-delivered
intervention
Lead sponsor: Macfarlane Burnet Institute for Medical Research and Public Health Ltd
Sponsor class: OTHER
Collaborators: name: Health Poverty Action
name: National Malaria Control Program, Myanmar
First posted: 2021-08-27
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Stepped-wedge cluster-randomized controlled trial (one-way crossover) with nested mixed methods study
Primary purpose: PREVENTION

Brief summary: This stepped-wedge cluster-randomized controlled trial with nested mixed methods study will assess the effectiveness, acceptability, feasibility and cost effectiveness of a personal protection package to reduce malaria transmission among mobile and migrant populations (MMPs) and the general population in their residing villages in Myanmar.

Detailed description: Over the last decade, the burden of malaria has fallen dramatically in the Greater Mekong Subregion, with deaths falling by 95% and cases by 76% between 2012 and 2019.The declining malaria burden in GMS has largely been attributed to the deployment of interventions of malaria prevention tools such as long-lasting Insecticidal Nets (LLIN), and widespread availability of rapid diagnostic tests and artemisinin combination therapies. However, residual transmission exists among high risk populations, particularly mobile and migrant populations who enter forests for work. New interventions targetting these high risk groups are needed if countries of the Greater Mekong Subregion are to achieve malaria elimination by 2030. The study will be conducted in malaria endemic areas of Myanmar which have large forest going MMP populations. The aim of the study is to assess the effectiveness, acceptability, feasibility and cost-effectiveness of a personal protection package to reduce malaria transmission among mobile and migrant populations (MMPs) and the general population in their residing villages in Myanmar. The personal protection package includes WHO prequalified long-lasting insecticidal net (LLIN), insect repellent (N, N-Diethyl-meta-toluamide (DEET), insecticide-treated clothes (ITC), and a MMP-tailored behavioural change communication (BCC) package. The study design is a stepped-wedge cluster-randomized controlled trial with nested mixed methods study. The stepped-wedge cluster randomized trial will estimate the effectiveness of a personal protection package provided to forest-going MMPs (the intervention) delivered by village malaria volunteers at the site (village/worksite) level on reducing Plasmodium spp. infections (primary outcome). Whilst the personal protection package will be provided to mobile and migrant populations in each village in a step-wise manner, primary and secondary outcomes relating to malaria testing will be collected in all consenting individuals in the village who present for malaria rapid diagnostic tests, whether they are mobile and migrant people or not. The study will also include investigation of antibody responses to Plasmodium spp. and mosquito vectors and molecular markers of antimalarial drug resistance.

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).

Eligibility criteria: Inclusion Criteria for states/regions:

* Capacity of Burnet Institute Myanmar to conduct field implementation
* Presence of ICMV networks managed by NMCP and HPA
* High malaria burden
* High MMP activities
* Available budget

Exclusion Criteria for states/regions:

* The township does not have an NMCP or HPA-provided ICMV network
* 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

Exclusion criteria for villages:

* 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

Inclusion Criteria for MMP participants (personal protection package intervention):

* 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

Inclusion criteria for the focus group discussion:

• Participants selected purposively from the same cohort of MMPs who have received the personal protection package during the study period

Inclusion criteria for semi-structured interviews with local health stakeholders:

* 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

Inclusion criteria for semi-structured interviews with ICMVs:

• ICMV participants will be selected purposively from the ICMVs actively working in the selected villages.

Primary outcomes:
measure: Plasmodium spp. infection diagnosed by RDT
timeFrame: Assessed weekly, longitudinally over 12 months
Secondary outcomes:
measure: Symptomatic malaria diagnosed by RDT
timeFrame: Assessed weekly, longitudinally over 12 months
measure: Plasmodium spp. infection as determined by polymerase chain reaction (PCR)
timeFrame: Assessed weekly, longitudinally over 12 months
measure: Plasmodium spp. drug resistance mutations
timeFrame: Assessed weekly, longitudinally over 12 months
measure: Prevalence of antibodies to Plasmodium spp.
timeFrame: Assessed weekly, longitudinally over 12 months
measure: Levels of antibodies to Plasmodium spp.
timeFrame: Assessed weekly, longitudinally over 12 months
measure: Prevalence of antibodies to vector salivary antigens
timeFrame: Assessed weekly, longitudinally over 12 months
measure: Levels of antibodies to vector salivary antigens
timeFrame: Assessed weekly, longitudinally over 12 months
measure: Levels of knowledge, attitude and practice regarding malaria prevention among MMPs (qualitative research)
timeFrame: At 12 months
measure: Proportion of survey respondents (MMPs) who accept and are willing to use/ did use the personal protection package according to the protocol
timeFrame: At 12 months
Other outcomes:
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