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

NCT ID: NCT06316102

Last Updated: 2025-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-14
• Study Completion Date: 2025-07-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Gender Affirming Abriendo Puertas (Opening Doors) (GAP)

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.

Group Type: EXPERIMENTAL

Gender Affirming Abriendo Puertas (Opening Doors) (GAP)

Intervention Type: BEHAVIORAL

Multilevel intervention with 4 components

Interventions

Gender Affirming Abriendo Puertas (Opening Doors) (GAP)

Multilevel intervention with 4 components

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Instituto Dermatológico y Cirugía de Piel (IDCP)

UNKNOWN

Sponsor Role: collaborator

George Washington University

OTHER

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clare Barrington, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

Instituto Dermatológico y Cirugía de Piel (IDCP)

Santo Domingo, , Dominican Republic

Countries

Dominican Republic

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R34MH129218

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22-3282

Identifier Type: -

Identifier Source: org_study_id