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

NCT ID: NCT02396979

Last Updated: 2024-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2014-12-31

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.

Detailed Description

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Conditions

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Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Opiate Addiction Drug Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Methadone Maintenance

Methadone induction and management provided

Group Type EXPERIMENTAL

Methadone

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

Holistic Health Recovery Program

Intervention Type BEHAVIORAL

Methadone Maintenance and Holistic Health Recovery Prorgram

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

Group Type EXPERIMENTAL

Methadone

Intervention Type DRUG

Holistic Health Recovery Program

Intervention Type BEHAVIORAL

Standard of Care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Methadone

Intervention Type DRUG

Holistic Health Recovery Program

Intervention Type BEHAVIORAL

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Malaya

OTHER

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frederick L Altice, M.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Adeeba Kamarulzaman, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Malaya

References

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Bazazi AR, Culbert GJ, Wegman MP, Heimer R, Kamarulzaman A, Altice FL. Impact of prerelease methadone on mortality among people with HIV and opioid use disorder after prison release: results from a randomized and participant choice open-label trial in Malaysia. BMC Infect Dis. 2022 Nov 11;22(1):837. doi: 10.1186/s12879-022-07804-6.

Reference Type DERIVED
PMID: 36368939 (View on PubMed)

Chandra DK, Bazazi AR, Nahaboo Solim MA, Kamarulzaman A, Altice FL, Culbert GJ. Retention in clinical trials after prison release: results from a clinical trial with incarcerated men with HIV and opioid dependence in Malaysia. HIV Res Clin Pract. 2019 Feb;20(1):12-23. doi: 10.1080/15284336.2019.1603433. Epub 2019 May 1.

Reference Type DERIVED
PMID: 31303149 (View on PubMed)

Other Identifiers

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R01DA025943

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0908005646

Identifier Type: -

Identifier Source: org_study_id

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