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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06316102
• Other study ID #: 22-3282
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 14, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: February 2024
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 121
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV

Intervention

Behavioral:
• Gender Affirming Abriendo Puertas (Opening Doors) (GAP)
Multilevel intervention with 4 components

Locations

Country	Name	City	State
Dominican Republic	Instituto Dermatológico y Cirugía de Piel (IDCP)	Santo Domingo

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	George Washington University, Instituto Dermatológico y Cirugía de Piel (IDCP)

Country where clinical trial is conducted

Dominican Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Depression, 6 months	Patient Health Questionnaire-9: 0-9=No depressive symptoms; 10-27=depressive symptoms.; Response options: No day, Several days, More than half the days, Almost every day; Items about previous 2 weeks: You have little interest or pleasure in doing things. You have felt down, depressed, or hopeless. You have had difficulty staying or falling asleep or you have slept too much You have felt tired or with little energy You have had little appetite or have eaten excessively You have felt badly about yourself - or you think you are a failure or that you have done wrong to yourself or your family You have had difficulty concentrating on certain activities, like watching tv or movies You have moved or talked so slowly that other people noticed it You have been so restless or agitated that you have been moving more than normal and others have noticed it You have thought that you would be better off dead or you have thought about harming yourself in some way	6 months
Secondary	Depression, 1 year	Patient Health Questionnaire-9: 0-9=No depressive symptoms; 10-27=depressive symptoms.; Response options: No day, Several days, More than half the days, Almost every day; Items about previous 2 weeks: You have little interest or pleasure in doing things. You have felt down, depressed, or hopeless. You have had difficulty staying or falling asleep or you have slept too much You have felt tired or with little energy You have had little appetite or have eaten excessively You have felt badly about yourself - or you think you are a failure or that you have done wrong to yourself or your family You have had difficulty concentrating on certain activities, like watching tv or movies You have moved or talked so slowly that other people noticed it You have been so restless or agitated that you have been moving more than normal and others have noticed it You have thought that you would be better off dead or you have thought about harming yourself in some way	1 year
Secondary	Anxiety, 6 months	positive screening for anxiety symptoms in the previous 2 weeks. Measured using the Hospital Anxiety and Depression Scale - Anxiety which consists of 7 items.; Score 0-7 = No anxiety symptoms Score 8-21 = anxiety symptoms; Items: I feel tense or nervous; All the times, many times, sometimes, never I have a strange feeling, as if there were butterflies in my stomach; Never, on occasion, frequently, very often I have a sense of fear, as if something horrible were going to happen to me; Definitely and it is very strong, yes but no too strongly, a little but it doesn't worry me, never I feel restless, as if I couldn't stop moving; A lot, a good deal, not much, never My mind is full of worries; most of the time, frequently, sometimes but not often, only on occasion Sudden feelings of panic come over me; very frequently, often, not often, rarely I can sit comfortably and feel relaxed; always, generally, not often, never	6 months
Secondary	Anxiety, 1 year	positive screening for anxiety symptoms in the previous 2 weeks. Measured using the Hospital Anxiety and Depression Scale - Anxiety which consists of 7 items.; Score 0-7 = No anxiety symptoms Score 8-21 = anxiety symptoms; Items: I feel tense or nervous; All the times, many times, sometimes, never I have a strange feeling, as if there were butterflies in my stomach; Never, on occasion, frequently, very often I have a sense of fear, as if something horrible were going to happen to me; Definitely and it is very strong, yes but no too strongly, a little but it doesn't worry me, never I feel restless, as if I couldn't stop moving; A lot, a good deal, not much, never My mind is full of worries; most of the time, frequently, sometimes but not often, only on occasion Sudden feelings of panic come over me; very frequently, often, not often, rarely I can sit comfortably and feel relaxed; always, generally, not often, never	1 year
Secondary	Substance use, 6 months	Yes = used any type of drug in the previous 6 months No = did not use any type of drug in the previous 6 months	6 months
Secondary	Substance use, 1 year	Yes = used any type of drug in the previous 6 months No = did not use any type of drug in the previous 6 months	1 year
Secondary	Binge drinking, 6 months	No = consumes 6+ drinks on one occasion less than once a month Yes = consume 6+ drinks on one occasion at least monthly	6 months
Secondary	Binge drinking, 1 year	No = consumes 6+ drinks on one occasion less than once a month Yes = consume 6+ drinks on one occasion at least monthly	1 year
Secondary	Self-esteem, 6 months	Rosenberg self-esteem scale; analyzed as a continuous variable. A higher score indicates higher self-esteem; Response options: Totally agree = 4 Agree = 3 Disagree = 2 Totally disagree = 1; Items: In general, I am satisfied with myself Sometimes, I think I am not good at anything I feel like I have some good qualities I am capable of doing things as well as the majority of people I feel like I don't have many things to feel proud about Sometimes I feel really useless I feel like I am worth less than most people I wish to respect myself more Definitively, I think I am a failure I have a positive attitude toward myself; *Items 2, 5, 6, 8, 9 are reverse scored.	6 months
Secondary	Self-esteem, 1 year	Rosenberg self-esteem scale; analyzed as a continuous variable. A higher score indicates higher self-esteem; Response options: Totally agree = 4 Agree = 3 Disagree = 2 Totally disagree = 1; Items: In general, I am satisfied with myself Sometimes, I think I am not good at anything I feel like I have some good qualities I am capable of doing things as well as the majority of people I feel like I don't have many things to feel proud about Sometimes I feel really useless I feel like I am worth less than most people I wish to respect myself more Definitively, I think I am a failure I have a positive attitude toward myself; *Items 2, 5, 6, 8, 9 are reverse scored.	1 year