Febrile IllnessCAM-VMWNCT05045547
Village Malaria Worker Expansion
An observational study of Febrile Illness, run by University of Oxford at 1 site in Cambodia.
Trial 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). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Febrile Illness
- How many people
- 7,191 participants
- Where
- 1 siteCambodia
- Study dates
- 17 Apr 2022to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Quantitative research
- Written informed consent
- Willingness to provide blood sample
- Fever (≥37.5 C) or history of fever within 24 hours
- Qualitative research
- 2.1 Health centre-based evaluation of novel diagnostics
Show all 11Show fewer
- 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
Who cannot join
- Quantitative research
- Participants requires urgent medical attention
- Qualitative research
- Identified with intellectual and/or cognitive disability
- History of or current psychiatric illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Expanding the Roles of Village Malaria Workers: Operational Research in Cambodia
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
Read the 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
- Keywords
- Febrile Illness, Village Health Worker, Cambodia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately 18-24 months
Secondary outcomes (8)
The number of VMWs that can correctly perform RDTS following a directly observed practical assessment and questionnaire.
The number of VMWs that can correctly perform RDTS following a directly observed practical assessment and questionnaire.
Measured: Approximately 18-24 months
The number of VMWs who correctly follow the treatment algorithms following a directly observed practical assessment and questionnaire.
The number of VMWs who correctly follow the treatment algorithms following a directly observed practical assessment and questionnaire.
Measured: Approximately 18-24 months
The overall consensus of stakeholders regarding the new roles of VMWs following stakeholder interviews
The overall consensus of stakeholders regarding the new roles of VMWs following stakeholder interviews
Measured: 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
The overall consensus of stakeholders of the impact on non-malarial febrile illness management following stakeholder interviews
Measured: 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.
The number of VMWs that can correctly deliver one of four health intervention packages following a directly observed practical assessment and questionnaire.
Measured: 0 months, mid-point of the study (12 months) and at study completion (24 months)
The number of health centre staff that can correctly perform RDTs following a directly observed practical assessment and questionnaire
The number of health centre staff that can correctly perform RDTs following a directly observed practical assessment and questionnaire
Measured: Approximately 18-24 months
The overall consensus of stakeholders on the use of novel RDTs following stakeholder interviews and focus group discussions.
The overall consensus of stakeholders on the use of novel RDTs following stakeholder interviews and focus group discussions.
Measured: Approximately 18-24 months
The overall consensus of stakeholders regarding these new roles following stakeholder interviews
The overall consensus of stakeholders regarding these new roles following stakeholder interviews
Measured: At study completion (24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start17 Apr 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Febrile IllnessStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 7,191 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Mahidol Oxford Tropical Medicine Research Unit
- Responsible party
- Sponsor
- Investigators
- Thomas J Peto, Dr., Principal investigator, Mahidol Oxford Tropical Medicine Research UnitJames J Callery, Dr., Principal investigator, Mahidol Oxford Tropical Medicine Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05045547
- Sponsor's protocol ID
- HCR21005
- Acronym
- CAM-VMW
- Status last verified
- Mar 2025
- First submitted
- 1 Jun 2021
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding the Roles of Village Malaria Workers: Operational Research in Cambodia
- ClinicalTrials.gov ID
- NCT05045547
- Acronym / sponsor ID
- CAM-VMW / HCR21005
- Conditions
- Febrile Illness
- Keywords
- Febrile Illness, Village Health Worker, Cambodia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,191 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Mahidol Oxford Tropical Medicine Research Unit
- Study start
- 17 Apr 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 16 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- Quantitative research
- 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
Key exclusion criteria (5 listed)
- Quantitative research
- Qualitative research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The number of VMW consultations by patients
Time frame: Approximately 18-24 months
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.
8 secondary outcomes
The number of VMWs that can correctly perform RDTS following a directly observed practical assessment and questionnaire.
Time frame: Approximately 18-24 months
The number of VMWs who correctly follow the treatment algorithms following a directly observed practical assessment and questionnaire.
Time frame: Approximately 18-24 months
The overall consensus of stakeholders regarding the new roles of VMWs following stakeholder interviews
Time frame: 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
Time frame: 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.
Time frame: 0 months, mid-point of the study (12 months) and at study completion (24 months)
The number of health centre staff that can correctly perform RDTs following a directly observed practical assessment and questionnaire
Time frame: Approximately 18-24 months
The overall consensus of stakeholders on the use of novel RDTs following stakeholder interviews and focus group discussions.
Time frame: Approximately 18-24 months
The overall consensus of stakeholders regarding these new roles following stakeholder interviews
Time frame: At study completion (24 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas J Peto, Dr. principal investigator
Mahidol Oxford Tropical Medicine Research Unit
James J Callery, Dr. principal investigator
Mahidol Oxford Tropical Medicine Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Febrile Illness, run by University of Oxford at 1 site in Cambodia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cambodia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of VMW consultations by patients (time frame: Approximately 18-24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.