Clinical trial NCT06316102: Promoting Viral Suppression Among Transgender Women Living With HIV in Santo Domingo
Official title: Piloting a Multilevel Intervention to Promote Viral Suppression Among Transgender Women Living With HIV in Santo Domingo
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HIV
Keywords: transgender women
transfeminine people
HIV
Stigma
Cohesion
Multilevel intervention
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Instituto Dermatológico y Cirugía de Piel (IDCP)
name: George Washington University
First posted: 2024-03-18
Enrollment: 121
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Viral Suppression (HIV), 6 months
timeFrame: 6 months
measure: Viral Suppression (HIV), 1 year
timeFrame: 1 year
measure: Retention in HIV care, 6 months
timeFrame: 6 months
measure: Retention in HIV care, 1 year
timeFrame: 1 year
measure: Antiretroviral therapy adherence, 6 months
timeFrame: 6 months
measure: Antiretroviral therapy adherence, 1 year
timeFrame: 1 year
measure: Antiretroviral therapy interruption, 6 months
timeFrame: 6 months
measure: Antiretroviral therapy interruption, 1 year
timeFrame: 1 year
Secondary outcomes:
measure: Depression, 6 months
timeFrame: 6 months
measure: Depression, 1 year
timeFrame: 1 year
measure: Anxiety, 6 months
timeFrame: 6 months
measure: Anxiety, 1 year
timeFrame: 1 year
measure: Substance use, 6 months
timeFrame: 6 months
measure: Substance use, 1 year
timeFrame: 1 year
measure: Binge drinking, 6 months
timeFrame: 6 months
measure: Binge drinking, 1 year
timeFrame: 1 year
measure: Self-esteem, 6 months
timeFrame: 6 months
measure: Self-esteem, 1 year
timeFrame: 1 year
Other outcomes:
Locations:
city: Santo Domingo
country: Dominican Republic
facility: Instituto Dermatológico y Cirugía de Piel (IDCP)
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Clare Barrington, PhD
role: PRINCIPAL_INVESTIGATOR
References: