N/A N=312 Randomized Health Services Research

Addiction, HIV and Tuberculosis in Malaysian Criminal Justice Settings

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

Bottom Line

View on ClinicalTrials.gov: NCT03089983 ↗

Enrolled (actual)

312

Serious AEs

0.0%

Results posted

Feb 2026

Primary outcome: Primary: TB Treatment Completion Rates in Prison — 114; 127 Participants — p=0.08

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Isoniazid (Drug); Rifapentine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Yale University
Primary completion: Apr 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY TB Treatment Completion Rates in Prison	114; 127	0.08
SECONDARY TB Treatment Adherence	9; 117	—
SECONDARY Discontinuation Due to Experiencing an Adverse Event	10; 1	—
SECONDARY Acceptability of Starting the Trial	316	—

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.

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria (screening):

Age ≥ 18 years
Newly admitted inmate at Kajang Prison

Inclusion Criteria (Trial):

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03089983). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.