Background With the advent of low‐cost generic direct‐acting antivirals (DAA), hepatitis C (HCV) elimination is now achievable even in low‐/middle‐income settings. We assessed the feasibility and effectiveness of a simplified clinical pathway using point‐of‐care diagnostic testing and non‐specialist‐led care in a decentralized, community‐based setting. Methods This feasibility study was conducted at two sites in Yangon, Myanmar: one for people who inject drugs (PWID), and the other for people with liver disease. Participants underwent on‐site rapid anti‐HCV testing and HCV RNA testing using GeneXpert(R). General practitioners determined whether participants started DAA therapy immediately or required specialist evaluation. Primary outcome measures were progression through the HCV care cascade, including uptake of RNA testing and treatment, and treatment outcomes. Findings All 633 participants underwent anti‐HCV testing; 606 (96%) were anti‐HCV positive and had HCV RNA testing. Of 606 tested, 535 (88%) were RNA positive and had pre‐treatment assessments; 30 (6%) completed specialist evaluation. Of 535 RNA positive participants, 489 (91%) were eligible to initiate DAAs, 477 (98%) completed DAA therapy and 421 achieved SVR12 (92%; 421/456). Outcomes were similar by site: PWID site: 91% [146/161], and liver disease site: 93% [275/295]). Compensated cirrhotic patients were treated in the community; they achieved an SVR12 of 83% (19/23). Median time from RNA test to DAA initiation was 3 days (IQR 2‐5). Conclusions Delivering a simplified, non‐specialist‐led HCV treatment pathway in a decentralized community setting was feasible in Yangon, Myanmar; retention in care and treatment success rates were very high. This care model could be integral in scaling up HCV services in Myanmar and other low‐ and middle‐income settings.

Background The advent of direct-acting antivirals (DAAs) and point-of-care (POC) testing platforms for hepatitis C allow for the decentralization of care to 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-and middle-income settings. Objective This study aims to assess the feasibility, acceptability, effectiveness, and cost-effectiveness of decentralized community-based POC 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 carried out on-site and, if reactive, were followed by POC GeneXpert hepatitis C RNA polymerase chain reaction tests. External laboratory blood tests to exclude other major health issues were undertaken. Results were given to participants at their next appointment, with the participants commencing DAA therapy that day if a specialist review was not required. Standard clinical data were collected, and the participants completed behavioral questionnaires. The primary outcome measures are the proportion of participants receiving GeneXpert hepatitis C RNA test, the proportion of participants commencing DAA therapy, the proportion of participants completing DAA therapy, and the proportion of participants achieving sustained virological response 12 weeks after completing DAA therapy. Results Recruitment was completed on September 30, 2019. Monitoring visits and treatment outcome visits are scheduled to continue until June 2020. Conclusions This feasibility study in Myanmar contributes to the evidence gap for community-based hepatitis C care in low- and middle-income settings. Evidence from this study will inform the scale-up of hepatitis C treatment programs in Myanmar and globally.

ObjectivesTo assess the feasibility considerations for a decentralised, one-stop-shop model of care implemented in Yangon, Myanmar.SettingTwo primary care level clinics in urban Yangon, Myanmar.DesignThis is a feasibility study of a highly effective care model. Using Intervention Complexity Framework by Gericke et al, we collated and analysed programmatic data and evaluation data to outline key project implementation requirements and experiences.ParticipantsProgrammatic data were collected from clinical records, GeneXpert device test and maintenance reports, national guidelines, product and device instructions and site monitoring visit reports. Healthcare providers involved in delivering care model contributed interview data.ResultsThe main feasibility considerations are appropriate storage for test kits and treatments (in response to temperature and humidity requirements), installation of a continuous stable electricity supply for the GeneXpert device, air-conditioning for the laboratory room hosting GeneXpert, access to a laboratory for pretreatment assessments and clear referral pathways for specialist consultation when required. Lessons from our project implementation experiences included the extensive time requirements for patient education, the importance of regular error monitoring and stock storage reviews and that flexible appointment scheduling and robust reminder system likely contributed to high retention in care.ConclusionsDetailed documentation and dissemination of feasibility requirements and implementation considerations is vital to assist others to successfully implement a similar model of care elsewhere. We provide 10 recommendations for successful implementation.Trial registration numberThe trial was registered at ClinicalTrials.gov NCT03939013 on May 6, 2019. This manuscript presents post-results data on feasibility.

Finding new ways to increase access to hepatitis C (HCV) treatment is integral to reducing liver diseaserelated deaths and achieving HCV elimination in the Asia-Pacific. Decentralised, non-specialist led care is essential to expand access to HCV treatment, both by increasing the number of providers and the geographical coverage. The vast majority of direct-acting antiviral (DAA) treatments for HCV do not need to be provided

Hepatitis C (HCV) infection elimination in low- and middle-income countries requires decentralised HCV services to increase testing and linkage to care. The CT2 Study investigated patients’ views of access to and acceptance of two community-based HCV care models in Myanmar using a mixed-methods approach. Point-of-care HCV testing and general practitioner-initiated HCV treatment were provided at two community clinics in Yangon, Myanmar–the Burnet Institute’s (BI) clinic focused on people who inject drugs (PWID), and the Myanmar Liver Foundation’s (MLF) clinic focused on people with liver-related diseases. Study staff administered quantitative questionnaires to 633 participants receiving anti-HCV antibody testing. Purposive sampling was used to recruit 29 participants receiving direct-acting antiviral treatment for qualitative interviews. Among participants completing quantitative questionnaires, almost all reported the clinic location was convenient (447/463, 97%), waiting time was acceptable (455/463, 98%), and HCV antibody and RNA testing methods were acceptable (617/632, 98% and 592/605, 97% respectively). Nearly all participants were satisfied with their clinic’s services (444/463, 96%) and preferred same-day test results (589/632, 93%). BI clinic participants were more confident that they understood HCV antibody and RNA results; MLF clinic participants were more comfortable disclosing their risk behaviour to staff and had slightly higher satisfaction with the overall care, privacy and secure storage of their information. In qualitative interviews, participants reported that flexible appointment scheduling, short wait times and rapid return of results increased the clinic’s accessibility. The simplified point-of-care testing and treatment procedures and supportive healthcare providers contributed to participants’ acceptance of the HCV care model. This decentralised community-based HCV testing and treatment model was highly accessible and acceptable to CT2 participants. Prioritizing patient-centred care, rapid provision of results, flexible appointments and convenient clinic locations can promote accessible and acceptable services which may in turn help accelerate progress in reaching HCV elimination targets.