Sexual Health Care for Transgender and Gender Diverse People.

The proportion of people who identify as transgender and gender diverse (TGD) is increasing. Health care for TGD people, including sexual health care, must affirm and respect patients' gender identities and expressions. Here, the authors outline strategies to make health care settings more welcoming to and inclusive of TGD people and describe concrete steps to improve sexual health care for TGD populations.

A PrEP Demonstration Project Using eHealth and Community Outreach to Justice-Involved Cisgender Women and Their Risk Networks.

Women involved in criminal justice systems (WICJ) are a key population at risk for HIV, and pre-exposure prophylaxis (PrEP) is critical for HIV prevention. This project was designed to evaluate the feasibility and acceptability of delivering PrEP via eHealth to WICJ and members of their risk network (RN). We recruited HIV-negative cisgender WICJ index participants (n = 38) and risk network (RN) members (n = 67) using modified respondent-driven sampling. TDF/FTC was initiated for PrEP in participants meeting clinical criteria and dispensed through eHealth using a community-based, low barrier-to-care outreach model. Key steps in the PrEP care continuum were measured over 12 months. Enrolled participants (n = 105) had high current and lifetime justice-involvement and were predominantly cisgender women and non-Hispanic white with a mean age of 40.9y (SD 9.6). Despite most having primary care providers and medical insurance, PrEP awareness was low, and participants experienced high levels of medical, psychiatric, substance use, social, and economic need. Fifty-two participants (50%) were PrEP-eligible, of whom 24 (46%) initiated PrEP. TDF/FTC was safe and well-tolerated throughout follow-up and 13 individuals chose to remain on PrEP following study conclusion. In this novel PrEP demonstration project for WICJ and RN members, despite high medical, psychiatric, and social comorbidity, PrEP was positively received and effectively delivered using a community outreach model via eHealth.Registered on clinicaltrials.gov under trial registration number NCT03293290.

Proactive strategies to optimize engagement of Black, Hispanic/Latinx, transgender, and nonbinary individuals in a trial of a novel agent for HIV pre-exposure prophylaxis (PrEP).

INTRODUCTION: Black and Hispanic/Latinx cisgender men who have sex with men (MSM), transgender women, transgender men, and gender nonbinary (TGNB) individuals have been historically underrepresented in HIV pre-exposure prophylaxis (PrEP) clinical trials. There is an urgent need for ongoing engagement with communities that have been the most impacted by HIV and diverse representation in clinical trials. Here we describe strategic approaches undertaken in the PURPOSE 2 trial to optimize engagement of underrepresented individuals. METHODS AND RESULTS: PURPOSE 2 is an ongoing Phase 3 trial evaluating the safety and efficacy of lenacapavir as PrEP in cisgender MSM and TGNB individuals. In PURPOSE 2, we used a multipronged approach aimed at enriching participation of underrepresented individuals. We conducted a review to identify evidence-informed recommendations from literature, engaged with stakeholders, and established the Global Community Advisory and Accountability Group (GCAG) to represent the needs of the community. Insights from stakeholders and GCAG members resulted in an expansion of the study population to include transgender men, gender nonbinary persons, and adolescents, and evaluation of population-specific outcomes. Feedback from stakeholders and GCAG members also informed investigator and site selection; these were selected based on prior experience working with persons from diverse racial, ethnic and gender identities, and estimates of local HIV incidence. Site selection was also expanded to include community-based clinics with services tailored towards Black, Hispanic/Latinx, and TGNB populations. We established a study-wide recruitment goal of 50% Black MSM and 20% Hispanic/Latinx MSM in US sites and 20% transgender women globally. Site-specific recruitment goals were also developed based on local demographics and HIV incidence. Mandatory trainings included Good Participatory Practice guidelines, gender inclusivity, and antiracism. CONCLUSION: While further work is needed to achieve equitable representation, the strategies we describe may serve as a framework for future clinical trials. TRIAL REGISTRATION: Clinical Trial Number: NCT04925752.