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

NCT06316102 | Completed

• 2 other identifiers: 22-3282R34MH129218
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

HIV

Keywords

transgender women; transfeminine people; HIV; Stigma; Cohesion; Multilevel intervention

Outcome Measures

Primary Outcomes (8)

• Viral Suppression (HIV), 6 months

  For viral load assessments of HIV, a 10 mL tube of ethylenediaminetetraacetic acid anti-coagulated blood will be drawn. \<400 copies/mL= viral suppression \>=400 copies/mL=no viral suppression

  6 months

• Viral Suppression (HIV), 1 year

  For viral load assessments of HIV, a 10 mL tube of ethylenediaminetetraacetic acid anti-coagulated blood will be drawn. \<400 copies/mL= viral suppression \>=400 copies/mL=no viral suppression

  1 year

• Retention in HIV care, 6 months

  Participants who have received HIV care will answer the question: In the past 6 months, how many HIV appointments have you missed? 0 = Retention in HIV care \>0 = No retention in HIV care

  6 months

• Retention in HIV care, 1 year

  Participants who have received HIV care will answer the question: In the past 6 months, how many HIV appointments have you missed? 0 = Retention in HIV care \>0 = No retention in HIV care

  1 year

• Antiretroviral therapy adherence, 6 months

  Participants on antiretroviral therapy will be asked: During the last 4 days, how many days did you not take your entire antiretroviral therapy dose? 0 = No antiretroviral therapy interruption \>0 = Antiretroviral therapy interruption

  6 months

• Antiretroviral therapy adherence, 1 year

  Participants on antiretroviral therapy will be asked: During the last 4 days, how many days did you not take your entire antiretroviral therapy dose? 0 = No antiretroviral therapy interruption \>0 = Antiretroviral therapy interruption

  1 year

• Antiretroviral therapy interruption, 6 months

  Participants on antiretroviral therapy will be asked: In the past 6 months, have you stopped or suspended your antiretrovirals? No = No antiretroviral therapy interruption Yes = Antiretroviral therapy interruption

  6 months

• Antiretroviral therapy interruption, 1 year

  Participants on antiretroviral therapy will be asked: In the past 6 months, have you stopped or suspended your antiretrovirals? No = No antiretroviral therapy interruption Yes = Antiretroviral therapy interruption

  1 year

Secondary Outcomes (10)

• Depression, 6 months

  6 months

• Depression, 1 year

  1 year

• Anxiety, 6 months

  6 months

• Anxiety, 1 year

  1 year

• Substance use, 6 months

  6 months

Study Arms (2)

Control

NO INTERVENTION

This group will not receive an intervention; however, provider training in gender affirmation will be conducted at the clinic level, so control participants may be exposed to changes in provider attitudes and practices.

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

Gender Affirming Abriendo Puertas (Opening Doors) (GAP)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participants must have a transfeminine identity.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Instituto Dermatológico y Cirugía de Piel (IDCP): collaborator
• George Washington University: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Instituto Dermatológico y Cirugía de Piel (IDCP)

Santo Domingo, Dominican Republic

Location

MeSH Terms

Conditions

Social Stigma

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Clare Barrington, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 18, 2024
• Study Start: July 14, 2023
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: November 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DO (1)