Intervention of HIV, Drug Use and the Criminal Justice System in Malaysia
Overview
- Phase
- Phase 4
- Intervention
- Methadone
- Conditions
- Human Immunodeficiency Virus
- Sponsor
- Yale University
- Enrollment
- 300
- Primary Endpoint
- HIV Risk Events
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Pregnancy or planning to become pregnant (female only)
Arms & Interventions
Methadone Maintenance
Methadone induction and management provided
Intervention: Methadone
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.
Intervention: Holistic Health Recovery Program
Methadone Maintenance and Holistic Health Recovery Prorgram
Methadone induction and management provided in combination with the Holistic Health Recovery Program (HHRP-M).
Intervention: Methadone
Methadone Maintenance and Holistic Health Recovery Prorgram
Methadone induction and management provided in combination with the Holistic Health Recovery Program (HHRP-M).
Intervention: Holistic Health Recovery Program
Outcomes
Primary Outcomes
HIV Risk Events
Time Frame: 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.
Secondary Outcomes
- 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)