TY - JOUR
T1 - Decentralized, community-based hepatitis C point-of-care testing and direct-acting antiviral treatment for people who inject drugs and the general population in myanmar
T2 - Protocol for a feasibility study
AU - Draper, Bridget Louise
AU - Pedrana, Alisa
AU - Howell, Jessica
AU - Yee, Win Lei
AU - Htay, Hla
AU - Aung, Khin Sanda
AU - Shilton, Sonjelle
AU - Kyi, Khin Pyone
AU - Naing, Win
AU - Hellard, Margaret
N1 - Funding Information:
The Hepatitis C: Community-based Testing and Treatment Study (CT2 study), undertaken by the Burnet Institute, is part of the Foundation for Innovative New Diagnostics (FIND)–led Hepatitis C Elimination through Access to Diagnostics (HEAD-Start) program funded by Unitaid. It was designed to assess the feasibility of a decentralized hepatitis C model of care in a resource-constrained setting, utilizing POC testing technologies with a GP initiating DAA therapy in the majority of participants, with a pathway of care to tertiary hospitals for people with decompensated cirrhosis. This paper describes the protocol of the CT2 study.
Funding Information:
This study was funded as part of the Unitaid HEAD-Start Project through FIND. The investigators are responsible for the study design, data collection and analysis, interpretation of data, and preparation of manuscripts. The authors gratefully acknowledge the contribution to this work of the Victorian Operational Infrastructure Support Program received by the Burnet Institute.
Publisher Copyright:
© Bridget Louise Draper, Alisa Pedrana, Jessica Howell, Win Lei Yee, Hla Htay, Khin Sanda Aung, Sonjelle Shilton, Khin Pyone Kyi, Win Naing, Margaret Hellard. Originally published in JMIR Research Protocols (http://www.researchprotocols.org),14.07.2020. This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.
PY - 2020/7
Y1 - 2020/7
N2 - 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.
AB - 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.
KW - Asia
KW - Community health services
KW - Delivery of health care
KW - Hepatitis C
KW - Point-of-care testing
KW - Primary health care
KW - Retention in care
KW - Southeastern
UR - http://www.scopus.com/inward/record.url?scp=85089595259&partnerID=8YFLogxK
U2 - 10.2196/16863
DO - 10.2196/16863
M3 - Article
C2 - 32673260
AN - SCOPUS:85089595259
VL - 9
JO - JMIR Research Protocols
JF - JMIR Research Protocols
SN - 1929-0748
IS - 7
M1 - e16863
ER -
