Integration of Buprenorphine Into HIV Clinical Settings - Primary Care Model (PCM)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Substance use outcomes measured by self-report
研究概览
简要总结
The purpose of this study is to assess the feasibility, cost and effectiveness of interventions designed to integrate buprenorphine treatment for opioid dependence into HIV primary care in ten HIV care centers in the U.S.
In the site led by Dr. Altice, we compare two models of providing HIV care and buprenorphine treatment. Assignments are based on participants' city of residence. In the onsite (integrated care) model, participants receive buprenorphine, substance abuse counseling and HIV care at one location: the Waterbury Hospital Infectious Disease Clinic. In the off-site model (non-integrated care) buprenorphine induction, substance abuse counseling, and HIV care will be provided at separate locations: the Community Health Care Van (CHCV), the Yale AIDS Program, and patients' own HIV providers, respectively. Data is collected from interviews with participants, reviews of medical records, and surveys and interviews with clinicians.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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-infected
- •Clinical diagnosis of opioid dependence
- •Fluent in English or Spanish
- •18 years or older
排除标准
- •Liver function tests (transaminase only) at five times or higher than normal level;
- •Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) criteria for benzodiazepine abuse or dependence within the past 6 months;
- •DSM-IV criteria for alcohol dependence within the past 6 months;
- •Actively suicidal;
- •Psychiatric impairment that impedes ability to consent (dementia, delusional, actively psychotic);
- •Methadone dose exceeding levels allowing for safe transition to buprenorphine;
- •Pregnant women and women actively trying to become pregnant;
- •Clinical judgment of local site principal investigator that patient is inappropriate
结局指标
主要结局
Substance use outcomes measured by self-report
时间窗: at 1, 3, 6, 9 and 12 months measured by self-report
Retention in and adherence to HIV care
时间窗: at 1, 3, 6, 9 and 12 months
Urine toxicology results
时间窗: at 1, 3, 6, 9 and 12 months
次要结局
- HIV-related health outcomes(at 1, 3, 6, 9, and 12 months)
- Quality of life(at 1, 3, 6, 9, and 12 months)