Trial Outcomes & Findings for Addiction, HIV and Tuberculosis in Malaysian Criminal Justice Settings (NCT NCT03089983)
NCT ID: NCT03089983
Last Updated: 2026-02-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
316 participants
Primary outcome timeframe
3 to 6 months
Results posted on
2026-02-09
Participant Flow
Of 327 eligible participants, 316 participants consented, 4 participants were excluded prior to randomization, and 312 randomized
Participant milestones
| Measure |
Standard Isoniazid (INH) for 26 Weeks
Participants 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
Participants will be randomized to receive INH + RIF as TB preventative treatment for 12 weeks while in prison.
|
|---|---|---|
|
Overall Study
STARTED
|
156
|
156
|
|
Overall Study
Initiated Treatment
|
152
|
153
|
|
Overall Study
COMPLETED
|
114
|
127
|
|
Overall Study
NOT COMPLETED
|
42
|
29
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Addiction, HIV and Tuberculosis in Malaysian Criminal Justice Settings
Baseline characteristics by cohort
| Measure |
Standard Isoniazid (INH) for 26 Weeks
n=156 Participants
Participants 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
n=156 Participants
Participants will be randomized to receive INH + RIF as TB preventative treatment for 12 weeks while in prison.
|
Total
n=312 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Education level
secondary school
|
119 Participants
n=41 Participants
|
100 Participants
n=1581 Participants
|
219 Participants
n=4626 Participants
|
|
Age, Continuous
|
43 years
n=41 Participants
|
42 years
n=1581 Participants
|
42.5 years
n=4626 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
156 Participants
n=41 Participants
|
156 Participants
n=1581 Participants
|
312 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
Malay
|
104 Participants
n=41 Participants
|
95 Participants
n=1581 Participants
|
199 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
17 Participants
n=41 Participants
|
17 Participants
n=1581 Participants
|
34 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
Indian
|
34 Participants
n=41 Participants
|
39 Participants
n=1581 Participants
|
73 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=41 Participants
|
5 Participants
n=1581 Participants
|
6 Participants
n=4626 Participants
|
|
Region of Enrollment
Malaysia
|
156 participants
n=41 Participants
|
156 participants
n=1581 Participants
|
312 participants
n=4626 Participants
|
|
Education level
Primary school and below
|
31 Participants
n=41 Participants
|
52 Participants
n=1581 Participants
|
83 Participants
n=4626 Participants
|
|
Education level
Tertiary school
|
6 Participants
n=41 Participants
|
4 Participants
n=1581 Participants
|
10 Participants
n=4626 Participants
|
|
Marital Status
Single/partner
|
91 Participants
n=41 Participants
|
89 Participants
n=1581 Participants
|
180 Participants
n=4626 Participants
|
|
Marital Status
Married
|
44 Participants
n=41 Participants
|
33 Participants
n=1581 Participants
|
77 Participants
n=4626 Participants
|
|
Marital Status
Widowed/Divorced
|
21 Participants
n=41 Participants
|
34 Participants
n=1581 Participants
|
55 Participants
n=4626 Participants
|
|
Employed prior to incarceration
|
136 Participants
n=41 Participants
|
119 Participants
n=1581 Participants
|
255 Participants
n=4626 Participants
|
|
Previously incarcerated
|
144 Participants
n=41 Participants
|
150 Participants
n=1581 Participants
|
294 Participants
n=4626 Participants
|
|
Median number of prior incarcerations
|
9 incarcerations
n=41 Participants
|
9 incarcerations
n=1581 Participants
|
9 incarcerations
n=4626 Participants
|
|
Homelessness
|
24 Participants
n=41 Participants
|
28 Participants
n=1581 Participants
|
52 Participants
n=4626 Participants
|
|
Previous TB disease
|
10 Participants
n=41 Participants
|
10 Participants
n=1581 Participants
|
20 Participants
n=4626 Participants
|
|
Previous diagnosis of HIV
|
22 Participants
n=41 Participants
|
17 Participants
n=1581 Participants
|
39 Participants
n=4626 Participants
|
|
Number of Participants previously prescribed ART
|
17 Participants
n=41 Participants
|
9 Participants
n=1581 Participants
|
26 Participants
n=4626 Participants
|
|
Previously taking ART prior to prison entry
|
12 Participants
n=41 Participants
|
6 Participants
n=1581 Participants
|
18 Participants
n=4626 Participants
|
|
Total people with HIV
|
23 Participants
n=41 Participants
|
18 Participants
n=1581 Participants
|
41 Participants
n=4626 Participants
|
|
Previous Opioid Use
|
124 Participants
n=41 Participants
|
130 Participants
n=1581 Participants
|
254 Participants
n=4626 Participants
|
|
Positive Rapid Opioid Dependence Screen (RODS) (≥3) on enrollment
|
112 Participants
n=41 Participants
|
124 Participants
n=1581 Participants
|
236 Participants
n=4626 Participants
|
|
Previous intravenous drug use (IVDU)
|
67 Participants
n=41 Participants
|
67 Participants
n=1581 Participants
|
134 Participants
n=4626 Participants
|
|
Elevated (>4) Alcohol Use Disorders Identification Test (AUDIT) C score
|
18 Participants
n=41 Participants
|
18 Participants
n=1581 Participants
|
36 Participants
n=4626 Participants
|
|
Median days since prison entry
|
67 days
n=41 Participants
|
76.5 days
n=1581 Participants
|
71 days
n=4626 Participants
|
|
Positive Hepatitis C
|
69 Participants
n=41 Participants
|
70 Participants
n=1581 Participants
|
139 Participants
n=4626 Participants
|
|
Median Body Mass Index (BMI)
|
22.6 kg/m²
n=41 Participants
|
21.51 kg/m²
n=1581 Participants
|
22.2 kg/m²
n=4626 Participants
|
PRIMARY outcome
Timeframe: 3 to 6 monthsTB 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.
Outcome measures
| Measure |
Standard Isoniazid (INH) for 26 Weeks
n=152 Participants
Participants 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
n=153 Participants
Participants will be randomized to receive INH + RIF as TB preventative treatment for 12 weeks while in prison.
|
|---|---|---|
|
TB Treatment Completion Rates in Prison
|
114 Participants
|
127 Participants
|
SECONDARY outcome
Timeframe: monthly for up to 6 monthsTB 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.
Outcome measures
| Measure |
Standard Isoniazid (INH) for 26 Weeks
n=152 Participants
Participants 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
n=153 Participants
Participants will be randomized to receive INH + RIF as TB preventative treatment for 12 weeks while in prison.
|
|---|---|---|
|
TB Treatment Adherence
|
9 Participants
|
117 Participants
|
SECONDARY outcome
Timeframe: up to 6 monthsThe number of participants that discontinued the trial due to experiencing an Adverse Event
Outcome measures
| Measure |
Standard Isoniazid (INH) for 26 Weeks
n=156 Participants
Participants 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
n=156 Participants
Participants will be randomized to receive INH + RIF as TB preventative treatment for 12 weeks while in prison.
|
|---|---|---|
|
Discontinuation Due to Experiencing an Adverse Event
|
10 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1Acceptability defined as the number of eligible participants that agreed to consent
Outcome measures
| Measure |
Standard Isoniazid (INH) for 26 Weeks
n=327 Participants
Participants 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
Participants will be randomized to receive INH + RIF as TB preventative treatment for 12 weeks while in prison.
|
|---|---|---|
|
Acceptability of Starting the Trial
|
316 Participants
|
—
|
Adverse Events
Standard Isoniazid (INH) for 26 Weeks
Serious events: 0 serious events
Other events: 112 other events
Deaths: 0 deaths
Short-course Isoniazid + Rifapentine (INH + RIF) for 12 Weks
Serious events: 0 serious events
Other events: 84 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard Isoniazid (INH) for 26 Weeks
n=156 participants at risk
Participants 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 Weks
n=156 participants at risk
Participants will be randomized to receive INH + RIF as TB preventative treatment for 12 weeks while in prison.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
13/156 • 6 months
|
2.6%
4/156 • 6 months
|
|
Gastrointestinal disorders
Stomach pain
|
9.0%
14/156 • 6 months
|
4.5%
7/156 • 6 months
|
|
General disorders
Yellow eyes or skin
|
0.00%
0/156 • 6 months
|
0.64%
1/156 • 6 months
|
|
Eye disorders
Blurred vision or loss of vision
|
3.8%
6/156 • 6 months
|
1.9%
3/156 • 6 months
|
|
Infections and infestations
Fever and sore throat
|
5.1%
8/156 • 6 months
|
4.5%
7/156 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
30.1%
47/156 • 6 months
|
17.9%
28/156 • 6 months
|
|
Psychiatric disorders
Mental depression
|
1.9%
3/156 • 6 months
|
1.3%
2/156 • 6 months
|
|
Psychiatric disorders
Mood or other mental changes
|
3.8%
6/156 • 6 months
|
3.8%
6/156 • 6 months
|
|
Skin and subcutaneous tissue disorders
Skin rashes
|
37.8%
59/156 • 6 months
|
21.8%
34/156 • 6 months
|
|
Injury, poisoning and procedural complications
Unusual bleeding or bruising
|
3.8%
6/156 • 6 months
|
0.00%
0/156 • 6 months
|
|
Nervous system disorders
Numbness, tingling, burning, or pain in hands and feet
|
11.5%
18/156 • 6 months
|
6.4%
10/156 • 6 months
|
|
General disorders
Unusual tiredness or weakness
|
6.4%
10/156 • 6 months
|
3.2%
5/156 • 6 months
|
|
General disorders
Red, orange, or brown discoloration of skin or body fluids
|
1.3%
2/156 • 6 months
|
7.1%
11/156 • 6 months
|
|
General disorders
Other
|
5.8%
9/156 • 6 months
|
5.1%
8/156 • 6 months
|
|
Metabolism and nutrition disorders
Loss of appetite
|
8.3%
13/156 • 6 months
|
3.2%
5/156 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
2.6%
4/156 • 6 months
|
3.2%
5/156 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
1.3%
2/156 • 6 months
|
1.9%
3/156 • 6 months
|
|
Nervous system disorders
Clumsiness or unsteadiness
|
1.3%
2/156 • 6 months
|
0.00%
0/156 • 6 months
|
|
Renal and urinary disorders
Dark urine
|
3.2%
5/156 • 6 months
|
6.4%
10/156 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place