Adaptation and Evaluation of an Intersectional Stigma Reduction Intervention to Increase HIV Care Engagement Among Women Who Use Drugs
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- HIV care engagement as assessed by the Number of participants who re-engage in HIV care
研究概览
简要总结
The goal of this study is to test whether a program reduce stigma will help women living HIV remain in HIV care.
详细描述
This study will evaluate the feasibility, acceptability, and preliminary efficacy of a behavioral intervention designed to reduce intersectional HIV- and drug use-related stigma and improve HIV care engagement among women living with HIV who use drugs in Ukraine. A total of 100 eligible women will be randomized to either the intervention or a control condition. Participants in both groups will receive standard HIV care and a one-time consultation with a social worker, complete baseline, 3-month, and 6-month assessments, and have HIV care outcomes assessed. Participants assigned to the intervention will additionally attend five small-group sessions focused on stigma coping, cognitive-behavioral skills, communication, social support, and HIV care engagement, with an optional individual session involving a support person. The study will examine effects on HIV care engagement, antiretroviral therapy adherence, and stigma-related psychosocial outcomes to inform a future fully powered randomized controlled trial.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Female; Age 18 years or older;
- •Registered in the national Medical Information System (MIS) as having received an HIV-positive diagnosis;
- •Registered in the MIS with injection drug use (IDU) as the probable mode of HIV transmission or with a documented history of injection drug use at any clinical visit.
排除标准
- •Does not meet the inclusion criteria;
- •Unable to provide informed consent;
- •Unable to provide informed consent due to intoxication, the effects of drug use, or severe psychiatric impairment at the time of consent.
研究组 & 干预措施
Standard of Care (Control)
Standard of Care (Control Arm): Participants randomized to the control arm will continue to receive standard HIV and substance use care available through the participant's usual healthcare providers. In addition, participants will receive a one-time consultation with a social worker (in person or remotely) and complete study assessments at baseline, 3 months, and 6 months. No stigma-reduction intervention sessions will be provided.
干预措施: standard of care (Behavioral)
Intervention Arm
Experimental Intervention Arm: Participants randomized to the intervention arm will continue to receive standard HIV and substance use care, a one-time consultation with a social worker, and complete study assessments at baseline, 3 months, and 6 months. In addition, they will participate in five in-person, small-group sessions delivered over approximately 2-3 weeks that focus on reducing HIV- and drug use-related stigma through cognitive-behavioral coping skills, communication and social support strategies, and HIV care engagement. Participants may also complete an optional individual session with a psychologist facilitator and a support person.
干预措施: Light Inside (Behavioral)
结局指标
主要结局
HIV care engagement as assessed by the Number of participants who re-engage in HIV care
时间窗: 6 months
Number of participants who re-engage in HIV care, defined as attending at least one HIV clinical care visit within 6 months after study enrollment, as documented in the Medical Information System (MIS).
Antiretroviral therapy (ART) adherence as assessed by the percentage of days covered by dispensed antiretroviral medication
时间窗: 6 months
ART adherence, measured as the percentage of days covered by dispensed antiretroviral medication during the 6 months after study enrollment, based on Medical Information System pharmacy records.
次要结局
未报告次要终点