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

Yale University

Status and phase: Completed; Phase 4

Conditions: Drug Dependence; Human Immunodeficiency Virus; Opiate Addiction; Acquired Immunodeficiency Syndrome

Treatments: Behavioral: Holistic Health Recovery Program; Drug: Methadone

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02396979

0908005646

R01DA025943 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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300 participants in 4 patient groups

Methadone Maintenance

Experimental group

Description:

Methadone induction and management provided

Treatment:

Drug: Methadone

Holistic Health Recovery Program

Experimental group

Description:

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.

Treatment:

Behavioral: Holistic Health Recovery Program

Methadone Maintenance and Holistic Health Recovery Prorgram

Experimental group

Description:

Methadone induction and management provided in combination with the Holistic Health Recovery Program (HHRP-M).

Treatment:

Drug: Methadone

Behavioral: Holistic Health Recovery Program

Standard of Care

No Intervention group

Description:

Standard of care provided for substance abuse treatment. No methadone maintenance or holistic health recovery program intervention provided.