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Addiction, HIV and Tuberculosis in Malaysian Criminal Justice Settings

NCT03089983 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 316

Last updated 2026-02-09

Study results available
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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

Interventions

DRUG

Isoniazid

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

DRUG

Rifapentine

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

Sponsors & Collaborators

  • University of Malaya

    collaborator OTHER

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Frederick Altice, MD · Yale University

  • Adeeba Kamarulzaman, MBBS · University of Malaya

  • Sheela Shenoi, MD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-21
Primary Completion
2024-04-04
Completion
2024-04-04

Countries

  • Malaysia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03089983 on ClinicalTrials.gov