CompletedNot Applicable

Addiction, HIV and Tuberculosis in Malaysian Criminal Justice Settings

Malaysia316 participantsStarted 2017-08-21

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

TB Treatment Completion Rates in Prison

Timeframe: 3 to 6 months

Trial details

NCT IDNCT03089983

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-04-04

Results submitted2025-04-02

View on ClinicalTrials.gov More Opioid Dependence trials