Accepted for/Published in: JMIR Research Protocols
Date Submitted: Nov 20, 2019
Date Accepted: Mar 26, 2020
Decentralized, community-based hepatitis C point-of-care testing and direct-acting antiviral treatment for people who inject drugs and general population in Myanmar (The CT2 Study): A Feasibility Study Protocol
ABSTRACT
Background:
The advent of direct-acting antivirals (DAAs) and point-of-care testing platforms for hepatitis C allow for the decentralization of care into primary care settings. In many countries, access to DAAs is generally limited to tertiary hospitals, with limited published research documenting decentralized models of care in low/middle income settings.
Objective:
This study aims to assess the feasibility, acceptability, effectiveness and cost-effectiveness of decentralized, community-based point-of-care testing and DAA therapy for hepatitis C among people who inject drugs and the general population in Yangon, Myanmar.
Methods:
Rapid diagnostic tests for anti-hepatitis C antibodies were performed on-site, and, if reactive, point-of-care GeneXpert hepatitis C RNA polymerase chain reaction tests. External laboratory investigations to exclude other major health issues were undertaken. Results were given to the participant at their next appointment, with participants commencing DAA therapy that day if specialist review was not required. Standard clinical data was collected and participants completed behavioral questionnaires. Primary outcome measures were proportion of patients receiving GeneXpert hepatitis C RNA test, proportion of patients commencing DAA therapy, proportion of patients completing DAA therapy and proportion of patients achieving sustained virological response 12 weeks after completing DAA therapy.
Results:
Recruitment was completed on 30 September 2019. Monitoring visits and treatment outcome visits will continue until June 2020.
Conclusions:
This feasibility study in Myanmar contributes to the evidence gap for decentralized community-based hepatitis C care in low/middle income settings. Evidence from this study will inform scale-up of hepatitis C treatment programs in Myanmar and globally. Clinical Trial: ClinicalTrials.gov, NCT03939013, https://clinicaltrials.gov/ct2/show/NCT03939013
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