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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05025761
Other study ID # 260/21_forest_Myanmar
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 1, 2022
Est. completion date June 2022

Study information

Verified date August 2021
Source Macfarlane Burnet Institute for Medical Research and Public Health Ltd
Contact Freya JI Fowkes, DPhil
Phone +61385062310
Email freya.fowkes@burnet.edu.au
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1200
Est. completion date June 2022
Est. primary completion date June 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Personal protection package
The personal protection package will be distributed to mobile and migrant peoples in each village according to the stepped wedge design.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Macfarlane Burnet Institute for Medical Research and Public Health Ltd Health Poverty Action, National Malaria Control Program, Myanmar

Outcome

Type Measure Description Time frame Safety issue
Primary Plasmodium spp. infection diagnosed by RDT Change in the number of Plasmodium spp. infections detected by RDT per week per village (SD Bioline P.f/P.v) Assessed weekly, longitudinally over 12 months
Secondary Symptomatic malaria diagnosed by RDT Change in the number of symptomatic Plasmodium spp. infections detected by RDT per week per village Assessed weekly, longitudinally over 12 months
Secondary Plasmodium spp. infection as determined by polymerase chain reaction (PCR) Change in the number of Plasmodium spp. infections as determined by PCR using from RDT cassettes and dried blood spots Assessed weekly, longitudinally over 12 months
Secondary Plasmodium spp. drug resistance mutations Prevalence and change in the number of Plasmodium spp. drug resistance mutations as determined by PCR from RDT cassettes and dried blood spots Assessed weekly, longitudinally over 12 months
Secondary Prevalence of antibodies to Plasmodium spp. Prevalence of antibodies to Plasmodium spp. determined by Enzyme Linked Immunosorbent assay (ELISA) from RDT and DBS samples Assessed weekly, longitudinally over 12 months
Secondary Levels of antibodies to Plasmodium spp. Levels of antibodies to Plasmodium spp. determined by Enzyme Linked Immunosorbent assay (ELISA) from RDT and DBS samples Assessed weekly, longitudinally over 12 months
Secondary Prevalence of antibodies to vector salivary antigens Prevalence of antibody biomarkers of vector exposure determined by Enzyme Linked Immunosorbent assay (ELISA) from RDT and DBS samples Assessed weekly, longitudinally over 12 months
Secondary Levels of antibodies to vector salivary antigens Levels of antibody biomarkers of vector exposure determined by Enzyme Linked Immunosorbent assay (ELISA) from RDT and DBS samples Assessed weekly, longitudinally over 12 months
Secondary Levels of knowledge, attitude and practice regarding malaria prevention among MMPs (qualitative research) Focus group discussions At 12 months
Secondary Proportion of survey respondents (MMPs) who accept and are willing to use/ did use the personal protection package according to the protocol Focus group discussions; Questionnaire At 12 months
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