Sustaining success: a qualitative study of gay and bisexual men's experiences and perceptions of HIV self-testing in a randomized controlled trial.

BACKGROUND: HIV self-testing was proved as an effective tool for increasing testing frequency in gay and bisexual men at high risk of infection. Questions remain about understanding why HIVST encouraged testing and how such success can be translated to programmatic implementation. METHODS: We conducted a qualitative investigation of how FORTH participants experienced and perceived HIVST. Stratified sampling was used to recruit gay and bisexual men participating in the FORTH HIVST intervention to take part in interviews, focusing on infrequent testers and those who had received inaccurate HIVST results. RESULTS: Our analysis identified several prominent themes organized into two overarching domains from the 15 interviews: (i) aspects of HIVST contributing to HIV testing frequency, and (ii) sustaining HIVST into the future. Participants also believed that their use of HIVST in the future would depend on the test kit's reliability, particularly when compared with highly reliable clinic-based testing. CONCLUSION: HIVST increases the frequency of HIV testing among gay and bisexual men due, in part, to the practical, psychological, and social benefits it offers. To capitalize fully on these benefits, however, strategies to ensure the availability of highly reliable HIVST are required to sustain benefits beyond the confines of a structured research study.

The longer-term effects of access to HIV self-tests on HIV testing frequency in high-risk gay and bisexual men: follow-up data from a randomised controlled trial.

BACKGROUND: A wait-list randomised controlled trial in Australia (FORTH) in high-risk gay and bisexual men (GBM) showed access to free HIV self-tests (HIVSTs) doubled the frequency of HIV testing in year 1 to reach guideline recommended levels of 4 tests per year, compared to two tests per year in the standard-care arm (facility-based testing). In year 2, men in both arms had access to HIVSTs. We assessed if the effect was maintained for a further 12 months. METHODS: Participants included GBM reporting condomless anal intercourse or > 5 male partners in the past 3 months. We included men who had completed at least one survey in both year 1 and 2 and calculated the mean tests per person, based on the validated self-report and clinic records. We used Poisson regression and random effects Poisson regression models to compare the overall testing frequency by study arm, year and testing modality (HIVST/facility-based test). FINDINGS: Overall, 362 men completed at least one survey in year 1 and 343 in year 2. Among men in the intervention arm (access to HIVSTs in both years), the mean number of HIV tests in year 2 (3⋅7 overall, 2⋅3 facility-based tests, 1⋅4 HIVSTs) was lower compared to year 1 (4⋅1 overall, 1⋅7 facility-based tests, 2⋅4 HIVSTs) (RR:0⋅84, 95% CI:0⋅75-0⋅95, p=0⋅002), but higher than the standard-care arm in year 1 (2⋅0 overall, RR:1⋅71, 95% CI:1⋅48-1.97, p<0⋅001). Findings were not different when stratified by sociodemographic characteristics or recent high risk sexual history. INTERPRETATION: In year 2, fewer HIVSTs were used on average compared to year 1, but access to free HIVSTs enabled more men to maintain higher HIV testing frequency, compared with facility-based testing only. HIV self-testing should be a key component of HIV testing and prevention strategies. FUNDING: This work was supported by grant 568971 from the National Health and Medical Research Council of Australia.

Physical Distancing Due to COVID-19 Disrupts Sexual Behaviors Among Gay and Bisexual Men in Australia: Implications for Trends in HIV and Other Sexually Transmissible Infections.

INTRODUCTION: In March 2020, Australian state and federal governments introduced physical distancing measures alongside widespread testing to combat COVID-19. These measures may decrease people's sexual contacts and thus reduce the transmission of HIV and other sexually transmissible infections (STIs). We investigated the impact of physical distancing measures due to COVID-19 on the sexual behavior of gay and bisexual men in Australia. METHODS: Between April 4, 2020, and April 29, 2020, 940 participants in an ongoing cohort study responded to questions to measure changes in sexual behaviors during the COVID-19 pandemic. Men reported the date they become concerned about COVID-19 and whether they engaged in sexual behavior with regular or casual partners or "fuckbuddies" in the 6 months before becoming concerned about COVID-19 (hereafter referred to as "before COVID-19"), and following the date, they become concerned about COVID-19 (hereafter referred to as "since COVID-19"). Before and since COVID-19 was based on individual participants' own perceived date of becoming concerned about COVID-19. RESULTS: The mean age of was 39.9 years (SD: 13.4). Most participants (88.3%) reported sex with other men during the 6 months before COVID-19. Of the 587 men (62.4%) who reported sex with casual partners before COVID-19, 93 (15.8%) continued to do so in the period since COVID-19, representing a relative reduction of 84.2%. CONCLUSION: Gay and bisexual men in Australia have dramatically reduced their sexual contacts with other men since COVID-19. These behavioral changes will likely result in short-term reductions in new HIV and STI diagnoses. If sexual health screenings are undertaken before resuming sexual activity, this could present a novel opportunity to interrupt chains of HIV and STI transmission.

Association of HIV Preexposure Prophylaxis With Incidence of Sexually Transmitted Infections Among Individuals at High Risk of HIV Infection.

Importance: Emerging evidence suggests that risk of bacterial sexually transmitted infections (STIs) increases among gay and bisexual men following initiation of HIV preexposure prophylaxis (PrEP). Objective: To describe STI incidence and behavioral risk factors among a cohort of predominantly gay and bisexual men who use PrEP, and to explore changes in STI incidence following PrEP commencement. Design, Setting, and Participants: The Pre-exposure Prophylaxis Expanded (PrEPX) Study, a multisite, open-label intervention study, was nested within the Australian Collaboration for Coordinated Enhanced Sentinel Surveillance (ACCESS) clinic network. A total of 4275 participants were enrolled (July 26, 2016-April 1, 2018) in Victoria, Australia. Of these, 2981 enrolled at 5 ACCESS clinics (3 primary care, 1 sexual health, and 1 community-based HIV rapid testing service), had at least 1 follow-up visit, and were monitored until April 30, 2018. Exposures: Upon enrollment, participants received daily oral tenofovir disoproxil fumurate and emtricitabine for HIV PrEP, quarterly HIV and STI testing, and clinical monitoring. Main Outcomes and Measures: The primary outcome was incidence of chlamydia, gonorrhea, or syphilis. Incidence rates and hazard ratios describing behavioral risk factors of STI diagnosis were calculated. Incidence rate ratios (IRRs), adjusted for change in testing frequency, described changes in STI incidence from 1-year preenrollment to study follow-up among participants with preenrollment testing data (n = 1378). Results: Among the 2981 individuals (median age, 34 years [interquartile range, 28-42]), 98.5% identified as gay or bisexual males, 29% used PrEP prior to enrollment, 89 (3%) withdrew and were censored at date of withdrawal, leaving 2892 (97.0%) enrolled at final follow-up. During a mean follow-up of 1.1 years (3185.0 person-years), 2928 STIs were diagnosed among 1427 (48%) participants (1434 chlamydia, 1242 gonorrhea, 252 syphilis). STI incidence was 91.9 per 100 person-years, with 736 participants (25%) accounting for 2237 (76%) of all STIs. Among 2058 participants with complete data for multivariable analysis, younger age, greater partner number, and group sex were associated with greater STI risk, but condom use was not. Among 1378 participants with preenrollment testing data, STI incidence increased from 69.5 per 100 person-years prior to enrollment to 98.4 per 100 person-years during follow-up (IRR, 1.41 [95% CI, 1.29-1.56]). After adjusting for testing frequency, the increase in incidence from 1 year preenrollment to follow-up was significant for any STI (adjusted IRR, 1.12 [95% CI, 1.02-1.23]) and for chlamydia (adjusted IRR, 1.17 [95% CI, 1.04-1.33]). Conclusions and Relevance: Among gay and bisexual men using PrEP, STIs were highly concentrated among a subset, and receipt of PrEP after study enrollment was associated with an increased incidence of STIs compared with preenrollment. These findings highlight the importance of frequent STI testing among gay and bisexual men using PrEP.

Protocol for an HIV Pre-exposure Prophylaxis (PrEP) Population Level Intervention Study in Victoria Australia: The PrEPX Study.

Background: Pre-exposure prophylaxis (PrEP) is the use of HIV anti-retroviral therapy to prevent HIV transmission in people at high risk of HIV acquisition. PrEP is highly efficacious when taken either daily, or in an on-demand schedule. In Australia co-formulated tenofovir-emtricitabine is registered for daily use for PrEP, however, this co-formulation is not listed yet on the national subsidized medicines list. We describe a study protocol that aims to demonstrate if the provision of PrEP to up to 3800 individuals at risk of HIV in Victoria, Australia reduces HIV incidence locally by 25% generally and 30% among GBM. Methods: PrEPX is a population level intervention study in Victoria, Australia in which generic PrEP will be delivered to 3800 individuals for up to 36 months. Study eligibility is consistent with the recently updated 2017 Australian PrEP guidelines. Participants will attend study clinics, shared care clinics, or outreach clinics for quarterly HIV/STI screening, biannual renal function tests and other clinical care as required. Study visits and STI diagnoses will be recorded electronically through the ACCESS surveillance system. At each study visit participants will be invited to complete behavioral surveys that collect demographics and sexual risk data. Diagnosis and behavioral data will be compared between PrEPX participants and other individuals testing within the ACCESS surveillance system. A subset of participants will complete in depth surveys and interviews to collect attitudes, beliefs and acceptability data. Participating clinics will provide clinic level data on implementation and management of PrEPX participants. The population level impact on HIV incidence will be assessed using Victorian HIV notification data. Discussion: This study will collect evidence on the real world impact of delivery of PrEP to 3800 individuals at risk of acquiring HIV in Victoria. This study will provide important information for the broader implementation of PrEP planning upon listing of the tenofovir-emtricitabine on the national subsidized list of medicines. The study is registered on the Australian New Zealand Clinical Trials Registry (ACTRN12616001215415).

Effect of availability of HIV self-testing on HIV testing frequency in gay and bisexual men at high risk of infection (FORTH): a waiting-list randomised controlled trial.

BACKGROUND: Frequent testing of individuals at high risk of HIV is central to current prevention strategies. We aimed to determine if HIV self-testing would increase frequency of testing in high-risk gay and bisexual men, with a particular focus on men who delayed testing or had never been tested before. METHODS: In this randomised trial, HIV-negative high-risk gay and bisexual men who reported condomless anal intercourse or more than five male sexual partners in the past 3 months were recruited at three clinical and two community-based sites in Australia. Enrolled participants were randomly assigned (1:1) to the intervention (free HIV self-testing plus facility-based testing) or standard care (facility-based testing only). Participants completed a brief online questionnaire every 3 months, which collected the number of self-tests used and the number and location of facility-based tests, and HIV testing was subsequently sourced from clinical records. The primary outcome of number of HIV tests over 12 months was assessed overall and in two strata: recent (last test ≤2 years ago) and non-recent (>2 years ago or never tested) testers. A statistician who was masked to group allocation analysed the data; analyses included all participants who completed at least one follow-up questionnaire. After the 12 month follow-up, men in the standard care group were offered free self-testing kits for a year. This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12613001236785. FINDINGS: Between Dec 1, 2013, and Feb 5, 2015, 182 men were randomly assigned to self-testing, and 180 to standard care. The analysis population included 178 (98%) men in the self-testing group (174 person-years) and 165 (92%) in the standard care group (162 person-years). Overall, men in the self-testing group had 701 HIV tests (410 self-tests; mean 4·0 tests per year), and men in the standard care group had 313 HIV tests (mean 1·9 tests per year); rate ratio (RR) 2·08 (95% CI 1·82-2·38; p<0·0001). Among recent testers, men in the self-testing group had 627 tests (356 self-tests; mean 4·2 per year), and men in the standard care group had 297 tests (mean 2·1 per year); RR 1·99 (1·73-2·29; p<0·0001). Among non-recent testers, men in the self-testing group had 74 tests (54 self-tests; mean 2·8 per year), and men in the standard care group had 16 tests (mean 0·7 per year); RR 3·95 (2·30-6·78; p<0·0001). The mean number of facility-based HIV tests per year was similar in the self-testing and standard care groups (mean 1·7 vs 1·9 per year, respectively; RR 0·86, 0·74-1·01; p=0·074). No serious adverse events were reported during follow-up. INTERPRETATION: HIV self-testing resulted in a two times increase in frequency of testing in gay and bisexual men at high risk of infection, and a nearly four times increase in non-recent testers, compared with standard care, without reducing the frequency of facility-based HIV testing. HIV self-testing should be made more widely available to help increase testing and earlier diagnosis. FUNDING: The National Health and Medical Research Council, Australia.

Following Lives Undergoing Change (Flux) study: Implementation and baseline prevalence of drug use in an online cohort study of gay and bisexual men in Australia.

BACKGROUND: Drug use among gay and bisexual men (GBM) is higher than most populations. The use of crystal methamphetamine, erectile dysfunction medication (EDM), and amyl nitrite have been associated with sexual risk behaviour and HIV infection among gay and bisexual men (GBM). OBJECTIVE: This paper describes an online prospective observational study of licit and illicit drug use among GBM and explores baseline prevalence of drug use in this sample. Capturing these data poses challenges as participants are required to disclose potentially illegal behaviours in a geographically dispersed country. To address this issue, an entirely online and study specific methodology was chosen. METHODS: Men living in Australia, aged 16.5 years of age or older, who identified as homosexual or bisexual or had sex with at least one man in the preceding 12 months were eligible to enrol. RESULTS: Between September 2014 and July 2015, a total of 2250 participants completed the baseline questionnaire, of whom, 1710 (76.0%) consented to six-monthly follow-up. The majority (65.7%) were recruited through Facebook targeted advertising. At baseline, over half (50.5%) the men reported the use of any illicit drug in the previous six months, and 28.0% had used party drugs. In the six months prior to enrolment, 12.0% had used crystal methamphetamine, 21.8% had used EDM, and 32.1% had used amyl nitrite. Among the 1710 men enrolled into the cohort, 790 men had used none of these drugs. CONCLUSION: Ease of entry and minimal research burden on participants helped ensure successful recruitment into this online cohort study. Study outcomes will include the initiation and cessation of drug use, associated risk behaviours, and health consequences, over time. Results will provide insights into the role gay community plays in patterns of drug use among GBM.

The Impact of a Social Marketing Campaign on HIV and Sexually Transmissible Infection Testing Among Men Who Have Sex With Men in Australia.

BACKGROUND: In response to increasing HIV and other sexually transmissible infection (HIV/STI) notifications in Australia, a social marketing campaign Drama Downunder (DDU) was launched in 2008 to promote HIV/STI testing among men who have sex with men (MSM). We analyzed prospective data from (1) an online cohort of MSM and (2) clinic-level HIV/STI testing to evaluate the impact of DDU on HIV, syphilis, gonorrhea, and chlamydia testing. MATERIALS AND METHODS: (1) Cohort participants who completed 3 surveys (2010-2014) contributed to a Poisson regression model examining predictors of recent HIV testing.(2) HIV, syphilis, gonorrhea, and chlamydia tests among MSM attending high caseload primary care clinics (2007-2013) were included in an interrupted time series analysis. RESULTS: (1) Although campaign awareness was high among 242 MSM completing 726 prospective surveys, campaign recall was not associated with self-reported HIV testing. Reporting previous regular HIV testing (adjusted incidence rate ratio, 2.4; 95% confidence interval, 1.3-4.4) and more than 10 partners in the previous 6 months (adjusted incidence rate ratio, 1.2; 95% confidence interval, 1.1-1.4) was associated with recent HIV testing. (2) Analysis of 257,023 tests showed increasing monthly HIV, syphilis, gonorrhea, and chlamydia tests pre-DDU. Post-DDU, gonorrhea test rates increased significantly among HIV-negative MSM, with modest and nonsignificant increasing rates of HIV, syphilis, and chlamydia testing. Among HIV-positive MSM, no change in gonorrhea or chlamydia testing occurred and syphilis testing declined significantly. CONCLUSIONS: Increasing HIV/STI testing trends among MSM occurred pre- and post-DDU, coinciding with other plausible drivers of testing. Modest changes in HIV testing post-DDU suggest that structural changes to improve testing access may need to occur alongside health promotion to increase testing frequency.

Rationale and design of FORTH: a randomised controlled trial assessing the effectiveness of HIV self-testing in increasing HIV testing frequency among gay and bisexual men.

BACKGROUND: Gay and bisexual men (GBM) are a major risk group for HIV acquisition, yet the majority of higher-risk GBM test for HIV less often than recommended (3-6 monthly). HIV self-testing has the potential to increase testing frequency and improve awareness of personal HIV status. HIV self-tests have been approved in some countries, however there are concerns whether self-testing would increase HIV testing frequency enough to compensate for the reduced sensitivity of self-tests in early infection. We describe here a randomised controlled trial to assess the effectiveness of self-testing in increasing HIV testing frequency among higher-risk GBM, and its acceptability. METHODS/DESIGN: Participants are higher-risk HIV negative GBM (>5 partners or condomless anal intercourse in previous 3 months; n = 350), including 50 GBM who tested for HIV over two years ago or never tested before ('infrequent-testers'). Participants are recruited from sexual health clinics and community-based organisations, and randomised 1:1 to either self-testing or standard-care (routine clinic-based testing) arms. The trial employs a wait-list control design: participants in the standard-care arm switch to self-testing arm in the second year, and gain access to self-test kits. Participants in the self-testing arm receive four oral-fluid self-test kits at enrolment, with additional kits provided on request. Demographics, sexual behaviour and HIV testing preferences are collected at baseline, and the frequency and pattern of HIV and sexually transmissible infection (STI) testing is collected via online 3-monthly questionnaires. The acceptability of self-testing is assessed at 12 months via an online questionnaire and in-depth interviews. A 24-h telephone support is provided, with expedited follow-up of those with reactive self-test results. The primary outcome is HIV testing frequency (mean number of HIV tests per person) over 12 months, and the secondary outcomes are: mean number of STI tests (chlamydia, gonorrhoea, syphilis) per person; reasons for HIV testing; and acceptability of HIV self-testing. DISCUSSION: This is the first trial to evaluate the use of self-testing among GBM in Australia, and the first internationally among infrequent testers. The study will provide evidence on whether self-testing increases HIV testing frequency, and its acceptability among GBM. The findings will improve our understanding of self-testing patterns, and whether GBM supplement or replace their existing testing routine. TRIAL REGISTRATION: Australian and New Zealand Clinical Trial Registration number: ACTRN12613001236785 , registered on November 12, 2013.

Understanding Gay Community Subcultures: Implications for HIV Prevention.

Gay and bisexual men (GBM) who participate in gay community subcultures have different profiles, including differing risk behaviors. We examined men's participation in gay community subcultures, and its association with risk behavior. In a cross-sectional survey, 849 GBM provided information about men in their personal networks. We devised measures of their participation in five subcultural groupings and explored their associations with sexual behavior. We identified five subcultural groupings: sexually adventurous; bear tribes; alternative queer; party scene; and sexually conservative. Higher scores on the sexually adventurous measure was associated with being older, having more gay friends, being HIV-positive, and being more sexually active. It was also independently associated with unprotected anal intercourse with casual partners (AOR 1.82; 95 % CI 1.20-2.76; p = 0.005). HIV prevention strategies need to account for the different subcultural groupings in which GBM participate. Measures of engagement with gay subcultures are useful indicators of differential rates of risk behavior and modes of participation in gay community life. Men in more sexually adventurous subcultures are more likely to engage in sexual risk behavior.

No drama: key elements to the success of an HIV/STI-prevention mass-media campaign.

We qualitatively examined gay men's reactions to the national "Drama Downunder" HIV/STI social marketing campaign targeting gay men in Australia to identify key campaign elements that underpinned the demonstrated effectiveness of the campaign. We present findings from six qualitative focus groups held with 49 participants as part of the evaluation of the sexual-health-promotion campaign over 2008-2009. Participants identified attention-grabbing images, a humorous approach, positive and simple tailored messaging, and the use of mainstream media as campaign features crucial in normalizing sexual health testing, driving campaign engagement, and ensuring high message exposure. Our results suggest that designers of future campaigns should strive to balance positive and negative campaign images and messages, and find new ways to engage men with sexual health topics, particularly younger gay men. We discuss the implications of our findings about campaign effectiveness for future health-promotion campaigns and message design.

Queer as F**k: reaching and engaging gay men in sexual health promotion through social networking sites.

BACKGROUND: A growing number of health promotion interventions are taking advantage of the popularity and interactivity of new social media platforms to foster and engage communities for health promotion. However, few health promotion interventions using social networking sites (SNS) have been rigorously evaluated. "Queer as F**k"(QAF) began as pilot project in 2010 to deliver sexual health promotion via short "webisodes" on SNS to gay men. Now in its fifth season, QAF is among the few published examples internationally to demonstrate the sexual health promotion potential of SNS. OBJECTIVE: The objective of this evaluation is to assess reach, interactivity, and engagement generated by QAF to inform future health interventions and evaluations using SNS. METHODS: We undertook a mixed method process evaluation using an uncontrolled longitudinal study design that compared multiple measurements over time to assess changes in reach and engagement. We adapted evaluation methods from the health promotion, information systems, and creative spheres. We incorporated online usage statistics, interviews informed by user diary-scrapbooks, and user focus groups to assess intervention reach and engagement. RESULTS: During Series 1-3 (April 2010 to April 2011), 32 webisodes were posted on the QAF Facebook and YouTube pages. These webisodes attracted over 30,000 views; ranging from 124-3092 views per individual episode. By April 2011, the QAF Facebook page had 2929 predominantly male fans. Interview and focus group participants supported the balance of education and entertainment. They endorsed the narrative "soap opera" format as an effective way to deliver sexual health messages in an engaging, informative, and accessible manner that encouraged online peer discussion of sexual health and promoted community engagement. CONCLUSIONS: QAF offers a successful example of exploiting the reach, interactivity, and engagement potential of SNS; findings from this process evaluation provide a model to inform the delivery and evaluation of future health promotion interventions on SNS.

Stop the drama Downunder: a social marketing campaign increases HIV/sexually transmitted infection knowledge and testing in Australian gay men.

INTRODUCTION: Since 2000, notifications of HIV and other sexually transmitted infections (STIs) have increased significantly in Australian gay men. We evaluated the impact of a social marketing campaign in 2008-2009 aimed to increase health-seeking behavior and STI testing and enhance HIV/STI knowledge in gay men. METHODS: A convenience sample of 295 gay men (18-66 years of age) was surveyed to evaluate the effectiveness of the campaign. Participants were asked about campaign awareness, HIV/STI knowledge, health-seeking behavior, and HIV/STI testing. We examined associations between recent STI testing and campaign awareness. Trends in HIV/STI monthly tests at 3 clinics with a high case load of gay men were also assessed. Logistic and Poisson regressions and χ tests were used. RESULTS: Both unaided (43%) and aided (86%) campaign awareness was high. In a multivariable logistic regression, awareness of the campaign (aided) was independently associated with having had any STI test within the past 6 months (prevalence ratio = 1.5; 95% confidence interval = 1.0-2.4. Compared with the 13 months before the campaign, clinic data showed significant increasing testing rates for HIV, syphilis, and chlamydia among HIV-negative gay men during the initial and continued campaign periods. CONCLUSION: These findings suggest that the campaign was successful in achieving its aims of increasing health-seeking behavior, STI testing, and HIV/STI knowledge among gay men in Victoria.

Developing health promotion interventions on social networking sites: recommendations from The FaceSpace Project.

Online social networking sites offer a novel setting for the delivery of health promotion interventions due to their potential to reach a large population and the possibility for two-way engagement. However, few have attempted to host interventions on these sites, or to use the range of interactive functions available to enhance the delivery of health-related messages. This paper presents lessons learnt from "The FaceSpace Project", a sexual health promotion intervention using social networking sites targeting two key at-risk groups. Based on our experience, we make recommendations for developing and implementing health promotion interventions on these sites. Elements crucial for developing interventions include establishing a multidisciplinary team, allowing adequate time for obtaining approvals, securing sufficient resources for building and maintaining an online presence, and developing an integrated process and impact evaluation framework. With two-way interaction an important and novel feature of health promotion interventions in this medium, we also present strategies trialled to generate interest and engagement in our intervention. Social networking sites are now an established part of the online environment; our experience in developing and implementing a health promotion intervention using this medium are of direct relevance and utility for all health organizations creating a presence in this new environment.