Piloting a Multilevel Intervention to Promote Viral Suppression Among Transgender Women Living With HIV in Santo Domingo
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 2
- 主要终点
- Viral Suppression (HIV), 1 year
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Gender Affirming Abriendo Puertas (Opening Doors) (GAP) (Behavioral)
Control
This group will not receive an intervention; control participants may be exposed to providers who participated in a training on gender-affirming care.
结局指标
主要结局
Viral Suppression (HIV), 1 year
时间窗: 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
Antiretroviral therapy adherence, 6 months
时间窗: 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
Retention in HIV care, 6 months
时间窗: 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
Antiretroviral therapy interruption, 6 months
时间窗: 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
Viral Suppression (HIV), 6 months
时间窗: 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
Antiretroviral therapy adherence, 1 year
时间窗: 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
Retention in HIV care, 1 year
时间窗: 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
Antiretroviral therapy interruption, 1 year
时间窗: 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
4-day Antiretroviral Therapy Adherence, 6 Months
时间窗: 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).
4-day Antiretroviral Therapy Adherence, 1 Year
时间窗: 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).
6-month Antiretroviral Therapy Interruption, 6 Months
时间窗: 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-month Antiretroviral Therapy Interruption, 1 Year
时间窗: 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).
次要结局
- Depression, 6 months(6 months)
- Depression, 1 year(1 year)
- Anxiety, 6 months(6 months)
- Substance use, 6 months(6 months)
- Binge drinking, 6 months(6 months)
- Anxiety, 1 year(1 year)
- Substance use, 1 year(1 year)
- Binge drinking, 1 year(1 year)
- Self-esteem, 6 months(6 months)
- Self-esteem, 1 year(1 year)