Background: Gay, bisexual, and other men who have sex with men (GBMSM) continue to be overrepresented in human immunodeficiency virus (HIV) infection in the United States. HIV prevention and care interventions that are tailored to an individual’s serostatus have the potential to lower the rate of new infections among GBMSM. Mobile technology is a critical tool for disseminating targeted messaging and increasing uptake of basic prevention services including HIV testing, sexually transmitted infection (STI) testing, and pre-exposure prophylaxis (PrEP). Mobile Messaging for Men (M-Cubed) is a mobile health HIV prevention intervention designed to deliver video- and text-based prevention messages, provide STI and HIV information, and link GBMSM to prevention and healthcare resources. The current report describes an iterative process of identifying and selecting publicly available videos to be used as part of the M-Cubed intervention. We also conducted interviews with GBMSM to assess the acceptability, comprehension, and potential audience reach of the selected video messages. Methods: The selection of videos included balancing of specific criteria [e.g., accuracy of scientific information, video length, prevention domains: HIV/STI testing, antiretroviral therapy (ART), PrEP, engagement in care, and condom use] to ensure that they were intended for our GBMSM audiences: HIV-negative men who engage in condomless anal sex, HIV-negative men who do not engage in condomless anal sex, and men living with HIV. This formative study included in-person interviews with 26 GBMSM from three U.S. cities heavily impacted by the HIV epidemic—New York City, Detroit, and Atlanta. Results: Following a qualitative content analysis, the study team identified five themes across the interviews: participant reactions to the video messages, message comprehension, PrEP concerns, targeting of video messaging, and prompted action. Conclusions: Study results informed a final selection of 12 video messages for inclusion in a randomized controlled trial of M-Cubed. Findings may serve as a guide for researchers who plan to develop HIV prevention interventions that utilize publicly available videos to promote behavioral change. Further, the findings presented here suggest the importance of developing videos with broad age and gender diversity for use in interventions such as M-Cubed, and in other health promotion settings.

Background: Gay, bisexual, and other men who have sex with men (MSM), particularly Black or African American MSM (BMSM) and Hispanic or Latino MSM (HLMSM), continue to be disproportionately affected by the HIV epidemic in the United States. Previous HIV self-testing programs have yielded high testing rates, although these studies predominantly enrolled White, non-Hispanic MSM. Mobile health tools can support HIV prevention, testing, and treatment. This protocol details an implementation study of mailing free HIV self-tests (HIVSTs) nested within a randomized controlled trial designed to assess the benefit of a mobile phone app for increasing the uptake of HIV prevention and other social services. Objective: This study was a comparative effectiveness trial of innovative recruitment and testing promotion strategies intended to effectively reach cisgender BMSM and HLMSM. We evaluated the use of a mobile app for increasing access to care. Methods: Study development began with individual and group consultations that elicited feedback from 3 core groups: HIV care practitioners and researchers, HIV service organization leaders from study states, and BMSM and HLMSM living in the study states. Upon completion of the formative qualitative work, participants from 11 states, based on the observed areas of highest rate of new HIV diagnoses among Black and Hispanic MSM, were recruited through social networking websites and smartphone apps. After eligibility was verified, participants consented and were randomized to the intervention arm (access to the Know@Home mobile app) or the control arm (referral to web resources). We provided all participants with HIVSTs. The evaluation of the efficacy of a mobile phone app to support linkage to posttest prevention services that included sexually transmitted infection testing, pre-exposure prophylaxis initiation, antiretroviral treatment, and acquisition of condoms and compatible lubricants has been planned. Data on these outcomes were obtained from several sources, including HIVST-reporting surveys, the 4-month follow-up survey, laboratory analyses of dried blood spot cards returned by the participant, and data obtained from the state health department surveillance systems. Where possible, relevant subgroup analyses were performed. Results: During the formative development phase, 9 consultations were conducted: 6 in-depth individual discussions and 3 group consultations. From February 2020 through February 2021, we enrolled 2093 MSM in the randomized controlled trial from 11 states, 1149 BMSM and 944 HLMSM. Conclusions: This study was designed and implemented to evaluate the effectiveness of recruitment strategies to reach BMSM and HMSM and of a mobile app with regard to linkage to HIV prevention or treatment services. Data were also obtained to allow for the analyses of cost and cost-effectiveness related to study enrollment, HIV testing uptake, identification of previously undiagnosed HIV, sexually transmitted infection testing and treatment, and linkage to HIV prevention or treatment services.

Background: The COVID-19 pandemic continues to have high caseloads in the US, with vaccines a critical component of the response. Disparities in COVID-19 morbidity and mortality have been identified across states and racial/ethnic groups, which are likely in part due to disparities in COVID-19 vaccine uptake. This study aims to better understand and contextualize COVID-19 vaccine hesitancy among persons from under-represented racial/ethnic populations in the Southern US. Methods: We conducted 29 in-depth interviews with a sample of households in Atlanta, GA that were selected from an address-based sampling frame. We purposively approached households, from February 6 to June 27, 2021, that declined participation in a national COVID-19 serosurvey to gain perspectives of people who are often under-represented in research. Interviews were conducted in-person or over phone calls for participants with that preference. Thematic analysis was used to identify barriers and facilitators of COVID-19 vaccination, and to contextualize drivers of vaccine hesitancy. Results: Decision-making about vaccination was described as dynamic, and was compared to the feeling of being on a roller coaster. The predominant reported sources of information were mass media and social media. Facilitators of vaccination included altruism, positive communication from trusted community members and workplace colleagues, and local vaccine provision sites. Driving reasons for vaccine hesitancy included limited trust in the government and concerns about COVID-19 vaccine safety, which one participant compared to jumping off a cliff without a tested rope. Among a subset of participants, beliefs regarding perceived intent to harm the Black community were prevalent. Opportunities to optimally address vaccine hesitancy included countering negative social media messages with positive messaging that matches the community’s vivid ways of discussing vaccines, collaborating with community stakeholders on vaccine promotion efforts, and offering workplace-based vaccine promotion efforts. Conclusions: This study presents data that indicate it may be optimal to more broadly define ‘community’ in COVID-19 vaccine promotion efforts to include social media and workplace venues. To optimize vaccine and vaccine booster uptake and equity, public health must address historic racism and other concerns by using outreach that is grounded in communities.

Health inequities have long defined health and the healthcare system in the USA. The clinical and research capacity across the USA is unparalleled, yet compared to other high and even some middle-income countries, the average health indicators of the population remain suboptimal in 2020, a finding at least in part explained by inequity in healthcare access. In this context, COVID-19 has rapidly emerged as a major threat to the public's health. While it was initially thought that severe acute respiratory syndrome coronavirus 2 would be the great equaliser as it would not discriminate, it is clear that COVID-19 incidence and mortality have rapidly reinforced health disparities drawn by historical and contemporary inequities. Here, we synthesise the data highlighting specific risks among particular marginalised and under-resourced communities including those in jails, prisons and detention centers, immigrants and the undocumented, people with disabilities and people experiencing homelessness across the USA. The drivers of these disparities are pervasive structural risks including limited access to preventive services, inability to comply with physical distancing recommendations, underlying health disparities and intersecting stigmas particularly affecting racial and ethnic minorities across the country, including African Americans, Latinx Americans and Native Americans. Advancing the COVID-19 response, saving lives and restarting the economy necessitate rapidly addressing these inequities rather than ignoring and even reinforcing them.

Background: Men who have sex with men (MSM) are disproportionately affected by the HIV epidemic in Malaysia and globally. Cross-cutting prevention strategies such as mobile health (mHealth), particularly smartphone apps, hold great promise for HIV prevention efforts among Malaysian MSM, especially when linked to HIV testing and pre-exposure prophylaxis (PrEP). Objective: This study aims to adapt an existing app to create and test a clinic-integrated app (JomPrEP), a virtual platform to deliver HIV testing and PrEP services for MSM in Malaysia. Methods: The JomPrEP project involves developing and testing an app-based platform for HIV prevention among Malaysian MSM and will be conducted in 2 phases. In phase I (development phase), we will adapt an existing mHealth app (HealthMindr) to create a new clinic-integrated app called “JomPrEP” to deliver holistic HIV prevention services (eg, HIV testing, PrEP, support services for mental health and substance use) among MSM in Malaysia. During phase II (testing phase), we will use a type I hybrid implementation science trial design to test the efficacy of JomPrEP while gathering information on implementation factors to guide future scale-up in real-world settings. Results: As of September 2022, we have completed phase I of the proposed study. Based on a series of formative work completed during phase I, we developed a fully functional, clinic-integrated JomPrEP app, which provides a virtual platform for MSM in Malaysia to facilitate their engagement in HIV prevention in a fast and convenient manner. Based on participant feedback provided during phase I, we are currently optimizing JomPrEP and the research protocols for a large-scale efficacy trial (phase II), which will commence in January 2023. Conclusions: Scant HIV prevention resources coupled with entrenched stigma, discrimination, and criminalization of same-sex sexual behavior and substance use hamper access to HIV prevention services in Malaysia. If found efficacious, JomPrEP can be easily adapted for a range of health outcomes and health care delivery services for MSM, including adaptation to other low- and middle-income countries. Trial Registration: ClinicalTrials.gov NCT05325476; https://clinicaltrials.gov/ct2/show/NCT05325476 International Registered Report Identifier (IRRID): DERR1-10.2196/43318

Background: Young Black gay, bisexual, and other men who have sex with men (YBMSM) are disproportionally affected by HIV. Seroadaptive strategies-modification of sexual behavior based on an individual's perceived serostatus, the perceived status of the partner, and/or HIV transmission risk by the type of sex act-are often used to reduce the risk of HIV transmission or acquisition. Methods: We used demographic, behavioral, and clinical data from Ele[MEN]t, a prospective cohort study of YBMSM aged 18-29 years in Atlanta, GA, conducted during 2015-2019. The prevalence of seroadaptive strategies at baseline was reported, and latent class analysis was used to identify the latent classes of strategies for both YBMSM known and not known to be living with HIV. Latent classes were compared by key behavioral and clinical characteristics to validate our findings. Results: In a 4-class model, the most common latent class of YBMSM not known to be living with HIV (32.4%) was characterized by all individuals reporting only having sex with men not perceived to be living with HIV. The most common latent class of YBMSM known to be living with HIV (48.2%) was characterized by a combination of serosorting strategies, including using condoms for anal sex with partners not known to be living with HIV and avoiding sex with men not known to be living with HIV. Conclusions: YBMSM use various patterns of strategies to reduce their HIV transmission or acquisition risk. Our study highlights the need for targeted HIV prevention recommendations based on individual behaviors.

Background: Daily oral pre-exposure prophylaxis (PrEP) is effective in preventing HIV infection, but no study has evaluated combination prevention interventions with PrEP for transgender women (TGW) and men who have sex with men (MSM) who sell sex. Methods: The Combination Prevention Effectiveness (COPE) study was a community-based, non-randomized implementation study in Bangkok and Pattaya, Thailand. Participants were HIV-negative MSM and TGW aged 18–26 years who reported exchanging sex with men in the prior 12 months and who met 2014 U.S. Public Health Service PrEP eligibility criteria. The intervention included quarterly HIV testing, semiannual testing for sexually transmitted infections, provision of condoms with lubricant, and the opportunity to initiate or end daily oral PrEP use at any time during study participation. Participants taking PrEP received monthly adherence counseling and short message service reminders. The primary outcome was HIV incidence rate ratio (IRR) on PrEP vs. not on PrEP. Secondary outcomes were PrEP initiation, PrEP use at 12 months, and PrEP adherence. Findings: From October 2017 to August 2019, 846 participants were enrolled: 531 (62.8%) immediately initiated PrEP; 104 (12.3%) subsequently initiated PrEP, and 211 (24.9%) never initiated PrEP. Among those initiating PrEP within 30 days of enrollment; 85.9% were on PrEP at the 12-months. When taking PrEP, participants reported adherent PrEP use at 94.2% of quarterly assessments. Ten HIV seroconversions occurred without PrEP use (incidence rate [IR] = 3.42 per 100 person-years [PY]; 95% CI = 1.64–6.30), while zero cases occurred with PrEP use (IR = 0.0 per 100PY; 95% CI = 0.0–0.62), with IRR = 0.0 (95% CI = 0.0–0.22; p < 0.001). Interpretation: Young Thai MSM and TGW who exchange sex can have high PrEP uptake, persistence and adherence, and low HIV incidence when offered in supportive community-based settings. Funding: U.S. National Institute of Allergy and Infectious Diseases; Centers for Disease Control and Prevention.

Background: HIV prevention programmes that include pre-exposure prophylaxis (PrEP) for men who have sex with men (MSM) and transgender women (TGW) in South Africa have not been widely implemented. Objectives: The authors examined oral PrEP uptake, adherence, and adverse events among HIV-uninfected MSM and TGW to inform intervention acceptability and feasibility. Method: In 2015, MSM and TGW in two South African cities were offered a comprehensive package of HIV prevention services, including daily oral PrEP, and were followed for one year. Different models of PrEP delivery were used at each site. Adherence was measured using self-report and pill-count data and tenofovir-diphosphate (TFV-DP) concentrations. Results: Among 135 participants who were eligible for PrEP, 82 (61%) initiated PrEP, of whom 67 (82%) were on PrEP at study end. Participants were on PrEP for a median of 294 out of 314.5 possible days (93% protected days). The median time from PrEP initiation to discontinuation or study end was 305 days (interquartile range: 232-325 days). Across the follow-up time points, 57% - 72% of participants self-reported taking protective levels of PrEP and 59% - 74% were adherent to PrEP as indicated by pill counts. Fewer (< 18%) achieved protective TFV-DP concentrations of > 700 fmol/punch in dried blood spots. Side effects, while typically mild, were the most commonly cited reason by participants for early PrEP discontinuation. Conclusion: Many MSM and TGW initiated and maintained PrEP, demonstrating that PrEP can be successfully delivered to South African MSM and TGW in diverse programmatic contexts. Biologic adherence measures suggest MSM and TGW may experience challenges taking PrEP regularly. Counselling for coping with side effects and motivating daily pill taking is recommended to support South African MSM and TGW in achieving protection with PrEP.

BACKGROUND: Within the United States, HIV affects men who have sex with men (MSM) disproportionally compared to the general population. In 2011, MSM represented nearly two-thirds of all new HIV infections while representing less than 2% of the US male population. Condoms continue to be the foundation of many HIV prevention programs; however, the failure rate of condoms during anal intercourse among MSM is estimated to be 0.5% to 8%, and condom breakages leave those affected at high risk for HIV transmission. OBJECTIVE: Estimate the frequency of condom breakage and associated demographic and behavioral factors during last act of anal intercourse using data from a national online HIV prevention survey of MSM. METHODS: From March 19 to April 16, 2009, data were collected on 9005 MSM through an online survey of US MSM recruited through a social networking site. Using multivariable logistic regression and controlling for several demographic and sexual risk behaviors, we estimated odds ratios of the association between condom breakage and several risk factors. RESULTS: In the study, 8063 participants reported having at least one male sexual partner in the last 12 months. The median age of participants was 21 years (range 18-65). More than two-thirds (68.2%, 5498/8063) reported anal intercourse during last sex and 16.90% (927/5498) reported using a condom during last anal intercourse act. Condom breakage was reported by 4.4% (28/635) participants who engaged in receptive anal intercourse and 3.5% (16/459) participants who engaged in insertive anal intercourse, with an overall failure rate of 4.0% (95% CI 3.2%-6.0%). Age (adjusted odds ratio [aOR] per 5 years: 0.53 (95% CI 0.30-0.94), number of male sex partners (aOR per 5 sex partners: 1.03 (95% CI 1.00-1.08), and being high or buzzed during sex with a casual sex partner (aOR: 3.14, 95% CI 1.02-9.60) were associated with condom breakage. CONCLUSIONS: Our results indicate condom breakage is an important problem for MSM that may be more common for younger men, for men with more partners, and during sex with casual partners after alcohol consumption or drug use. A better understanding of why condom breakage occurs more often in these groups is needed to improve educational efforts. Further, during this time of expanded interest in new condom designs, consideration should be given to how condom design might minimize breakage during anal sex.

BACKGROUND: Men who have sex with men (MSM) are disproportionately affected by human immunodeficiency virus (HIV) and there is evidence that this population is participating in increasingly risky sexual behavior. These changes are occurring in the context of new modes of online social interaction-many MSM now report first meeting their sex partners on the Internet. Better monitoring of key behavioral indicators among MSM requires the use of surveillance strategies that capitalize on these new modes of interaction. Therefore, we developed an annual cross-sectional behavioral survey of MSM in the United States, the American Men's Internet Survey (AMIS). OBJECTIVE: The purpose of this paper was to provide a description of AMIS methods. In addition we report on the first cycle of data collection (December 2013 through May 2014; AMIS-2013) on the same key indicators used for national HIV behavioral surveillance. METHODS: AMIS-2013 recruited MSM from a variety of websites using banner advertisements or email blasts. Adult men currently residing in the United States were eligible to participate if they had ever had sex with a man. We examined demographic and recruitment characteristics using multivariable regression modeling (P<.05) stratified by the participants' self-reported HIV status. RESULTS: In the AMIS-2013 round, 79,635 persons landed on the study page and 14,899 were eligible, resulting in 10,377 completed surveys from MSM representing every US state. Participants were mainly white, 40 years or older, living in the US South, living in urban areas, and recruited from a general social networking website. Self-reported HIV prevalence was 10.73% (n=1113). Compared to HIV-negative/unknown status participants, HIV-positive participants were more likely to have had anal sex without a condom with any male partner in the past 12 months (72.24% versus 61.24%, respectively; P<.001) and more likely to have had anal sex without a condom with their last male sex partner who was discordant/unknown HIV status (42.95% versus 13.62%, respectively; P<.001). Illicit substance use in the past 12 months was more likely to be reported by HIV-positive participants than HIV-negative/unknown status participants (39.17% versus 26.85%, respectively; P<.001). The vast majority of HIV-negative/unknown status participants (84.05%) had been previously HIV tested, but less than half (44.20%) had been tested in the past 12 months. Participants 18-24 years of age were more likely than those 40 years or older to have had anal sex without a condom with a discordant/unknown HIV status partner, were more likely to report substance use, and were less likely to have been HIV tested. Compared to general social networking, those from a geospatial social networking website were more likely to have reported all risk behaviors but were more likely to have been HIV tested. CONCLUSIONS: The first round of AMIS generated useful behavioral measures from more than 10,000 MSM Internet users. Preliminary findings identified some subgroups of MSM Internet users that are at potentially higher risk of HIV acquisition/transmission. AMIS will provide an ongoing data source for examining trends in sexual risk behavior of MSM. This will help to plan and monitor the impact of programs to improve this population's health.