HCV Self-Testing to Expand Testing: A Pilot Among Men Who Have Sex With Men in China

Abstract

BackgroundHepatitis C virus self-testing (HCVST) may increase test uptake especially among marginalized key populations such as men who have sex with men (MSM). We conducted an observational study to assess the usability, acceptability and feasibility of HCVST among MSM in China.MethodsAn observational study with convenience sampling was performed among MSM in Guangzhou, China in 2019. The OraQuick® HCV Rapid Antibody Test kits were used in this study. Participants performed all 12 HCVST steps and interpreted the results in the presence of a trained observer. Usability was defined as the number and percentage of participants who completed all testing steps correctly without assistance and interpreted the results correctly. Inter-reader concordance was calculated as the percentage agreement between the results interpreted by the participant and those interpreted by a trained staff member. The same process was used to estimate inter-operator agreement between the self-testing and professional use test results. Acceptability was assessed using an interviewer-administered semi-structured questionnaire.ResultsAmong 100 participants with median age 27 (interquartile range 23–30) years, 4% reported prior history of HCV testing, 41% reported using blood-based HIV self-testing in the past, 54% (95%CI: 43.7–64.0%) completed all self-testing steps correctly without assistance and interpreted the results correctly. Both the inter-reader and inter-operator concordance were excellent at 97% (95%CI: 91.5–99.4%) and 98% (95%CI: 93.0–99.8%), respectively. The majority rated the HCVST process as very easy (52%, 95%CI: 41.8–62.1%) or easy (41%, 95%CI: 31.3–51.3%), 76% (95%CI: 66.4–84.0%) were willing to use HCVST again, and 75% (95%CI: 65.3–83.1%) would recommend it to their family and friends.ConclusionsOur findings demonstrate that oral fluid HCVST has high usability and acceptability among Chinese MSM. More implementation research is needed to plan how best to position and scale-up HCVST alongside other facility-and community-based testing approaches and ensure data linkage into health systems.

Acceptability and usability of oral fluid HCV self‐testing for hepatitis C diagnosis: A systematic review and meta‐analysis

“…Finally, screening and full‐text assessment resulted in six included manuscripts comprising 870 individuals from six countries (United States of America [ n = 95 people with chronic liver diseases], Kenya [ n = 150 PWID], Egypt [ n = 116 participants from the general population], Vietnam [ n = 104 MSM and n = 105 PWID], China [ n = 100 MSM] and Georgia [ n = 100 MSM and n = 100 PWID]) (Figure 1). 20–25 All studies were published in English and used OraQuick® HCV Rapid Antibody Test (OraSure Technologies Inc). HCVST results were checked by a healthcare provider in all studies.…”

“…However, it is expected a decrease of HCVST kits price due to the competition on the pipeline of WHO pre‐qualification. A cost‐effectiveness analysis (CEA) using data from those publications from China, 24 Georgia, 25 Vietnam 22 and Kenya 23 was reported in the WHO guideline (Web Annex F—https://www.who.int/publications/i/item/9789240031128). The cost per HCV diagnosis by the standard‐of‐care was extremely variable among those countries (from US$ 35 in Vietnam to US$ 361 in Kenya).…”

“…However, it is expected a decrease of HCVST kits price due to the competition on the pipeline of WHO pre-qualification. A cost-effectiveness analysis (CEA) using data from those publications from China, 24 Georgia, 25 Corporation Pvt Ltd., Gujarat, India). 19 An ongoing Malaysian study is comparing HCVST using an oral fluid (OraQuick®) and a blood-based (First Response®) HCVST in key population (NCT04982718).…”

“…19 MSM and n = 100 PWID]) (Figure 1). [20][21][22][23][24][25] All studies were published in English and used OraQuick® HCV Rapid Antibody Test (OraSure Technologies Inc). HCVST results were checked by a healthcare provider in all studies.…”

Expanding hepatitis C virus test uptake using self-testing among men who have sex with men in China: two parallel randomized controlled trials

“…Although there are currently no tests approved for HCV self-testing by WHO prequalification or other stringent regulatory authorities, several quality-assured tests are in the pipeline. To adapt and introduce self-testing for HCV, in 2019, the Foundation for Innovative New Diagnostics (FIND), in collaboration with WHO, conducted a series of pilot studies of HCV self-testing in Egypt [ 25 ], Vietnam [ 26 ], Georgia, Kenya, and China [ 27 ], which showed a high usability, acceptability and feasibility of using HCV self-testing among MSM. The pilot study in China showed that 76.0% (95% CI: 66.4 to 84.0%) of MSM found HCV self-testing acceptable [ 27 ].…”