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

Yale University300 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Opiate Addiction Drug Dependence

Interventions

MethadoneDRUG

Holistic Health Recovery ProgramBEHAVIORAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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.

Time frame: Change from Baseline in HIV Risk Events at Months 3, 6, 9 and 12

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Change from Baseline in Addiction Severity at Months 3, 6, 9 and 12

Reincarceration

Data from ClinicalTrials.gov

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