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

Human Immunodeficiency Virus Clinical Trial

— Harapan  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02396979
• Other study ID #: 0908005646
• Secondary ID: R01DA025943
• Status: Completed
• Phase: Phase 4
• Start date: January 2010
• Est. completion date: December 2014

Study information

• Verified date: February 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Drug Dependence
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes
• Opiate Addiction
• Opioid-Related Disorders
• Substance-Related Disorders

Intervention

Drug:
• Methadone

Behavioral:
• Holistic Health Recovery Program

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA), University of Malaya

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Change from Baseline in HIV Quality of Life at Months 3, 6, 9 and 12
Secondary	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.	Change from Baseline in Relapse to Drug Use at Months 3, 6, 9 and 12
Secondary	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.	Change from Baseline in Addiction Severity at Months 3, 6, 9 and 12
Secondary	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.	Any reincarceration to prison during the 12 month post-release follow-up period