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.