Opioid DependenceHARAPAN IINCT03089983
Addiction, HIV and Tuberculosis in Malaysian Criminal Justice Settings
A study testing Isoniazid and Rifapentine in people with Opioid Dependence and Addiction, run by Yale University at 1 site in Malaysia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Dependence, Addiction, HIV/AIDS
- What is being tested?
- Isoniazid and Rifapentine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- 1 siteMalaysia
- Study dates
- 21 Aug 2017to 4 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Newly admitted inmate at Kajang Prison
- 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
Who cannot join
- Unable to provide informed consent
- On a protease inhibitor
- Women who are pregnant or are planning on becoming pregnant
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Screening: All newly admitted prisoners (80-120 new inmates on admission days) undergo a complete assessment, including a brief exam and mandatory rapid HIV test by the prison medical unit. Each prisoner waiting to be evaluated will be invited for participation in TB screening activities (not currently part of standard care). If they verbally assent to wanting to learn more in a group session, their names and ID will be recorded and then invited for informed consent privately, followed by a brief survey, WHO symptom assessment, tuberculin skin testing (TST) with reading after 72 hours, sputum induction on 2 consecutive mornings for AFB smear, TB culture (results back 6-8 weeks using the BACTEC MGIT 960 liquid culture gold standard), and point-of care (POC) Gene Xpert. Each person will have phlebotomy for HBV and HCV Ab, LFTs, and if HIV+, CD4 testing (all of these are POC using Alere™). For those with CD4<50, they will undergo POC low-cost, urinary TB-LAM lateral flow testing (sensitivity=67%) (Alere™ Determine) to identify disseminated TB. Additional demographic, drug use, and TB risks will also be assessed along with prison data (release date, previous incarcerations, type of offense). Participants will then undergo CXR testing. A TB specialist will review all patients and results, ensuring that patients with suspected TB initiate treatment. All suspected or confirmed cases active TB cases in HIV+ prisoners will have ART initiated after 2 weeks of TB treatment initiation (if CNS TB not suspected) if CD4<50 and within 8 weeks for all others.
Trial: All HIV+ and HIV- prisoners with latent TB infection (LTBI) (TST reaction 10 mm or greater) from screening will be asked to participate in the trial. Enrolled participants will undergo block stratified randomization, stratifying on three factors: a) CD4<350; b) HCV Ab status; and c) ART status. After randomization and allocation to 12HR or 40H, participants will be provided 12HR weekly (12 weeks) and INH daily (26 weeks) as directly observed therapy. Every 4 weeks, patients will be monitored for AST/ALT and adverse side effects. Premature treatment discontinuation will occur for any DAIDS Grade 4 toxicity or patient refusal to continue.
The focus of this registration is the RCT. Outcomes measures were updated to match most recent protocol March 2025.
- Conditions
- Opioid Dependence, Addiction, HIV/AIDS, Tuberculosis, Hepatitis
- Being tested
- Isoniazid, Rifapentine
- Keywords
- prison
- Medical subject headings
- Opioid-Related Disorders, Behavior, Addictive, Acquired Immunodeficiency Syndrome, Tuberculosis, Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsoniazidDrug
Participants will be randomized to receive standard INH as TB preventative treatment
RifapentineDrug
Participants will be randomized to receive short course INH + RIF as TB preventative treatment
| Study group | Role | What they receive |
|---|---|---|
| Standard Isoniazid (INH) for 26 weeks | Active comparator | Participants will be randomized to receive INH, the standard of care in Malaysia, for 26 weeks while in prison as TB preventative treatment Receives: Drug: Isoniazid |
| Short-course isoniazid + rifapentine (INH + RIF) for 12 weeks | Experimental | Participants will be randomized to receive INH + RIF as TB preventative treatment for 12 weeks while in prison. Receives: Drug: Isoniazid; Drug: Rifapentine |
What is being measured
The primary outcome is the main question the study is designed to answer.
TB Treatment Completion Rates in Prison
TB treatment completion in prison will be verified using medical records. All TB treatment in prison will be administered under directly observed therapy (DOTs), and treatment administration will be recorded in the participant's prison medical record. Data presented here is the number of participants that completed TB treatment of those that initiated treatment.
Measured: 3 to 6 months
Secondary outcomes (3)
TB Treatment Adherence
TB treatment adherence in prison will be verified using medical records. All TB treatment in prison will be administered under directly observed therapy (DOTs), and treatment administration will be recorded in the participant's prison medical record. Data presented here is the number of participants that adhered to TB treatment of those that initiated treatment.
Measured: monthly for up to 6 months
Discontinuation Due to Experiencing an Adverse Event
The number of participants that discontinued the trial due to experiencing an Adverse Event
Measured: up to 6 months
Acceptability of Starting the Trial
Acceptability defined as the number of eligible participants that agreed to consent
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start21 Aug 2017
- Primary completion4 Apr 2024
- Study completion4 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Opioid DependenceStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 316 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Malaya, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Frederick Altice, MD, Principal investigator, Yale UniversityAdeeba Kamarulzaman, MBBS, Principal investigator, University of MalayaSheela Shenoi, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03089983
- Sponsor's protocol ID
- 2000020053
- Other IDs
- 1R01DA041271
- Acronym
- HARAPAN II
- Status last verified
- Feb 2026
- First submitted
- 16 Feb 2017
- Last updated
- 9 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addiction, HIV and Tuberculosis in Malaysian Criminal Justice Settings
- ClinicalTrials.gov ID
- NCT03089983
- Acronym / sponsor ID
- HARAPAN II / 2000020053
- Conditions
- Opioid Dependence, Addiction, HIV/AIDS, Tuberculosis, Hepatitis
- Keywords
- prison
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 316 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- University of Malaya, National Institute on Drug Abuse (NIDA)
- Study start
- 21 Aug 2017 (actual)
- Primary completion
- 4 Apr 2024 (actual)
- Study completion
- 4 Apr 2024 (actual)
- First posted
- 24 Mar 2017 (actual)
- Results
- Posted 9 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Screening: All newly admitted prisoners (80-120 new inmates on admission days) undergo a complete assessment, including a brief exam and mandatory rapid HIV test by the prison medical unit. Each prisoner waiting to be evaluated will be invited for participation in TB screening activities (not currently part of standard care). If they verbally assent to wanting to learn more in a group session, their names and ID will be recorded and then invited for informed consent privately, followed by a brief survey, WHO symptom assessment, tuberculin skin testing (TST) with reading after 72 hours, sputum induction on 2 consecutive mornings for AFB smear, TB culture (results back 6-8 weeks using the BACTEC MGIT 960 liquid culture gold standard), and point-of care (POC) Gene Xpert. Each person will have phlebotomy for HBV and HCV Ab, LFTs, and if HIV+, CD4 testing (all of these are POC using Alere™). For those with CD4<50, they will undergo POC low-cost, urinary TB-LAM lateral flow testing (sensitivity=67%) (Alere™ Determine) to identify disseminated TB. Additional demographic, drug use, and TB risks will also be assessed along with prison data (release date, previous incarcerations, type of offense). Participants will then undergo CXR testing. A TB specialist will review all patients and results, ensuring that patients with suspected TB initiate treatment. All suspected or confirmed cases active TB cases in HIV+ prisoners will have ART initiated after 2 weeks of TB treatment initiation (if CNS TB not suspected) if CD4<50 and within 8 weeks for all others.
Trial: All HIV+ and HIV- prisoners with latent TB infection (LTBI) (TST reaction 10 mm or greater) from screening will be asked to participate in the trial. Enrolled participants will undergo block stratified randomization, stratifying on three factors: a) CD4<350; b) HCV Ab status; and c) ART status. After randomization and allocation to 12HR or 40H, participants will be provided 12HR weekly (12 weeks) and INH daily (26 weeks) as directly observed therapy. Every 4 weeks, patients will be monitored for AST/ALT and adverse side effects. Premature treatment discontinuation will occur for any DAIDS Grade 4 toxicity or patient refusal to continue.
The focus of this registration is the RCT. Outcomes measures were updated to match most recent protocol March 2025.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Isoniazid (INH) for 26 weeks | Active comparator | Drug: IsoniazidParticipants will be randomized to receive INH, the standard of care in Malaysia, for 26 weeks while in prison as TB preventative treatment |
| Short-course isoniazid + rifapentine (INH + RIF) for 12 weeks | Experimental | Drug: Isoniazid, Drug: RifapentineParticipants will be randomized to receive INH + RIF as TB preventative treatment for 12 weeks while in prison. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Newly admitted inmate at Kajang Prison
- Age ≥ 18 years HIV-1 seropositivity
- Confirmed LTBI (TST ≥ 5mm if HIV+; TST ≥ 10 mm if HIV-)
- Meets DSM-V criteria for opioid dependence
Key exclusion criteria (3 listed)
- Unable to provide informed consent
- On a protease inhibitor
- Women who are pregnant or are planning on becoming pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IsoniazidParticipants will be randomized to receive standard INH as TB preventative treatment | Drug | Short-course isoniazid + rifapentine (INH + RIF) for 12 weeks, Standard Isoniazid (INH) for 26 weeks |
| RifapentineParticipants will be randomized to receive short course INH + RIF as TB preventative treatment | Drug | Short-course isoniazid + rifapentine (INH + RIF) for 12 weeks |
Primary outcome
TB Treatment Completion Rates in Prison
Time frame: 3 to 6 months
TB treatment completion in prison will be verified using medical records. All TB treatment in prison will be administered under directly observed therapy (DOTs), and treatment administration will be recorded in the participant's prison medical record. Data presented here is the number of participants that completed TB treatment of those that initiated treatment.
3 secondary outcomes
TB Treatment Adherence
Time frame: monthly for up to 6 months
Discontinuation Due to Experiencing an Adverse Event
Time frame: up to 6 months
Acceptability of Starting the Trial
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederick Altice, MD principal investigator
Yale University
Adeeba Kamarulzaman, MBBS principal investigator
University of Malaya
Sheela Shenoi, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isoniazid and Rifapentine in people with Opioid Dependence and Addiction, run by Yale University at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TB Treatment Completion Rates in Prison (time frame: 3 to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.