Stigma-Treatment Enhanced Incentivized Directly Observed Therapy for People With HIV Who Inject Drugs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Feasibility of iDOT intervention
研究概览
简要总结
This study will implement a pilot randomized controlled trial (RCT, N=50) to refine and assess the feasibility and acceptability of an emotion regulation and communication skills intervention designed to improve engagement in HIV-care among HIV+ people who report opioid and/or stimulant use and are sub-optimally engaged in HIV care.
详细描述
Eligible study participants will be screened and enrolled at Fenway Health (Boston, MA). All participants will receive substance use treatment referral information if interested. Participants will be randomized to one of two treatment arms. Participants in both arms will receive a mobile application-facilitated incentivized directly observed therapy (iDOT) intervention. Participants in the control arm will receive iDOT alone. Participants in the intervention arm will receive iDOT in combination with the iSTRIVE intervention. After randomization, participants in the iSTRIVE intervention group will be offered 6 therapy sessions focused on behavioral strategies for improving HIV self-care, meta-cognitive awareness of emotions and thoughts, cognitive restructuring, and assertive communication skills. Participants in the iSTRIVE intervention arm will also receive messages containing customized compassionate self-statements to enhance HIV-related self-care. All participants will be compensated for every research visit and adherence to the iDOT protocol.
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
- All
- 接受健康志愿者
- 否
入选标准
- •HIV positive
- •HIV virally unsuppressed (>20 copies/mL) in past year or no past-year HIV viral load result
- •Opioid and/or stimulant use behavior endorsed in past 6 months
- •Able to provide informed consent
- •18 years or older
- •English speaking
排除标准
- •HIV negative
- •Denying drug use in past 6 months
结局指标
主要结局
Feasibility of iDOT intervention
时间窗: change from baseline to 12 weeks after intervention completion
Percent of DOT video check ins completed by participants (≥50% considered indicative of feasibility).
Feasibility of iSTRIVE intervention
时间窗: change from baseline to 12 weeks after intervention completion
Percent of sessions completed (≥70% considered indicative of feasibility).
Acceptability of intervention
时间窗: 12 weeks after intervention completion
A qualitative analysis of exit interviews conducted with iSTRIVE study intervention participants.
次要结局
- HIV Viral Load(change from baseline to 12 weeks after intervention completion)
- Substance Use(change from baseline to 12 weeks after intervention completion)
- Injection Drug Use Behaviors(change from baseline to 12 weeks after intervention completion)
研究者
Abigail Batchelder, Ph.D., M.P.H.
Associate Professor
Massachusetts General Hospital