Feasibility of Indirect Secondary Distribution of HIV Self-test Kits via WeChat Among Men Who Have Sex With Men: National Cross-sectional Study in China.

BACKGROUND: HIV self-testing (HIVST) kits are common in key sexually active populations. Direct secondary distribution of HIVST kits (DSDHK) is effective in improving the uptake of HIVST. However, there are concerns about the various limitations of DSDHK, including limited geographic reach, payment problems, and need for face-to-face interactions. OBJECTIVE: In this study, we aim to evaluate the feasibility and characteristics of indirect secondary distribution of HIVST kits (ISDHK) via WeChat (distributing HIVST application links and follow-up HIVST kits to partners) among men who have sex with men (MSM). METHODS: From October 2017 to September 2019, an HIVST recruitment advertisement was disseminated on the WeChat social media platform to invite MSM to apply for the HIVST kits (referred to as index participants [IPs]). All MSM participants were encouraged to distribute the HIVST application link to their friends and sexual partners (referred to as alters) through their social networks. All the alters were further encouraged to continue distributing the HIVST application link. All participants paid a deposit (US $7), which was refundable upon completion of the questionnaire, and uploaded the test results via a web-based survey system. RESULTS: A total of 2263 MSM met the criteria and successfully applied for HIVST. Of these, 1816 participants returned their HIVST results, including 1422 (88.3%) IPs and 394 (21.7%) alters. More alters had condomless anal intercourse, a higher proportion of them had never previously tested for HIV, and they showed a greater willingness to distribute HIVST kits to their sexual partners (P=.002) than the IPs. After controlling for age, education, and income, the alters had a greater proportion of MSM who had never tested for HIV before (adjusted odds ratio [aOR] 1.29, 95% CI 1.00-1.68), were more willing to distribute the HIVST application link (aOR 1.71, 95% CI 1.21-2.40), had a lower number of sexual partners (aOR 0.71, 95% CI 0.57-0.90), and were less likely to search for sexual partners on the web (aOR 0.78, 95% CI 0.60-1.02) than IPs. In comparison, the rates of reactive HIVST results, conducting HIV confirmatory tests, HIV seropositivity, and initiation of HIV antiretroviral therapy were similar for IPs and alters. CONCLUSIONS: The ISDHK model of distributing HIVST application links among the MSM population via social media is feasible. The ISDHK model should be used to supplement the DSDHK model to enable a greater proportion of the MSM population to know their HIV infection status.

Internet-Based HIV Self-Testing Among Men Who Have Sex With Men Through Pre-exposure Prophylaxis: 3-Month Prospective Cohort Analysis From China.

BACKGROUND: Routine HIV testing accompanied with pre-exposure prophylaxis (PrEP) requires innovative support in a real-world setting. OBJECTIVE: This study aimed to determine the usage of HIV self-testing (HIVST) kits and their secondary distribution to partners among men who have sex with men (MSM) in China, who use PrEP, in an observational study between 2018 and 2019. METHODS: In 4 major cities in China, we prospectively followed-up MSM from the China Real-world oral PrEP demonstration study, which provides daily or on-demand PrEP for 12 months, to assess the usage and secondary distribution of HIVST on quarterly follow-ups. Half of the PrEP users were randomized to receive 2 HIVSTs per month in addition to quarterly facility-based HIV testing. We evaluated the feasibility of providing HIVST to PrEP users. RESULTS: We recruited 939 MSM and randomized 471 to receive HIVST, among whom 235 (49.9%) were daily and 236 (50.1%) were on-demand PrEP users. At baseline, the median age was 29 years, 390 (82.0%) men had at least college-level education, and 119 (25.3%) had never undergone facility-based HIV testing before. Three months after PrEP initiation, 341 (74.5%) men had used the HIVST provided to them and found it very easy to use. Among them, 180 of 341 (52.8%) men had distributed the HIVST kits it to other MSM, and 132 (51.6%) among the 256 men who returned HIVST results reported that used it with their sexual partners at the onset of intercourse. Participants on daily PrEP were more likely to use HIVST (adjusted hazard ratio=1.3, 95% CI 1.0-1.6) and distribute HIVST kits (adjusted hazard ratio=1.3, 95% CI 1.1-1.7) than those using on-demand PrEP. CONCLUSIONS: MSM who used PrEP had a high rate of usage and secondary distribution of HIVST kits, especially among those on daily PrEP, which suggested high feasibility and necessity for HIVST after PrEP initiation. Assuming that fourth-generation HIVST kits are available, HIVST may be able to replace facility-based HIV testing to a certain extent. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR1800020374; https://www.chictr.org.cn/showprojen.aspx?proj=32481. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2019-036231.

Preference for daily versus on-demand pre-exposure prophylaxis for HIV and correlates among men who have sex with men: the China Real-world Oral PrEP Demonstration study.

INTRODUCTION: This study explores the preference for daily versus on-demand pre-exposure prophylaxis (PrEP) among men who have sex with men (MSM) in developing countries when both regimens are available. METHODS: From 11 December 2018 to 19 October 2019, we recruited MSM for an open-label real-world PrEP demonstration study in four major cities in China. Subjects selected their preferred PrEP (oral tenofovir/emtricitabine) regimen (daily vs. on-demand) at recruitment and underwent on-site screening before initiation of PrEP. We used logistic regression to assess preference for daily PrEP and correlates. RESULTS: Of 1933 recruited MSM, the median age was 29 years, 7.6% was currently married to or living with a female; the median number of male sexual partners was four and 6.1% had used post-exposure prophylaxis (PEP) in the previous six months. HIV infection risk was subjectively determined as very high (>75%) in 7.0% of subjects, high (50% to 75%) in 13.3%, moderate (25% to 49%) in 31.5% and low or none (0% to 24%) in 48.1%. On average, participants preferred on-demand PrEP over daily PrEP (1104 (57.1%) versus 829 (42.9%)) at recruitment. In multivariable analysis, currently being married to or living with a female was associated with 14.6 percentage points lower preference for daily PrEP (marginal effect = -0.146 [95% CI: -0.230, -0.062], p = 0.001); whereas the number of male sexual partners (marginal effect = 0.003 [95% CI: 0.000, 0.005], p = 0.034) and a subjective assessment of being very high risk of HIV infection (vs. low and no risk, marginal effect size = 0.105 [95% CI: 0.012, 0.198], p = 0.027) were associated with increased preference for daily versus on-demand PrEP. Among the 1933 potential participants, 721 (37.3%) did not attend the subsequent on-site screening. Lower-income, lower education level, lower subjective expected risk of HIV infection risk and younger age positively correlated with the absence of on-site screening. CONCLUSIONS: MSM in China prefer both daily and on-demand PrEP when both regimens are provided free. Social structural factors and subjective risk of HIV infection have significant impacts on PrEP preference and use. The upcoming national PrEP guideline should consider incorporating both regimens and the correlates to help implement PrEP in China.

Correction: Risk-Taking Behaviors and Adherence to HIV Pre-Exposure Prophylaxis in Users of Geosocial Networking Apps: Real-World, Multicenter Study.

[This corrects the article DOI: 10.2196/22388.].

Risk-Taking Behaviors and Adherence to HIV Pre-Exposure Prophylaxis in Users of Geosocial Networking Apps: Real-World, Multicenter Study.

BACKGROUND: Over half of men who have sex with men (MSM) use geosocial networking (GSN) apps to encounter sex partners. GSN apps' users have become a unique large subpopulation among MSM for interventions concerning HIV prevention and control. Pre-exposure prophylaxis (PrEP) is a promising measure for HIV prevention, especially for MSM, but its effectiveness largely depends on medication adherence. However, little is known about PrEP adherence among GSN apps' users, which is critical to addressing the overall optimization of PrEP compliance outside of clinical trials in the context of large-scale implementation. OBJECTIVE: The objective of this study is to understand the correlation between GSN apps' use and medication adherence among MSM receiving PrEP, with the aim to increase their awareness about PrEP use in order to increase adherence. METHODS: This study based on the China Real-world Oral intake of PrEP (CROPrEP) project, a multicenter, real-world study of Chinese MSM on daily and event-driven PrEP. Eligible participants completed a detailed computer-assisted self-interview on sociodemographic, GSN apps' use, and sexual behavior. Then participants were followed up for 12 months and assessed for various characteristics (eg, PrEP delivery, adherence assessment, PrEP coverage of sexual activities, and regimens switch). A generalized estimation equation was used to analyze the predictors of medication adherence and regimen conversion among GSN apps' users and nonusers. RESULTS: At baseline, 756 of the 1023 eligible participants (73.90%) reported primarily using GSN apps to seek sexual partners, and GSN apps' users are more likely to have high-risk behaviors such as multiple sex partners and condomless anal intercourse than other nonusers (all P<.05). During follow-up, GSN apps' users had a significantly low level of pill-counting adherence than nonusers (adjusted odds ratio [aOR] 0.8, 95% CI 0.6-1.0, P=.038). In the event-driven group, GSN apps' users had marginally lower levels of self-reported adherence (aOR 0.7, 95% CI 0.4-1.0, P=.060) and lower PrEP coverage of sexual practices (aOR 0.6, 95% CI 0.4-1.0, P=.038). Additionally, GSN apps' users seemed more likely to switch from event-driven to daily regimen (aOR 1.8, 95% CI 0.9-3.3, P=.084). CONCLUSIONS: GSN apps' users are highly prevalent among MSM, despite their higher sexual risk and lower adherence levels, suggesting that eHealth needs to be introduced to the GSN platform to promote PrEP adherence. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR-IIN-17013762; https://tinyurl.com/yy2mhrv4. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12879-019-4355-y.

HIV and other STIs self-testing to reduce risk compensation among men who have sex with men who use oral pre-exposure prophylaxis in China: protocol for a randomised waitlist-controlled trial.

INTRODUCTION: Pre-exposure prophylaxis (PrEP) reduces the risk of HIV infection among men who have sex with men by up to 99%. However, in real-world settings, PrEP users may exhibit risk compensation after uptake of PrEP, including more condomless anal intercourse (CAI) and increased sexually transmitted infection (STI) acquisition. HIV self-testing (HIVST) decreases CAI among men who have sex with men (MSM) by providing awareness of the HIV status of oneself and one's sexual partners. Here, we describe the rationale and design of a randomised waitlist-controlled trial to examine the impact of HIVST on risk compensation among PrEP users. METHODS AND ANALYSIS: The study is a two-arm randomised waitlist-controlled trial with 1000 HIV-negative MSM in four major cities in China who will be taking oral PrEP (involving tenofovir disoproxil fumarate/emtricitabine) either daily (n=500) or in an event-driven regimen (n=500). The participants will be randomised (1:1) to either the immediate HIVST intervention arm (HIVST plus standard facility-based counselling and testing from 0 to 12 months) or the waitlist arm (standard facility-based counselling and testing from 0 to 6 months, then crossover to receive the HIVST intervention in months 7-12). Participants will provide blood samples to assess the incidence of syphilis and herpes simplex virus type 2 (HSV-2) during a follow-up. The primary outcomes will be the occurrence of CAI, number of sexual partners and incidence of syphilis and HSV-2 during a follow-up. The secondary outcomes will be the HIV and STI testing frequency and STI treatment adherence during a follow-up. The planned start and end dates for the study is 26 December 2018 and 31 December 2020. ETHICS AND DISSEMINATION: The Medical Science Research Ethics Committee of The First Affiliated Hospital of China Medical University has approved the study (IRB(2018)273). TRIAL REGISTRATION NUMBER: ChiCTR1800020374.

Real-time monitoring and just-in-time intervention for adherence to pre-exposure prophylaxis among men who have sex with men in China: a multicentre RCT study protocol.

BACKGROUND: Pre-exposure prophylaxis (PrEP) is an effective biomedical strategy to prevent transmission of HIV infection, although medication adherence remains a challenge. We present the protocol for a multicentre randomised controlled trial to measure the effectiveness of a real-time monitoring and just-in-time intervention on medication adherence among PrEP users in China. METHODS: Study participants will include 1000 men who have sex with men (MSM) from four cites in China (Shenyang, Beijing, Chongqing and Shenzhen) attending a tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) PrEP project as part of a real-world, prospective multicentre cohort study (CROPrEP). Participants will be randomised into the intervention and control arms in a 1:1 ratio. Participants in the intervention arm will be provided with remote real-time monitoring equipment that triggers twice just-in-time SMS (Short Messaging Service) medication reminders to PrEP users every half an hour when a scheduled dosage is missed, and followed with just-in-time SMS medication reminders to clinicians half an hour when there is no supplement after the second just-in-time SMS reminder to PrEP users. Clinicians will initiate individualised telephone intervention as soon as possible upon receipt of the just-in-time SMS missed dose alert. Those in the control arm will only receive generic weekly SMS reminders. The study will last 6 months. Participants will be seen at follow-up visits at three and 6 months. Trial outcomes to be measured include self-reported adherence assessed via questionnaire and pill counts, as well as drug concentration test results. DISCUSSION: Medication adherence is critical to achieve optimal benefits from PrEP. This study will be the first individualised behaviour intervention using real-time technology to increase adherence among MSM PrEP users globally. If found effective, a real-time monitoring and just-in-time intervention system may be utilized for improving adherence and thus effectiveness of global PrEP application. TRIAL REGISTRATION: This study registered at ClinicalTrials.gov ( ChiCTR1900025604 ) on September 2, 2019.