Intervention of HIV, Drug Use and the Criminal Justice System in Malaysia

Study Overview
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Brief Summary
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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.

Official Title
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Intervention of HIV, Drug Use and the Criminal Justice System in Malaysia

Conditions
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Human Immunodeficiency Virus, Acquired Immunodeficiency Syndrome, Opiate Addiction, Drug Dependence

Intervention / Treatment
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* Drug: Methadone
* Behavioral: Holistic Health Recovery Program


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Methadone Maintenance<br>Methadone induction and management provided | Drug: Methadone<br> <br> |
| Experimental: Holistic Health Recovery Program<br>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. | Behavioral: Holistic Health Recovery Program<br> <br> |
| Experimental: Methadone Maintenance and Holistic Health Recovery Prorgram<br>Methadone induction and management provided in combination with the Holistic Health Recovery Program (HHRP-M). | Drug: Methadone<br> <br> Behavioral: Holistic Health Recovery Program<br> <br> |
| No Intervention: Standard of Care<br>Standard of care provided for substance abuse treatment. No methadone maintenance or holistic health recovery program intervention provided. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV Risk Events | 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. | Change from Baseline in HIV Risk Events at Months 3, 6, 9 and 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV Quality of Life | This outcome will be measured by a series of questions that will be used to produce a composite score that will indicate the participant's overall quality of life as it relates to their HIV status. These questions will ask about your general health and your ability to perform daily activities in your life. All data will be self-reported by the participant. | Change from Baseline in HIV Quality of Life at Months 3, 6, 9 and 12 | 
| Relapse to Drug Use | This outcome will be measured as any opioid drug use after release from prison. This outcome will be measured in two ways. First, participants will provide a monthly urine sample that will be tested for the presence of opioids. Second, participants will answer questions about their drug use since the time of their last interview. | Change from Baseline in Relapse to Drug Use at Months 3, 6, 9 and 12 | 
| Addiction Severity | This outcome will be measured by a series of questions about the participant's drug use. These questions will be used to produce a composite score which indicates the severity of the participant's addiction. | Change from Baseline in Addiction Severity at Months 3, 6, 9 and 12 | 
| Reincarceration | This outcome will be measured by both self-report and objective data from the Malaysian Ministry of Prisons. Self-report questions will be used to ask participants if they have been arrested by police (placed in jail) or incarcerated in prison during the time since the last interview. Objective data will also be obtained from the Ministry of Prisons which will indicate if the participant has been reincarcerated in one of Malaysia's prison during the 12 months since they were initially released from prison. | Any reincarceration to prison during the 12 month post-release follow-up period |