Reducing Malaria Transmission in Forest-going Mobile and Migrant Populations in Myanmar

NCT05025761 | Unknown

• 1 other identifier: 260/21_forest_Myanmar
• Study Type: interventional
• Target: 1,200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Plasmodium Falciparum Infection

Keywords

malaria; prevention; vector; migrant; elimination; vivax; falciparum; community-delivered; intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Symptomatic malaria diagnosed by RDT

  Assessed weekly, longitudinally over 12 months

• Plasmodium spp. infection as determined by polymerase chain reaction (PCR)

  Assessed weekly, longitudinally over 12 months

• Plasmodium spp. drug resistance mutations

  Assessed weekly, longitudinally over 12 months

• Prevalence of antibodies to Plasmodium spp.

  Assessed weekly, longitudinally over 12 months

• Levels of antibodies to Plasmodium spp.

  Assessed weekly, longitudinally over 12 months

Study Arms (2)

Personal protection package

EXPERIMENTAL

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

Other: Personal protection package

Control

NO INTERVENTION

No personal protection package

Interventions

Personal protection package OTHER

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

Personal protection package

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Macfarlane Burnet Institute for Medical Research and Public Health Ltd: lead
• Health Poverty Action: collaborator
• National Malaria Control Program, Myanmar: collaborator

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Central Study Contacts

Freya JI Fowkes, DPhil

CONTACT

+61385062310; freya.fowkes@burnet.edu.au

Win Han Oo, PhD

CONTACT

+951375785; winhan.oo@burnet.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stepped-wedge cluster-randomized controlled trial (one-way crossover) with nested mixed methods study

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 27, 2021
• Study Start: January 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: November 4, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share