Intervention of HIV, Drug Use and the Criminal Justice System in Malaysia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 300
- 主要终点
- HIV Risk Events
研究概览
简要总结
The purpose of this study is to evaluate the relative impact a medical drug (methadone) or behavioral counseling program (Holistic Health Recovery Program) or both (methadone and Holistic Health Recovery Program) has on reducing HIV-related risk behaviors and illicit drug use among opioid-dependent, HIV-infected individuals in prison when given 90 to 180 days prior to leaving prison.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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-infected
- •Clinical Diagnosis of Opioid Dependence
- •Fluent in Bahasa Malaysia or English
- •Within 90 to 180 days of release from prison
- •Planning to live in Klang Valley region after release from prison
- •Able to provide informed consent
排除标准
- •Pregnancy or planning to become pregnant (female only)
研究组 & 干预措施
Methadone Maintenance
Methadone induction and management provided
干预措施: Methadone (Drug)
Holistic Health Recovery Program
Administration of the Holistic Health Recovery Program (HHRP-M), which is an eight-session substance abuse relapse prevention and harm reduction program administered by a trained substance abuse counselor.
干预措施: Holistic Health Recovery Program (Behavioral)
Methadone Maintenance and Holistic Health Recovery Prorgram
Methadone induction and management provided in combination with the Holistic Health Recovery Program (HHRP-M).
干预措施: Methadone (Drug)
Methadone Maintenance and Holistic Health Recovery Prorgram
Methadone induction and management provided in combination with the Holistic Health Recovery Program (HHRP-M).
干预措施: Holistic Health Recovery Program (Behavioral)
结局指标
主要结局
HIV Risk Events
时间窗: Change from Baseline in HIV Risk Events at Months 3, 6, 9 and 12
The primary outcome is the number of HIV high risk events. This outcome will be constructed from a composite measure counting the number of unprotected vaginal and anal insertive events and needle-or-syringe-sharing events with an HIV- or HIV-status-unknown partner that might result in HIV transmission to an uninfected partner. As such, the primary outcome will be the number of high-risk events during the period of observation in the intervention. All data will be self-reported by the participant.
次要结局
- Addiction Severity(Change from Baseline in Addiction Severity at Months 3, 6, 9 and 12)
- Reincarceration(Any reincarceration to prison during the 12 month post-release follow-up period)
- HIV Quality of Life(Change from Baseline in HIV Quality of Life at Months 3, 6, 9 and 12)
- Relapse to Drug Use(Change from Baseline in Relapse to Drug Use at Months 3, 6, 9 and 12)