IRIS: Intervention to Reduce Internalized Stigma (IRIS) Among People Living With HIV Who Use Substances
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- HIV-Related Internalized Stigma
研究概览
简要总结
The goal of this clinical trial is to test an intervention to reduce stigma among people living with HIV who use opioids and cocaine. The main question it aims to answer is:
- Does reducing internalized stigma about HIV and/or drug use lead to improved HIV care outcomes?
After a year spent adapting an existing intervention to be applied specifically among people living with HIV who use substances, 70 participants will be randomized to receive either treatment-as-usual or the newly adapted intervention. The intervention itself will consist of five one-on-one sessions with a trained interventionist to discuss and work through the stigmas people commonly associate with HIV and/or substance use.
详细描述
Different types of stigma (e.g., anticipated, enacted, internalized) associated with illicit substance use (SU) and HIV positive status impede HIV treatment outcomes (incl. HIV healthcare retention, antiretroviral therapy [ART] adherence and viral load suppression). The premise of this study is that individuals can learn to diminish the personal effects of public stigma, thereby reducing internalized stigma and improving expected health outcomes.
To this end, this study adapted an existing evidence-based stigma reduction intervention, Ending Self-Stigma (ESS), which has shown efficacy in reducing internalized and anticipated stigma in populations experiencing mental health challenges, to be applied specifically among people living with HIV and using drugs and/or alcohol (or are currently in treatment for substance use). The new one-on-one intervention is IRIS, and it uses cognitive behavioral therapy strategies and social cognitive theory constructs to facilitate reductions in internalized stigma.
In the first phase, an iterative process beginning with formative interviews with service delivery key informants and people living with HIV/AIDS (PLWH) who use substances generated an initial version of IRIS. Intervention content was adapted based on participant feedback and intervention delivery was adapted for a virtual format.
In the second phase, a small pilot of the newly created IRIS intervention was carried out with persons living with HIV and using substances. Feedback from participants and intervention staff were used to refine the IRIS intervention.
In the third phase, a clinical trial testing the newly adapted IRIS intervention will be carried out with 70 participants (Group 1: Minimally Enhanced Treatment-as-Usual; Group 2: IRIS; 1:1 randomization) to determine feasibility and acceptability of the intervention in addition to collecting data on intervening variables (incl. internalized and anticipated stigma, depressive symptoms, anxiety, etc.).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18+ years of age
- •English speaking
- •Living with HIV
- •Self-report recent drug and/or alcohol use OR currently enrolled in substance use treatment
- •Willing and able to provide full informed consent
- •Responds affirmatively to having ever experienced one or more of the following types of stigma related to HIV status or SU: (1) enacted, (2) anticipated, and/or internalized.
排除标准
- •Does not meet all inclusion criteria.
研究组 & 干预措施
Minimally Enhanced TAU
Participants assigned to the minimally enhanced treatment-as-usual condition will receive an educational pamphlet about internalized stigma to read at their leisure and will be encouraged to continue in all their customary HIV- and substance use-related services.
IRIS
Using the materials developed during study phase one, five approximately 60-90 minute sessions will be carried out with the 35 participants randomized to receive IRIS. Each by session will be administered by a trained interventionist and will be carried out over a virtual platform (e.g., Zoom, Teams). The sessions are based on cognitive behavioral therapy and social cognitive theory, and are intended to reduce negative thoughts about the self and improve self-efficacy to engage with HIV and substance use treatment. Any session hand-outs will be mailed and/or emailed to participants prior to each session and shared onscreen. Participants in the IRIS condition may also receive study-provided journals to supplement their IRIS experience.
干预措施: Ending Self Stigma for Persons living with HIV and Use Substances (Behavioral)
结局指标
主要结局
HIV-Related Internalized Stigma
时间窗: 30 Days
Change in Berger HIV Stigma scale scores (1 to 4, with higher scores meaning more internalized stigma)
Substance Use-Related Internalized Stigma
时间窗: 30 days
Changes in Substance Use Stigma Mechanism scores (1 to 5, with higher scores meaning more internalized stigma)
次要结局
- ART Adherence(30 days)
- Intervention Satisfaction(30 days)
- Substance Use(30 days)
- Mental Health Symptoms(7 days)