scholarly journals 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

BMJ Open ◽  
2020 ◽  
Vol 10 (7) ◽  
pp. e036231
Author(s):  
Jing Zhang ◽  
Xiaojie Huang ◽  
Yaokai Chen ◽  
Hui Wang ◽  
Yonghui Zhang ◽  
...  

IntroductionPre-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 analysisThe 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 disseminationThe Medical Science Research Ethics Committee of The First Affiliated Hospital of China Medical University has approved the study (IRB(2018)273).Trial registration numberChiCTR1800020374

2020 ◽  
Author(s):  
Tianyi Lu ◽  
Hang Li ◽  
Xiang Mao ◽  
Erlei Peng ◽  
Yangyang Gao ◽  
...  

BACKGROUND Disclosure of HIV serostatus is important for the 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 serostatus disclosure. OBJECTIVE The primary objective of our trial is to evaluate the effect of HIVST on improving serostatus disclosure to sexual partners. We hypothesize that MSM in an intervention condition will have a higher awareness of the HIV status of their sexual partners compared with MSM in the control condition. The secondary aims are to evaluate (i) changes in sexual behaviors after disclosure of HIV status by sexual partners, (ii) promotion of the frequency of HIV and syphilis testing on participants and their sexual partners, and (iii) factors that restrict the disclosure of HIV infection to sexual partners. We hypothesize that MSM in the intervention condition will exhibit safer sexual decision making and a higher rate of HIV testing uptake compared with MSM in the control condition. METHODS A stepped wedge randomized controlled trial will be conducted throughout China. Study recruitment of 800 MSM will be promoted 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 past 3 months will be recruited. Eligible men will be randomly divided (1:1:1:1) into four groups and randomized. The group cluster will initiate the intervention so that participants will be provided with 2-4 free finger prick–based HIVST kits until trial completion. The intervention period for participants in each of the four groups will be initiated at 3-month intervals. Men in both groups will be required to complete a baseline and four follow-up surveys every 3 months. The primary intervention outcome will evaluate the effect of the 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 Subject recruitment began in August 2018. The first round of follow-up surveys post intervention is complete, with three rounds remaining to be done. Data analysis was scheduled for April 2020 and the results will be 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 facilitate the implementation of HIVST services to help control the spread of HIV among MSM in China. CLINICALTRIAL Chinese Clinical Trial Registry ChiCTR1800019453; http://www.chictr.org.cn/showproj.aspx?proj=30158 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/17788


10.2196/17788 ◽  
2020 ◽  
Vol 9 (7) ◽  
pp. e17788
Author(s):  
Tianyi Lu ◽  
Hang Li ◽  
Xiang Mao ◽  
Erlei Peng ◽  
Yangyang Gao ◽  
...  

Background Disclosure of HIV serostatus is important for the 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 serostatus disclosure. Objective The primary objective of our trial is to evaluate the effect of HIVST on improving serostatus disclosure to sexual partners. We hypothesize that MSM in an intervention condition will have a higher awareness of the HIV status of their sexual partners compared with MSM in the control condition. The secondary aims are to evaluate (i) changes in sexual behaviors after disclosure of HIV status by sexual partners, (ii) promotion of the frequency of HIV and syphilis testing on participants and their sexual partners, and (iii) factors that restrict the disclosure of HIV infection to sexual partners. We hypothesize that MSM in the intervention condition will exhibit safer sexual decision making and a higher rate of HIV testing uptake compared with MSM in the control condition. Methods A stepped wedge randomized controlled trial will be conducted throughout China. Study recruitment of 800 MSM will be promoted 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 past 3 months will be recruited. Eligible men will be randomly divided (1:1:1:1) into four groups and randomized. The group cluster will initiate the intervention so that participants will be provided with 2-4 free finger prick–based HIVST kits until trial completion. The intervention period for participants in each of the four groups will be initiated at 3-month intervals. Men in both groups will be required to complete a baseline and four follow-up surveys every 3 months. The primary intervention outcome will evaluate the effect of the 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 Subject recruitment began in August 2018. The first round of follow-up surveys post intervention is complete, with three rounds remaining to be done. Data analysis was scheduled for April 2020 and the results will be 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 facilitate the implementation of HIVST services to help control the spread of HIV among MSM in China. Trial Registration Chinese Clinical Trial Registry ChiCTR1800019453; http://www.chictr.org.cn/showproj.aspx?proj=30158 International Registered Report Identifier (IRRID) DERR1-10.2196/17788


2021 ◽  
Author(s):  
Li Shangcao ◽  
Jing Zhang ◽  
Xiang Mao ◽  
Tianyi Lu ◽  
Yangyang Gao ◽  
...  

BACKGROUND The use of HIV self-test (HST) kits is commonplace in key sexually active populations. The direct secondary distribution of HST kits (DSDHK) is effective in improving the uptake of HIV self-testing. However, there are concerns about various limitations of DSDHK, including limited geographic location, payment problems, and face-to-face interaction. OBJECTIVE We evaluated the feasibility and characteristics of the indirect secondary distribution of HST kits (ISDHK) via WeChat (distributing HST application links and follow-up HST kits to partners) among men who have sex with men (MSM). METHODS From October 2017 to September 2019, an HIV self-testing (HIVST) recruitment advertisement was disseminated on the WeChat social media platform to invite MSM to apply for HST kits (referred to as “index participants” [Ips]). All of the MSM participants were encouraged to distribute the HST application link to their friends and sexual partners (referred to as “Alters”) through their social networks. All Alters were further encouraged to continue to distribute the HST application link. All participants paid a deposit (USD 7), refundable upon completion of the questionnaire and uploading of the test result via an online survey system. RESULTS 2,263 MSM met the criteria and successfully applied for HST. Of these, 1,816 participants returned their HST test results, including 1,422 (88.3%) IPs and 394 (21.7%) Alters. Compared with the IPs, the Alters practiced more condomless anal intercourse (CAI), a higher proportion of them never previously had an HIV test, and they had a greater willingness to distribute HST kits to sexual partners (all p < 0.05). After controlling for age, education, and income, the Alters had a greater proportion of MSM who had never tested for HIV before (aOR = 1.29, 95% CI 1.00–1.68), were more willing to distribute the HST 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 via online means (aOR = 0.78, 95% CI 0.60–1.02). In comparison, the rates of reactive HST results, conducting HIV confirmatory tests, HIV seropositivity, and initiation of HIV antiretroviral therapy (ART) were similar for IPs and Alters. CONCLUSIONS The ISDHK mode of distributing HST application links via social media is feasible among the MSM population. The ISDHK mode should be used to supplement the DSDHK mode in order to enable a greater proportion of the MSM population to know their HIV infection status.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yajie Wang ◽  
Wei Zhang ◽  
Dongping Bao ◽  
Jason J. Ong ◽  
Joseph D. Tucker ◽  
...  

Abstract Background Syphilis is a common sexually transmitted infection (STI) among men who have sex with men (MSM). Increasing syphilis testing is important to syphilis control. However, in low- and middle-income countries like China, syphilis testing rates remain low among MSM. We describe a randomized controlled trial protocol to examine the effectiveness of social network distribution approaches of syphilis self-testing among MSM in China. Methods We will recruit index and alter MSM. Indexes will be eligible if they: are born biologically male; aged 18 years or above; ever had sex with another man; are willing to distribute syphilis testing packages or referral links to their alters; and willing to provide personal contact information for future follow-up. Three hundred MSM will be recruited and randomly assigned in a 1:1:1 ratio into three arms: standard of care (control arm); standard syphilis self-testing (SST) delivery arm; and referral link SST delivery arm. Indexes will distribute SST packages or referral links to encourage alters to receive syphilis testing. All indexes will complete a baseline survey and a 3-month follow-up survey. Syphilis self-test results will be determined by photo verification via a digital platform. The primary outcome is the mean number of alters who returned verified syphilis testing results per index in each arm. Discussion The trial findings will provide practical implications in strengthening syphilis self-testing distribution and increasing syphilis testing uptake among MSM in China. This study also empowers MSM community in expanding syphilis testing by using their own social network. Trial registration Chinese Clinical Trial Registry, ChiCTR2000036988. Registered 26 August 2020 - Retrospectively registered.


PLoS Medicine ◽  
2020 ◽  
Vol 17 (10) ◽  
pp. e1003365
Author(s):  
Ci Zhang ◽  
Deborah Koniak-Griffin ◽  
Han-Zhu Qian ◽  
Lloyd A. Goldsamt ◽  
Honghong Wang ◽  
...  

2020 ◽  
Author(s):  
Yajie Wang ◽  
Wei Zhang ◽  
Dongping Bao ◽  
Jason J. Ong ◽  
Joseph D. Tucker ◽  
...  

Abstract Background Syphilis is a common sexually transmitted infection (STI) among men who have sex with men (MSM). Increasing syphilis testing is important to syphilis control. However, in low- and middle-income countries like China, syphilis testing rates remain low among MSM. We describe a randomized controlled trial protocol to examine the effectiveness of social network distribution approaches of syphilis self-testing among MSM in China. Methods We will recruit index and alter MSM. Indexes will be eligible if they: are born biologically male; aged 18 years or above; ever had sex with another man; are willing to distribute syphilis testing packages or referral links to their alters; and willing to provide personal contact information for future follow-up. Three hundred MSM will be recruited and randomly assigned in a 1:1:1 ratio into three arms: standard of care (control arm); standard syphilis self-testing (SST) delivery arm; and referral link SST delivery arm. Indexes will distribute SST packages or referral links to encourage alters to receive syphilis testing. All indexes will complete a baseline survey and a 3-month follow-up survey. Syphilis self-test results will be determined by photo verification via a digital platform. The primary outcome is the mean number of alters who returned verified syphilis testing results per index in each arm. Discussion The trial findings will provide practical implications in strengthening syphilis self-testing distribution and increasing syphilis testing uptake among MSM in China. This study also empowers MSM community in expanding syphilis testing by using their own social network. Trial registration: Chinese Clinical Trial Registry, ChiCTR2000036988. Registered on 26 August 2020


2021 ◽  
Author(s):  
Xia Jin ◽  
Zhenxing Chu ◽  
Xiangjun Zhang ◽  
Tianyi Lu ◽  
Jing Zhang ◽  
...  

BACKGROUND Men who have sex with men (MSM) have high HIV incidence and prevalence burdens but relatively low HIV testing rates. Literature showed insufficient evidence on the efficacy of Social media (WeChat) based HIV self-testing (HIVST) kits distribution approaches among MSM and their sexual partners. OBJECTIVE This study evaluated an Social media (WeChat) based HIVST distribution intervention in increasing HIV testing uptake among MSM and their sexual partners in China. METHODS The study used a 12-month stepped-wedge randomized controlled trial design and an online survey mode. MSM who were HIV-negative or with unknown HIV status were recruited through social media marketing and outreaches by community opinion leaders between August and December 2018 in Shenyang, Beijing, Chongqing, and Shenzhen. Participants were randomly allocated to four groups, which were intervened by sequence. The intervention group received free HIVST kits on top of the control condition that participants received standard education and care. Participants were followed up from January to December 2019. Generalized linear models were used to assess HIV testing coverage and frequency difference between the intervention and the control stage. RESULTS Each group enrolled 140 eligible MSM with a total of 560 participants. Twelve participants were diagnosed with HIV infections, and 4 of them were in the follow-up period. Participants in the intervention stage were nine times likely to receive an HIV test than in the control stage (85.6% vs. 39.2%, risk ratio [RR]=9.21, 95%CI 5.92~14.33). The intervention also increased participants’ HIV testing frequency (1.48 vs. 0.59 times, risk difference [RD]=0.89, 95%CI 0.82~0.96). Moreover, the intervention increased HIV testing proportion (49.0% vs. 30.1%, RR=2.23, 95%CI 1.46~3.40) and mean HIV testing frequency (0.69 vs. 0.35 times, RD=0.26, 95%CI 0.15~0.38) among participants sexual partners who received HIVST through secondary distribution. CONCLUSIONS An Social media (WeChat) based HIVST distribution intervention effectively increased HIV testing coverage and frequency in MSM and their sexual partners. Future programs could apply this approach in HIV education and testing efforts to reduce HIV incidence. CLINICALTRIAL This study was registered at the Chinese Clinical Trials website (http://www.chictr.org.cn/index.aspx) with the registration tracking number of ChiCTR1800019453 on November 12, 2018. INTERNATIONAL REGISTERED REPORT RR2-10.2196/17788


BMJ Open ◽  
2018 ◽  
Vol 8 (12) ◽  
pp. e024423 ◽  
Author(s):  
Ci Zhang ◽  
Xianhong Li ◽  
Deborah Koniak-Griffin ◽  
Lloyd A. Goldsamt ◽  
Jing Zhou

IntroductionHIV epidemic is increasing among men who have sex with men (MSM) in China, yet HIV testing uptake remains low. As an emerging approach, HIV self-testing (HIVST) has the potential to promote HIV testing coverage and frequency in this population. However, evidence of the effectiveness on implementation of HIVST among Chinese MSM and their sexual partners is scarce.Methods and analysisThe randomised controlled trial will be performed in Changsha, Changde, Shaoyang and Yiyang, Hunan province, China, recruiting 184 recent testers (men who had at least one HIV test within the past 2 years) and 26 non-recent testers (men who did not have HIV tests within 2 years or never had an HIV test). Eligible men will be randomly divided 1:1 into two groups: intervention (with free HIVST kits plus site-based HIV testing services) and control (site-based HIV testing services only). Participants in the intervention group will be provided with two free finger-prick-based HIVST kits, and can apply for two to four kits every 3 months for 1 year.Participants in both groups will complete questionnaires via WeChat at five separate times: baseline, third, sixth, ninth and twelfth month. The primary outcome is the mean number of HIV tests for MSM over the 12-month study period. The secondary outcome is the mean number of HIV tests for sexual partners of MSM over the 12-month study period. The tertiary outcomes are the self-reported proportion of consistent condom usage for anal sex, and the numbers of sexual partners during the 12-month study period.Ethics and disseminationThe study has been approved by the Institutional Review Board of Behavioural and Nursing Research in Xiangya School of Nursing of Central South University, China (2018002). Study results will be disseminated through conferences and academic journals.Trial registration numberChiCTR1800015584; Pre-results.


2018 ◽  
Author(s):  
Tyrel J Starks ◽  
Gabriel Robles ◽  
Mark Pawson ◽  
Ruben H Jimenez ◽  
Monica Gandhi ◽  
...  

BACKGROUND Men who have sex with men (MSM) currently account for more than two-thirds of new HIV diagnoses in the United States and, among young MSM (YMSM) aged 20 to 29 years, as many as 79% to 84% of new infections occur between primary partners. Contributing to HIV risk, YMSM use drugs at comparatively high rates. To date, no interventions have been developed that specifically address the unique needs of partnered YMSM or incorporate a focus on relationship factors in addressing personal motivation for change. OBJECTIVE The study’s primary aim is to evaluate the efficacy of the PARTNER intervention and evaluate potential moderators or mediators of intervention effects. The study’s secondary aims were to gather ideographic data to inform a future effectiveness implementation study and develop a novel biomarker for pre-exposure prophylaxis (PrEP) adherence by analyzing PrEP drug levels in fingernails. METHODS PARTNER is a 4-session motivational interviewing–based intervention that integrates video-based communication training to address drug use and HIV prevention among partnered YMSM. This study utilizes a randomized controlled trial design to compare the PARTNER intervention with an attention-matched psychoeducation control arm that provides information about HIV-risk reduction, PrEP, and substance use. Participants are randomized in a 1-to-1 ratio stratified on age disparity between partners, racial composition of the couple, and relationship length. Follow-up assessments are conducted at 3-, 6-, 9-, and 12-months postbaseline. The study recruits and enrolls 240 partnered YMSM aged between 18 to 29 years at a research center in New York City. Participants will be HIV-negative and report recent (past 30-day) drug use and condomless anal sex with casual partners; a nonmonogamous primary partner (regardless of HIV status); or a serodiscordant primary partner (regardless of sexual agreement). Primary outcomes (drug use and HIV sexual transmission risk behavior) are assessed via a Timeline Follow-back interview. Biological markers of outcomes are collected for drug use (fingernail assay), sexual HIV transmission risk (rectal and urethral gonorrhea and chlamydia testing), and PrEP adherence (dried blood spots and fingernails for a novel PrEP drug level assay). RESULTS The study opened for enrollment in February 2018. Anticipated completion of enrollment is October 2021. Primary outcome analyses will begin after final follow-up completion. CONCLUSIONS Existing research on partnered YMSM within the framework of Couples Interdependence Theory (CIT) has suggested that relationship factors (eg, dyadic functioning and sexual agreements) are meaningfully related to drug use and HIV transmission risk. Results pertaining to the efficacy of the proposed intervention and the identification of putative moderators and mediators will substantially inform the tailoring of interventions for YMSM in relationships and contribute to a growing body of relationship science focused on enhancing health outcomes. CLINICALTRIAL ClinicalTrials.gov NCT03396367; https://clinicaltrials.gov/ct2/show/NCT03396367 (Archived by WebCite at http://www.webcitation.org/78ti7esTc. INTERNATIONAL REGISTERED REPOR DERR1-10.2196/13015


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