Buprenorphine Group Medical Visits for Drug Users at Risk for HIV
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Number of Participants With Opioid Abstinence at 8 Weeks
研究概览
简要总结
The primary goal of this research is to improve the effectiveness of buprenorphine maintenance treatment (BMT) within primary care.
Investigators propose that providing BMT as part of a group medical visit (instead of an individual visit) will improve treatment outcomes for patients with persistent opioid abuse, because members become accountable to the group, are exposed to beneficial habits of others (i.e. positive deviance), and can receive efficacious behavioral interventions concomitantly with medical management
详细描述
Investigators have developed a preliminary model of BMT group medical visits, conducted focus groups with BMT patients and providers, and will use this data to develop a manualized group-based BMT intervention (G-BMT). Investigators will then conduct a randomized controlled trial (RCT) of the G-BMT intervention within primary care to preliminarily test its efficacy, acceptability, and feasibility. Participants who have persistent opioid abuse while receiving BMT in primary care will be randomized to the G-BMT intervention (40 participants in 5 groups) or to intensify BMT (treatment as usual) with their individual primary care physician (40 participants).
Hypothesis
In a 16-week RCT of G-BMT, participants who receive the G-BMT intervention (vs. treatment as usual) will have higher abstinence rates (primary outcome, efficacy), fewer HIV risk behaviors (efficacy), and greater satisfaction with treatment (acceptability) and adherence to medical visits (feasibility).
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
- •Currently receiving BMT at Montefiore community health center (CHC).
- •Received BMT for 12 or more weeks.
- •Persistent opioid abuse (positive toxicology for an unprescribed opioid at most recent test or in 50% or more of collected tests in the previous 6 months.)
- •Fluent in English of Spanish
排除标准
- •1) Pregnancy
研究组 & 干预措施
G-BMT, Buprenorphine
This arm will receive the G-BMT intervention, which will include group visits where 5-10 patients simultaneously receive care from a multidisciplinary team of a generalist physician and a behavioral specialist. The G-BMT intervention will last 90 minutes and include: BMT education, instruction on self-management skills, peer support, and individual medical management.
干预措施: Buprenorphine (Drug)
Treatment as usual, Buprenorphine
Primary care physicians who prescribe buprenorphine will be trained to follow a protocol of BMT intensification, which includes increased visit frequency, referral for mental health counseling, and referral to addiction treatment specialist.
干预措施: Treatment as usual (Behavioral)
Treatment as usual, Buprenorphine
Primary care physicians who prescribe buprenorphine will be trained to follow a protocol of BMT intensification, which includes increased visit frequency, referral for mental health counseling, and referral to addiction treatment specialist.
干预措施: Buprenorphine (Drug)
G-BMT, Buprenorphine
This arm will receive the G-BMT intervention, which will include group visits where 5-10 patients simultaneously receive care from a multidisciplinary team of a generalist physician and a behavioral specialist. The G-BMT intervention will last 90 minutes and include: BMT education, instruction on self-management skills, peer support, and individual medical management.
干预措施: G-BMT (Behavioral)
结局指标
主要结局
Number of Participants With Opioid Abstinence at 8 Weeks
时间窗: 8 weeks
Opioid abstinence will be based on self-reported opioid use in the prior 30 days at the 8 week visit and the results of urine toxicology test at the 8 week visit. Abstinence (yes) will require no self-reported opioid use and negative urine toxicology test for opiates, methadone, and oxycodone.
次要结局
- Number of Participants Who Were Retained in Buprenorphine Treatment at 3 Months and 6 Months(3 months, 6 months)
- Number of Participants Who Reported Sharing Injection Equipment at 8 Weeks(8 weeks)
- Acceptability (Scale)(16 weeks)
- Feasibility (Percentage of Visits Attended)(8 weeks)
研究者
Aaron D. Fox
Assistant Professor of Medicine
Montefiore Medical Center