JMIR Publications

ABSTRACT

Background:

Disclosure of human immunodeficiency virus (HIV) serostatus is important for the reduction and prevention of HIV infection among men who have sex with men (MSM). However, knowledge of sexual partners’ HIV status among MSM in China is low. As a complement to HIV-testing services, HIV self-testing (HIVST) has considerable potential to promote HIV serostatus disclosure.

Objective:

The primary objective of our trial is to evaluate the effect of HIVST on improving HIV serostatus disclosure from sexual partners. The hypothesis is that MSM in an intervention condition will have higher awareness of the HIV status of sexual partners compared with MSM in the control condition. The secondary aims are to determine the: (i) changes in sexual behaviors after disclosure of HIV status from sexual partners; (ii) promotion of the frequency of HIV and syphilis testing on participants and their sexual partners; (iii) factors that restrict the disclosure of HIV infection to sexual partners. The hypotheses are that MSM in the intervention condition will have safer sexual-decision making and a higher rate of HIV uptake compared with MSM in the control condition.

Methods:

A stepped-wedge randomized controlled trial will be conducted throughout China. Eight-hundred MSM will be recruited through advertisements released on WeChat public accounts. Individuals who are born biologically male, aged ≥18 years, HIV-negative, and who have 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. The group cluster will initiate the intervention, so participants will be provided with 2–4 free finger prick-based HIVST kits until trial completion. The intervention time for the participants of the four groups will be initiated at 3-month intervals. Men in both groups will be required to complete baseline and four follow-up surveys every 3 months. The primary intervention outcome will evaluate the effect of distribution of HIVST kits on improvement in the disclosure of sexual partners’ HIV status. The secondary outcomes will be changes in sexual behaviors after disclosure of HIV status from sexual partners, the promotion of the frequency of HIVST on participants and their sexual partners, and the factors that restrict disclosure of HIV status to sexual partners.

Results:

Subjects recruitment took place from August 2018. The first round of the follow-up survey post-intervention are complete, and three rounds has not yet been done. The data analysis will be conducted in April 2020 and the results disseminated through conferences and peer-reviewed publications.

Conclusions:

Few studies have evaluated interventions to increase knowledge of sexual partners’ HIV status among MSM. Our trial will provide information on the link between HIVST and HIV serostatus disclosure. The findings of this trial will further scale-up implementation of HIVST services, and help control the spread and infection of HIV epidemics among MSM in China. Clinical Trial: Chinese Clinical Trial Registry: ChiCTR1800019453; http://www.chictr.org.cn/listbycreater.aspx；Retrospectively registered on 12 November 2018.