Clinical trial NCT05045547: Village Malaria Worker Expansion
Official title: Expanding the Roles of Village Malaria Workers: Operational Research in Cambodia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Febrile Illness
Keywords: Febrile Illness
Village Health Worker
Cambodia
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Mahidol Oxford Tropical Medicine Research Unit
First posted: 2021-09-16
Enrollment: 7191
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.

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

Primary outcomes:
measure: The number of VMW consultations by patients
timeFrame: Approximately 18-24 months
Secondary outcomes:
measure: The number of VMWs that can correctly perform RDTS following a directly observed practical assessment and questionnaire.
timeFrame: Approximately 18-24 months
measure: The number of VMWs who correctly follow the treatment algorithms following a directly observed practical assessment and questionnaire.
timeFrame: Approximately 18-24 months
measure: The overall consensus of stakeholders regarding the new roles of VMWs following stakeholder interviews
timeFrame: 0 months, mid-point of the study (12 months) and at study completion (24 months)
measure: The overall consensus of stakeholders of the impact on non-malarial febrile illness management following stakeholder interviews
timeFrame: 0 months, mid-point of the study (12 months) and at study completion (24 months)
measure: The number of VMWs that can correctly deliver one of four health intervention packages following a directly observed practical assessment and questionnaire.
timeFrame: 0 months, mid-point of the study (12 months) and at study completion (24 months)
measure: The number of health centre staff that can correctly perform RDTs following a directly observed practical assessment and questionnaire
timeFrame: Approximately 18-24 months
measure: The overall consensus of stakeholders on the use of novel RDTs following stakeholder interviews and focus group discussions.
timeFrame: Approximately 18-24 months
measure: The overall consensus of stakeholders regarding these new roles following stakeholder interviews
timeFrame: At study completion (24 months)
Other outcomes:
measure: The number of patients appropriately referred for further care
timeFrame: Approximately 18-24 months
Locations:
city: Battambang
country: Cambodia
facility: Action for Health and Development
Study officials:
affiliation: Mahidol Oxford Tropical Medicine Research Unit
name: Thomas J Peto, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Mahidol Oxford Tropical Medicine Research Unit
name: James J Callery, Dr.
role: PRINCIPAL_INVESTIGATOR
References: