Abstract

BackgroundIn China, the prevalence of HIV infection is high among men who have sex with men (MSM), but the HIV testing rate is rather low. HIV and sexuality stigma are the main barriers faced by Chinese MSM to testing for HIV with available testing services. The aim of this study was to assess the accuracy and acceptability of oral-based home self-testing, which might address the issue. MethodThis two-stage interventional study of HIV testing at baseline and at follow-up took place in two big cities and involved 3 clinics in Beijing and Nanning. The study population is MSM in the previous year, 18 years or older, currently living in Beijing or Nanning. The two main recruitment methods were peer-referral and disseminating testing and survey information through internet. We collected data by asking participants to fill out a questionnaire, which covers demographic characteristics, behaviour characteristics, HIV testing history, willingness to use the oral fluid rapid HIV test, and test preference. The questionnaire was pretested among five MSM and modified according to the MSM's suggestion. We also sampled blood for HIV tests and monitored oral fluid rapid self-testing. Follow-up was in the 3–12 months range after baseline study. The diagnostic accuracy of oral fluid rapid test kit for HIV infection were measured with sensitivity, specificity, and conformity by comparing oral test results with blood tests for ELISA/Western blot. The blood tests was done after the oral fluid self testing at baseline. HIV-negative MSM at the baseline were recommended to use oral testing kits as HIV home test kits to repeatedly test for HIV between baseline and follow-up. Sample size was estimated with the formula of screening. All participants provided written informed consent for voluntary rapid oral fluid testing and/or blood testing, and participation in questionnaire interview. The study protocol and informed consent form was approved by the institutional review board of Guangxi Provincial Center for Disease Control and Prevention. FindingsBetween April, 2013, and April, 2014, we enrolled 510 MSM for baseline analysis, 279 of whom were available for follow-up. The sensitivity of oral fluid HIV self-testing at baseline was 86% (95% CI 81·09–95·62); and the specificity was 98·2% (97·88–98·52). 401 (79%) MSM at baseline were willing to test for HIV with oral fluid testing kits. The associated factors were no passive unprotected anal intercourse (UAI) with male partners in the past 6 months, active UAI with regular male partners in the past 6 months, and the first choice of being tested for HIV being an oral test. 176 (35%) MSM at baseline and 125 (40%) MSM at follow-up preferred oral HIV testing. The associated factors at baseline were to grow up in urban areas and willingness to self-test for HIV using oral test kit in future. 102 (25%) MSM were willing to purchase oral fluid test kit in the following 6 months. The associated factors were 25 years of age or younger, college-level or higher education, known HIV serostatus of non-regular male sex partners through testing, and the oral test being the first choice of test. InterpretationHome HIV self-testing using oral fluid rapid testing kit of high accuracy is promising to facilitate HIV testing among MSM in China. Self-testing with oral fluid self testing kits in our study was mainly in a supervised context and the researcher could provide on-site post counseling and refer to care immediately, hence lacking data on linkage into care following a positive HIV test. FundingGuangxi Provincial Center for Disease Prevention and Control.

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