HIV and Hepatitis Care Coordination in Methadone Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 489
- 试验地点
- 3
- 主要终点
- Vaccination adherence visits
研究概览
简要总结
This randomized clinical trial will examine the effectiveness of a strategy of HIV and Hepatitis Care Coordination (HCC) consisting of testing, education, counseling and vaccination for methadone maintenance patients compared with standard Testing, Education, and Counseling (TEC).
详细描述
In the HCC model, HIV and hepatitis screening, and HAV and HBV vaccination will be done on site and participants receive on site theory-based HIV and hepatitis education, counseling, and case management to promote adherence to HIV and HCV evaluation; in TEC hepatitis screening is done on site, but vaccination and medical care will be provided by off site referral. Primary aims are to assess the impact of the HCC intervention on adherence to hepatitis A virus (HAV) and hepatitis B virus (HBV) vaccination and attendance at an initial appointment with an HIV and/or HCV care provider. Secondary aims include examining intervention effects on HIV and hepatitis knowledge, risky behaviors, alcohol use; follow-up with later stages of HIV and hepatitis C care; to identify psychological mediators of intervention outcomes; and to estimate the incremental cost of the HCC intervention to facilitate fuller economic evaluations of the intervention if proven effective.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •>=18 years of age
- •be able to provide informed consent
- •agree to participate in hepatitis/HIV intervention
- •expect to be available to participate in the study for the entire duration of the study
- •HCV negative, of unknown HCV status, or have not received any previous medical care for HCV
排除标准
- •have already had a formal hepatitis C evaluation
- •are obtaining medical care for hepatitis C
- •not interested in obtaining medical care for hepatitis
结局指标
主要结局
Vaccination adherence visits
时间窗: 30 days
Health Care Utilization Survey
时间窗: 12 months
Intervention Costs & Hepatitis Care Utilization: DATCAP, public and private health care system administrative databases
时间窗: 12 months
次要结局
- Hepatitis A Knowledge Test(post-intervention & 90 days)
- Hepatitis B Knowledge Test(post-intervention & 90 days)
- Hepatitis C Knowledge Test(post-intervention & 90 days)
- HIV Knowledge Test(post-intervention & 90 days)
- Risk Behavior Survey(3 months, 9 months, 12 months)
- Addiction Severity Index(3 months, 9 months, 12 months)