Comprehensive HIV and Harm Prevention Via Telehealth: CHARIOT, a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 2
- 主要终点
- HIV prevention via pre-exposure prophylaxis (PrEP)
研究概览
简要总结
The purpose of this study is to test 2 different ways to offer medications to prevent human immunodeficiency virus (HIV), cure hepatitis C virus (HCV) (if applicable) and treat substance use disorder (if desired) in 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
- Prevention
- 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 or Spanish
- •willing and able to sign informed consent, provide locator information and medical records release
- •non-reactive result on rapid HIV test
- •use of SSP to exchange syringes 2 times in the past 3 months
- •planning to stay in the area for 12 months
排除标准
- •reactive HIV test
- •currently on medications for opioid use disorder (MOUD) by urine drug screen
- •currently on PrEP by self-report
- •Principal or site investigator discretion
- •currently in prison or jail
- •current enrollment in Clinical Trials Network 121
- •receipt of tele-harm reduction in previous 3 months
- •signs or symptoms of acute HIV infection
研究组 & 干预措施
Comprehensive Tele-harm Reduction
Participants will have enhanced access to a physician and clinical psychologist via remote video technology wherever the participant is located and prefers engagement (SSP, home, shelter, encampment). Participants will be in this group for 12 months.
干预措施: Comprehensive Tele-harm Reduction (Behavioral)
Off-site Linkage to HIV prevention
Participants in this group will receive off-site linkage to HIV care by having case management/social work services through our community engagement team. Participants will be in this group for 12 months.
干预措施: Off-site Linkage to HIV Prevention (Behavioral)
结局指标
主要结局
HIV prevention via pre-exposure prophylaxis (PrEP)
时间窗: up to 12 months
Intracellular levels of tenofovir diphosphate (TFV-DP) by DBS or cabotegravir injection in previous 8 weeks or lenacapavir injection in previous 6 months by electronic health record abstraction
HIV prevention via medications for opioid use disorder
时间窗: up to 12 months
Buprenorphine/norbuprenorphine or methadone on urine drug screen; or naltrexone or buprenorphine extended-release injection in previous 4 weeks by electronic health record abstraction
次要结局
- syringe coverage(up to 12 months)
- PrEP Adherence(up to 12 months)
- Engagement in HCV treatment(Up to 12 months)
- HCV cure(up to 12 months)
- treatment of sexually transmitted infections(up to 12 months)
- time to harm(up to 12 months)
- number of harms(up to 12 months)
研究者
Hansel Tookes
Associate Professor
University of Miami