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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02396979
Recruitment Status : Completed
First Posted : March 24, 2015
Last Update Posted : January 17, 2018
Sponsor:
Collaborators:
University of Malaya
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Yale University

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.

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Opiate Addiction Drug Dependence Drug: Methadone Behavioral: Holistic Health Recovery Program Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intervention of HIV, Drug Use and the Criminal Justice System in Malaysia
Study Start Date : January 2010
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02396979


Sponsors and Collaborators
Yale University
University of Malaya
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Frederick L Altice, M.D. Yale University
Principal Investigator: Adeeba Kamarulzaman, M.D. University of Malaya

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02396979    
Other Study ID Numbers: 0908005646
R01DA025943 ( U.S. NIH Grant/Contract )
First Posted: March 24, 2015    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Substance-Related Disorders
Opioid-Related Disorders
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Chemically-Induced Disorders
Mental Disorders
Methadone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents