CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 139 enrolled / 139 target
Drug / intervention
Gender Affirming Abriendo Puertas (Opening Doors) (GAP)behavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06316102
NCT06316102N/ACompletedHigh Momentum (3.9/mo)Completion was 11mo ago

Piloting a Multilevel Intervention to Promote Viral Suppression Among Transgender Women Living With HIV in Santo Domingo

University of North Carolina, Chapel Hill·interventional·Posted Mar 18, 2024·Updated Jun 30, 2026

In Brief

A clinical study evaluating Gender Affirming Abriendo Puertas (Opening Doors) (GAP) for HIV. Completed, enrolled 139 participants across 1 site.

Signals

Enrolling ahead of pace

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV
CountriesDominican Republic

Timeline

N/ACompletedFinished
202420252026
First PostedMar 18, 2024
Enrollment StartJul 14, 2023
Primary CompletionJul 30, 2025
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 2.3 years ago

Arms & Interventions

Controlno_intervention

This group will not receive an intervention; control participants may be exposed to providers who participated in a training on gender-affirming care.

Gender Affirming Abriendo Puertas (Opening Doors) (GAP)experimental

This group will be exposed to all four components of the multilevel intervention. 1\) individual counseling and education; 2) peer navigation; 3) provider capacity building; and 4) community support building.

Behavioral: Gender Affirming Abriendo Puertas (Opening Doors) (GAP)

Interventions

Gender Affirming Abriendo Puertas (Opening Doors) (GAP)behavioral

Multilevel intervention with 4 components