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IntroductionSexual minority (e.g., bisexual, gay, lesbian, queer) and gender minority (e.g., transgender, non-binary, gender expansive) individuals (SGMI) experience higher rates of alcohol and other substance use disorders than their heterosexual and cisgender (i.e., non-transgender) counterparts. 12-Step programs are currently the most common source of support for alcohol and other substance use-related problems in the United States. Little is known about rates and levels of participation and outcomes of SGMI in 12-Step programs. Examining SGMI with a lifetime alcohol or other substance use disorder, this study aims to: 1) describe lifetime attendance rates (any vs. none) and levels of participation (number of program activities) in 12-Step groups among SGMI overall and compare rates of attendance and levels of participation across sexual and gender minority identities and 2) determine how lifetime level of participation in 12-Step programs relates to past-year alcohol and other substance use outcomes.MethodsWe used data collected through The PRIDE Study, a national, large-scale, longitudinal health study of adult SGMI, administering supplemental questions to assess alcohol and other substance use disorders and 12-step participation. Zero-Inflated Negative Binomial models (N = 1353) run with sexual and gender identities as predictors of lifetime 12-step attendance (yes/no) and level of 12-Step participation determine if greater levels of 12-Step participation were associated with lower levels of past-year Alcohol and Substance Use Disorder (AUD & SUD) symptoms. The study ran models for those with lifetime AUD (n = 1074) and SUD (n = 659) separately.ResultsParticipants who engaged in greater levels of 12-Step participation had lower levels of past-year AUD and SUD symptoms. Gay and queer respondents with AUD were more likely and lesbian respondents with SUD were less likely than other participants to have ever participated in 12-Step programs. All other associations between sexual/gender identities and 12-Step participation disappeared when age was added to the model.ConclusionsThis study provides preliminary evidence that 12-Step participation may be an effective resource for reducing AUD and SUD symptoms among SGMI. Younger SGMI and SGMI holding sexual/gender identities other than gay and queer may require additional support to initiate participation in 12-Step programs.

IntroductionDrug use behaviors are closely associated with increased risk for HIV and other STIs among men who have sex with men (MSM) globally. Less is known about the drug use characteristics and their association with HIV/STI risk among MSM in Mexico, who have 13 times higher risk of acquiring HIV than the general population. We characterized distinct classes of drug use behaviors among a nationwide sample of MSM in Mexico and tested their associations with HIV risk behaviors.MethodsWe used latent class analysis (LCA) to analyze injection/non-injection drug use data collected by the online Encuesta de Sexo Entre Hombres self-administered survey among 15,875 MSM living in Mexico between May-June 2017. MSM were recruited on general social media sites (e.g. Facebook and Twitter), popular LGBT + focused web pages (e.g. Soy Homosensual and Desastre), and dating apps (e.g. Grindr and Hornet). We used robust Poisson regression to examine associations between drug use classes and recent sexual risk behaviors while adjusting for sociodemographic characteristics.ResultsMost participants were under 30 years of age (65.5%), received a Bachelor's degree or higher (65.2%), gay-identified (82.5%), HIV negative (58.1%), and lived in the Mexico City/State of Mexico region (34.5%). We identified five distinct drug use classes: Limited Drug Use (75.4%), Marijuana Only (15.1%), Sex Event Popper + Marijuana (4.3%), Club Drug + Marijuana (4.2%), and Elevated Polydrug Use (1.0%). Compared to the Limited Drug Use class, participants in all other drug use classes were significantly more likely to engage in condomless anal intercourse (aPR = 1.14-1.39; p

IntroductionThe ability to objectively measure chronic stress has important implications for research, prevention, and treatment. Cortisol is currently the most used biological marker in the investigation of stress and can be measured via blood, saliva, and urine; however, these methods have disadvantages. The measurement of cortisol in hair is a more recently developed method that quantifies the cumulative production of cortisol over longer periods of time. Given the potential benefits of hair as a chronic stress biometric, research with this novel method is burgeoning, yet rarely involves transgender ("trans") populations, despite high levels of reported stress among trans people due to experiences of stigma and discrimination. Since hair is a key part of gender presentation, trans people might be less likely than cisgender people to donate hair for research. To explore the feasibility and acceptability of hair collection for use as a stress biometric with trans women, we nested a study into an ongoing clinical trial in São Paulo, Brazil, "Manas por Manas" (Sisters for Sisters). Here, we describe the hair biometric substudy protocol, as well as the feasibility and acceptability of collecting hair in the study cohort.MethodsWe randomly selected a subsample (n = 180) from the Manas por Manas cohort (n = 392), all of whom are trans women, age 18 or older. We messaged participants via phone, WhatsApp, or social media for at least three attempted contacts. Study visits included four components: (1) video introduction, including a demonstration of hair sampling; (2) informed consent; (3) a brief survey with the validated Short Stress Overload Scale (translated to Portuguese) and questions on hair care that could moderate stress hormone results; and (4) hair sample collection. Hair samples were collected and stored using validated protocols. Participants were reimbursed for travel costs.ResultsBetween April and December 2022, we messaged with 143 individuals out of the 180 sampled (79%) and invited them to participate in the study. Of those invited to participate, we scheduled study visits with 102 people (71.3% of those invited to participate), of whom 100 attended their study visits and completed all activities. Two people did not attend their study visits and stopped communication. Of those who were invited to participate and declined a study visit, four individuals declined due to the hair sample collection procedures (2.8% of those invited to participate). Other reasons for declining to participate included having moved (n = 7), lack of time (n = 11), not interested in research participation (n = 8), or unknown/stopped responding to messages (n = 11). Most participants reported that they chemically treated their hair to bleach, color, or straighten it, which could impact laboratory assays.ConclusionWe found hair sampling for stress measurement to be feasible and acceptable to our participants. We successfully completed all study activities for our desired sample size, and most recruited individuals volunteered to participate. Reasons provided for declining study participation reflected general barriers to research participation, with only four people declining due to hair sample collection procedures.

ObjectivesTo evaluate the prevalence of weight discrimination (the perception of being treated unfairly based on weight) and its sociodemographic associations among early adolescents aged 10 to 13 in the United States.MethodsWe analyzed cross-sectional data from the Adolescent Brain Cognitive Development (ABCD) Study in Year Two (2018-2020). Multivariable logistic regression analyses were conducted, with perceived weight discrimination as the dependent variable and age, sex, sexual orientation, race and ethnicity, body mass index (BMI) category, household income, and highest parental education level as adjusted independent variables. Interaction with BMI category and weight discrimination by sex, sexual orientation, race and ethnicity, and household income was tested for.ResultsIn our analytical sample (N = 7129), we found that 5.46 % of early adolescents reported experiencing weight discrimination. Adolescents with BMI percentile ≥95th (adjusted odds ratio [AOR], 6.41; 95 % confidence interval [CI], 4.71-8.70),

ObjectiveSexual and gender minority individuals are more likely to use tobacco and cannabis and have lower cigarette cessation. This study examined cannabis use associations with daily cigarettes smoked in sexual and gender minority individuals before and during a quit attempt.MethodParticipants included dual smoking same-sex/gender couples from California that were willing to make a quit attempt (individual n = 205, 68.3% female sex). Participants reported baseline past 30-day cannabis use and number of cigarettes smoked and cannabis use (yes/no) during 35 nightly surveys. Individuals with current cannabis use reported baseline cannabis use and/or nightly survey cannabis use. Multilevel linear models predicted number of cigarettes smoked by cannabis use.ResultsNumber of cigarettes decreased from before to during a quit attempt, but this decrease was smaller in individuals with current cannabis use compared to no current cannabis use (p < .001). In individuals with current cannabis use, number of cigarettes smoked was greater on days with cannabis use (p < .001). Furthermore, cannabis use that day increased overall number of cigarettes in those with relatively high overall cannabis use but only during a quit attempt in those with relatively low cannabis use (Within-Subject Cannabis Use × Between-Subject Cannabis Use × Quit Attempt interaction; p < .001).ConclusionsSexual and gender minority individuals with cannabis and cigarette use may have a harder time quitting smoking than those who do not use cannabis. For those with cannabis use, guidance on not using cannabis during a quit attempt may improve cigarette cessation outcomes. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

In the United States, immigrant Latino men who have sex with men (ILMSM) are, compared to white MSM, disproportionately burdened by HIV and lack access to highly effective HIV prevention strategies, such as pre-exposure prophylaxis (PrEP). Qualitative research centered on exploring barriers that ILMSM experience in accessing PrEP and other sexual services is extremely limited, despite a high prevalence of HIV in this population. In this study, a purposive sample of ILMSM (n = 25) was recruited to participate in a semi-structured in-depth interview to identify the distinct barriers and facilitators ILMSM experience in accessing sexual health services given their complex intersectional identities of being an immigrant, Latino, and a sexual minority man. Using a thematic analysis approach, nine themes were generated from the data representing barriers and facilitators. Barriers included: (1) cost and a lack of health insurance, (2) complexity of PrEP assistance programs; (3) challenges related to the immigrant experience; (4) impact of gay stigma; and (5) communication challenges. Facilitators included: (1) improving affordability and accessibility of PrEP services; (2) receiving services from LGBT- or Latine LGBT-centered clinics; (3) receiving services from medical providers who are gay and/or Latino; and (4) providing targeted community outreach, education, and promotion of PrEP to ILMSM. While many of the barriers illuminated in the study were structural (e.g., cost and lack of health insurance), and not easy to overcome, the findings highlight a range of facilitators that can support access to PrEP and other sexual health services for ILMSM. Considering these findings, we suggest strategies that may enhance access to needed sexual health services among ILMSM.

Hazardous alcohol consumption is highly prevalent for men who have sex with men (MSM). The 4 treatments currently approved by the Food and Drug Administration for alcohol use are reaching an alarmingly low percentage of people who would benefit from a reduction in their alcohol use. There is increasing interest in alternative methods of treatment, such as herbal supplements, to address hazardous drinking. However, research on the acceptability of alternative pharmacotherapies among MSM remains limited. We examined the prevalence and correlates of expressing interest in using herbal supplements for alcohol treatment among MSM with hazardous alcohol consumption. We conducted a secondary data analysis from a cross-sectional study of MSM who use alcohol, conducted from March 2015 to July 2017 in San Francisco, California, to assess the overall prevalence of interest in using herbal supplements to help reduce alcohol consumption. Associations between expressing interest in herbal supplements and demographic, social, and clinical characteristics were examined using bivariate and multivariable logistic regression models. One-third (66/200, 33%) of the participants expressed interest in an herbal supplement for reducing alcohol consumption. In the multivariable analyses, weekly binge drinking (adjusted odds ratio [aOR] 2.85, 95% CI 1.17-6.93), interest in abstaining from alcohol use (aOR 5.04, 95% CI 1.46-17.40), higher severity of alcohol dependence score (aOR 1.22, 95% CI 1.04-1.41), and interest in naltrexone (aOR 3.22, 95% CI 2.12-4.91) were independently associated with higher odds of being interested in using an herbal supplement to reduce alcohol consumption, adjusting for age, race or ethnicity, and education. We found that MSM who have hazardous drinking habits, more severe alcohol dependence, and interest in pharmacotherapy were more likely to express interest in using an herbal supplement for reducing alcohol consumption. To our knowledge, this is the first study that has evaluated correlates of interest in herbal supplements for alcohol use among MSM. As researchers implement novel alcohol treatment studies, they should focus on recruitment efforts among MSM with a motivation to reduce their alcohol use patterns.

Substance use disparities among sexual and gender minority (SGM) people are attributed to minority stress, but few studies have examined minority stress and cannabis use over time or investigated differences in cannabis use trajectories by less-studied gender subgroups. We examined if longitudinal cannabis use trajectories are related to baseline minority stressors and if gender differences persisted after accounting for minority stress. Cannabis use risk was measured annually over four years (2017-2021) within a longitudinal cohort study of SGM adults in the United States (N = 11,813). Discrimination and victimization, internalized stigma, disclosure and concealment, and safety and acceptance comprised minority stress (n = 5,673). Latent class growth curve mixture models identified five cannabis use trajectories: 'low or no risk', 'low moderate risk', 'high moderate risk', 'steep risk increase', and 'highest risk'. Participants who reported past-year discrimination and/or victimization at baseline had greater odds of membership in any cannabis risk category compared to the 'low risk' category (odds ratios [OR] 1.17-1.33). Internalized stigma was related to 'high moderate' and 'highest risk' cannabis use (ORs 1.27-1.38). After accounting for minority stress, compared to cisgender men, gender expansive people and transgender men had higher odds of 'low moderate risk' (ORs 1.61, 1.67) or 'high moderate risk' (ORs 2.09, 1.99), and transgender men had higher odds of 'highest risk' (OR 2.36) cannabis use. This study indicates minority stress is related to prospective cannabis use risk trajectories among SGM people, and transgender men and gender expansive people have greater odds of trajectories reflecting cannabis use risk.

Sexual and gender minority (SGM) communities are underrepresented in biomedical studies, highlighting the importance of developing biospecimen collection protocols aimed at engaging SGM participants. We aimed to learn more about SGM participants’ experiences with a remote (i.e., not performed at a central location) biospecimen collection study pioneered by The PRIDE Study, a cohort study of SGM adults residing in the United States and its territories. Feedback was collected from 112 SGM participants following blood donation for a parent study investigating the relationship between minority stress, substance use, and epigenetic markers of substance use and minority stress. We used an inductive and collaborative approach to qualitative analysis and identified major themes and areas for protocol improvement. Major themes among participant feedback were as follows: (1) communication with the research team, (2) convenience of donation, (3) interactions with clinical laboratory staff, and (4) anonymity and privacy. Most participants indicated that they experienced little to no problems during the donation process and expressed approval for the clarity and transparency of the informed consent process, ease of communication with the research team, and measures taken to protect participant confidentiality during their appointment. The most common challenges encountered by participants related to the inconvenience of handling and transporting study materials to the clinical laboratory site and the clinical laboratory staff’s unfamiliarity with the study protocol. Some participants indicated a preference for more elements of the study protocol (e.g., transporting collection materials) to be left to the responsibility of the research team. Future studies should carefully consider the delegation of responsibility between participants and the research team to balance both study reach and participant accessibility. Alternative formats, such as at-home collection or collaboration with community health workers, may further enhance participant satisfaction and convenience.

The study aimed to document factors affecting willingness to engage in biospecimen donation for substance use research among Black and Hispanic/Latinx sexual and gender minority (SGM) people. From May to July 2022, we interviewed 22 Black and Hispanic/Latinx SGM people from The PRIDE Study, a cohort of SGM people in the United States and its territories, using Zoom videoconferencing software. Fourteen participants were sexual minority people, and eight participants were gender minority people. We took an inductive, collaborative qualitative analytic approach to identify themes. Themes included: (1) community benefits, (2) personal benefits, (3) community exploitation, (4) personal risks, (5) convenience, (6) trustworthiness of the research team, (7) perceived value in donating, and (8) normalization of biospecimen collection. Participants were generally motivated to engage in biospecimen donation for altruistic purposes. The most cited concerns were related to data security, misuse, and privacy. Researchers must be proactive in building trust with Black and Hispanic/Latinx SGM communities to increase engagement, diversify biospecimen repositories and reduce health inequities. Future research involving biospecimens should provide biospecimen education during the consent process and prioritize participant convenience.

BackgroundDespite national testing guidelines, rates of testing for HIV, sexually transmitted infections, and hepatitis C remain lower than recommended for men who have sex with men (MSM) in the US. To help address this, the TakeMeHome (TMH) program was started in March 2020 by a consortium of public health organizations and dating apps - Building Healthy Online Communities - to work with health departments to increase access to HIV testing for MSM on dating apps.MethodsUsers of participating dating apps were sent messages about opportunities for testing with self-collected specimens through TMH. Program users were eligible to receive test kits if they lived in a participating zip code and were aged at least 18. Users who were interested in testing could order kits to be mailed to them for lab-based testing of HIV, hepatitis C, chlamydia, gonorrhea, and/or syphilis, depending on risk and availability in their zip code. Orders were sent via application programming interface (API) to Molecular Testing Labs (MTL) for fulfillment; kits were provided at no cost to the program user. Within approximately 24 hours of order receipt, MTL mailed program users a kit with required collection supplies, directions, and a link to a video instruction for self-collection. Program users received an automated email after testing was complete with a link to access results through their online account. Individuals with positive results on any of the relevant tests were directed to additional information and supported with linkage to additional testing or treatment, depending on local protocols.ResultsThe positivity rate of specimens processed through TMH was 1.4% for HIV, 0.6% for hepatitis C, and 2.9% for all STIs combined. The per-person positivity rate was 15.3% across all STIs.Conclusions: The TakeMeHome program demonstrates that self-collected lab-processed testing is feasible and effective at identifying new HIV and STI cases.

Benefits of parental gender-affirming behaviors on the mental health and well-being of the broader gender-expansive youth population have been extensively documented. However, the nature and impact of these behaviors have not been explored by centering Black and Latine transgender/non-binary youth (BLTY). This article offers a new framework called the "Parental Gender Affirmation Model." This framework conceptualizes parental gender-affirming behaviors toward BLTY through the lenses of intersectional stigma and cultural gender norms and uses the Theory of Planned Behavior and Modified Gender Affirmation Model as foundational frameworks. We analyzed qualitative data from 43 interviews with BLTY, parents of BLTY, and Black and Latine transgender/non-binary young adults from California in the United States to develop the framework. The "Parental Gender Affirmation Model" starts with behavioral antecedents and ends with impacts of these behaviors on BLTY's well-being. This framework will inform the development of critically needed, culturally-informed interventions to support parental gender affirmation of BLTY.

IntroductionGlobally, transgender ('trans') women experience extreme social and economic marginalisation due to intersectional stigma, defined as the confluence of stigma that results from the intersection of social identities and positions among those who are oppressed multiple times. Among trans women, gender-based stigma intersects with social positions such as engagement in sex work and substance use, as well as race-based stigma to generate a social context of vulnerability and increased risk of HIV acquisition. In Brazil, trans women are the 'most at-risk' group for HIV, with 55 times higher estimated odds of HIV infection than the general population; further, uptake of HIV testing and pre-exposure prophylaxis (PrEP) among trans women is significantly lower than other at-risk groups. Through extensive formative work, we developed Manas por Manas, a multilevel intervention using HIV prevention strategies with demonstrated feasibility and acceptability by trans women in Brazil, to address intersectional stigma and increase engagement in the HIV prevention continuum.Methods and analysisWe are conducting a two-arm randomised wait-list controlled trial of the intervention's efficacy in São Paulo, Brazil, to improve uptake of HIV testing and PrEP among transgender women (N=400). The primary outcomes are changes in HIV testing (self-testing and clinic based), changes in PrEP uptake and changes in PrEP persistence at baseline and follow-up assessment for 12 months at 3-month intervals.Ethics and disseminationThis study was approved by University of California, San Francisco Institutional Review Board (15-17910) and Comissão Nacional de Ética em Pesquisa (Research Ethics National Commission, CAAE: 25215219.8.0000.5479) in Brazil. Participants provided informed consent before enrolment. We are committed to collaboration with National Institutes of Health officials, other researchers, and health and social services communities for rapid dissemination of data and sharing of materials. The results will be published in peer-reviewed academic journals and scientific presentations.Trial registration numberNCT03081559.

Purpose: Sexual and gender minority (SGM) individuals may receive social support through active use of social media (i.e., posting and interacting). This study examined associations between active social media use, social support, and health indicators in a large sample of SGM adults in the United States. Methods: Data were derived from the 2017 wave of The PRIDE Study, a national cohort study of SGM health. SGM-identified adults reporting social media use (N = 5995) completed measures of active social media use, social support, depressive symptoms, cigarette smoking, hazardous drinking, sleep, and physical activity. Regression models examined main and interactive effects of active social media use and social support on health indicators. Results: The sample reported a moderate level of active social media use (mean [M] = 3.2 [1.0], scale = 1-5) and relatively high social support (M = 16.7 [3.3], scale = 4-20); 31.8% reported moderate-to-severe depressive symptoms. Participants with greater active social media use were more likely to experience depressive symptoms (adjusted odds ratio [AOR] = 1.18, 95% confidence interval [CI] = 1.10-1.26), cigarette smoking (AOR = 1.11, 95% CI = 1.01-1.22), insufficient sleep (AOR = 1.13, 95% CI = 1.06-1.21), and physical inactivity (AOR = 1.09, 95% CI = 1.02-1.15) than those with less active social media use. Active social media use did not significantly interact with social support to predict any health indicators (p values >0.159). Conclusions: Among SGM adults, active social media use was associated with several negative health indicators. Active social media use may increase health risks, or SGM adults with poor health may actively use social media to maintain social connections. Moderate active social media use may be compatible with health.

Purpose: Sexual and gender minority (SGM) people are at greater risk for substance use than heterosexual and cisgender people, but most prior work is limited by cross-sectional analyses or the examination of single substance use. This study examined substance use over time among SGM people to identify patterns of polysubstance use at the intersection of sex and gender. Methods: Data were collected annually over 4 years from SGM respondents (n = 11,822) in The Population Research in Identity and Disparities for Equality (PRIDE) Study. Differences in substance use patterns (any prior 30-day use of 15 substances) by gender subgroup were examined with latent class analysis, and multinomial regression models tested relationships between gender subgroup and substance use. Results: Eight classes of substance use were observed. The three most common patterns were low substance use (49%), heavy episodic alcohol use (≥5 alcoholic drinks on one occasion) with some cannabis and tobacco use (14%), and cannabis use with some tobacco and declining heavy episodic alcohol use (13%). Differences observed included lower odds of patterns defined by heavy episodic alcohol use with some cannabis and tobacco use in all gender subgroups relative to cisgender men and persons with low substance use (odds ratios [ORs] 0.26-0.60). Gender expansive people assigned female at birth, gender expansive people assigned male at birth, and transgender men had greater odds of reporting cannabis use with small percentages of heavy episodic alcohol and tobacco use (ORs: 1.41-1.60). Conclusion: This study suggests that there are unique patterns of polysubstance use over time among gender subgroups of SGM people.

The 21st century has seen shifts in social and scientific understandings of gender and sexuality in the United States. From the legitimization of same-sex marriage to the heightened visibility of transgender identities, nonbinary gender, and forms of intimate diversity such as asexuality, kink, and polyamory, core cultural and scientific assumptions about gender and sexuality have been challenged. This article situates these changes in the historical context of 21st century social technologies, which challenge traditional sources of authority about information and provide enhanced opportunities for individuals to experience authenticity in gender and sexuality. We frame authenticity as a master cultural narrative in the United States characterized by feeling a heightened sense of self-authorship and alignment between inner experience and embodiment of gender and sexuality. Five narratives now circulate in the United States, four of which support sexual and gender diversity: (a) gender as self-constructed; (b) sexuality as plural, playful, flexible, and fluid; (c) sexuality and monogamy as cultural compulsions; and (d) intersectionality as central to the experience of sexuality and gender. A fifth narrative seeking to legitimize hierarchies (e.g., patriarchy) is hostile to sexual and gender diversity but remains anchored in a metanarrative of authenticity and has benefitted equally from the affordances of social technologies. This historical moment provides researchers and practitioners with the opportunity to more intentionally ground their work in lived experience, challenge normative thinking about sexuality and gender, practice affirmation, center the phenomenon of diversity over discrete identity categories in an ever-exclusionary acronym (lesbian, gay, bisexual, transgender, queer/questioning, and more identities [LGBTQ+]), and embrace fluid and nonlinear narratives of social change. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Developmental assets are critical to the health and wellbeing of youth. The current study examines the influence of developmental assets on PrEP use and HIV testing among YBMSM ages 18-24. Using a cross-sectional survey of YBMSM (N = 225), this study explored the role of external (e.g., family support, other adult support) and internal (e.g., personal responsibility) assets in explaining HIV prevention behaviors. Participants were recruited from Mechanical Turk (M-Turk) internet-based platform, social media sites, and community-based organizations. A path analysis was conducted to investigate the direct/indirect effects of internal and external assets on PrEP use and HIV testing. Family support (β = 0.40, p

IntroductionHPTN 083 demonstrated the superiority of long-acting cabotegravir (CAB-LA) versus daily oral emtricitabine/tenofovir disoproxil fumarate (TDF/FTC) as pre-exposure prophylaxis (PrEP) among cisgender men and transgender women who have sex with men (MSM/TGW). HPTN 083 provided the first opportunity to understand experiences with injectable PrEP in a clinical trial.MethodsParticipants from two US sites (Chicago, IL and Atlanta, GA) and one international site (Rio de Janeiro, Brazil) were purposively sampled for individual qualitative interviews (N = 40), between November 2019 and March 2020, to explore trial experiences, barriers to adherence and other factors that may have impacted study implementation or outcomes. The blinded phase ended early due to efficacy; this analysis includes interviews conducted prior to unblinding with three groups defined by adherence (i.e. injection visit attendance): adherent (n = 27), non-adherent (n = 12) and early discontinuers (n = 1). Data were organized using NVivo software and analysed using content analysis.ResultsParticipants (mean age: 27) were primarily cisgender MSM (90%) and Black/African American (60%). Reasons for trial enrolment and PrEP use included a preference for using HIV prevention medication versus treatment in the event of HIV acquisition; the ability to enhance health via study-related education and services; access to a novel, convenient HIV prevention product at no cost; and contributing to MSM/TGW communities through research. Participants contrasted positive experiences with study staff with their routine clinical care, and emphasized increased scheduling flexibility, thorough communication, non-judgemental counselling and open, affirming environments (e.g. compassion, less stigma) as adherence facilitators. Injection experiences were positive overall; some described early injection-related anxiety, which abated with time and when given some measure of control (e.g. pre-injection countdown), and minimal injection site discomfort. Some concerns and misperceptions about injectable PrEP were reported. Barriers to adherence, across all adherence categories, included structural factors (e.g. financial constraints, travel) and competing demands (e.g. work schedules).ConclusionsRespondents viewed injectable PrEP trial participation as a positive experience and a means of enhancing wellbeing. Study site flexibility and affirming clinic environments, inclusive of non-judgemental counselling, were key facilitators of adherence. To support injection persistence, interventions that address structural barriers and promote flexible means of injection delivery may be most effective.

Background: Trans women in Vietnam are among the most vulnerable groups with high HIV risk and limited access to care. TransAction is an evidence-based intervention to reduce trans women's HIV risks and increase social support and access to care.Aims: The aim of this study was to adapt TransAction to the specific needs of trans women in Vietnam. Methods: This study was conducted in Ho Chi Minh City from November 2020 through June 2021 Using the ADAPT-ITT framework, interviews, focus groups, and community advisory board meetings were conducted with trans women, service providers, and community members to better understand Vietnamese contexts of gender transition, HIV risks, and service gaps. Feedback was solicited on TransAction content and format adaptation. Results: Trans women in Vietnam faced unique challenges related to family norms, policy and regulatory constraints, and limited transgender-specific or gender-inclusive services. TransAction was modified to accommodate identified challenges and needs, and intervention components to enhance family support were added. Strategies to cope with stigma and seek support and services were adapted to Vietnamese culture and policies. Discussion: Post-adaptation interviews and focus groups demonstrated strong feasibility and acceptability for the adapted intervention, which can potentially be used to reduce Vietnamese trans women's HIV risks and increase their social support.

IntroductionThe increasing burden of non-communicable diseases, such as hypertension, diabetes and dyslipidaemia, presents key challenges to achieving optimal HIV care outcomes among ageing people living with HIV. These diseases are often comorbid and are exacerbated by psychosocial and structural inequities. This interaction among multiple health conditions and social factors is referred to as a syndemic. In the USA, there are substantial disparities by social position (ie, racial, ethnic and socioeconomic status) in the prevalence and/or control of non-communicable diseases and HIV. Intersecting stigmas, such as racism, classism and homophobia, may drive these health disparities by contributing to healthcare avoidance and by contributing to a psychosocial syndemic (stress, depression, violence victimisation and substance use), reducing success along the HIV and non-communicable disease continua of care. Our hypothesis is that marginalised populations experience disparities in non-communicable disease incidence, prevalence and control, mediated by intersectional stigma and the psychosocial syndemic.Methods and analysisCollecting data over a 4 year period, we will recruit sexual minority men (planned n=1800) enrolled in the MACS/WIHS Combined Cohort Study, a long-standing mixed-serostatus observational cohort in the USA, to investigate the following specific aims: (1) assess relationships between social position, intersectional stigma and the psychosocial syndemic among middle-aged and ageing sexual minority men, (2) assess relationships between social position and non-communicable disease incidence and prevalence and (3) assess relationships between social position and HIV and non-communicable disease continua of care outcomes, mediated by intersectional stigma and the psychosocial syndemic. Analyses will be conducted using generalised structural equation models using a cross-lagged panel model design.Ethics and disseminationThis protocol is approved as a single-IRB study (Advarra Institutional Review Board: Protocol 00068335). We will disseminate results via peer-reviewed academic journals, scientific conferences, a dedicated website, site community advisory boards and forums hosted at participating sites.

BackgroundDespite high rates of HIV transmission among men who have sex with men (MSM) in Lima, Peru, limited data exist on the sexual network characteristics or risk factors for secondary HIV transmission among MSM with uncontrolled HIV infection. We report the frequency of serodiscordant, condomless anal intercourse (CAI) and associated sexual network characteristics among MSM in Lima with detectable HIV viremia and compare to those with undetectable viremia.MethodsThis cross-sectional analysis includes MSM who tested positive for HIV-1 during screening for a trial of partner management and STI control (June 2022-January 2023). Participants were tested for HIV, gonorrhoea, chlamydia, and syphilis, and completed questionnaires on their demographic characteristics, sexual identity and behaviour, sexual network structures and engagement in HIV care.FindingsOf 665 MSM, 153 (23%) had detectable (>200 copies/mL) viremia. 75% (499/662) of men living with HIV were previously diagnosed, with 94% (n = 469/499) reporting that they were on ART, and 93% (n = 436/469) virally suppressed. 96% (n = 147/153) of men with detectable viremia reported serodiscordant CAI with at least one of their last three sexual partners, and 74% (n = 106/144) reported the same with all three of their recent partners. In contrast, 62% (n = 302/489) of men with undetectable viral load reported serodiscordant CAI with all of their last three partners (p

Purpose: We assessed whether anticipated stigma (i.e., fear of public mistreatment due to gender identity) impacts communication between transgender women (TGW) living with HIV and health care providers. Methods: This is a secondary analysis of baseline data from Trans Amigas, a study conducted in Brazil, 2018. The study population consisted of TGW living with HIV, older than 18 years, residing in the São Paulo metropolitan area. We used multivariable logistic regression (α = 0.05), mediation, and bootstrapping for the analysis. Results: One hundred and thirteen participants completed the study. Fear of public mistreatment had an adjusted odds ratio (aOR) of 7.42 (p = 0.003) for difficulty reporting new symptoms to providers. Concerning fear of public mistreatment, we found that unemployment had an aOR of 3.62 (p = 0.036); sex work, an aOR of 2.95 (p = 0.041); and issues related to name change in documents, an aOR of 2.71 (p = 0.033). For the indirect effect on difficulty reporting new symptoms, mediated by fear of public mistreatment, unemployment had an aOR of 1.52 (confidence interval [CI] = 0.88-2.24); sex work, an aOR of 1.48 (CI = 0.81-2.52); and name change issues, an aOR of 1.47 (CI = 0.96-2.43). Conclusions: Anticipated stigma was associated with communication difficulties between TGW living with HIV and providers. Our data suggest that structural factors associated with anticipated stigma could indirectly impact on difficulty reporting new symptoms. These findings indicate the importance of considering social contexts that intersect with individual experiences when analyzing communication barriers between providers and patients, and the need to strengthen social policies for TGW in Brazil. Clinical Trial Registration number: R34MH112177.

Unhealthy alcohol use, which encompasses heavy episodic drinking to alcohol use disorder, has been identified as a modifiable barrier to optimal HIV care continuum outcomes. Despite the demonstrated efficacy of couples-based interventions for addressing unhealthy alcohol use, there are no existing couples-based alcohol interventions designed specifically for people living with HIV. This study presents the development and refinement of a three-session couples-based motivational intervention (ReACH2Gether) to address unhealthy alcohol use among a sample of 17 sexual minority men living with HIV and their partners living in the United States. To increase potential population reach, the intervention was delivered entirely remotely. Throughout an original and a modified version, results indicated that the ReACH2Gether intervention was acceptable and there were no reports of intimate partner violence or adverse events. Session engagement and retention were high. In pre-post-test analyses, the ReACH2Gether intervention showed trends in reducing Alcohol Use Disorder Identification Test scores and increasing relationship-promoting dynamics, such as positive support behaviors and goal congruence around alcohol use. Results support the need for continued work to evaluate the ReACH2Gether intervention.

Despite tremendous advances in HIV research, women and gender diverse people-particularly women from racial and ethnic groups under-represented in research, transgender women, and young women-remain disproportionately affected by HIV. Women and gender diverse people face unique challenges and have been under-represented in HIV research. The National Institutes of Health (NIH) is tasked to apply fundamental knowledge about the nature and behaviour of living systems to enhance health, lengthen life, and reduce disability. Rigorous exploration of-and interventions for-the individual, social, biological, structural, and environmental factors that influence HIV prevention, transmission, treatment, and cure is crucial to advance research for women, girls, and gender diverse people across the lifespan. In this Position Paper, we introduce a framework for an intersectional, equity-informed, data-driven approach to research on HIV and women and highlight selected issues for women and gender diverse people, including HIV prevention, HIV cure, ageing with HIV, substance use and misuse, violence, pregnancy, and breastfeeding or chestfeeding. This framework underlines a new HIV and Women Signature Programme from the NIH Office of AIDS Research and Office of Research on Women's Health that advances the NIH vision for women's health, in which all women receive evidence-based HIV prevention, treatment, and care across their lifespan tailored to their unique needs, circumstances, and goals. The time is now to centre the health of women, girls, and gender diverse people across the HIV research continuum.

BackgroundPre-exposure prophylaxis (PrEP), condom use, post-exposure prophylaxis (PEP), and sexual partner reduction help to prevent HIV acquisition but have low uptake among young people. We aimed to assess the efficacy of automated text messaging and monitoring, online peer support, and strengths-based telehealth coaching to improve uptake of and adherence to PrEP, condom use, and PEP among adolescents aged 12-24 years at risk of HIV acquisition in Los Angeles, CA, USA, and New Orleans, LA, USA.MethodsWe conducted a four-arm randomised controlled factorial trial, assessing interventions designed to support uptake and adherence of HIV prevention options (ie, PrEP, PEP, condom use, and sexual partner reduction). We recruited young people aged 12-24 years who were at risk of HIV acquisition from 13 community-based organisations, adolescent medicine clinics, and organisations serving people who are unstably housed, people who were previously incarcerated, and other vulnerable young people, and through dating apps, peer referrals, and social venues and events in Los Angeles, CA, USA, and New Orleans, LA, USA. Young people who tested seronegative and reported being gay, bisexual, or other men who have sex with men, transgender men or women, or gender diverse (eg. non-binary or genderqueer) were eligible for inclusion. Participants were randomly assigned to one of four intervention groups in a factorial design: automated text messaging and monitoring (AMMI) only, AMMI plus peer support via private social media, AMMI plus strengths-based telehealth coaching by near-peer paraprofessionals, or AMMI plus peer support and coaching. Assignment was further stratified by race or ethnicity and sexual orientation within each interviewer's group of participants. Participants were masked to intervention assignment until after baseline interviews when offered their randomly assigned intervention, and interviewers were masked throughout the study. Interventions were available throughout the 24-month follow-up period, and participants completed baseline and follow-up assessments, including rapid diagnostic tests for sexually transmitted infections, HIV, and substance use, at 4-month intervals over 24 months. The primary outcomes were uptake and adherence to HIV prevention options over 24 months, measured by self-reported PrEP use and adherence, consistent condom use with all partners, PEP prescription and adherence, and number of sexual partners in participants with at least one follow-up. We used Bayesian generalised linear modelling to assess changes in outcomes over time comparing the four study groups. This study is registered with ClinicalTrials.gov (NCT03134833) and is completed.FindingsWe screened 2314 adolescents beginning May 1, 2017, to enrol 1037 participants (45%) aged 16-24 years between May 6, 2017, and Aug 30, 2019, of whom 895 (86%) had follow-up assessments and were included in the analytical sample (313 assigned to AMMI only, 205 assigned to AMMI plus peer support, 196 assigned to AMMI plus coaching, and 181 assigned to AMMI plus peer support and coaching). Follow-up was completed on Nov 8, 2021. Participants were diverse in race and ethnicity (362 [40%] Black or African American, 257 [29%] Latinx or Hispanic, 184 [21%] White, and 53 [6%] Asian or Pacific Islander) and other sociodemographic factors. At baseline, 591 (66%) participants reported anal sex without a condom in the past 12 months. PrEP use matched that in young people nationally, with 101 (11%) participants reporting current PrEP use at baseline, increasing at 4 months to 132 (15%) and continuing to increase in the AMMI plus peer support and coaching group (odds ratio 2·31, 95% CI 1·28-4·14 vs AMMI control). There was no evidence for intervention effect on condom use, PEP use (ie, prescription or adherence), PrEP adherence, or sexual partner numbers. No unanticipated or study-related adverse events occurred.InterpretationResults are consistent with hypothesised synergistic intervention effects of evidence-based functions of informational, motivational, and reminder messaging; peer support for HIV prevention; and strengths-based, goal-focused, and problem-solving telehealth coaching delivered by near-peer paraprofessionals. These core functions could be flexibly scaled via combinations of technology platforms and front-line or telehealth HIV prevention workers.FundingAdolescent Medicine Trials Network for HIV/AIDS Interventions, US National Institutes of Health.

BackgroundPrEP, a biomedical HIV prevention option, continues to be underutilized among transgender women who could benefit from sustained use, especially women of color and those who identify as Latina and/or reside in the southeastern US.ObjectiveWe explored the barriers and facilitators experienced by transgender women who live in Florida regarding accessing, using, and/or staying on PrEP.MethodsIn-depth interviews and focus groups were conducted in either Spanish or English with adult transgender women living in Florida (N = 22). The interviews were audio-recorded, transcribed, and coded in ATLAS.ti using thematic analyses.ResultsThe mean age of the participants was 42.2 years. Among the participants, 73% were Hispanic/Latina, 59% were foreign-born, and approximately one-third were living with HIV (but had past experience with PrEP). Transgender women cited the following barriers to accessing or considering PrEP: (1) costs and benefits of PrEP use; (2) under-representation in clinical trials resulting in unknown or misinformation regarding PrEP side effects; (3) chronic poverty; and (4) trauma and discrimination. Other stressors, such as behavioral healthcare needs, were identified.ConclusionsOur analysis revealed interlocking systems of oppression like transphobia, discrimination, and misgendering, which were common barriers experienced by our participants. These synergistically epidemic (i.e., syndemic) barriers contributed to their feelings of being systematically excluded in social spaces, research, public health planning and policies, laws, and social programs related to PrEP. These structural barriers are impediments to HIV preventive care but also act as a source of stress that contributes to mental health problems, financial vulnerability, substance abuse, and other deleterious health outcomes.

PurposeGay, bisexual, and other cisgender men who have sex with men, and racial minority youth are at elevated risk of acquiring HIV infection. The Adolescent Trials Network 147 recruited youth with acute/recent HIV-infection for early antiretroviral treatment. The cohort make-up is described here.MethodsTreatment-naïve, recently identified HIV + youth, aged 12-24 years, from Los Angeles and New Orleans were recruited from community centers, clinics, social media, and a high-risk seronegative cohort (n = 1,727, the Adolescent Trials Network 149) using point-of-care assays. Acute HIV infection was determined by Fiebig staging. HIV RNA viral load (VL) and CD4 cell counts, along with demographic and behavioral data were assessed at enrollment.ResultsBetween July 2017 and July 2021, 103 newly diagnosed youth were enrolled, initiating antiretroviral treatment within a week. Mean age was 20.8 years (standard deviation: 2.4); 90.3% identified as cis male, 83.5% were single or in casual relationships, 71.8% were gay, bisexual, and other cisgender men who have sex with men; 60.2% were Black. One-fourth (24.3%) reported homelessness ever; 10.7% within last 4 months. At enrollment, median plasma VL was 37,313 HIV RNA copies/ml (interquartile range: 5,849-126,162) and median CD4 count 445.5 cells/mm3 (interquartile range: 357-613). 40% of youth reported acute retroviral symptoms before or at enrollment. Acutely infected, seroconverting youth had the highest VL. Sexually transmitted coinfections were present at enrollment in 56% of the cohort, with syphilis being most frequent (39%).DiscussionEarly identification and treatment of HIV can increase positive HIV outcomes. A high sexually transmitted infection burden was present in recently HIV-infected youth. Acute retroviral symptoms were not reported by most participants, demonstrating that broad universal HIV screening is needed for identification of recent infection in youth.

Background/purposeThe American Society of Clinical Oncology has called for an increased priority to improve cancer care for sexual and gender minority (SGM) populations because of heightened risk of receiving disparate treatment and having suboptimal experiences, including perceived discrimination. We demonstrate how integrating trauma-informed care (TIC) principles across the cancer continuum is a key strategy to improving care delivery and outcomes among SGM populations.MethodThis empirically informed perspective expands on the concepts generated through the American Society of Clinical Oncology position statement and uses the Substance Abuse and Mental Health Services Association's "Four Rs" Toward Trauma Informed Care: Realize, Recognize, Response, and Resist Traumatization.ResultsRecommendations for each component of TIC include: (1) Realize: Implement SGM cultural humility training, including modules on SGM-specific trauma, discrimination, harassment, and violence; (2) Recognize: Routinely screen for emotional distress using methods to ensure privacy, and/or normalize mental health screenings to cancer patients; (3) Respond: Create and widely disseminate policies and patients' rights that prohibit discrimination and ensure access to gender-neutral clinical environments; and (4) Resist Traumatization: Establish and respond to quality metrics (e.g., standardized patients, patient satisfaction surveys) that are informed by a community advisory board with the purpose of ensuring and maintaining quality care.Conclusions and implicationsIntegrating TIC principles into cancer care for SGM populations is crucial to address disparities in treatment and clinical outcomes. Our recommendations offer practical approaches for oncology teams to implement TIC care and ensure equitable and inclusive cancer care for patients and their families.

IntroductionMethamphetamine use is highly prevalent among men who have sex with men (MSM), but knowledge of the long-term dynamics, and how they are affected by substance use treatment, is limited. This study aimed to describe trajectories of methamphetamine use among MSM, and to evaluate the impact of treatment for any kind of substance use on frequency of methamphetamine use.MethodsThis analysis used data from a cohort of MSM in Los Angeles, CA, who participated in semi-annual study visits from 2014 to 2022. The study characterized trajectories of methamphetamine use using a continuous time multistate Markov model with three states. States were defined using self-reported frequency of methamphetamine use in the past six months: frequent (daily), occasional (weekly or less), and never. The model estimated the association between receiving treatment for any kind of substance use and changes in state of frequency of methamphetamine use.ResultsThis analysis included 2348 study visits among 285 individuals who were followed-up for an average of 4.4 years. Among participants who were in the frequent use state, 65 % (n = 26) of those who were receiving any kind of substance use treatment at a study visit had reduced their methamphetamine use at their next visit, compared to 33 % (n = 95) of those who were not receiving treatment. Controlling for age, race/ethnicity, and HIV-status, those who reported receiving current treatment for substance use were more likely to transition from occasional to no use (HR: 1.63, 95 % CI: 1.10-2.42) and frequent to occasional use (HR: 4.25, 95 % CI: 2.11-8.59) in comparison to those who did not report receiving current treatment for substance use.ConclusionsFindings from this dynamic modeling study provide a new method for assessing longitudinal methamphetamine use outcomes and add important evidence outside of clinical trials that substance use treatment may reduce methamphetamine use.

Homoprejudiced violence is a type of aggression against an individual or a community based on their actual or perceived sexual orientation. It may be linked to risks of acquiring HIV/STI via psychosocial variables. This study explored the association between homoprejudiced violence experiences and high-risk sexual behaviors, and potential psychosocial mediators. Using cross-sectional survey data collected in China through Blued among men who have sex with men (MSM) in January 2021, this study conducted multiple mediation analyses. Standard instruments were used to collect data on depressive symptoms in the last two weeks (PHQ-9), recreational drug usage in the last three months, and ever experiencing homoprejudiced violence (12-item survey instrument). Dependent variables were having condomless anal sex and having three or more sexual partners in the last three months. Among 1828 MSM, nearly half (847, 46%) had experienced homoprejudiced violence. Twenty-three percent (427) reached a score that suggested moderate or severe depression and 35% (644) had used recreational drugs. In the last three months, 40% (731) had condomless anal sex and 34% (626) had three or more sexual partners. The indirect mediational coefficients through depression on condomless anal sex and multiple sexual partners were 0.04 (95% CI: [0.02, 0.07]) and 0.02 (95% CI: [0.001, 0.05]), respectively. The indirect mediational coefficient of homoprejudiced violence experience on multiple sexual partners through recreational drug use was 0.05 (95% CI: [0.03, 0.08]). These findings suggest that more comprehensive interventions are needed to address the syndemic of homoprejudiced violence, mental health issues, and HIV/STI-related risks.

Black and Latinx transgender women in the United States (U.S.) are at disproportionately high risk for HIV. Although HIV pre-exposure prophylaxis (PrEP) reduces the risk of HIV infection, uptake and persistence (i.e., ability to continue taking PrEP over time) can be a challenge for Black and Latinx transgender women due to myriad social and structural forces. In this qualitative study, we present unique data on the facilitators of PrEP persistence from Black and Latinx transgender women who initiated PrEP and exhibited varying levels of persistence during a demonstration project in Southern California. PrEP persistence was assessed by collecting quantitative intracellular tenofovir-diphosphate (TFV-DP) levels on dried blood spot (DBS) samples collected at weeks 12 and 48. Informed by the socioecological framework, we conducted and analyzed interviews using qualitative content analysis to determine themes on the facilitators of PrEP persistence. Individual-level facilitators included the use of reminders, having high individual-level HIV risk perception, feeling empowered to take PrEP, and reporting having improved peace of mind and mental health because of taking PrEP. Interpersonal/Community-level facilitators included feeling motivation to prevent HIV in the community, motivation to prevent HIV in the context of sex work, and having high community-level risk perception. Structural-level facilitators included having positive experiences in affirming healthcare settings and having PrEP visits combined with other gender-related healthcare visits. Interventions aiming to increase PrEP uptake and persistence among Black and Latinx transgender women in the U.S. should harness the multiple levels of support exhibited by those who were able to start and persist on PrEP in the face of the myriad social and structural barriers.

BackgroundSexual orientation discrimination increases the risks of negative health outcomes for sexual minorities. Previous studies have found increased rates of eating disorder symptoms in sexual minority individuals, which is attributable to minority stress and discrimination that they experience. Emerging research suggests relationships between sexual orientation discrimination and eating disorder symptoms. However, there is a lack of studies focusing on early adolescents. The objective of this study was to determine prospective associations between discrimination based on sexual orientation and eating disorder symptoms in a national sample of 10-13-year-old early adolescents in the U.S.MethodsWe examined prospective data from Year 2 (2018-2020) and Year 3 (2019-2021) of the Adolescent Brain Cognitive Development (ABCD) Study (N = 8976). Multiple logistic regression analyses were used to estimate associations between self-reported experiences of sexual orientation discrimination in Year 2 and eating disorder symptoms in Year 3, adjusting for potential confounders, including eating disorder symptoms in Year 2. Sexual orientation discrimination was assessed based on the Perceived Discrimination Scale, which measures adolescents' perception of being treated unfairly based on various sociodemographic characteristics. Eating disorder symptoms were based on the parent-reported Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS-5).ResultsIn this demographically diverse sample of early adolescents (N = 8976, age range 10-13 years at Year 2), 5.5% of adolescents reported sexual orientation discrimination in Year 2. The prevalence of parent-reported eating disorder symptoms in Year 3 varied from 1.0 to 8.3%. In the adjusted models, sexual orientation discrimination was prospectively associated with worry about weight gain (adjusted odds ratio [aOR] 2.33, 95% confidence interval [CI] 1.15-4.69) and self-worth tied to weight (aOR 1.60, 95% CI 1.01-2.53) one year later.ConclusionsEarly adolescents who have experienced sexual orientation discrimination have higher odds of experiencing eating disorder symptoms, particularly worrying about weight gain and tying self-worth to weight. Clinicians may consider screening for sexual orientation discrimination and providing affirmative, trauma-informed care when evaluating and treating even younger sexual minority adolescents for eating disorder symptoms.

BackgroundIn the United States, most (~ 70%) annual newly diagnosed HIV infections are among substance-using sexual minority men (SMM) and gender minority transgender women (trans women). Trans women and SMM are more likely to report or be diagnosed with a substance use disorder (SUD) than their cisgender or heterosexual counterparts and the presence of an SUD substantially increases the risk of HIV infection in both groups. Although Pre-Exposure Prophylaxis (PrEP) is highly effective, initiation, adherence, and persistence are exclusively behavioral outcomes; thus, the biomedical benefits of PrEP are abrogated by substance use. SUD is also associated with reduced quality-of-life, and increased overdose deaths, utilization of high-cost healthcare services, engagement in a street economy, and cycles of incarceration.ObjectiveTo determine the optimal (considering efficacy and cost-effectiveness) strategy for advancement along the PrEP Care Continuum among trans women and SMM with an SUD.MethodsThis study will implement a randomized controlled trial, evaluating two Stepped Care approaches involving A.S.K.-PrEP vs. standard of care (SOC) to determine optimal intervention strategies for trans women and SMM with an SUD (N = 250; n = 83 trans women; n = 167 SMM) for advancement along the PrEP Care Continuum. Participants will be randomized (3:1) to Stepped Care (n = 187) or SOC (n = 63). Participants in the Stepped Care arm will be assessed at 3-months for intervention response; responders will be maintained in A.S.K.-PrEP, while non-responders will receive added attention to their SUD via Contingency Management (CM). Non-responders will be re-randomized (1:1) to either (a) receive A.S.K.-PrEP + CM, or (b) shift the primary focus to their SUD (CM alone).ResultsRecruitment and enrollment began in May 2023. Recruitment will span approximately 36 months. Data collection, including all follow-up assessments, is expected to be completed in April 2027.DiscussionTrans women and SMM with an SUD have the two highest HIV prevalence rates in the United States, which underscores the urgent need for effective measures to develop scalable behavioral interventions that can encourage advancement along the PrEP Care Continuum. To improve public health, researchers must identify scalable and cost-effective behavioral interventions to promote PrEP initiation, adherence, and persistence among trans women and SMM who use substances.Trial registrationThis trial has been registered at ClinicalTrials.gov under the number NCT05934877.

Research demonstrates that programming and curricula that is affirmative and inclusive of sexual and gender minority (SGM) people is potentially lifesaving for students in middle and high school. There has been little examination, however, of SGM-affirmative programming at the elementary school level. Elementary school level programming has the potential to benefit SGM youth and families, as well as lead to more affirmative attitudes in later school settings. The study reports on the factors that create and sustain an elementary after school program that has implemented SGM-affirmative programming within a social justice and arts framework for over 20 years. We conducted thematic analysis of interviews with teachers, administrators, and parents in the program and the associated elementary school to identify factors that contribute to the program’s success in affirming and including SGM people. Findings highlight affirmative policies and systems (inclusive mission statements, policies encouraging expression, and hiring diverse staff) and consistent enactment of inclusive and affirmative behaviors (affirming diversity, implementing inclusive curriculum, using inclusive language, and disrupting normativity and implementing restorative practices) as key components of an SGM-affirmative program with elementary-aged students. Results highlight that creating an SGM-affirmative elementary level program is possible and provide an exemplar of this programming in action. Implications and potential focus areas for policy and practice implementation are discussed.

Sexual minority men (SMM) and transgender women in South Africa engage in HIV care at lower rates than other persons living with HIV and may experience population-specific barriers to HIV treatment and viral suppression (VS). As part of a pilot trial of an SMM-tailored peer navigation (PN) intervention in Ehlanzeni district, South Africa, we assessed factors associated with ART use and VS among SMM at trial enrolment. A total of 103 HIV-positive SMM and transgender women enrolled in the pilot trial. Data on clinical visits and ART adherence were self-reported. VS status was verified through laboratory analysis (

Molecular surveillance of viral pathogens and inference of transmission networks from genomic data play an increasingly important role in public health efforts, especially for HIV-1. For many methods, the genetic distance threshold used to connect sequences in the transmission network is a key parameter informing the properties of inferred networks. Using a distance threshold that is too high can result in a network with many spurious links, making it difficult to interpret. Conversely, a distance threshold that is too low can result in a network with too few links, which may not capture key insights into clusters of public health concern. Published research using the HIV-TRACE software package frequently uses the default threshold of 0.015 substitutions/site for HIV pol gene sequences, but in many cases, investigators heuristically select other threshold parameters to better capture the underlying dynamics of the epidemic they are studying. Here, we present a general heuristic scoring approach for tuning a distance threshold adaptively, which seeks to prevent the formation of giant clusters. We prioritize the ratio of the sizes of the largest and the second largest cluster, maximizing the number of clusters present in the network. We apply our scoring heuristic to outbreaks with different characteristics, such as regional or temporal variability, and demonstrate the utility of using the scoring mechanism's suggested distance threshold to identify clusters exhibiting risk factors that would have otherwise been more difficult to identify. For example, while we found that a 0.015 substitutions/site distance threshold is typical for US-like epidemics, recent outbreaks like the CRF07_BC subtype among men who have sex with men (MSM) in China have been found to have a lower optimal threshold of 0.005 to better capture the transition from injected drug use (IDU) to MSM as the primary risk factor. Alternatively, in communities surrounding Lake Victoria in Uganda, where there has been sustained heterosexual transmission for many years, we found that a larger distance threshold is necessary to capture a more risk factor-diverse population with sparse sampling over a longer period of time. Such identification may allow for more informed intervention action by respective public health officials.

ObjectiveTo investigate the prevalence and sociodemographic associations of online dating in a demographically diverse U.S. national cohort of early adolescents.MethodsWe analyzed cross-sectional data from the Adolescent Brain Cognitive Development Study (Year 2, 2018-2020, ages 11-12; N = 10,157). Multivariable logistic regression analyses were employed to estimate associations between sociodemographic factors (e.g., age, sex, race/ethnicity, sexual orientation, household income, parental education) and early adolescent-reported online dating behaviors.ResultsOverall, 0.4% (n = 38) of participants reported ever using a dating app. Males (AOR 2.72, 95% CI 1.11-6.78) had higher odds of online dating compared to females, and sexual minority identification (e.g., lesbian, gay, or bisexual; AOR 12.97, 95% CI 4.32-38.96) was associated with greater odds of online dating compared to heterosexual identification.ConclusionGiven the occurrence of online dating among early adolescents despite age restrictions, interventions might address age misrepresentation. Adolescent sexual health education may consider incorporating anticipatory guidance on online dating, especially for males and sexual minorities. Future research could further investigate online dating patterns from early to late adolescence and associated health effects.

ObjectiveTransgender and gender diverse (TGD) people experience higher levels of stigma, discrimination, and interpersonal violence due to their gender identity and/or expression, particularly TGD people with a migration background. This study aimed to conduct and evaluate group psychotherapy for TGD migrants to provide opportunities for exploring and developing interpersonal skills and relationships.MethodThe group therapy included five individuals who identified as TGD and originated from the Middle East. The TGD group therapy consisted of 12 weekly sessions of 90 minutes each and was facilitated by a psychiatrist. All sessions were conducted online and in Turkish. The sessions were guided by the group process and discussions.ResultsAfter completing 12 group therapy sessions, members of the group reported benefiting from observing and emulating others who shared their problem constellation. Through the interpersonal skills that they built up throughout the sessions, they became more open to share their feelings experiencing fewer social barriers, and reduced anxiety.ConclusionThis observational study indicates the significance of offering group-based psychotherapy to enhance affirmation and social connection within gender minority groups and emphasizes the need to empirically evaluate the effectiveness of group psychotherapy with TGD individuals, with special attention to the unique needs of TGD migrants.

Transgender women (TW) face inequities in HIV and unique barriers to PrEP, an effective biomedical intervention to prevent HIV acquisition. To improve PrEP retention among TW, we examined factors related to retention using a two-phase, sequential explanatory mixed methods approach. In Phase I, we used data from a trial of 170 TW who were provided oral PrEP to examine predictors of 24-week retention. In Phase II, we conducted 15 in-depth interviews with PrEP-experienced TW and used thematic analysis to explain Phase I findings. In Phase I, more participants who were not retained at 24 weeks reported sex work engagement (18% versus 7%) and substantial/severe drug use (18% versus 8%). In Phase II, participants reported drug use as a barrier to PrEP, often in the context of sex work, and we identified two subcategories of sex work. TW engaged in "non-survival sex work" had little difficulty staying on PrEP, while those engaged in "survival sex work" struggled to stay on PrEP. In Phase I, fewer participants not retained at 24 weeks reported gender-affirming hormone therapy (GAHT) use (56% versus 71%). In Phase II, participants prioritized medical gender affirmation services over PrEP but also described the bidirectional benefits of accessing GAHT and PrEP. TW who engaged in "survival sex work" experience barriers to PrEP retention (e.g., unstable housing, drug use) and may require additional support to stay in PrEP care.

IntroductionErectile dysfunction (ED) has been established as a comorbidity among men living with HIV, but comparisons by HIV serostatus of ED incidence in a longitudinal follow-up cohort of men are lacking. We sought to evaluate the incidence of ED spanning a period of 12 years in a longitudinal cohort of sexual minority men (SMM) living with and without HIV.MethodsWe analyzed ED incidence data for 625 participants in the longitudinal Multicenter AIDS Cohort Study from visits spanning October 2006 to April 2019.ResultsSMM living with HIV were more likely to have incident ED compared with those living without HIV (rate ratio: 1.41; 95% CI: 1.14-1.75). Older age, current diabetes, cumulative cigarette use, and cumulative antidepressant use were associated with increased incidence of ED in the entire sample. Self-identifying as Hispanic, current diabetes, and cumulative antidepressant use were positively associated with ED incidence among SMM living with HIV. Cumulative cigarette use was positively associated with greater ED incidence only among SMM living without HIV.DiscussionIn summary, age (full sample/ with HIV), current diabetes (full sample/with HIV), cumulative cigarette use (full sample/without HIV), and cumulative antidepressant use (full sample/with HIV) were associated with increased ED incidence. Skillful management of diabetes and careful titration of antidepressants, along with smoking cessation practices, are recommended to mitigate ED in this population.

The workforce of mental health providers serving lesbian, gay, bisexual, transgender, queer, and/or questioning (LGBTQ+) youth lags far behind the demand for LGBTQ-focused mental health care. Unsatisfactory training and a lack of standardized training metrics for accredited programs perpetuate the lack of preparedness among providers. The presence of LGBTQ+ faculty and mentors in medical education increases the amount of LGBTQ+ content taught to trainees and improves professional development for LGBTQ+ trainees. Inclusive workplace practices and affirming care policies may also improve retention and recruitment of LGBTQ-serving mental health providers.

IntroductionLesbian, gay, bisexual, transgender, and queer/questioning (LGBTQ) individuals use tobacco at disproportionately high rates but are as likely as straight tobacco users to want to quit and to use quitlines. Little is known about the demographics and geographic distribution of LGBTQ quitline participants, their engagement with services, or their long-term outcomes.Aims and methodsCalifornians (N = 333 429) who enrolled in a statewide quitline 2010-2022 were asked about their sexual and gender minority (SGM) status and other baseline characteristics. All were offered telephone counseling. A subset (n = 19 431) was followed up at seven months. Data were analyzed in 2023 by SGM status (LGBTQ vs. straight) and county type (rural vs. urban).ResultsOverall, 7.0% of participants were LGBTQ, including 7.4% and 5.4% of urban and rural participants, respectively. LGBTQ participants were younger than straight participants but had similar cigarette consumption. Fewer LGBTQ participants reported a physical health condition (42.1% vs. 48.4%) but more reported a behavioral health condition (71.1% vs. 54.5%; both p's < .001). Among both LGBTQ and straight participants, nearly 9 in 10 chose counseling and both groups completed nearly three sessions on average. The groups had equivalent 30-day abstinence rates (24.5% vs. 23.2%; p = .263). Similar patterns were seen in urban and rural subgroups.ConclusionsLGBTQ tobacco users engaged with and appeared to benefit from a statewide quitline even though it was not LGBTQ community-based. A quitline with staff trained in LGBTQ cultural competence can help address the high prevalence of tobacco use in the LGBTQ community and reach members wherever they live.ImplicationsThis study describes how participants of a statewide tobacco quitline broke down by sexual orientation and gender. It compares participants both by SGM status and by type of county to provide a more complete picture of quitline participation both in urban areas where LGBTQ community-based cessation programs may exist and in rural areas where they generally do not. To our knowledge, it is the first study to compare LGBTQ and straight participants on their use of quitline services and quitting aids, satisfaction with services received, and rates of attempting quitting and achieving prolonged abstinence from smoking.

Health studies using biospecimens have an underrepresentation of sexual and/or gender minority (SGM) participants, making it difficult to use data to advance SGM health knowledge. This study examined: 1) the willingness of SGM adults to provide research biospecimens, 2) if SGM groups differ in their willingness, 3) the relationship of demographic characteristics with willingness, and 4) the ideas/concerns of SGM adults toward providing research biospecimens. Data collected in 2018-2019 from The Population Research in Identity and Disparities for Equality Study were analyzed. Regressions examined willingness to provide biospecimens (blood, buccal swab, hair, saliva, and urine) across SGM groups (cisgender sexual minority [SM] men, cisgender SM women, gender-expansive, transfeminine, and transmasculine adults; N = 4,982) and the relationship of demographics with a willingness to provide each biospecimen type. A thematic analysis of an open-ended item elucidated SGM adults' (N = 776) perspective toward providing biospecimens. Most SGM adults were willing to provide biospecimens. Cisgender SM women were less willing to provide some types (blood 54% and urine 63%) than the other groups. Cisgender SM men were most willing to provide all types. Older age, identifying as pansexual, and income >$50,000/year were associated with increased odds of providing biospecimen(s). Gender identity was a significant predictor for all biospecimen types. A gender identity other than cisgender man was associated with 1.6-2.4× lower odds of providing biospecimen(s). Participants expressed concerns about data confidentiality and privacy, data access and misuse, research purposes, and inadvertent disclosure of SGM status. SGM adults' concerns about donating biospecimens can be used to create an affirming and inclusive methodology.

BackgroundInjectable cabotegravir was superior to daily oral tenofovir disoproxil fumarate plus emtricitabine for HIV prevention in two clinical trials. Both trials had the primary aim of establishing the HIV prevention efficacy of long-acting injectable cabotegravir pre-exposure prophylaxis (PrEP) compared with tenofovir disoproxil fumarate plus emtricitabine daily oral PrEP. Long-acting PrEP was associated with diagnostic delays and integrase strand-transfer inhibitor (INSTI) resistance. This report presents findings from the first unblinded year of the HIV Prevention Trials Network (HPTN) 083 study.MethodsThe HPTN 083 randomised controlled trial enrolled HIV-uninfected cisgender men and transgender women at elevated HIV risk who have sex with men, from 43 clinical research sites in Africa, Asia, Latin America, and the USA. Inclusion criteria included: a negative HIV serological test at the screening and study entry, undetectable HIV RNA levels within 14 days of study entry, age 18 years or older, overall good health as determined by clinical and laboratory evaluations, and a creatinine clearance of 60 mL/min or higher. Participants were randomly allocated to receive long-acting injectable cabotegravir or daily oral tenofovir disoproxil fumarate plus emtricitabine PrEP. After study unblinding, participants remained on their original regimen awaiting an extension study. HIV infections were characterised retrospectively at a central laboratory. Here we report the secondary analysis of efficacy and safety for the first unblinded year. The primary outcome was incident HIV infection. Efficacy analyses were done on the modified intention-to-treat population using a Cox regression model. Adverse events were compared across treatment groups and time periods (blinded vs unblinded). This trial is registered with ClinicalTrials.gov, NCT02720094.FindingsOf the 4488 participants who contributed person-time to the blinded analysis, 3290 contributed person-time to the first unblinded year analysis between May 15, 2020, and May 14, 2021. Updated HIV incidence in the blinded phase was 0·41 per 100 person-years for long-acting injectable cabotegravir PrEP and 1·29 per 100 person-years for daily oral tenofovir disoproxil fumarate plus emtricitabine PrEP (hazard ratio [HR] 0·31 [95% CI 0·17-0·58], p=0·0003). HIV incidence in the first unblinded year was 0·82 per 100 person-years for long-acting PrEP and 2·27 per 100 person-years for daily oral PrEP (HR 0·35 [0·18-0·69], p=0·002). Adherence to both study products decreased after study unblinding. Additional infections in the long-acting PrEP group included two with on-time injections; three with one or more delayed injections; two detected with long-acting PrEP reinitiation; and 11 more than 6 months after their last injection. Infection within 6 months of cabotegravir exposure was associated with diagnostic delays and INSTI resistance. Adverse events were generally consistent with previous reports; incident hypertension in the long-acting PrEP group requires further investigation.InterpretationLong-acting injectable cabotegravir PrEP retained high efficacy for HIV prevention in men and transgender women who have sex with men during the first year of open-label follow-up, with a near-identical HR for HIV risk reduction between long-acting injectable cabotegravir and daily oral tenofovir disoproxil fumarate plus emtricitabine PrEP during the first year after unblinding compared with the blinded period. Extended follow-up further defined the risk period for diagnostic delays and emergence of INSTI resistance.FundingDivision of AIDS at the National Institute of Allergy and Infectious Diseases, ViiV Healthcare, and Gilead Sciences.

BackgroundMeeting sex partners online is associated with increased risk of acquiring sexually transmitted infections. We examined whether different venues where men who have sex with men (MSM) meet sex partners was associated with prevalent Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infection, and whether prevalence increased during (vs before) the COVID-19 pandemic.MethodsWe conducted a cross-sectional analysis of data from San Diego's 'Good To Go' sexual health clinic from two enrolment periods: (1) March-September 2019 (pre-COVID-19) and (2) March-September 2021 (during COVID-19). Participants completed self-administered intake assessments. This analysis included males aged ≥18 years self-reporting sex with males within 3 months before enrolment. Participants were categorised as (1) meeting new sex partners in-person only (eg, bars, clubs), (2) meeting new sex partners online (eg, applications, websites) or (3) having sex only with existing partners. We used multivariable logistic regression, adjusting for year, age, race, ethnicity, number of sex partners, pre-exposure prophylaxis use and drug use to examine whether venue or enrolment period were associated with CT/NG infection (either vs none).ResultsAmong 2546 participants, mean age was 35.5 (range: 18-79) years, 27.9% were non-white and 37.0% were Hispanic. Overall, CT/NG prevalence was 14.8% and was higher during COVID-19 vs pre-COVID-19 (17.0% vs 13.3%). Participants met sex partners online (56.9%), in-person (16.9%) or only had existing partners (26.2%) in the past 3 months. Compared with having only existing sex partners, meeting partners online was associated with higher CT/NG prevalence (adjusted OR (aOR) 2.32; 95% CI 1.51 to 3.65), while meeting partners in-person was not associated with CT/NG prevalence (aOR 1.59; 95% CI 0.87 to 2.89). Enrolment during COVID-19 was associated with higher CT/NG prevalence compared with pre-COVID-19 (aOR 1.42; 95% CI 1.13 to 1.79).ConclusionsCT/NG prevalence appeared to increase among MSM during COVID-19, and meeting sex partners online was associated with higher prevalence.

BackgroundUnderstanding the impact of incarceration on HIV transmission among Black men who have sex with men is important given their disproportionate representation among people experiencing incarceration and the potential impact of incarceration on social and sexual networks, employment, housing, and medical care. We developed an agent-based network model (ABNM) of 10,000 agents representing young Black men who have sex with men in the city of Chicago to examine the impact of varying degrees of post-incarceration care disruption and care engagement interventions following release from jail on HIV incidence.MethodsExponential random graph models were used to model network formation and dissolution dynamics, and network dynamics and HIV care continuum engagement were varied according to incarceration status. Hypothetical interventions to improve post-release engagement in HIV care for individuals with incarceration (e.g., enhanced case management, linkage to housing and employment services) were compared to a control scenario with no change in HIV care engagement after release.FindingHIV incidence at 10 years was 4.98 [95% simulation interval (SI): 4.87, 5.09 per 100 person-years (py)] in the model population overall; 5.58 (95% SI 5.38, 5.76 per 100 py) among those with history of incarceration, and 12.86 (95% SI 11.89, 13.73 per 100 py) among partners of agents recently released from incarceration. Sustained post-release HIV care for agents with HIV and experiencing recent incarceration resulted in a 46% reduction in HIV incidence among post-incarceration partners [incidence rate (IR) per 100 py = 5.72 (95% SI 5.19, 6.27) vs. 10.61 (95% SI 10.09, 11.24); incidence rate ratio (IRR) = 0.54; (95% SI 0.48, 0.60)] and a 19% reduction in HIV incidence in the population overall [(IR per 100 py = 3.89 (95% SI 3.81-3.99) vs. 4.83 (95% SI 4.73, 4.92); IRR = 0.81 (95% SI 0.78, 0.83)] compared to a scenario with no change in HIV care engagement from pre-to post-release.InterpretationDeveloping effective and scalable interventions to increase HIV care engagement among individuals experiencing recent incarceration and their sexual partners is needed to reduce HIV transmission among Black men who have sex with men.FundingThis work was supported by the following grants from the National Institutes of Health: R01DA039934; P20 GM 130414; P30 AI 042853; P30MH058107; T32 DA 043469; U2C DA050098 and the California HIV/AIDS Research Program: OS17-LA-003; H21PC3466.

Family rejection has negative health consequences for Latinx sexual minority men (LSMM). However, LSMM often reconcile with their families, a phenomenon cross-sectional studies miss. We analyzed longitudinal data from the Healthy Young Men's Study in Los Angeles. We used individual fixed-effects Poisson regression to model changes over time in the associations among family support, drug use, and depressive symptoms. We found that (1) the initiation of drug use was associated with a 7.2% (Ratio=1.072, 95% CI 1.006 - 1.142, p = 0.03) increase in family support among LSMM who reported high depressive symptoms (depression subscale T-score ≥ 63) in at least one data wave; (2) a 1-unit increase in family support was associated with a 4.7% (RR = ;0.953, 95% CI 0.931 - 0.976, p < 0.001) decrease in the probability of high depressive symptoms; and (3) no significant association between a change in drug use and a change in high depressive symptoms. Over time, LSMM appear to benefit from the health effects of family support associated with Latinx family structures.

Background and objectivesLoneliness is associated with frailty among older adults (60+), and there is evidence suggesting that this association may be bidirectional. However, there is limited evidence of this relationship over time among middle-aged and aging sexual minority men. We explored the bidirectional relationship between loneliness and frailty over 2 years among sexual minority men living with or without human immunodeficiency virus (HIV) from the Healthy Aging substudy of the Multicenter AIDS Cohort Study.Research design and methodsWe used data from 1 118 men (561 living with HIV; 557 living without HIV) aged 40 years or older with measurement of frailty or loneliness at Times 1 (September 2016 to March 2017) and 2 (September 2018 to March 2019). Descriptive statistics were generated. We used autoregressive cross-lagged panel analysis to examine the bidirectional association between frailty and loneliness at both time points while adjusting for time-stable and time-dependent covariates at Time 1. Adjusted odds ratios (aORs) and 95% confidence intervals (CIs) were generated.ResultsThe estimated prevalence of loneliness at both time points was 35.5%. The estimated prevalence of frailty at Times 1 and 2 were 7.8% and 12.1%, respectively. Participants reporting loneliness at Time 1 had greater odds of being frail at Time 2 (aOR = 2.14; 95% CI: 1.23-3.73). Frailty at Time 1 was not associated with loneliness at Time 2 (aOR = 1.00; 95% CI: .44-2.25). The autoregressive effects of frailty (aOR = 23.43; 95% CI: 11.94-46) and loneliness (aOR = 13.94; 95% CI: 9.42-20.61) were large.Discussion and implicationsMen who felt lonely had higher odds of being frail 2 years later while the reciprocal association was not shown. This suggests that loneliness preceded frailty and not the other way around. Early and frequent assessments of loneliness may present opportunities for interventions that minimize the risk of frailty among sexual minority men living with and without HIV.

BackgroundThe HIV Prevention Trials Network (HPTN) 083 trial showed that long-acting injectable cabotegravir was more effective than tenofovir disoproxil fumarate plus emtricitabine in preventing HIV in cisgender men and transgender women who have sex with men. We aimed to characterise the cohort of transgender women included in HPTN 083.MethodsHPTN 083 is an ongoing, phase 2b/3, randomised, multicentre, double-blind, double-dummy clinical trial done at 43 sites in seven countries (Argentina, Brazil, Peru, the USA, South Africa, Thailand, and Viet Nam). HIV-negative participants were randomly assigned (1:1) to receive injectable cabotegravir or tenofovir disoproxil fumarate plus emtricitabine. The study design and primary outcomes of the blinded phase of HPTN 083 have already been reported. An enrolment minimum of 10% transgender women was set for the trial. Here we characterise the cohort of transgender women enrolled from Dec 6, 2016, to May 14, 2020, when the study was unblinded. We report sociodemographic characteristics, use of gender affirming hormone therapy, and behavioural assessments of the transgender women participants. Laboratory testing and safety evaluations are also reported. The trial is registered at ClinicalTrials.gov, NCT02720094.FindingsHPTN 083 enrolled 570 transgender women (304 tenofovir disoproxil fumarate plus emtricitabine; 266 injectable cabotegravir). Transgender women were primarily from Asia (225 [39%]) and Latin America (205 [36%]); 330 (58%) reported using gender affirming hormone therapy. Intimate partner violence was common (270 [47%] reported emotional abuse and 172 [30%] reported physical abuse) and 323 (57%) reported a history of childhood sexual abuse. 159 (28%) transgender women disagreed that they were at risk for HIV, and 142 (25%) screened positive for depressive symptoms. During study follow-up, incidence of syphilis was 16·25% (95% CI 13·28-19·69), rectal gonorrhoea was 11·66% (9·14-14·66), and chlamydia was 20·61% (17·20-24·49). Frequency of adverse events was similar between the treatment groups. Nine seroconversions occurred among transgender women during the blinded phase of the study (seven in the tenofovir disoproxil fumarate plus emtricitabine group and two in the injectable cabotegravir group); overall incidence was 1·19 per 100 person-years (95% CI 0·54-2·25): 1·80 per 100 person-years (0·73-3·72) in the tenofovir disoproxil fumarate plus emtricitabine group and 0·54 per 100 person-years (0·07-1·95) in the injectable cabotegravir group (hazard ratio 0·34 [95% CI 0·08-1·56]). Cabotegravir concentrations did not differ by gender affirming hormone therapy use.InterpretationHIV prevention strategies for transgender women cannot be addressed separately from social and structural vulnerabilities. Transgender women were well represented in HPTN 083 and should continue to be prioritised in HIV prevention studies. Our results suggest that injectable cabotegravir is a safe and effective pre-exposure prophylaxis option for transgender women.FundingNational Institute of Allergy and Infectious Diseases and ViiV Healthcare.