Addiction, HIV and Tuberculosis in Malaysian Criminal Justice Settings (HARAPAN II)
Opioid Dependence, Addiction, HIV/AIDS
About this trial
This is an interventional health services research trial for Opioid Dependence focused on measuring prison
Eligibility 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
Sites / Locations
- Kajang PrisonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Active Comparator
Active Comparator
Experimental
Active Comparator
Experimental
No medication-assisted treatment (control group)
Methadone maintenance treatment (MMT)
Buprenorphine/Naloxone
Standard Isoniazid (INH) for 26 weeks
Short-course isoniazid + rifapentine (INH + RIF) for 12 weeks
The control group will choose to receive no opioid agonist treatment upon release from prison.
Methadone maintenance treatment (MMT) is the standard of care in Malaysia, and participants who choose this arm will receive MMT upon release from prison.
Participants who choose buprenorphine/naloxone will receive an induction phase for 10 days and then move on to receiving it in the community for 6 months. Buprenorphine/naloxone has been authorized and is available for use in Malaysia.
Participants will be randomized to receive INH, the standard of care in Malaysia, for 26 weeks while in prison.
Participants will be randomized to receive INH + RIF as TB treatment while in prison.