Village Malaria Worker Expansion

NCT ID: NCT05045547

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 7191 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-17
• Study Completion Date: 2023-06-30

Brief Summary

This project will conduct pragmatic operational research in rural communities served by approximately 12 health centres and 120 village malaria workers in Battambang/Pailin, western Cambodia.

This study is funded by Global Fund/Regional Artemisinin Initiative (RAI3E). The grant reference number is QSE-M-UNOPS-MORU-20864-007-42

Detailed Description

This is an integration of activities with the South and Southeast Asian Community-based Trials Network (SEACTN) that is ongoing in Lao PDR and Bangladesh. The SEACTN study aims to identify the most relevant ways in which village health worker roles can be expanded to include management of community febrile illness. A number of SEACTN activities will also be conducted in Cambodia alongside this project.

For this project, the study team will test specific examples of expanded roles of VMWs including testing for other causes of fever in people who are malaria negative and assessing the feasibility of diagnostics other than malaria RDTs at health centres. Quantitative and qualitative data will be collected to determine acceptability, a mixed-methods approach will be used for the assessment:

• Quantitative method

Participants with febrile illness attending village malaria workers will be tested by novel rapid diagnostic tests (Dengue and CRP rapid test) in addition to a standard malaria test. Village malaria workers (VMWs)/ mobile malaria workers (MMWs) will be trained to conduct a package of activities ((i) hygiene and sanitation; (ii) disease surveillance; (iii) EPI and ANC support; (iv) management of mild common illnesses that they will carry out alongside their usual role of testing (RDTs) and treating malaria. If possible, within a week of conducting a novel RDT, a well-being follow up will be undertaken by the VMW, either via telephone or face-to-face. For the primary outcomes, the study team will report numbers and proportions of training modules passed, malaria tests performed, new diagnostic tests performed correctly, algorithms followed correctly, number of consultations, coverage estimates, and the study team will use the national malaria information system to provide a comparison in activity levels compared to other areas of Cambodia. The study team will record the incidence and aetiology of febrile illnesses.

• Qualitative method

A set of interviews/discussions with health centre staffs and local stakeholders will be conducted to refine the intervention design and implementation strategy. To this end, the interviews will elicit the views and experience of local stakeholders on (1) health care needs and gaps in local communities, (2) views and past experiences concerning the implementation of the VMW programme, with a focus on challenges and good practices around the use of RDTs, and (3) their views about suitable methods and strategies to expand the current VMW programme considering the new technologies available.

Findings from the study will highlight to the wider scientific community the benefits and challenges of expanding the roles of VMW/MMWs.

Conditions

Febrile Illness

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with febrile illness

Febrile patients attending village malaria workers (VMWs)

No interventions assigned to this group

Health centre staffs

Health centre staffs from 12 rural health centres

No interventions assigned to this group

Key stakeholders

Key stakeholders , for example health managers and health professionals:

• the director, deputy-directors, and technical officers at the National Malaria Control Program;
• the directors and deputy-directors of the Provincial Health Departments in Battambang and Pailin province;
• health officers actively involved in community-based (malaria) programmes at the district levels in Battambang and Pailin provinces;
• health workers (i.e., nurses or doctors) actively involved in community-based (malaria) programmes in Battambang and Pailin provinces;
• community representatives and village malaria workers from villages in both Battambang Pailin province.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Quantitative research

• Written informed consent
• Willingness to provide blood sample
• Fever (≥37.5 C) or history of fever within 24 hours

2. Qualitative research

2.1 Health centre-based evaluation of novel diagnostics

• Health centre staff who have received training in the use of the novel diagnostics used in the study
• Willing and able to give informed consent for participation in the study

2.2 Stakeholder analysis

• Adults, male or female, aged 18 years and over
• Willing and able to give informed consent for participation in the study

Exclusion Criteria

1. Quantitative research

• Participants requires urgent medical attention

2. Qualitative research

• Identified with intellectual and/or cognitive disability
• History of or current psychiatric illness

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mahidol Oxford Tropical Medicine Research Unit

OTHER

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas J Peto, Dr.

Role: PRINCIPAL_INVESTIGATOR

Mahidol Oxford Tropical Medicine Research Unit

James J Callery, Dr.

Role: PRINCIPAL_INVESTIGATOR

Mahidol Oxford Tropical Medicine Research Unit

Locations

Action for Health and Development

Battambang, , Cambodia

Countries

Cambodia

Other Identifiers

HCR21005

Identifier Type: -

Identifier Source: org_study_id