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N/A N=121 Randomized Treatment

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

HIV

Enrolled (actual)
121
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Number of Participants With Viral Suppression (HIV), 6 Months — 31; 33 Participants — p=0.489

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Gender Affirming Abriendo Puertas (Opening Doors) (GAP) (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
Male
Sponsor
University of North Carolina, Chapel Hill
Primary completion
Jul 2025

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Viral Suppression (HIV), 6 Months
31; 33 0.489
PRIMARY
Number of Participants With Viral Suppression (HIV), 1 Year
29; 34 0.465
PRIMARY
Retention in HIV Care, 6 Months
35; 36; 7; 6 0.763
PRIMARY
Retention in HIV Care, 1 Year
30; 30; 6; 11 0.283
PRIMARY
Antiretroviral Therapy Adherence, 6 Months
33; 35; 4; 5 0.818
PRIMARY
Antiretroviral Therapy Adherence, 1 Year
31; 33; 4; 3 0.710
PRIMARY
Antiretroviral Therapy Interruption, 6 Months
31; 33; 11; 9 0.608
PRIMARY
Antiretroviral Therapy Interruption, 1 Year
32; 34; 2; 2 0.953
SECONDARY
Depression, 6 Months
17; 8; 26; 34 0.038 sig
SECONDARY
Depression, 1 Year
6; 8; 30; 33 0.747
SECONDARY
Anxiety, 6 Months
13; 18; 30; 24 0.227
SECONDARY
Anxiety, 1 Year
20; 16; 18; 25 0.225
SECONDARY
Substance Use, 6 Months
16; 18; 23; 21 0.648
SECONDARY
Substance Use, 1 Year
16; 12; 22; 29 0.233
SECONDARY
Binge Drinking, 6 Months
16; 15; 27; 27 0.886
SECONDARY
Binge Drinking, 1 Year
16; 25; 22; 16 0.093
SECONDARY
Self-esteem, 6 Months
19.605; 19.738 0.888
SECONDARY
Self-esteem, 1 Year
19.947; 19.756 0.996

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).

Eligibility Criteria

Inclusion Criteria

  • being at least 18 years of age;
  • assigned male at birth but self-identify as transfeminine (using locally appropriate terminology);
  • confirmed HIV positive diagnosis using a single rapid test

Exclusion Criteria

  • There is a small group of individuals (approximately 20) who participated in a previous adaptation study to develop the intervention that will be tested in the proposed study. These individuals will not be eligible since they have already been exposed to an earlier version of the intervention.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06316102). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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