Addressing Internalized Stigma and Shame as Barriers to Engagement in HIV Care Among Men Who Have Sex With Men (MSM) With Substance Use Disorders (Project Matter)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Feasibility of Intervention
研究概览
简要总结
This study will implement a pilot randomized controlled trial (RCT, N=60) to assess the feasibility and acceptability a refined emotion regulation intervention designed to improve engagement in HIV-care among substance using HIV+ MSM sub-optimally engaged in HIV care.
详细描述
Eligible study participants will be screened and enrolled at Fenway Health (Boston, MA). Participants will be randomized to an enhanced treatment as usual (E-TAU) arm or the intervention arm. All participants (in both the E-TAU and intervention groups) will receive a one-session behavioral engagement in care intervention, substance use treatment referral information, and the opportunity to discuss and problem solve barriers to substance use treatment with an interventionist, informed by motivational interviewing principles. After randomization, participants in the intervention group will attend 5 therapy sessions focused on behavioral strategies for improving HIV self-care, meta-cognitive awareness of emotions and thoughts, and cognitive restructuring. All participants will receive texts queries about antiretroviral therapy (ART) adherence and substance use, and participants in the intervention group will also receive text queries about mood. All participants will be compensated for every research visit and completed text message blocks.
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
- •HIV positive
- •Cisgender male
- •Man who has sex with men (MSM)
- •Elevated levels of internalized stigma related to HIV, substance use, or homophobia
- •Poorly engaged in HIV care
- •Able to provide informed consent
- •18 years or older
- •English speaking
排除标准
- •Non-cisgender men
- •Do not identify as gay, bisexual, or MSM
结局指标
主要结局
Feasibility of Intervention
时间窗: change from baseline to 12 weeks after intervention completion
Percent of sessions completed (≥70% considered indicative of feasibility) and percent of text messages responded to by participants (≥70% considered indicative of feasibility).
Acceptability of Intervention
时间窗: change from baseline to 12 weeks after intervention completion
The summary score of the Client Satisfaction Questionnaire (CSQ-8) (Sum of 8 questions with response options ranging from 1-4).
次要结局
- Engagement in HIV Care(change from baseline to 12 weeks after intervention completion)
研究者
Abigail Batchelder, Ph.D., M.P.H.
Assistant Professor and Staff Psychologist
Massachusetts General Hospital