CID 1007 - Randomized Controlled Trial of an Augmented Test, Treat, Link & Retain Model for NC and TX Prisoners (imPACT Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 381
- 试验地点
- 2
- 主要终点
- HIV RNA level (Viral Load)
研究概览
简要总结
Purpose: The purpose of this study is to determine if a comprehensive intervention supporting seek-test-and-treat results in a significant reduction in the potential for HIV-infected prisoners to transmit their virus after release from prison.
Aim 2: Compare the effect of standard prison test-and-treat (sTNT) with the TNT-imPACT (imPACT) intervention on viral load 24 weeks following prison release.
Aim 3: Describe and model secondary outcomes, comparing them between sTNT and TNT-imPACT study arms. These outcomes include post-release HIV transmission risk behaviors, incident STIs, adherence to ART, medical care appointments, emergence of ART resistance mutations, and predicted HIV transmission events.
详细描述
For Aims 2 and 3:
Participants:
We will enroll 400 HIV-infected men and women, age 18 years and older who are incarcerated in the NC Department of Correction (NCDOC) or the Texas Department of Criminal Justice (TDCJ) and scheduled for prison release in approximately 12 weeks, who are receiving ART and have an HIV RNA level that is below 400 copies/mL.
Procedures (methods): Participants will be consented, enrolled, and then randomized 1:1 to one of two conditions:
- standard test-and-treat (sTNT), which is the current standard of care, wherein following HIV testing, the DOC provides to HIV-infected inmates ART during incarceration and referral to community-based care and services by prison staff as well as a supply of antiretroviral medication (30 days in NC, 10 in TX) upon release, or
- TNT-imPACT (imPACT),which includes the sTNT plus our integrated, multi-component intervention targeting multiple levels to enhance adherence to HIV therapy and linkage to and engagement in clinical care, to maintain viral suppression after release.
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
- •Documented HIV infection
- •Incarcerated in the NCDOC at a facility within a 3 hour drive from Chapel Hill OR incarcerated in the TDCJ at a facility within a 3 hour drive from Ft. Worth
- •Age 18 years or older
- •Receiving ART for at least 30 days
- •Last recorded viral load (must be within 90 days of entry) <400 copies/mL
- •English speaking
- •Able and willing to provide informed consent
- •Willing to participate in post-release study activities
- •For NC - planning to remain in state after release and returning to a community within a 3 hour drive of Chapel Hill
- •For TX - returning to one of the following areas: Houston, Dallas, and Ft. Worth (including their suburbs)
- •Scheduled for release from prison
排除标准
- •Conviction for offenses that includes sexual assault or death or serious injury to a victim or is otherwise found, in the opinion of the investigators, to be at high risk for injury to staff (this criterion is designed to minimize risk to study personnel who will conduct study-related visits with participants in the communities to which they return and may be informed by input from correctional staff)
- •Pending charges that would likely lead to transfer of custody or other condition which would otherwise prevent or significantly delay release from custody.
研究组 & 干预措施
Text reminders, counseling, link coordinator
Text reminders, counseling, link coordination
干预措施: Text reminders, counseling, and link coordination (Behavioral)
Standard of care - control arm
干预措施: Standard of care - control arm (Behavioral)
结局指标
主要结局
HIV RNA level (Viral Load)
时间窗: Week 24 post-release from prison
次要结局
未报告次要终点
研究者
David A Wohl, MD
Clinical Associate Professor
University of North Carolina, Chapel Hill