HIV Self-Testing To Promote HIV Testing Among Men Who Have Sex With Men In China: A Stepped-Wedge Randomized Controlled Trial

Background: Human immunodeficiency virus(HIV)testing among high-risk groups is essential to know their HIV status,and reduce the risk of HIV infection and transmission,while the level of HIV testing remains unsatisfactory worldwide.Men who have sex with men(MSM),as an important high-risk group,is essential for control of global(HIV)epidemic.Affected by discrimination,insults,and uneven distribution of location-based testing resources,the HIV testing among MSM in China still low.HIV self-test(HIVST)has been widely accepted as a new approach for HIV testing.However,the effect of HIVST in promoting HIV testing among MSM in China,and the strategy of second-distribution of HIVST to promote partner HIV testing and serostatus disclosure is not clear.Objective: To evaluate the effect of providing HIV self-tests on frequency of HIV testing among MSM in China,and the strategy of second-distribution of HIVST to promote partner HIV testing and serostatus disclosure.Method: MSM will be recruited through advertisements released on WeChat public accounts.Individuals provided informed consent,and who were born biologically male,aged ≥16 years,HIV-negative,who had sex with men previously and had not undergone HIV testing in the previous 3 months will be recruited.Eligible men will be randomly divided(1:1:1:1)into four groups and randomized to initiate intervention.A stepped-wedge randomized controlled trial was used to conduct a one-year prospective online survey.MSM participants in Group A,Group B,Group C Group D will receive HIVST in 0,3,6,and 9 months after enrollment.MSM participants in four groups will be required to complete baseline and follow-up questionnaires online.The baseline questionnaire includes social background,HIV testing information,and sexual behaviors in past 3 months.The follow-up questionnaire mainly includes information about the HIV testing(including use of HIV self-tests),sexual behavior,HIV serostatus disclosure from sexual partners in the past 3 months.Frequency,percentage and chi-square comparison were used to describe the distribution of sociodemographic and sexual behavior characteristics of MSM participants in each group.The generalized mixed linear model(GLMM)was used to evaluate the association between HIVST on HIV testing of MSM participants and their regular partners,as well as the promotion of HIV serostatus disclosure from sexual partners.A mixed linear model was also used to evaluate the effect of HIVST on the frequency of HIV testing among MSM participants and their regular partners.Results: Between August to December in 2018,a total of 560 MSM were enrolled(140 in each group).Most were ≤30 years old(69.3%),had a college degree or higher(83.2%),had monthly income≤2000 Yuan(49.1%),currently not living in the residence(57.9%),and most(70.4%)identified their sexual orientation as homosexual.465(83.0%)participated in at least one prospective follow-up,and 394(70.4%)completed the last follow-up.74.4%(346/465)of the respondents applied for self-test reagents during the study period,and 1556 HIVST reagents were mailed in total,and 90.4% results were feedbacked.The HIV test proportion of individuals during the intervention periods was greater than during the control periods(86.0% vs.36.9%;P<0.001).The frequency of HIV testing in the intervention group was 0.89 times higher than during the control periods in the past 3 months(95% CI = 0.78-1.00).Through secondary-distribution,the proportion of regular partners receiving an HIV test(50.0% vs.27.9%;P<0.001)and frequency of HIV testing(0.34 times;95%CI = 0.24-0.34)in the intervention periods was also greater than during the control periods.The proportion of HIV serostatus disclosure from regular partners in the intervention periods was also greater than during the control periods(73.8% vs.65.9%).219 participants shared HIV self-tests with their regular partners.Of these,94.5%(260/275)used HIV self-tests for couple testing.During the study period,2.9%(12/412)participants reported HIV positive,and 4 individuals seroconverted,and 4.9%(9/182)individuals shared HIVST from participants reported HIV positive.Conclusion: HIV Self-testing can effectively improve the HIV testing of MSM population in China.Through the strategy of secondary-distribution can promote the HIV testing of sexual partners,as well as the disclosure of HIV serostatus and couple testing.The Policies of HIVST should be further developed to promote the application of HIVST in MSM,so as to effectively control the HIV epidemic among MSM in China.