A Cautionary Tale: Digital Clinical Trial Implementation of a Couples-Based HIV Prevention Study among Transgender Women and Their Partners in the United States.

This study investigates baseline differences in couples enrolled in the "It Takes Two" HIV prevention intervention for transgender women and their partners, comparing in-person participation pre-COVID-19 and digital participation during the pandemic. Among 52 couples (40% in-person, 60% digital), bivariate analyses revealed that in-person participants were more likely to be African American, have cisgender male partners, report higher unemployment, incarceration histories, greater relationship stigma, and lower relationship quality. The findings highlight the limitations of digital modalities in engaging transgender women of color and those with structural vulnerabilities. The study emphasizes that reliance on digital methods in HIV research jeopardizes the inclusion of those lacking technological access and literacy, especially communities disproportionately impacted by HIV. Researchers must incorporate hybrid or in-person options and engage communities to ensure equity and inclusion, thus overcoming barriers and ensuring comprehensive population reach in HIV prevention studies.

The ethical imperative to reduce HIV stigma through community-engaged, status-neutral interventions designed with and for transgender women of colour in the United States.

INTRODUCTION: In the era of biomedical HIV prevention and treatment technologies, such as treatment as prevention (TasP) and pre-exposure prophylaxis (PrEP), there is momentum to develop and rigorously evaluate interventions focused on PrEP among those at risk for HIV acquisition and antiretroviral therapy (ART) adherence among people living with HIV. While HIV status-specific interventions focused on PrEP or ART provide valuable information, status-segregated interventions can create, perpetuate, and even increase HIV stigma among transgender women of colour and other marginalized communities in the United States (US). DISCUSSION: Due largely to community advocacy, discourses that support status-neutral approaches have emerged in the scientific literature. Although US-based funding mechanisms have typically designated awards focused on a specific HIV status, intervention developers and implementing agencies find creative ways to design and implement status-neutral programmes despite such restrictions. We present our experience with intervention research in New York, Detroit, New Orleans, Puerto Rico and the San Francisco Bay Area, all Ending the HIV Epidemic (EHE) priority jurisdictions. Kickin it with the Gurlz' was developed to be status-neutral through two grants due to community demands for a unifying approach. The Transgender Women Engagement and Entry to (TWEET) Care Project was designed to improve HIV care engagement for transgender women living with HIV, but developers realized the importance of including participants of any HIV status. Healthy Divas was designed for transgender women living with HIV but subsequent implementing agencies prioritized adapting it to be status-neutral. These examples support the urgency of designing, implementing and evaluating status-neutral interventions. CONCLUSIONS: Community-based organizations strive for inclusivity in their programming and are rightly often reluctant to segregate services based on the HIV status of their clients. As researchers, we have an ethical imperative to work to reduce HIV stigma and respond to the needs of those most impacted by HIV, including transgender women of colour. As such, we call upon funders to develop mechanisms that support the development and testing of HIV status-neutral interventions to reduce HIV stigma and support community building, thereby increasing the possibility of fully realizing the benefits of biomedical HIV prevention and treatment technologies for all.

Randomized Controlled Trial of Healthy Divas: A Gender-Affirming, Peer-Delivered Intervention to Improve HIV Care Engagement Among Transgender Women Living With HIV.

BACKGROUND: Transgender women are disproportionately affected by HIV and are less likely to be optimally engaged in care than other groups because of psychosocial challenges. With community collaboration, we developed Healthy Divas, an individual-level intervention to increase healthcare empowerment and gender affirmation to improve engagement in HIV care. Healthy Divas comprises 6 peer-led individual sessions and one group workshop facilitated by a healthcare provider with expertise in HIV care and transgender health. SETTING/METHODS: To test the intervention's efficacy, we conducted a randomized controlled clinical trial in San Francisco and Los Angeles among transgender women living with HIV; control was no intervention. Transgender field staff conducted recruitment. Assessments occurred at baseline and 3, 6, 9, and 12 months postrandomization. The primary outcome was engagement in HIV care, defined as the sum of (1) self-reported HIV care provider visit, past 6 months, (2) knowledge of most recent CD4 count, (3) self-reported antiretroviral therapy adherence ≥90%, and (4) self-reported antiretroviral therapy adherence ≥80%. RESULTS: We enrolled 278 participants; almost half (46%) were African American/Black and one-third (33%) were Hispanic/Latina. At 6 months, participants in the intervention arm had over twice the odds of being in a higher HIV care engagement category than those in the control arm (aOR = 2.17; 95% CI: 1.06 to 4.45; P = 0.04); there were no significant study arm differences in the outcome at the other time points. CONCLUSIONS: This trial demonstrates the short-term efficacy of an urgently needed behavioral intervention to improve engagement in HIV care among transgender women living with HIV; ongoing intervention may be needed to maintain positive impact over time. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT03081559.