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: Protocol for a Feasibility Study.
Asia, Southeastern
community health services
delivery of health care
hepatitis C
point-of-care testing
primary health care
retention in care
Journal
JMIR research protocols
ISSN: 1929-0748
Titre abrégé: JMIR Res Protoc
Pays: Canada
ID NLM: 101599504
Informations de publication
Date de publication:
14 Jul 2020
14 Jul 2020
Historique:
received:
20
11
2019
accepted:
26
03
2020
revised:
15
03
2020
entrez:
17
7
2020
pubmed:
17
7
2020
medline:
17
7
2020
Statut:
epublish
Résumé
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. 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. 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. Recruitment was completed on September 30, 2019. Monitoring visits and treatment outcome visits are scheduled to continue until June 2020. 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.
Sections du résumé
BACKGROUND
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
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
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
RESULTS
Recruitment was completed on September 30, 2019. Monitoring visits and treatment outcome visits are scheduled to continue until June 2020.
CONCLUSIONS
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.
Identifiants
pubmed: 32673260
pii: v9i7e16863
doi: 10.2196/16863
pmc: PMC7388045
doi:
Types de publication
Journal Article
Langues
eng
Pagination
e16863Informations de 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.
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