NCT Number: NCT02396979
Intervention of HIV, Drug Use and the Criminal Justice System in Malaysia
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.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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)
Treatment and study plan
Holistic Health Recovery Program
BehavioralPrimary outcomes
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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 outcomes
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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.
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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.
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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.
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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.
Sponsors and collaborators
Lead sponsor
Yale University
Other
Collaborators
- National Institute on Drug Abuse (NIDA)
- University of Malaya
Registry information
Acronym: Harapan
Important dates
- Study start
- 2010
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Mar 24, 2015
- Registry last updated
- Feb 26, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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