Tele-Harm Reduction for Rapid Initiation of Antiretrovirals in People Who Inject Drugs: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Viral suppression
研究概览
简要总结
The purpose of this study is to test 2 different methods for offering medications that treat HIV, cure Hepatitis C Virus (HCV) (if applicable) and treat substance use disorder (if desired) to people who inject drugs.
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
- •age 18 or older
- •able to speak English
- •enrolled in IDEA Miami or IDEA Tampa SSPs
- •injection drug use in past 12 months by self-report
- •willing and able to sign informed consent, provide locator information and medical records release
- •testing reactive for HIV by rapid test
- •HIV RNA>200 copies/ml as determined by on-site labs or abstracted medical records (result within 3 months of randomization date)
排除标准
- •testing HIV negative via rapid test
- •receipt of THR intervention in the past 6 months
- •inability to provide informed consent
- •planning to leave the area within 12 months
- •Principal or site investigator discretion
- •currently in prison or jail
- •Enrollment in Clinical Trials Network 121
研究组 & 干预措施
off-site linkage to HIV care
introduces the participant to an SSP HIV/HCV linkage specialist and discusses linkage to a traditional Ryan White clinic
干预措施: off-site linkage (Other)
Tele-Harm Reduction (THR)
THR utilizes 2 components. Component 1: telehealth technology facilitated by a peer harm reduction counselor to connect the participant with medical case managers and enroll patients in Ryan White/AIDS Drug Assistance Program (ADAP). Component 2: utilizes the syringe services program (SSP)-based peer harm reduction counselor to work with participants in identifying individual-specific barriers and facilitators to medication adherence.
干预措施: Tele-Harm Reduction (Behavioral)
结局指标
主要结局
Viral suppression
时间窗: up to 12 months
HIV viral load \<200 copies/ml time-averaged
次要结局
- HCV cure(up to 12 months)
- Initiation of medications for opioid use disorder(up to 12 months)
研究者
Hansel Tookes
Associate Professor
University of Miami