Introduction Trans masculine people who have sex with cisgender (“cis”) men (“trans MSM”) may be at‐risk for HIV infection when they have cis MSM partners or share needles for hormone or recreational drug injection. Limited data are available characterizing indications and uptake of pre‐exposure prophylaxis (PrEP) in trans MSM. The aim of this study was to assess PrEP indication and uptake as a means of primary HIV prevention for adult trans MSM in the U.S. Methods Between November and December 2017, a national convenience sample of trans MSM in the U.S. (n = 857) was recruited using participatory methodologies and completed an online survey of demographics, HIV risk, PrEP, behavioural and psychosocial factors. Self‐reported receptive anal sex or frontal/vaginal sex (with or without a condom) with a cis male sex partner in past six months was an eligibility criterion. A multivariable logistic regression procedure was used to model PrEP indications (yes/no) per an interpretation of U.S. Centers of Disease Control and Prevention recommendations among those without HIV (n = 843). Results The diverse sample was 4.9% Black; 22.1% Latinx ethnicity; 28.4% non‐binary gender identity; 32.6% gay‐identified; 82.7% on testosterone. Overall, 84.1% had heard of PrEP. Of these, 33.3% reported lifetime PrEP use (21.8% current and 11.5% past). Based on HIV behavioural risk profiles in the last six months, 55.2% of respondents had indications for PrEP. In a multivariable model, factors associated with PrEP indication included where met sex partners, not having sex exclusively with cismen, higher perceived HIV risk, greater number of partners and high cis male partner stigma (all p < 0.05). Discussion The majority of trans MSM in this sample had a PrEP indication. Stigma was associated with risk for HIV acquisition and represents a critical target for HIV biobehavioural prevention interventions for trans MSM, who appear to be underutilizing PrEP. Conclusions Results from this study support the full inclusion of trans MSM in HIV biobehavioural prevention efforts. Public health interventions and programmes are needed to reach trans MSM that attend to general MSM risk factors as well as to vulnerabilities specific to trans MSM, including the context of stigma from cis male sexual partners.

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Background The purpose of this formative study was to assess barriers and facilitators to participation of transgender and gender diverse (TGD) patients in clinical research to solicit specific feedback on perceived acceptability and feasibility of research methods to inform creation of a multisite longitudinal cohort of primary care patients engaged in care at two community health centers. Method Between September–November 2018, four focus groups (FGs) were convened at two community health centers in Boston, MA and New York, NY (N = 28 participants across all 4 groups; 11 in Boston and 17 in New York). FG guides asked about patient outreach, acceptability of study methods and measures, and ideas for study retention. FGs were facilitated by TGD study staff, lasted approximately 90 min in duration, were audio recorded, and then transcribed verbatim by a professional transcription service. Thematic analyses were conducted by two independent analysts applying a constant comparison method. Consistency and consensus were achieved across code creation and application aided by Dedoose software. Results Participants were a mean age of 33.9 years (SD 12.3; Range 18–66). Participants varied in gender identity with 4 (14.3%) men, 3 (10.7%) women, 8 (28.6%) transgender men, 10 (35.7%) transgender women, and 3 (10.7%) nonbinary. Eight (26.6%) were Latinx, 5 (17.9%) Black, 3 (10.7%) Asian, 3 (10.7%) another race, and 5 (17.9%) multiracial. Motivators and facilitators to participation were: research creating community, research led by TGD staff, compensation, research integrated into healthcare, research applicable to TGD and non-TGD people, and research helping TGD communities. Barriers were: being research/healthcare averse, not identifying as TGD, overlooking questioning individuals, research coming from a ‘cisgender lens”, distrust of how the research will be used, research not being accessible to TGD people, and research being exploitative. Conclusion Though similarities emerged between the perspectives of TGD people and research citing perspectives of other underserved populations, there are barriers and facilitators to research which are unique to TGD populations. It is important for TGD people to be involved as collaborators in all aspects of research that concerns them.

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Background: Transgender and gender diverse (TGD) adults in the United States experience health disparities, especially in HIV infection. Medical gender affirmation (eg, hormone therapy and gender-affirming surgeries) is known to be medically necessary and to improve some health conditions. To our knowledge, however, no studies have assessed the effects of gender-affirming medical care on HIV-related outcomes. Objective: This study aims to evaluate the effects of medical gender affirmation on HIV-related outcomes among TGD primary care patients. Secondary objectives include characterizing mental health, quality of life, and unmet medical gender affirmation needs. Methods: LEGACY is a longitudinal, multisite, clinic-based cohort of adult TGD primary care patients from two federally qualified community health centers in the United States: Fenway Health in Boston, and Callen-Lorde Community Health Center in New York. Eligible adult TGD patients contribute electronic health record data to the LEGACY research data warehouse (RDW). Patients are also offered the option to participate in patient-reported surveys for 1 year of follow-up (baseline, 6-month, and 12-month assessments) with optional HIV and sexually transmitted infection (STI) testing. Biobehavioral data from the RDW, surveys, and biospecimen collection are linked. HIV-related clinical outcomes include pre-exposure prophylaxis uptake (patients without HIV), viral suppression (patients with HIV), and anogenital STI diagnoses (all patients). Medical gender affirmation includes hormones, surgeries, and nonhormonal and nonsurgical interventions (eg, voice therapy).