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

February 23, 2024 updated by: Yale University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
Time Frame: Change from Baseline in HIV Quality of Life at Months 3, 6, 9 and 12
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
Time Frame: Change from Baseline in Relapse to Drug Use at Months 3, 6, 9 and 12
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
Time Frame: Change from Baseline in Addiction Severity at Months 3, 6, 9 and 12
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
Time Frame: Any reincarceration to prison during the 12 month post-release follow-up period
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institute on Drug Abuse (NIDA)
University of Malaya

Investigators

  • Principal Investigator: Frederick L Altice, M.D., Yale University
  • Principal Investigator: Adeeba Kamarulzaman, M.D., University of Malaya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

February 23, 2015

First Submitted That Met QC Criteria

March 17, 2015

First Posted (Estimated)

March 24, 2015

Study Record Updates

Last Update Posted (Estimated)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0908005646
  • R01DA025943 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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