Reducing Malaria Transmission in Forest-going Mobile and Migrant Populations in Lao PDR and Cambodia

NCT05117567 | Unknown

• 1 other identifier: 388/21_forest_Cambodia_Laos
• Study Type: interventional
• Target: 5,868
• 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 Lao People's Democratic Republic (PDR) and Cambodia.

Conditions

Plasmodium 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

  Assessed weekly, longitudinally over 12 months

Secondary Outcomes (10)

• Symptomatic malaria diagnosed by RDT

  Assessed weekly, longitudinally over 12 months

• Plasmodium spp. infection as determined by polymerase chain reaction (PCR) on RDT cassette samples

  Assessed weekly, longitudinally over 12 months

• Plasmodium spp. infection as determined by polymerase chain reaction (PCR) on dried blood spot samples

  Assessed weekly, longitudinally over 12 months

• Plasmodium spp. infections with drug resistance mutations

  Assessed weekly, longitudinally over 12 months

• Prevalence 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 (Icaridin), and mobile and migrant population-tailored behavioural change communication (BCC) package

Combination Product: Personal protection package

Control

NO INTERVENTION

No personal protection package

Interventions

Personal protection package COMBINATION_PRODUCT

A personal protection package that includes Long-lasting insecticidal hammock net (LLIHN), insect repellent (Icaridin), and MMP-tailored behavioural change communication (BCC) package

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:

• Mobile and migrant individuals aged 18 years and over in selected villages including:
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Macfarlane Burnet Institute for Medical Research and Public Health Ltd: lead
• Health Poverty Action: collaborator
• Centre of Malariology Parasitology and Entomology, Department of Communicable Diseases Control, Ministry of Health, Lao PDR: collaborator
• National Centre for Parasitology, Entomology and Malaria Control, Cambodia: collaborator

Related Publications (2)

• 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.

  PMID: 37602418 DERIVED

• 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.

  PMID: 36153501 DERIVED

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

+613 8506 2310; freya.fowkes@burnet.edu.au

Julia C Cutts, PhD

CONTACT

+61408397376; julia.cutts@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: November 11, 2021
• Study Start: December 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: November 11, 2021

Record last verified: 2021-11