Addiction, HIV and Tuberculosis in Malaysian Criminal Justice Settings

NCT03089983 | Completed Results DMC

• 2 other identifiers: 20000200531R01DA041271
• Study Type: interventional
• Target: 316
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to conduct empiric studies of tuberculosis (TB) among people in prison with and without a history of opioid dependence. A RCT of latent TB infection prevention strategies among HIV+ and HIV- prisoners with high prevalence of hepatitis C (HCV) using standard 40-week daily isoniazid (40H) vs short-course weekly isoniazid + rifapentine (12HR). Investigators will also use this data, and publicly available data to complete agent-based modeling for comparative and cost-effectiveness of various TB screening and treatment strategies among prisoners.

Conditions

Opioid Dependence; Addiction; HIV/AIDS; Tuberculosis; Hepatitis

Keywords

prison

Outcome Measures

Primary Outcomes (1)

• TB Treatment Completion Rates in Prison

  TB treatment completion in prison will be verified using medical records. All TB treatment in prison will be administered under directly observed therapy (DOTs), and treatment administration will be recorded in the participant's prison medical record. Data presented here is the number of participants that completed TB treatment of those that initiated treatment.

  3 to 6 months

Secondary Outcomes (3)

• TB Treatment Adherence

  monthly for up to 6 months

• Discontinuation Due to Experiencing an Adverse Event

  up to 6 months

• Acceptability of Starting the Trial

  Day 1

Study Arms (2)

Standard Isoniazid (INH) for 26 weeks

ACTIVE COMPARATOR

Participants will be randomized to receive INH, the standard of care in Malaysia, for 26 weeks while in prison as TB preventative treatment

Drug: Isoniazid

Short-course isoniazid + rifapentine (INH + RIF) for 12 weeks

EXPERIMENTAL

Participants will be randomized to receive INH + RIF as TB preventative treatment for 12 weeks while in prison.

Drug: Isoniazid; Drug: Rifapentine

Interventions

Isoniazid DRUG

Participants will be randomized to receive standard INH as TB preventative treatment

Short-course isoniazid + rifapentine (INH + RIF) for 12 weeks; Standard Isoniazid (INH) for 26 weeks

Rifapentine DRUG

Participants will be randomized to receive short course INH + RIF as TB preventative treatment

Short-course isoniazid + rifapentine (INH + RIF) for 12 weeks

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Newly admitted inmate at Kajang Prison
• Age ≥ 18 years HIV-1 seropositivity
• Confirmed LTBI (TST ≥ 5mm if HIV+; TST ≥ 10 mm if HIV-)
• Meets DSM-V criteria for opioid dependence
• \>9 months before release (to ensure treatment completion in prison)
• AST/ALT \< 3x upper limit normal

You may not qualify if:

• Unable to provide informed consent
• On a protease inhibitor
• Women who are pregnant or are planning on becoming pregnant

Sponsors & Collaborators

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

Study Sites (1)

Kajang Prison

Kajang, Selangor, Malaysia

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Behavior, Addictive; Acquired Immunodeficiency Syndrome; Tuberculosis; Hepatitis

Interventions

Isoniazid; rifapentine

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior; 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; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Hydrazines; Organic Chemicals; Isonicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Sheela Shenoi
• Organization: Yale School of Medicine

Sheela.shenoi@yale.edu

203-737-6133

Study Officials

• Frederick Altice, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• Adeeba Kamarulzaman, MBBS

  University of Malaya

  PRINCIPAL INVESTIGATOR

• Sheela Shenoi, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2017
• First Posted: March 24, 2017
• Study Start: August 21, 2017
• Primary Completion: April 4, 2024
• Study Completion: April 4, 2024
• Last Updated: February 9, 2026
• Results First Posted: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)