Trauma-informed, Resilience-based Telehealth Intervention for Improving HIV Prevention and HCV Care for Persons Who Inject Drugs in the Deep South
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Feasibility of the Intervention
研究概览
简要总结
Evaluate the feasibility, acceptability, and usability of the intervention (primary outcomes) and coping skills and resilience (secondary outcomes) of the telehealth intervention over two months (8 weekly sessions) in a waitlist-controlled, randomized pilot trial using a cross-over design among 40 PWID. The primary outcomes will be feasibility, acceptability, and usability of the intervention. Secondary outcomes will be increased coping skills and resilience, which in turn, will increase status neutral HIV and HCV care and MOUD uptake (longer-term outcomes). Outcomes will be assessed using pre- and post-intervention surveys.
详细描述
The telehealth intervention will include components from the LIFT intervention: identifying and expressing emotion related to stressors; identifying different stressors and coping difficulties; and developing adaptive strategies to reduce stress. The intervention will also include developing health goals and a health plan on PrEP, DAA, and MOUD, as well as components from RISE-UP: baseline assessment of individual assets (e.g., self-esteem, emotion regulation, positive future orientation), coping with addictive behavior (stress reduction, avoiding unsafe sexual and injection practices, self-care), building relationships (with peers, family, provider), and social support (finding and seeking social support). It will consist of 8 sessions (4 addressing stress and 4 addressing stigma). Each session will last an hour and be conducted weekly for eight consecutive weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 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
- 是
入选标准
- •People who actively inject drugs verified by visible injection stigmata (needle tracks)
- •HIV negative
- •Adult (≥18 years)
- •lives in rural areas
排除标准
- •Living with HIV
- •Lives in urban areas
- •Not proficient in English
结局指标
主要结局
Feasibility of the Intervention
时间窗: Months 31-60
Feasibility of the telehealth intervention will be assessed during baseline, at 2-months, and 4-months among both PWID and interventionists. Feasibility will be assessed by the completion rates of the interventionist training sessions and the participation/drop-out rates of the PWID.
Acceptability of the telehealth intervention
时间窗: Months 31-60
Acceptability of the telehealth intervention will be assessed during baseline, at 2-months, and 4-months among both PWID and interventionists. Acceptability will be examined by Likert scale like responses, e.g., "convenient," "a nuisance," "easy to use," and "time-consuming."
Usability of the telehealth intervention
时间窗: Months 31-60
Usability of the telehealth intervention will be assessed during baseline, at 2-months, and 4-months among both PWID and interventionists. Usability will be assessed with the USE questionnaire, which captures the perceived usefulness, satisfaction, and ease of use.
次要结局
- Sexual behavior(Months 31-60)
- Risky Injection Bheavior(Months 31-60)
- Depressive symptoms(Months 31-60)
- Resilience(Months 31-60)
- Intersecting stigma of HIV, HCV, and drug use(Months 31-60)
研究者
Mohammad Rifat Haider
Assistant Professor
University of Georgia