Village Malaria Worker Expansion

Febrile Illness Clinical Trial

— CAM-VMW  

Official title:

Expanding the Roles of Village Malaria Workers: Operational Research in Cambodia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05045547
• Other study ID #: HCR21005
• Status: Recruiting
• Start date: February 17, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: University of Oxford
• Contact: Thomas J Peto, Dr.
• Phone: +66802187460
• Email: tom[@]tropmedres.ac
• Is FDA regulated: No
• Study type: Observational

Clinical 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). The grant reference number is QSE-M-UNOPS-MORU-20864-007-42

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7000
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Febrile Illness
• Fever
• Hyperthermia
• Malaria

Locations

Country	Name	City	State
Cambodia	Action for Health and Development	Battambang

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	Mahidol Oxford Tropical Medicine Research Unit

Country where clinical trial is conducted

Cambodia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The number of patients appropriately referred for further care	The number of patients appropriately referred for further care	Approximately 18-24 months
Primary	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	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.	Approximately 18-24 months
Secondary	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.	Approximately 18-24 months
Secondary	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	0 months, mid-point of the study (12 months) and at study completion (24 months)
Secondary	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	0 months, mid-point of the study (12 months) and at study completion (24 months)
Secondary	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.	0 months, mid-point of the study (12 months) and at study completion (24 months)
Secondary	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	Approximately 18-24 months
Secondary	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.	Approximately 18-24 months
Secondary	The overall consensus of stakeholders regarding these new roles following stakeholder interviews	The overall consensus of stakeholders regarding these new roles following stakeholder interviews	At study completion (24 months)