Addiction, HIV and Tuberculosis in Malaysian Criminal Justice Settings

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to conduct empiric studies of tuberculosis (TB) among prison inmates with a history of opioid dependence. This includes: a) comprehensive TB diagnostic study (symptom screening, chest x-ray, tuberculin skin test, acid-fast bacilli smear, Gene Xpert, and sputum culture) to determine best practices for screening HIV+ and HIV- prisoners; b) 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); and c) a 3-arm preference trial comparing post-release TB treatment completion in patients on opioid agonist treatment (methadone vs naltrexone implant) vs no opioid agonist treatment in patients being treated for active or latent TB who are transitioning to the community. 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, and upon community transition post-release from prison.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborators: National Institute on Drug Abuse (NIDA); University of Malaya
• Treatments: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Isoniazid; Methadone; Naloxone; Naltrexone; Rifapentine

Criteria

Inclusion Criteria:

Inclusion Criteria (part A):

• Age ≥ 18 years

• Newly admitted inmate at Kajang Prison

Inclusion Criteria (part B):

• 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

Inclusion Criteria (part C):

• Age ≥ 18 years

• Confirmed active (chest X-ray or laboratory) or LTBI (TST ≥ 5mm if HIV+; TST ≥ 10 mm if HIV-)

• Meets DSM-V criteria for opioid dependence

• < 3 months before release, but more > 3 months of TB treatment remaining.

• Living with in the Klang Valley after release (within 25 km of community research site)

• AST/ALT <5x upper limit normal

• Malaysian citizen (non-Malaysians not eligible for receiving standard of care)

Exclusion Criteria:

• Unable to provide informed consent

• On a protease inhibitor

• Women who are pregnant or are planning on becoming pregnant