Trial · NCT03089983

Addiction, HIV and Tuberculosis in Malaysian Criminal Justice Settings

NCT03089983, Not applicable, Completed, Yale University; results first posted 2026-02-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Addiction, HIV and Tuberculosis in Malaysian Criminal Justice Settings. Trials, record NCT03089983. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03089983

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Addiction, HIV and Tuberculosis in Malaysian Criminal Justice Settings
NCT number: NCT03089983
Status: Completed
Phases: Not applicable
Enrollment: 316 participants, actual
Lead sponsor: Yale University
Conditions: Opioid Dependence, Addiction, HIV/AIDS, Tuberculosis, Hepatitis
Interventions: Isoniazid, Rifapentine
First posted: 2017-03-24
Last updated: 2026-02-09
Results first posted: 2026-02-09

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	TB Treatment Completion Rates in Prison	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.
Secondary	TB Treatment Adherence	monthly for up to 6 months	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.
Secondary	Discontinuation Due to Experiencing an Adverse Event	up to 6 months	The number of participants that discontinued the trial due to experiencing an Adverse Event
Secondary	Acceptability of Starting the Trial	Day 1	Acceptability defined as the number of eligible participants that agreed to consent

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	TB Treatment Completion Rates in Prison	3 to 6 months	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	TB Treatment Adherence	monthly for up to 6 months	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Discontinuation Due to Experiencing an Adverse Event	up to 6 months	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Acceptability of Starting the Trial	Day 1	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group7

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
TB Treatment Completion Rates in Prison	Standard Isoniazid (INH) for 26 Weeks	114	Participants
TB Treatment Completion Rates in Prison	Short-course Isoniazid + Rifapentine (INH + RIF) for 12 Weeks	127	Participants
TB Treatment Adherence	Standard Isoniazid (INH) for 26 Weeks	9	Participants
TB Treatment Adherence	Short-course Isoniazid + Rifapentine (INH + RIF) for 12 Weeks	117	Participants
Discontinuation Due to Experiencing an Adverse Event	Standard Isoniazid (INH) for 26 Weeks	10	Participants
Discontinuation Due to Experiencing an Adverse Event	Short-course Isoniazid + Rifapentine (INH + RIF) for 12 Weeks	1	Participants
Acceptability of Starting the Trial	Eligible Participants	316	Participants

Source ClinicalTrials.gov

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Standard Isoniazid (INH) for 26 Weeks	156
Overall Study	STARTED	Short-course Isoniazid + Rifapentine (INH + RIF) for 12 Weeks	156
Overall Study	Initiated Treatment	Standard Isoniazid (INH) for 26 Weeks	152
Overall Study	Initiated Treatment	Short-course Isoniazid + Rifapentine (INH + RIF) for 12 Weeks	153
Overall Study	COMPLETED	Standard Isoniazid (INH) for 26 Weeks	114
Overall Study	COMPLETED	Short-course Isoniazid + Rifapentine (INH + RIF) for 12 Weeks	127
Overall Study	NOT COMPLETED	Standard Isoniazid (INH) for 26 Weeks	42
Overall Study	NOT COMPLETED	Short-course Isoniazid + Rifapentine (INH + RIF) for 12 Weeks	29

Source ClinicalTrials.gov

Adverse events38

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Clumsiness or unsteadiness	Nervous system disorders	Standard Isoniazid (INH) for 26 Weeks	2	156
other	Clumsiness or unsteadiness	Nervous system disorders	Short-course Isoniazid + Rifapentine (INH + RIF) for 12 Weks	0	156
other	Dark urine	Renal and urinary disorders	Standard Isoniazid (INH) for 26 Weeks	5	156
other	Dark urine	Renal and urinary disorders	Short-course Isoniazid + Rifapentine (INH + RIF) for 12 Weks	10	156
other	Loss of appetite	Metabolism and nutrition disorders	Standard Isoniazid (INH) for 26 Weeks	13	156
other	Loss of appetite	Metabolism and nutrition disorders	Short-course Isoniazid + Rifapentine (INH + RIF) for 12 Weks	5	156
other	Nausea	Gastrointestinal disorders	Standard Isoniazid (INH) for 26 Weeks	4	156
other	Nausea	Gastrointestinal disorders	Short-course Isoniazid + Rifapentine (INH + RIF) for 12 Weks	5	156
other	Vomiting	Gastrointestinal disorders	Standard Isoniazid (INH) for 26 Weeks	2	156
other	Vomiting	Gastrointestinal disorders	Short-course Isoniazid + Rifapentine (INH + RIF) for 12 Weks	3	156

1 to 10 of 38Source ClinicalTrials.gov

See all 38 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Standard Isoniazid (INH) for 26 Weeks	0	156
Total, all-cause mortality	Short-course Isoniazid + Rifapentine (INH + RIF) for 12 Weks	0	156
Total, other adverse events	Standard Isoniazid (INH) for 26 Weeks	112	156
Total, other adverse events	Short-course Isoniazid + Rifapentine (INH + RIF) for 12 Weks	84	156
Total, serious adverse events	Standard Isoniazid (INH) for 26 Weeks	0	156
Total, serious adverse events	Short-course Isoniazid + Rifapentine (INH + RIF) for 12 Weks	0	156

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01DA041271	Addiction, HIV and Tuberculosis in Malaysian Criminal Justice Settings	SHENOI, SHEELA	YALE UNIVERSITY	NATIONAL INSTITUTE ON DRUG ABUSE	2016 to 2021

Source NIH RePORTER

Trial comparisons5

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Standard Isoniazid (INH) for 26 Weeks vs Short-course Isoniazid + Rifapentine (INH + RIF) for 12 Weeks: TB Treatment Adherence	Trial comparisons
Standard Isoniazid (INH) for 26 Weeks vs Short-course Isoniazid + Rifapentine (INH + RIF) for 12 Weeks: TB Treatment Completion Rates in Prison	Trial comparisons
Standard Isoniazid (INH) for 26 Weeks vs Short-course Isoniazid + Rifapentine (INH + RIF) for 12 Weeks: Discontinuation Due to Experiencing an Adverse Event	Trial comparisons
Standard Isoniazid (INH) for 26 Weeks vs Short-course Isoniazid + Rifapentine (INH + RIF) for 12 Weks: deaths from any cause	Trial comparisons
Standard Isoniazid (INH) for 26 Weeks vs Short-course Isoniazid + Rifapentine (INH + RIF) for 12 Weks: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03089983

GET https://conductscience.org/api/trials/v1/NCT03089983/events?page=2

API reference For AI assistants