Buprenorphine to Improve HIV Care Engagement and Outcomes: A Randomized Trial (BRAVO)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 281
- 试验地点
- 6
- 主要终点
- Number of Participants With HIV Viral Suppression
研究概览
简要总结
The purpose of this study is to compare two models of substance abuse treatment in Vietnam, and how they each affect HIV care. In Vietnam, the current model for treating people with HIV who are also dependent on opioids is to refer them to methadone maintenance treatment centers. The new model the protocol will study is treatment of HIV and opioid dependence with buprenorphine/naloxone and counseling in the HIV clinic.
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
- •Current moderate or severe Diagnostic and Statistical Manual (DSM-V) opioid use disorder
- •Urine drug screen positive for opioids
- •Interested in receiving treatment for opioid dependence
- •Age at least 18 years old
- •Willing to practice an effective method of birth control, if female
排除标准
- •Known hypersensitivity to buprenorphine or naloxone
- •aspartate aminotransferase (AST) & alanine aminotransferase (ALT) > 5x upper limit
- •Currently pregnant or breastfeeding
- •Serious medical or psychiatric illness in past 30 days (e.g. opportunistic infection, psychosis) that precludes safe participation in the opinion of study physician
- •Methadone maintenance treatment within 30 days of consent
研究组 & 干预措施
Buprenorphine/naloxone
Office based treatment of opioid dependence with buprenorphine/naloxone
干预措施: Buprenorphine/naloxone (Drug)
Methadone Maintenance Therapy
Referral to methadone maintenance therapy for treatment of opioid dependence.
干预措施: Methadone Maintenance Therapy (Drug)
结局指标
主要结局
Number of Participants With HIV Viral Suppression
时间窗: 12 months
HIV-1 RNA \< 200 copies/mL
Participants With Heroin Use (Urine Drug Screen)
时间窗: 12 months
Participants With Heroin Use (Self-report)
时间窗: 12 months
次要结局
- Number of Participants in Receipt of Antiretroviral Therapy (ART)(12 months)
- Number of Participants in Retention in HIV Care(12 months)
研究者
P. Todd Korthuis, MD
Professor of Medicine
Oregon Health and Science University