protocolSection identificationModule nctId: NCT06316102, orgStudyIdInfo id: 22-3282, briefTitle: Promoting Viral Suppression Among Transgender Women Living With HIV in Santo Domingo, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-07-14, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-01-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: University of North Carolina, Chapel Hill, class: OTHER, collaborators name: Instituto Dermatológico y Cirugía de Piel (IDCP), collaborators name: George Washington University, descriptionModule briefSummary: 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)., conditionsModule conditions: HIV, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 121, type: ACTUAL, armsInterventionsModule interventions name: Gender Affirming Abriendo Puertas (Opening Doors) (GAP), outcomesModule primaryOutcomes measure: Viral Suppression (HIV), 6 months, primaryOutcomes measure: Viral Suppression (HIV), 1 year, primaryOutcomes measure: Retention in HIV care, 6 months, primaryOutcomes measure: Retention in HIV care, 1 year, primaryOutcomes measure: Antiretroviral therapy adherence, 6 months, primaryOutcomes measure: Antiretroviral therapy adherence, 1 year, primaryOutcomes measure: Antiretroviral therapy interruption, 6 months, primaryOutcomes measure: Antiretroviral therapy interruption, 1 year, secondaryOutcomes measure: Depression, 6 months, secondaryOutcomes measure: Depression, 1 year, secondaryOutcomes measure: Anxiety, 6 months, secondaryOutcomes measure: Anxiety, 1 year, secondaryOutcomes measure: Substance use, 6 months, secondaryOutcomes measure: Substance use, 1 year, secondaryOutcomes measure: Binge drinking, 6 months, secondaryOutcomes measure: Binge drinking, 1 year, secondaryOutcomes measure: Self-esteem, 6 months, secondaryOutcomes measure: Self-esteem, 1 year, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Instituto Dermatológico y Cirugía de Piel (IDCP), city: Santo Domingo, country: Dominican Republic, geoPoint lat: 18.50012, lon: -69.98857, documentSection largeDocumentModule largeDocs typeAbbrev: SAP, hasProtocol: False, hasSap: True, hasIcf: False, label: Statistical Analysis Plan, date: 2024-03-21, uploadDate: 2024-03-22T10:41, filename: SAP_000.pdf, size: 86302, hasResults: False