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

June 3, 2026 updated by: University of North Carolina, Chapel Hill

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
139

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Dominican Republic
      • Santo Domingo, Dominican Republic
        • Instituto Dermatológico y Cirugía de Piel (IDCP)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Behavioral: Gender Affirming Abriendo Puertas (Opening Doors) (GAP)
Multilevel intervention with 4 components
No Intervention: Control
This group will not receive an intervention; control participants may be exposed to providers who participated in a training on gender-affirming care.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Viral Suppression (HIV), 6 Months
Time Frame: 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 and >=400 copies/mL= no viral suppression.
6 months
Number of Participants With Viral Suppression (HIV), 1 Year
Time Frame: 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 and >=400 copies/mL= no viral suppression.
1 year
Retention in HIV Care, 6 Months
Time Frame: 6 months
Participants who have received HIV care will answer the question: "In the past 6 months, how many HIV appointments have you missed?" Response options are 0 = Retention in HIV care (i.e., Retained) and >0 = No retention in HIV care (i.e., Not Retained).
6 months
Retention in HIV Care, 1 Year
Time Frame: 1 year
Participants who have received HIV care will answer the question: "In the past 6 months, how many HIV appointments have you missed?" Response options are 0 = Retention in HIV care (i.e., Retained) and >0 = No retention in HIV care (i.e., Not Retained).
1 year
4-day Antiretroviral Therapy Adherence, 6 Months
Time Frame: 6 months
Participants currently on antiretroviral therapy will be asked: "During the last 4 days, how many days did you not take your entire antiretroviral therapy dose?" Response options are 0 = No antiretroviral therapy interruption (i.e., Adherent) and >0 = Antiretroviral therapy interruption (i.e., Non-Adherent).
6 months
4-day Antiretroviral Therapy Adherence, 1 Year
Time Frame: 1 year
Participants currently on antiretroviral therapy will be asked: "During the last 4 days, how many days did you not take your entire antiretroviral therapy dose?" Response options are 0 = No antiretroviral therapy interruption (i.e., Adherent) and >0 = Antiretroviral therapy interruption (i.e., Non-Adherent).
1 year
6-month Antiretroviral Therapy Interruption, 6 Months
Time Frame: 6 months
Participants who reported ever having taken antiretroviral therapy will be asked: "In the past 6 months, have you stopped or suspended your antiretrovirals?" Response options are No = No antiretroviral therapy interruption (Adherent) and Yes = Antiretroviral therapy interruption (Non-Adherent).
6 months
6-month Antiretroviral Therapy Interruption, 1 Year
Time Frame: 1 year
Participants on antiretroviral therapy will be asked: "In the past 6 months, have you stopped or suspended your antiretrovirals?" Response options are No = No antiretroviral therapy interruption (Adherent) and Yes = Antiretroviral therapy interruption (Non-Adherent).
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Depression, 6 Months
Time Frame: 6 months
The Patient Health Questionnaire (PHQ-9) is a 9-item screener to assess the frequency of depressed mood/anhedonia over the past two weeks. Participants respond to how often they have been bothered by symptoms, from 0 (not at all) to 3 (nearly every day). Scores range from 0-27, with higher scores suggestive of greater depression. Per protocol 0-9=No depressive symptoms; 10-27=depressive symptoms.
6 months
Depression, 1 Year
Time Frame: 1 year
The Patient Health Questionnaire (PHQ-9) is a 9-item screener to assess the frequency of depressed mood/anhedonia over the past two weeks. Participants respond to how often they have been bothered by symptoms, from 0 (not at all) to 3 (nearly every day). Total scores range from 0-27, with higher scores suggestive of greater depression. Per protocol total scores between 0-9=No depressive symptoms; and between 10-27=depressive symptoms.
1 year
Anxiety, 6 Months
Time Frame: 6 months
The Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire that includes two 7-item subscales assessing anxiety (HADS-A) and depression (HADS-D), each rated on a 0-3 scale. For this study only HADS-A subscale was used. Raw scores range from 0-21 with higher scores indicating higher anxiety. Per protocol, scores from 0-7 = no anxiety symptoms, scores from 8-21 = anxiety symptoms.
6 months
Anxiety, 1 Year
Time Frame: 1 year
The Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire that includes two 7-item subscales assessing anxiety (HADS-A) and depression (HADS-D), each rated on a 0-3 scale. For this study only HADS-A subscale was used. Raw scores range from 0-21 with higher scores indicating higher anxiety. Per protocol, scores from 0-7 = no anxiety symptoms, scores from 8-21 = anxiety symptoms.
1 year
Substance Use, 6 Months
Time Frame: 6 months
Participants were asked a series of questions about illicit substance use in the previous 6 months. Options were: Yes = used any type of illicit drug in the previous 6 months and No = did not use any type of illicit drug in the previous 6 months.
6 months
Substance Use, 1 Year
Time Frame: 1 year
Participants were asked a series of questions about illicit substance use in the previous 6 months. Options were: Yes = used any type of illicit drug in the previous 6 months and No = did not use any type of illicit drug in the previous 6 months.
1 year
Binge Drinking, 6 Months
Time Frame: 6 months
Participants were asked about binge drinking. Binge drinking was defined per protocol as 6 or more drinks on one occasion. Options were: Yes = consume 6+ drinks on one occasion at least monthly and No = consumes 6+ drinks on one occasion less than once a month.
6 months
Binge Drinking, 1 Year
Time Frame: 1 year
Participants were asked about binge drinking. Binge drinking was defined per protocol as 6 or more drinks on one occasion. Options were: Yes = consume 6+ drinks on one occasion at least monthly and No = consumes 6+ drinks on one occasion less than once a month.
1 year
Self-esteem, 6 Months
Time Frame: 6 months
The Rosenberg self-esteem scale is a 10-item Likert-type scale that assesses participants' self-esteem. As used in this study, the total scale score range from 0-30, where higher scores indicate greater self-esteem. Response options were: Totally agree = 3, Agree = 2, Disagree = 1, and Totally disagree = 0.
6 months
Self-esteem, 1 Year
Time Frame: 1 year
The Rosenberg self-esteem scale is a 10-item Likert-type scale that assesses participants' self-esteem. As used in this study, the total scale score range from 0-30, where higher scores indicate greater self-esteem. Response options were: Totally agree = 3, Agree = 2, Disagree = 1, and Totally disagree = 0.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of North Carolina, Chapel Hill

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)
George Washington University
Instituto Dermatológico y Cirugía de Piel (IDCP)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Clare Barrington, PhD, University of North Carolina, Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 14, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 22-3282
  • R34MH129218 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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