Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jun 18, 2024
Date Accepted: Aug 13, 2024
Mixed Method Study Protocol: Community versus facility-based services to improve the screening of active HCV infection in Cambodia: the ANRS 12384 Cam-C cluster randomized controlled trial
ABSTRACT
Background:
In Cambodia, hepatitis C constitutes a significant public health challenge, particularly among older adults (>45 years) for whom prevalence is estimated to be 5%. To facilitate the elimination of hepatitis C among the general population, enhancing access to screening and treatment is imperative. In this regard, the evaluation of community-based screening programs emerges as a crucial step towards improving healthcare accessibility.
Objective:
The study aim to assess the comparative efficacy of a community-based versus a facility-based approach in enhancing the uptake of hepatitis C antibody testing among the general population aged over 40 years in Cambodia.
Methods:
The CAM-C study employs a cluster-randomized controlled trial design across two Cambodian provinces to compare community-based and facility-based hepatitis testing interventions. Sampling involves a multistage cluster approach, targeting individuals over 40 years old due to their higher prevalence and risk of chronic hepatitis complications. The study incorporates a qualitative analysis of acceptability and a cost-effectiveness comparison. Interventions include facility-based testing with subsequent referral and community-based testing with direct in-home assessments. Follow-up for positive cases involves comprehensive management and potential Direct-Acting Antiviral treatment. The study aims to identify a significant increase in testing uptake, requiring screening of 6000 individuals over 40 years old, facilitated by a structured sampling and intervention approach to minimize contamination risks.
Results:
The final protocol including quantitative, qualitative and cost effectiveness part of the study was registered and was approved in 202 by the NECHR. Inclusions are currently being finalized, with analyses due to start in may 2024.
Conclusions:
Employing a mixed-methods approach that combines a robust methodology (cluster randomized trial) with a cost-effectiveness analysis and qualitative research, such a study should provide invaluable information to guide the Ministry of Health in its HCV screening strategy and move towards elimination. Clinical Trial: ClinicalTrials.gov NCT03992313; https://clinicaltrials.gov/study/NCT03992313
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