Promoting Viral Suppression Among Transgender Women Living With HIV in Santo Domingo - Trial NCT06316102

Timeline & Enrollment

Primary Outcome

Viral Suppression (HIV), 6 months,Viral Suppression (HIV), 1 year,Retention in HIV care, 6 months,Retention in HIV care, 1 year,Antiretroviral therapy adherence, 6 months,Antiretroviral therapy adherence, 1 year,Antiretroviral therapy interruption, 6 months,Antiretroviral therapy interruption, 1 year

Summary

This study includes an adapted multilevel intervention, Abriendo Puertas (Opening Doors),
 including individual counseling, peer navigation, and community mobilization for
 transfeminine people living with HIV in the Dominican Republic using an iterative
 consultation process. Prior to this randomized controlled trial, feasibility and initial
 effects on HIV care and treatment behaviors were assessed with 30 trans women living with HIV
 (no control group) and documented positive trends in antiretroviral therapy use (70% to 85%,
 p=0.03), missed care appointments (35% to 20%, p=0.39) and antiretroviral therapy adherence
 (86% to 96%, p=0.50). Participants emphasized that trusting intervention staff and being
 treated with respect in individual sessions allowed them to improve self-esteem. Limited
 trust and cohesion among trans women, however, inhibited more extensive engagement with peer
 navigation and community activities. In response, the study team identified two key
 modifications to strengthen and further tailor the intervention for transfeminine people
 living with HIV: 1) integrate more gender affirming content, including with providers and 2)
 focus on building trust among transfeminine people through sequential implementation of
 individual and then community components. The purpose of the proposed study is to conduct a
 pilot randomized trial of the Gender-affirming Abriendo Puertas intervention. In Aim 1, the
 preliminary efficacy of the Gender-affirming Abriendo Puertas intervention on viral
 suppression among transfeminine people randomized to the intervention compared to those
 randomized to control will be assessed. The research study will randomly assign transfeminine
 people living with HIV to the Gender-affirming Abriendo Puertas intervention (n=60)
 (individual counseling, peer navigation, provider training, and community support building)
 or control group (n=60). There will be baseline, 6, and 12-month surveys and viral load
 assessments to assess differences across study arms. In Aim 2, the study team will examine
 pathways of influence (e.g. decreased stigma, increased cohesion) and experiences with the
 intervention to identify specific areas for improvement and scale up. Longitudinal
 qualitative interviews will be conducted at baseline, 6, and 12 months with 20 intervention
 participants. Together with surveys, the study team will assess how Gender-affirming Abriendo
 Puertas participation affects pathways between stigma, cohesion, and HIV outcomes. The study
 team will also elicit experiences and recommendations from providers and intervention staff
 in focus groups at 6 (n=2) and 12 months (n=2).

ICD-10 Classifications