A Randomized Trial of an Abstinence-reinforcing Contingency Management Intervention to Suppress HIV Viral Load
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 242
- 试验地点
- 6
- 主要终点
- HIV viral load
研究概览
简要总结
This study will test whether contingency management (monetary vouchers contingent on abstinence from drugs) that reinforces one behavior (achieving abstinence from drugs) leads to improved outcomes in other related behaviors (achieving HIV viral load suppression). In a randomized controlled trial, the investigators propose to test whether an abstinence-reinforcing contingency management intervention improves viral load suppression in HIV-infected drug users.
详细描述
Using a randomized controlled study design, the investigators will test the efficacy of an abstinence-reinforcing contingency management intervention compared with a control condition (Performance Feedback) on HIV viral load suppression. The investigators will enroll 202 opioid-dependent HIV-infected individuals who are receiving opioid agonist treatment with buprenorphine or methadone, who continue to use opiates, oxycodone or cocaine (drugs that are consistently associated with poor HIV treatment outcomes), and who are prescribed antiretroviral medication, but with suboptimal viral load suppression. The contingency management group will have the potential to receive compensation in vouchers over the 16-week intervention based on drug-free urine. Participants will be followed for 28 weeks, with research visits occurring twice weekly during the Baseline Period (weeks 1-4) and Intervention Period (weeks 5-20), then every two weeks during the Post-Intervention Period (weeks 21-28). Data sources will include blood tests (viral load and CD4 count), urine toxicology tests, questionnaires, pill counts, and medical records. The primary outcome will be change in HIV viral load, and secondary outcomes will include CD4 count, antiretroviral adherence, and abstinence.
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
- •at least 18 years old
- •English or Spanish fluency
- •HIV-infected
- •Currently taking highly active antiretroviral therapy
- •a) opioid use disorder and receiving opioid agonist treatment with methadone or buprenorphine, or b) cocaine use disorder
- •urine toxicology positive for cocaine, oxycodone, or opioids during the run-in period
- •detectable viral load while prescribed highly active antiretroviral therapy in the prior 6 months
- •self-reported adherence to HAART <100%
排除标准
- •inability to give informed consent
- •inability to follow the research protocol (e.g., visits twice weekly)
- •frequent hospitalizations (>2) in the prior 6 months
- •currently with a chronic pain condition in which the participant has been prescribed opioid analgesics for longer than the past month
结局指标
主要结局
HIV viral load
时间窗: Viral load will be measured every 4 weeks over the 28-week follow-up period.
Every 4 weeks participants will undergo phlebotomy to measure HIV viral load. Viral load will be analyzed as a continuous measure (log10 copies/ml). In secondary analyses, viral load will be analyzed dichotomously, as undetectable (\<45 copies/ml) or not.
次要结局
- CD4 count(CD4 count will be measured at weeks 0, 4, 20, and 28.)
- Abstinence from opiates, oxycodone, and cocaine(Abstinence will be measured twice weekly during weeks 0-20, then every two weeks during weeks 21-28.)
- Antiretroviral adherence(Antiretroviral adherence will be measured every 4 weeks during the 28-week follow-up period)
研究者
Chinazo Cunningham
Associate Professor of Medicine
Albert Einstein College of Medicine