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

Primary Purpose

Human Immunodeficiency Virus, Acquired Immunodeficiency Syndrome, Opiate Addiction

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Methadone
Holistic Health Recovery Program
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Human Immunodeficiency Virus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    No Intervention

    Arm Label

    Methadone Maintenance

    Holistic Health Recovery Program

    Methadone Maintenance and Holistic Health Recovery Prorgram

    Standard of Care

    Arm Description

    Methadone induction and management provided

    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.

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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    Reincarceration
    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.

    Full Information

    First Posted
    February 23, 2015
    Last Updated
    January 12, 2018
    Sponsor
    Yale University
    Collaborators
    University of Malaya, National Institute on Drug Abuse (NIDA)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02396979
    Brief Title
    Intervention of HIV, Drug Use and the Criminal Justice System in Malaysia
    Acronym
    Harapan
    Official Title
    Intervention of HIV, Drug Use and the Criminal Justice System in Malaysia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2010 (undefined)
    Primary Completion Date
    December 2014 (Actual)
    Study Completion Date
    December 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Yale University
    Collaborators
    University of Malaya, National Institute on Drug Abuse (NIDA)

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Human Immunodeficiency Virus, Acquired Immunodeficiency Syndrome, Opiate Addiction, Drug Dependence

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Factorial Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    300 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Methadone Maintenance
    Arm Type
    Experimental
    Arm Description
    Methadone induction and management provided
    Arm Title
    Holistic Health Recovery Program
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Methadone Maintenance and Holistic Health Recovery Prorgram
    Arm Type
    Experimental
    Arm Description
    Methadone induction and management provided in combination with the Holistic Health Recovery Program (HHRP-M).
    Arm Title
    Standard of Care
    Arm Type
    No Intervention
    Arm Description
    Standard of care provided for substance abuse treatment. No methadone maintenance or holistic health recovery program intervention provided.
    Intervention Type
    Drug
    Intervention Name(s)
    Methadone
    Intervention Type
    Behavioral
    Intervention Name(s)
    Holistic Health Recovery Program
    Primary Outcome Measure Information:
    Title
    HIV Risk Events
    Description
    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 Outcome Measure Information:
    Title
    HIV Quality of Life
    Description
    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
    Title
    Relapse to Drug Use
    Description
    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
    Title
    Addiction Severity
    Description
    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
    Title
    Reincarceration
    Description
    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.
    Time Frame
    Any reincarceration to prison during the 12 month post-release follow-up period

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Frederick L Altice, M.D.
    Organizational Affiliation
    Yale University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Adeeba Kamarulzaman, M.D.
    Organizational Affiliation
    University of Malaya
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    36368939
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    31303149
    Citation
    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.
    Results Reference
    derived

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

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