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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
121
Multilevel intervention with 4 components
Instituto Dermatológico y Cirugía de Piel (IDCP)
Santo Domingo, Dominican Republic
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
Time frame: 6 months
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
Time frame: 1 year
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
Time frame: 6 months
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
Time frame: 1 year
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
Time frame: 6 months
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
Time frame: 1 year
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
Time frame: 6 months
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
Time frame: 1 year
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
Time frame: 6 months
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
Time frame: 1 year
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
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Time frame: 6 months
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
Time frame: 1 year
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
Time frame: 6 months
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
Time frame: 1 year
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
Time frame: 6 months
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
Time frame: 1 year
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.
Time frame: 6 months
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.
Time frame: 1 year