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

NCT02396979 | Completed Phase 4

• 2 other identifiers: 0908005646R01DA025943
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• HIV Quality of Life

  Change from Baseline in HIV Quality of Life at Months 3, 6, 9 and 12

• Relapse to Drug Use

  Change from Baseline in Relapse to Drug Use at Months 3, 6, 9 and 12

• Addiction Severity

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

• Reincarceration

  Any reincarceration to prison during the 12 month post-release follow-up period

Study Arms (4)

Methadone Maintenance

EXPERIMENTAL

Methadone induction and management provided

Drug: Methadone

Holistic Health Recovery Program

EXPERIMENTAL

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

Methadone Maintenance and Holistic Health Recovery Prorgram

EXPERIMENTAL

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

Drug: Methadone; Behavioral: Holistic Health Recovery Program

Standard of Care

NO INTERVENTION

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

Interventions

Methadone DRUG

Methadone Maintenance; Methadone Maintenance and Holistic Health Recovery Prorgram

Holistic Health Recovery Program BEHAVIORAL

Holistic Health Recovery Program; Methadone Maintenance and Holistic Health Recovery Prorgram

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy or planning to become pregnant (female only)

Sponsors & Collaborators

• Yale University: lead
• University of Malaya: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Related Publications (2)

• 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.

  PMID: 36368939 DERIVED

• 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.

  PMID: 31303149 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Opioid-Related Disorders; Substance-Related Disorders

Interventions

Methadone

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals

Study Officials

• Frederick L Altice, M.D.

  Yale University

  PRINCIPAL INVESTIGATOR

• Adeeba Kamarulzaman, M.D.

  University of Malaya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2015
• First Posted: March 24, 2015
• Study Start: January 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 26, 2024

Record last verified: 2024-02