NCT05045547

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,191

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 16, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

April 17, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

1.2 years

First QC Date

June 1, 2021

Last Update Submit

March 18, 2025

Conditions

Keywords

Febrile IllnessVillage Health WorkerCambodia

Outcome Measures

Primary Outcomes (1)

  • The number of VMW consultations by patients

    The number of VMW consultations by patients with a febrile and/or non-febrile illness along with the number of malaria RDTs used will be recorded. Comparing these data across the different intervention packages introduced for VMWs.

    Approximately 18-24 months

Secondary Outcomes (8)

  • The number of VMWs that can correctly perform RDTS following a directly observed practical assessment and questionnaire.

    Approximately 18-24 months

  • The number of VMWs who correctly follow the treatment algorithms following a directly observed practical assessment and questionnaire.

    Approximately 18-24 months

  • The overall consensus of stakeholders regarding the new roles of VMWs following stakeholder interviews

    0 months, mid-point of the study (12 months) and at study completion (24 months)

  • The overall consensus of stakeholders of the impact on non-malarial febrile illness management following stakeholder interviews

    0 months, mid-point of the study (12 months) and at study completion (24 months)

  • The number of VMWs that can correctly deliver one of four health intervention packages following a directly observed practical assessment and questionnaire.

    0 months, mid-point of the study (12 months) and at study completion (24 months)

  • +3 more secondary outcomes

Other Outcomes (1)

  • The number of patients appropriately referred for further care

    Approximately 18-24 months

Study Arms (3)

Patients with febrile illness

Febrile patients attending village malaria workers (VMWs)

Health centre staffs

Health centre staffs from 12 rural health centres

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.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

1. Quantitative research Participants: Febrile patients attending village malaria workers (VMWs) 2. Qualitative research 2.1 Health centre-based evaluation of novel diagnostics Participants: Health centre staffs from 12 rural health centres 2.2 Stakeholder analysis Participants: 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.

You may qualify if:

  • Quantitative research
  • Written informed consent
  • Willingness to provide blood sample
  • Fever (≥37.5 C) or history of fever within 24 hours
  • Qualitative research
  • 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
  • Stakeholder analysis
  • Adults, male or female, aged 18 years and over
  • Willing and able to give informed consent for participation in the study

You may not qualify if:

  • Quantitative research
  • Participants requires urgent medical attention
  • Qualitative research
  • Identified with intellectual and/or cognitive disability
  • History of or current psychiatric illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Action for Health and Development

Battambang, Cambodia

Location

Study Officials

  • Thomas J Peto, Dr.

    Mahidol Oxford Tropical Medicine Research Unit

    PRINCIPAL INVESTIGATOR
  • James J Callery, Dr.

    Mahidol Oxford Tropical Medicine Research Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2021

First Posted

September 16, 2021

Study Start

April 17, 2022

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

March 19, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

Data collected for this study will be under the custodianship of MORU. With participant's consent, data from this study may be shared in a de-identified form with other groups or researchers in accordance with the MORU Data Sharing Policy.

Time Frame
After completion of trial activities and reporting
Access Criteria
MORU Data Sharing Policy. (http://www.tropmedres.ac/data-sharing-policy)

Locations