Trial Outcomes & Findings for Screen, Treat and Retain Meth-using People With Opioid Use Disorders at Methadone Clinics (NCT NCT04706624)
NCT ID: NCT04706624
Last Updated: 2026-01-23
Results Overview
HIV viral load was assessed at baseline (Week 0), Week 13, and Week 24 after enrollment. Viral load was categorized as: ≥200 copies/mL; ≥20 to \<200 copies/mL; or undetectable (\<20 copies/mL). This outcome measure reports viral suppression status at baseline (Week 0) and Week 24 in order to evaluate change in viral suppression following completion of the full intervention period.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
667 participants
Primary outcome timeframe
Baseline (start of Stage 1) and week 24 (end of Stage 2)
Results posted on
2026-01-23
Participant Flow
Participant enrollment began on 29 June 2021 and ended 1 April 2023. We screened 6708 people with opioid use disorder from 15 methadone clinics in Hanoi and Ho Chi Minh City and enrolled 667 participants.
After enrollment, 2 participants withdrew consent and declined to participate in the intervention. Thus, they were not randomized. This study employed a Sequential Multiple Assignment Randomized Trial (SMART) design. In the first phase, participants were randomized to one of two frontline interventions for 12 weeks. At Week 13, they were re-assigned to one of three adaptive strategies for an additional 12 weeks. We report outcomes stratified by the initial frontline intervention groups.
Participant milestones
| Measure |
High Intensity Frontline Intervention
Participants randomized to the high intensity frontline intervention arm (12 weeks of contingency management)
|
Low Intensity Frontline Intervention
Participants randomized into the low intensity frontline intervention arm (6 weeks of contingency management plus 6 weeks of group education)
|
Received High Intensity Frontline Intervention in Stage 1 and SMS in Stage 2
The high-intensity frontline intervention consisted of 12 weeks of Contingency Management (CM), delivered through rewards for methamphetamine-negative urine samples. Participants who responded to Stage 1 continued to receive SMS reminders in Stage 2. SMS consisted of two daily reminders plus one weekly self-monitoring assessment, delivered for 12 weeks. This intervention was a Stage 2 add-on intervention for Stage 1 responders.
|
Received High Intensity Frontline Intervention in Stage 1 and Matrix in Stage 2
The high-intensity frontline intervention consisted of 12 weeks of CM. Participants who did not respond to Stage 1 were randomized and received the Matrix intervention in Stage 2, attending 12 weekly group counseling sessions. This intervention was a Stage 2 add-on intervention for Stage 1 non-responders.
|
Received High Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 2
The high-intensity frontline intervention consisted of 12 weeks of CM. Participants who did not respond to Stage 1 were randomized and received the Matrix + CM intervention in Stage 2, attending 12 weekly Matrix group counseling sessions plus 12 weeks of CM. This intervention was a Stage 2 add-on intervention for Stage 1 non-responders.
|
Received Low Intensity Frontline Intervention in Stage 1 and SMS in Stage 2
The low-intensity frontline intervention consisted of 6 weeks of CM, followed by 6 weeks of Group Education (GE). Participants who responded to Stage 1 continued to receive SMS reminders in Stage 2, consisting of two daily reminders plus one weekly self-monitoring assessment delivered for 12 weeks. This intervention was a Stage 2 add-on intervention for Stage 1 responders.
|
Received Low Intensity Frontline Intervention in Stage 1 and Matrix in Stage 2
The low-intensity frontline intervention consisted of 6 weeks of CM, followed by 6 weeks of GE. Participants who did not respond to Stage 1 were randomized and received the Matrix intervention in Stage 2, attending 12 weekly group counseling sessions. This intervention was a Stage 2 add-on intervention for Stage 1 non-responders.
|
Received Low Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 2
The low-intensity frontline intervention consisted of 6 weeks of CM, followed by 6 weeks of GE. Participants who did not respond to Stage 1 were randomized and received the Matrix + CM intervention in Stage 2, attending 12 weekly Matrix group counseling sessions plus 12 weeks of CM. This intervention was a Stage 2 add-on intervention for Stage 1 non-responders.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1 Intervention (Weeks 0 to 12)
STARTED
|
328
|
337
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1 Intervention (Weeks 0 to 12)
COMPLETED
|
315
|
328
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1 Intervention (Weeks 0 to 12)
NOT COMPLETED
|
13
|
9
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 2 Intervention (Weeks 13 to 26)
STARTED
|
0
|
0
|
230
|
40
|
45
|
198
|
68
|
62
|
|
Stage 2 Intervention (Weeks 13 to 26)
COMPLETED
|
0
|
0
|
220
|
30
|
41
|
189
|
64
|
55
|
|
Stage 2 Intervention (Weeks 13 to 26)
NOT COMPLETED
|
0
|
0
|
10
|
10
|
4
|
9
|
4
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Screen, Treat and Retain Meth-using People With Opioid Use Disorders at Methadone Clinics
Baseline characteristics by cohort
| Measure |
High Intensity Frontline Intervention
n=328 Participants
Participants randomized to the high intensity frontline intervention (12 weeks of contingency management)
|
Low Intensity Frontline Intervention
n=337 Participants
Participants randomized to the low intensity frontline intervention (6 weeks of contingency management plus 6 weeks of group education)
|
Total
n=665 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.4 years
STANDARD_DEVIATION 7.2 • n=270 Participants
|
41.5 years
STANDARD_DEVIATION 7.5 • n=4 Participants
|
41.4 years
STANDARD_DEVIATION 7.4 • n=9 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=270 Participants
|
39 Participants
n=4 Participants
|
74 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
293 Participants
n=270 Participants
|
298 Participants
n=4 Participants
|
591 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
328 Participants
n=270 Participants
|
337 Participants
n=4 Participants
|
665 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
Vietnam
|
328 participants
n=270 Participants
|
337 participants
n=4 Participants
|
665 participants
n=9 Participants
|
|
Alcohol, Smoking and Substance Involvement Screening Test
|
16.3 units on a scale
STANDARD_DEVIATION 8.1 • n=270 Participants
|
16.7 units on a scale
STANDARD_DEVIATION 8.3 • n=4 Participants
|
16.5 units on a scale
STANDARD_DEVIATION 8.2 • n=9 Participants
|
|
HIV status
Negative
|
271 Participants
n=270 Participants
|
262 Participants
n=4 Participants
|
533 Participants
n=9 Participants
|
|
HIV status
Positive
|
57 Participants
n=270 Participants
|
75 Participants
n=4 Participants
|
132 Participants
n=9 Participants
|
|
Currently married
No
|
179 Participants
n=270 Participants
|
198 Participants
n=4 Participants
|
377 Participants
n=9 Participants
|
|
Currently married
Yes
|
149 Participants
n=270 Participants
|
139 Participants
n=4 Participants
|
288 Participants
n=9 Participants
|
|
Education
Less than 12th grade
|
225 Participants
n=270 Participants
|
242 Participants
n=4 Participants
|
467 Participants
n=9 Participants
|
|
Education
12th grade or higher
|
103 Participants
n=270 Participants
|
95 Participants
n=4 Participants
|
198 Participants
n=9 Participants
|
|
Has a paid job
No
|
125 Participants
n=270 Participants
|
124 Participants
n=4 Participants
|
249 Participants
n=9 Participants
|
|
Has a paid job
Yes
|
203 Participants
n=270 Participants
|
213 Participants
n=4 Participants
|
416 Participants
n=9 Participants
|
|
Methamphetamine urine drug screen
Negative
|
130 Participants
n=270 Participants
|
122 Participants
n=4 Participants
|
252 Participants
n=9 Participants
|
|
Methamphetamine urine drug screen
Positive
|
198 Participants
n=270 Participants
|
215 Participants
n=4 Participants
|
413 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Baseline (start of Stage 1) and week 24 (end of Stage 2)Population: Only participants classified as Stage 1 responders with completed viral load assessments at week 24 were included in this analysis.
HIV viral load was assessed at baseline (Week 0), Week 13, and Week 24 after enrollment. Viral load was categorized as: ≥200 copies/mL; ≥20 to \<200 copies/mL; or undetectable (\<20 copies/mL). This outcome measure reports viral suppression status at baseline (Week 0) and Week 24 in order to evaluate change in viral suppression following completion of the full intervention period.
Outcome measures
| Measure |
Received High Intensity Frontline Intervention in Stage 1 and SMS in Stage 2
n=40 Participants
The high-intensity frontline intervention consisted of 12 weeks of Contingency Management (CM), delivered through rewards for methamphetamine-negative urine samples. Participants who responded to Stage 1 continued to receive SMS reminders in Stage 2. SMS consisted of two daily reminders plus one weekly self-monitoring assessment, delivered for 12 weeks. This intervention was a Stage 2 add-on intervention for Stage 1 responders.
|
Received Low Intensity Frontline Intervention in Stage 1 and SMS in Stage 2
n=43 Participants
The low-intensity frontline intervention consisted of 6 weeks of CM, followed by 6 weeks of Group Education (GE). Participants who responded to Stage 1 continued to receive SMS reminders in Stage 2, consisting of two daily reminders plus one weekly self-monitoring assessment delivered for 12 weeks. This intervention was a Stage 2 add-on intervention for Stage 1 responders.
|
Received High Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 2
The high-intensity frontline intervention consisted of 12 weeks of CM. Participants who did not respond to Stage 1 were randomized and received the Matrix + CM intervention in Stage 2, attending 12 weekly Matrix group counseling sessions plus 12 weeks of CM. This intervention was a Stage 2 add-on intervention for Stage 1 non-responders.
|
Received Low Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 2
The low-intensity frontline intervention consisted of 6 weeks of CM, followed by 6 weeks of GE. Participants who did not respond to Stage 1 were randomized and received the Matrix + CM intervention in Stage 2, attending 12 weekly Matrix group counseling sessions plus 12 weeks of CM. This intervention was a Stage 2 add-on intervention for Stage 1 non-responders.
|
|---|---|---|---|---|
|
Increase in HIV Viral Suppression for HIV-positive Participants: High- vs. Low-Intensity Frontline Intervention With SMS in Stage 2
Baseline · Undetected or <20copies/mL
|
31 Participants
|
35 Participants
|
—
|
—
|
|
Increase in HIV Viral Suppression for HIV-positive Participants: High- vs. Low-Intensity Frontline Intervention With SMS in Stage 2
Baseline · >=20 copies/mL & <200 copies/mL
|
6 Participants
|
3 Participants
|
—
|
—
|
|
Increase in HIV Viral Suppression for HIV-positive Participants: High- vs. Low-Intensity Frontline Intervention With SMS in Stage 2
Baseline · >= 200 copies/mL
|
3 Participants
|
5 Participants
|
—
|
—
|
|
Increase in HIV Viral Suppression for HIV-positive Participants: High- vs. Low-Intensity Frontline Intervention With SMS in Stage 2
Week 24 · Undetected or <20copies/mL
|
33 Participants
|
39 Participants
|
—
|
—
|
|
Increase in HIV Viral Suppression for HIV-positive Participants: High- vs. Low-Intensity Frontline Intervention With SMS in Stage 2
Week 24 · >=20 copies/mL & <200 copies/mL
|
3 Participants
|
1 Participants
|
—
|
—
|
|
Increase in HIV Viral Suppression for HIV-positive Participants: High- vs. Low-Intensity Frontline Intervention With SMS in Stage 2
Week 24 · >= 200 copies/mL
|
4 Participants
|
3 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (start of Stage 1) and week 24 (end of Stage 2)Population: Only participants classified as Stage 1 non-responders with completed viral load assessments at week 24 were included in this analysis.
HIV viral load was assessed at baseline (Week 0), Week 13, and Week 24 after enrollment. Viral load was categorized as: ≥200 copies/mL; ≥20 to \<200 copies/mL; or undetectable (\<20 copies/mL). This outcome measure reports viral suppression status at baseline (Week 0) and Week 24 in order to evaluate the change in viral suppression following completion of the full intervention period.
Outcome measures
| Measure |
Received High Intensity Frontline Intervention in Stage 1 and SMS in Stage 2
n=6 Participants
The high-intensity frontline intervention consisted of 12 weeks of Contingency Management (CM), delivered through rewards for methamphetamine-negative urine samples. Participants who responded to Stage 1 continued to receive SMS reminders in Stage 2. SMS consisted of two daily reminders plus one weekly self-monitoring assessment, delivered for 12 weeks. This intervention was a Stage 2 add-on intervention for Stage 1 responders.
|
Received Low Intensity Frontline Intervention in Stage 1 and SMS in Stage 2
n=11 Participants
The low-intensity frontline intervention consisted of 6 weeks of CM, followed by 6 weeks of Group Education (GE). Participants who responded to Stage 1 continued to receive SMS reminders in Stage 2, consisting of two daily reminders plus one weekly self-monitoring assessment delivered for 12 weeks. This intervention was a Stage 2 add-on intervention for Stage 1 responders.
|
Received High Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 2
n=6 Participants
The high-intensity frontline intervention consisted of 12 weeks of CM. Participants who did not respond to Stage 1 were randomized and received the Matrix + CM intervention in Stage 2, attending 12 weekly Matrix group counseling sessions plus 12 weeks of CM. This intervention was a Stage 2 add-on intervention for Stage 1 non-responders.
|
Received Low Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 2
n=12 Participants
The low-intensity frontline intervention consisted of 6 weeks of CM, followed by 6 weeks of GE. Participants who did not respond to Stage 1 were randomized and received the Matrix + CM intervention in Stage 2, attending 12 weekly Matrix group counseling sessions plus 12 weeks of CM. This intervention was a Stage 2 add-on intervention for Stage 1 non-responders.
|
|---|---|---|---|---|
|
Increase in HIV Viral Suppression for HIV-positive Participants: High- vs. Low-Intensity Frontline Intervention With Matrix/Matrix + CM in Stage 2
Week 24 · Undetected or < 20 copies/mL
|
5 Participants
|
9 Participants
|
4 Participants
|
9 Participants
|
|
Increase in HIV Viral Suppression for HIV-positive Participants: High- vs. Low-Intensity Frontline Intervention With Matrix/Matrix + CM in Stage 2
Week 24 · ≥ 20 copies/mL & < 200 copies/mL
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Increase in HIV Viral Suppression for HIV-positive Participants: High- vs. Low-Intensity Frontline Intervention With Matrix/Matrix + CM in Stage 2
Baseline · Undetected or < 20 copies/mL
|
4 Participants
|
10 Participants
|
6 Participants
|
8 Participants
|
|
Increase in HIV Viral Suppression for HIV-positive Participants: High- vs. Low-Intensity Frontline Intervention With Matrix/Matrix + CM in Stage 2
Baseline · ≥ 20 copies/mL & < 200 copies/mL
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Increase in HIV Viral Suppression for HIV-positive Participants: High- vs. Low-Intensity Frontline Intervention With Matrix/Matrix + CM in Stage 2
Week 24 · ≥ 200 copies/mL
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Increase in HIV Viral Suppression for HIV-positive Participants: High- vs. Low-Intensity Frontline Intervention With Matrix/Matrix + CM in Stage 2
Baseline · ≥ 200 copies/mL
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Baseline (start of Stage 1) and week 24 (end of Stage 2)Population: Only participants classified as Stage 1 responders with completed assessments at week 24 were included in this analysis.
Structured questionnaires will collect self-reported data at baseline and week 24 after enrolment. HIV risk behaviors were grouped into two types: 1. sexual risk behaviors, such as having sex with partners who were HIV-positive or whose status was unknown, having sex while using drugs or alcohol, or using methamphetamine to find partners or enhance sex 2. needle/syringe risk behaviors, such as reusing needles or syringes that had already been used by others (even if cleaned) or reusing their own needles or syringes multiple times.
Outcome measures
| Measure |
Received High Intensity Frontline Intervention in Stage 1 and SMS in Stage 2
n=222 Participants
The high-intensity frontline intervention consisted of 12 weeks of Contingency Management (CM), delivered through rewards for methamphetamine-negative urine samples. Participants who responded to Stage 1 continued to receive SMS reminders in Stage 2. SMS consisted of two daily reminders plus one weekly self-monitoring assessment, delivered for 12 weeks. This intervention was a Stage 2 add-on intervention for Stage 1 responders.
|
Received Low Intensity Frontline Intervention in Stage 1 and SMS in Stage 2
n=192 Participants
The low-intensity frontline intervention consisted of 6 weeks of CM, followed by 6 weeks of Group Education (GE). Participants who responded to Stage 1 continued to receive SMS reminders in Stage 2, consisting of two daily reminders plus one weekly self-monitoring assessment delivered for 12 weeks. This intervention was a Stage 2 add-on intervention for Stage 1 responders.
|
Received High Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 2
The high-intensity frontline intervention consisted of 12 weeks of CM. Participants who did not respond to Stage 1 were randomized and received the Matrix + CM intervention in Stage 2, attending 12 weekly Matrix group counseling sessions plus 12 weeks of CM. This intervention was a Stage 2 add-on intervention for Stage 1 non-responders.
|
Received Low Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 2
The low-intensity frontline intervention consisted of 6 weeks of CM, followed by 6 weeks of GE. Participants who did not respond to Stage 1 were randomized and received the Matrix + CM intervention in Stage 2, attending 12 weekly Matrix group counseling sessions plus 12 weeks of CM. This intervention was a Stage 2 add-on intervention for Stage 1 non-responders.
|
|---|---|---|---|---|
|
Reduction in HIV Risk Behaviors for Both HIV-positive and HIV-negative Participants: High- vs. Low-Intensity Frontline Intervention With SMS in Stage 2
Baseline: Sexual risk behaviors · Yes
|
41 Participants
|
24 Participants
|
—
|
—
|
|
Reduction in HIV Risk Behaviors for Both HIV-positive and HIV-negative Participants: High- vs. Low-Intensity Frontline Intervention With SMS in Stage 2
Baseline: Sexual risk behaviors · No
|
181 Participants
|
168 Participants
|
—
|
—
|
|
Reduction in HIV Risk Behaviors for Both HIV-positive and HIV-negative Participants: High- vs. Low-Intensity Frontline Intervention With SMS in Stage 2
Week 24: Sexual risk behaviors · Yes
|
16 Participants
|
14 Participants
|
—
|
—
|
|
Reduction in HIV Risk Behaviors for Both HIV-positive and HIV-negative Participants: High- vs. Low-Intensity Frontline Intervention With SMS in Stage 2
Week 24: Sexual risk behaviors · No
|
206 Participants
|
178 Participants
|
—
|
—
|
|
Reduction in HIV Risk Behaviors for Both HIV-positive and HIV-negative Participants: High- vs. Low-Intensity Frontline Intervention With SMS in Stage 2
Baseline: HIV needle/syringe risk behaviors · Yes
|
0 Participants
|
3 Participants
|
—
|
—
|
|
Reduction in HIV Risk Behaviors for Both HIV-positive and HIV-negative Participants: High- vs. Low-Intensity Frontline Intervention With SMS in Stage 2
Baseline: HIV needle/syringe risk behaviors · No
|
222 Participants
|
189 Participants
|
—
|
—
|
|
Reduction in HIV Risk Behaviors for Both HIV-positive and HIV-negative Participants: High- vs. Low-Intensity Frontline Intervention With SMS in Stage 2
Week 24: HIV needle/syringe risk behaviors · Yes
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Reduction in HIV Risk Behaviors for Both HIV-positive and HIV-negative Participants: High- vs. Low-Intensity Frontline Intervention With SMS in Stage 2
Week 24: HIV needle/syringe risk behaviors · No
|
222 Participants
|
191 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (start of Stage 1) and week 24 (end of Stage 2)Population: Only participants classified as Stage 1 non-responders with completed assessments at week 24 were included in this analysis.
Structured questionnaires will collect self-reported data at baseline and 24 weeks after enrolment. HIV risk behaviors were grouped into two types: 1. sexual risk behaviors, such as having sex with partners who were HIV-positive or whose status was unknown, having sex while using drugs or alcohol, or using methamphetamine to find partners or enhance sex. 2. needle/syringe risk behaviors, such as reusing needles or syringes that had already been used by others (even if cleaned) or reusing their own needles or syringes multiple times.
Outcome measures
| Measure |
Received High Intensity Frontline Intervention in Stage 1 and SMS in Stage 2
n=33 Participants
The high-intensity frontline intervention consisted of 12 weeks of Contingency Management (CM), delivered through rewards for methamphetamine-negative urine samples. Participants who responded to Stage 1 continued to receive SMS reminders in Stage 2. SMS consisted of two daily reminders plus one weekly self-monitoring assessment, delivered for 12 weeks. This intervention was a Stage 2 add-on intervention for Stage 1 responders.
|
Received Low Intensity Frontline Intervention in Stage 1 and SMS in Stage 2
n=65 Participants
The low-intensity frontline intervention consisted of 6 weeks of CM, followed by 6 weeks of Group Education (GE). Participants who responded to Stage 1 continued to receive SMS reminders in Stage 2, consisting of two daily reminders plus one weekly self-monitoring assessment delivered for 12 weeks. This intervention was a Stage 2 add-on intervention for Stage 1 responders.
|
Received High Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 2
n=41 Participants
The high-intensity frontline intervention consisted of 12 weeks of CM. Participants who did not respond to Stage 1 were randomized and received the Matrix + CM intervention in Stage 2, attending 12 weekly Matrix group counseling sessions plus 12 weeks of CM. This intervention was a Stage 2 add-on intervention for Stage 1 non-responders.
|
Received Low Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 2
n=56 Participants
The low-intensity frontline intervention consisted of 6 weeks of CM, followed by 6 weeks of GE. Participants who did not respond to Stage 1 were randomized and received the Matrix + CM intervention in Stage 2, attending 12 weekly Matrix group counseling sessions plus 12 weeks of CM. This intervention was a Stage 2 add-on intervention for Stage 1 non-responders.
|
|---|---|---|---|---|
|
Reduction in HIV Risk Behaviors for Both HIV-positive and HIV-negative Participants: High- vs. Low-Intensity Frontline Intervention With Matrix/Matrix + CM in Stage 2
Week 24: Sexual risk behaviors · Yes
|
3 Participants
|
8 Participants
|
4 Participants
|
10 Participants
|
|
Reduction in HIV Risk Behaviors for Both HIV-positive and HIV-negative Participants: High- vs. Low-Intensity Frontline Intervention With Matrix/Matrix + CM in Stage 2
Week 24: Sexual risk behaviors · No
|
30 Participants
|
57 Participants
|
37 Participants
|
46 Participants
|
|
Reduction in HIV Risk Behaviors for Both HIV-positive and HIV-negative Participants: High- vs. Low-Intensity Frontline Intervention With Matrix/Matrix + CM in Stage 2
Baseline: HIV needle/syringe risk behaviors · Yes
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Reduction in HIV Risk Behaviors for Both HIV-positive and HIV-negative Participants: High- vs. Low-Intensity Frontline Intervention With Matrix/Matrix + CM in Stage 2
Baseline: HIV needle/syringe risk behaviors · No
|
33 Participants
|
64 Participants
|
41 Participants
|
55 Participants
|
|
Reduction in HIV Risk Behaviors for Both HIV-positive and HIV-negative Participants: High- vs. Low-Intensity Frontline Intervention With Matrix/Matrix + CM in Stage 2
Week 24: HIV needle/syringe risk behaviors · No
|
33 Participants
|
65 Participants
|
39 Participants
|
56 Participants
|
|
Reduction in HIV Risk Behaviors for Both HIV-positive and HIV-negative Participants: High- vs. Low-Intensity Frontline Intervention With Matrix/Matrix + CM in Stage 2
Baseline: Sexual risk behaviors · Yes
|
5 Participants
|
13 Participants
|
8 Participants
|
13 Participants
|
|
Reduction in HIV Risk Behaviors for Both HIV-positive and HIV-negative Participants: High- vs. Low-Intensity Frontline Intervention With Matrix/Matrix + CM in Stage 2
Baseline: Sexual risk behaviors · No
|
28 Participants
|
52 Participants
|
33 Participants
|
43 Participants
|
|
Reduction in HIV Risk Behaviors for Both HIV-positive and HIV-negative Participants: High- vs. Low-Intensity Frontline Intervention With Matrix/Matrix + CM in Stage 2
Week 24: HIV needle/syringe risk behaviors · Yes
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Weeks 11-12 (end of Stage 1) and week 24-25 (end of Stage 2)Population: Participants were analyzed according to their Stage 1 intervention assignment. Although participants could be re-randomized to different intervention groups in Stage 2, Stage 2 assignments were not considered in this analysis. Intervention response after Stage 2 was compared based on participants' original Stage 1 group.
Methamphetamine use was measured using twice-weekly urine drug tests. Treatment response is defined as testing methamphetamine-negative in 4 out of a possible 4 urine tests during Weeks 11-12 and during Weeks 24-25.
Outcome measures
| Measure |
Received High Intensity Frontline Intervention in Stage 1 and SMS in Stage 2
n=328 Participants
The high-intensity frontline intervention consisted of 12 weeks of Contingency Management (CM), delivered through rewards for methamphetamine-negative urine samples. Participants who responded to Stage 1 continued to receive SMS reminders in Stage 2. SMS consisted of two daily reminders plus one weekly self-monitoring assessment, delivered for 12 weeks. This intervention was a Stage 2 add-on intervention for Stage 1 responders.
|
Received Low Intensity Frontline Intervention in Stage 1 and SMS in Stage 2
n=337 Participants
The low-intensity frontline intervention consisted of 6 weeks of CM, followed by 6 weeks of Group Education (GE). Participants who responded to Stage 1 continued to receive SMS reminders in Stage 2, consisting of two daily reminders plus one weekly self-monitoring assessment delivered for 12 weeks. This intervention was a Stage 2 add-on intervention for Stage 1 responders.
|
Received High Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 2
The high-intensity frontline intervention consisted of 12 weeks of CM. Participants who did not respond to Stage 1 were randomized and received the Matrix + CM intervention in Stage 2, attending 12 weekly Matrix group counseling sessions plus 12 weeks of CM. This intervention was a Stage 2 add-on intervention for Stage 1 non-responders.
|
Received Low Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 2
The low-intensity frontline intervention consisted of 6 weeks of CM, followed by 6 weeks of GE. Participants who did not respond to Stage 1 were randomized and received the Matrix + CM intervention in Stage 2, attending 12 weekly Matrix group counseling sessions plus 12 weeks of CM. This intervention was a Stage 2 add-on intervention for Stage 1 non-responders.
|
|---|---|---|---|---|
|
Reduction in Methamphetamine Use: High- vs. Low-Intensity Frontline Intervention
Week 11-12
|
230 Participants
|
198 Participants
|
—
|
—
|
|
Reduction in Methamphetamine Use: High- vs. Low-Intensity Frontline Intervention
Week 24-25
|
194 Participants
|
187 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 24-25 (end of stage 2)Population: Non-responders who were re-randomized to the Matrix intervention in Stage 2 are compared to non-responders who were re-randomized to the Matrix + contingency management in Stage 2; data are aggregated over both Stage 1 interventions.
Treatment response is defined as testing methamphetamine-negative in 4 out of a possible 4 urine tests during Weeks 24-25.
Outcome measures
| Measure |
Received High Intensity Frontline Intervention in Stage 1 and SMS in Stage 2
n=108 Participants
The high-intensity frontline intervention consisted of 12 weeks of Contingency Management (CM), delivered through rewards for methamphetamine-negative urine samples. Participants who responded to Stage 1 continued to receive SMS reminders in Stage 2. SMS consisted of two daily reminders plus one weekly self-monitoring assessment, delivered for 12 weeks. This intervention was a Stage 2 add-on intervention for Stage 1 responders.
|
Received Low Intensity Frontline Intervention in Stage 1 and SMS in Stage 2
n=107 Participants
The low-intensity frontline intervention consisted of 6 weeks of CM, followed by 6 weeks of Group Education (GE). Participants who responded to Stage 1 continued to receive SMS reminders in Stage 2, consisting of two daily reminders plus one weekly self-monitoring assessment delivered for 12 weeks. This intervention was a Stage 2 add-on intervention for Stage 1 responders.
|
Received High Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 2
The high-intensity frontline intervention consisted of 12 weeks of CM. Participants who did not respond to Stage 1 were randomized and received the Matrix + CM intervention in Stage 2, attending 12 weekly Matrix group counseling sessions plus 12 weeks of CM. This intervention was a Stage 2 add-on intervention for Stage 1 non-responders.
|
Received Low Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 2
The low-intensity frontline intervention consisted of 6 weeks of CM, followed by 6 weeks of GE. Participants who did not respond to Stage 1 were randomized and received the Matrix + CM intervention in Stage 2, attending 12 weekly Matrix group counseling sessions plus 12 weeks of CM. This intervention was a Stage 2 add-on intervention for Stage 1 non-responders.
|
|---|---|---|---|---|
|
Reduction in Methamphetamine Use: Matrix vs. Matrix + CM Adaptive Intervention
|
13 Participants
|
28 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 11-12 (end of Stage 1) and Weeks 24-25 (end of Stage 2)Population: Participants were analyzed according to their Stage 1 intervention assignment. Although participants could be re-randomized to different intervention groups in Stage 2, Stage 2 assignments were not considered in this analysis. Heroin-negative after Stage 2 was compared based on participants' original Stage 1 group.
Heroin use was measured using twice-weekly urine drug tests. Participants were classified as heroin-negative if all four urine drug tests conducted during Weeks 11-12 and during Weeks 24-25 were negative for heroin.
Outcome measures
| Measure |
Received High Intensity Frontline Intervention in Stage 1 and SMS in Stage 2
n=328 Participants
The high-intensity frontline intervention consisted of 12 weeks of Contingency Management (CM), delivered through rewards for methamphetamine-negative urine samples. Participants who responded to Stage 1 continued to receive SMS reminders in Stage 2. SMS consisted of two daily reminders plus one weekly self-monitoring assessment, delivered for 12 weeks. This intervention was a Stage 2 add-on intervention for Stage 1 responders.
|
Received Low Intensity Frontline Intervention in Stage 1 and SMS in Stage 2
n=337 Participants
The low-intensity frontline intervention consisted of 6 weeks of CM, followed by 6 weeks of Group Education (GE). Participants who responded to Stage 1 continued to receive SMS reminders in Stage 2, consisting of two daily reminders plus one weekly self-monitoring assessment delivered for 12 weeks. This intervention was a Stage 2 add-on intervention for Stage 1 responders.
|
Received High Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 2
The high-intensity frontline intervention consisted of 12 weeks of CM. Participants who did not respond to Stage 1 were randomized and received the Matrix + CM intervention in Stage 2, attending 12 weekly Matrix group counseling sessions plus 12 weeks of CM. This intervention was a Stage 2 add-on intervention for Stage 1 non-responders.
|
Received Low Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 2
The low-intensity frontline intervention consisted of 6 weeks of CM, followed by 6 weeks of GE. Participants who did not respond to Stage 1 were randomized and received the Matrix + CM intervention in Stage 2, attending 12 weekly Matrix group counseling sessions plus 12 weeks of CM. This intervention was a Stage 2 add-on intervention for Stage 1 non-responders.
|
|---|---|---|---|---|
|
Heroin-negative Test: High- vs. Low-Intensity Frontline Intervention
Week 12
|
252 Participants
|
237 Participants
|
—
|
—
|
|
Heroin-negative Test: High- vs. Low-Intensity Frontline Intervention
Week 25
|
238 Participants
|
248 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24-25 (end of Stage 2)Population: Heroin -negative among non-responders who were re-randomized to the Matrix intervention in Stage 2 are compared to non-responders who were re-randomized to the Matrix + contingency management in Stage 2; data are aggregated over both Stage 1 interventions.
Heroin use was measured using twice-weekly urine drug tests. Participants were classified as heroin-negative if all four urine drug tests conducted during Weeks 24-25 were negative for heroin.
Outcome measures
| Measure |
Received High Intensity Frontline Intervention in Stage 1 and SMS in Stage 2
n=108 Participants
The high-intensity frontline intervention consisted of 12 weeks of Contingency Management (CM), delivered through rewards for methamphetamine-negative urine samples. Participants who responded to Stage 1 continued to receive SMS reminders in Stage 2. SMS consisted of two daily reminders plus one weekly self-monitoring assessment, delivered for 12 weeks. This intervention was a Stage 2 add-on intervention for Stage 1 responders.
|
Received Low Intensity Frontline Intervention in Stage 1 and SMS in Stage 2
n=107 Participants
The low-intensity frontline intervention consisted of 6 weeks of CM, followed by 6 weeks of Group Education (GE). Participants who responded to Stage 1 continued to receive SMS reminders in Stage 2, consisting of two daily reminders plus one weekly self-monitoring assessment delivered for 12 weeks. This intervention was a Stage 2 add-on intervention for Stage 1 responders.
|
Received High Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 2
The high-intensity frontline intervention consisted of 12 weeks of CM. Participants who did not respond to Stage 1 were randomized and received the Matrix + CM intervention in Stage 2, attending 12 weekly Matrix group counseling sessions plus 12 weeks of CM. This intervention was a Stage 2 add-on intervention for Stage 1 non-responders.
|
Received Low Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 2
The low-intensity frontline intervention consisted of 6 weeks of CM, followed by 6 weeks of GE. Participants who did not respond to Stage 1 were randomized and received the Matrix + CM intervention in Stage 2, attending 12 weekly Matrix group counseling sessions plus 12 weeks of CM. This intervention was a Stage 2 add-on intervention for Stage 1 non-responders.
|
|---|---|---|---|---|
|
Heroin-negative Test: Matrix vs. Matrix + CM Adaptive Intervention
|
48 Participants
|
50 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (start of Stage 1) and week 24 (end of Stage 2)Population: Only participants classified as Stage 1 responders who completed the Week 24 assessment and received ART were included in this analysis.
This information will be collected using the study questionnaire at baseline, weeks 12th, and 24th. People who adhered to ART was defined as currently on ART and either (1) within 4 days they never forgot to take HIV medication or (2) never took HIV medication later 2 hours than required or (3) forgot to take their HIV medication at the weekend. This outcome measure reports ART adherence at baseline (Week 0) and Week 24 in order to evaluate change in ART adherence following completion of the full intervention period.
Outcome measures
| Measure |
Received High Intensity Frontline Intervention in Stage 1 and SMS in Stage 2
n=38 Participants
The high-intensity frontline intervention consisted of 12 weeks of Contingency Management (CM), delivered through rewards for methamphetamine-negative urine samples. Participants who responded to Stage 1 continued to receive SMS reminders in Stage 2. SMS consisted of two daily reminders plus one weekly self-monitoring assessment, delivered for 12 weeks. This intervention was a Stage 2 add-on intervention for Stage 1 responders.
|
Received Low Intensity Frontline Intervention in Stage 1 and SMS in Stage 2
n=41 Participants
The low-intensity frontline intervention consisted of 6 weeks of CM, followed by 6 weeks of Group Education (GE). Participants who responded to Stage 1 continued to receive SMS reminders in Stage 2, consisting of two daily reminders plus one weekly self-monitoring assessment delivered for 12 weeks. This intervention was a Stage 2 add-on intervention for Stage 1 responders.
|
Received High Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 2
The high-intensity frontline intervention consisted of 12 weeks of CM. Participants who did not respond to Stage 1 were randomized and received the Matrix + CM intervention in Stage 2, attending 12 weekly Matrix group counseling sessions plus 12 weeks of CM. This intervention was a Stage 2 add-on intervention for Stage 1 non-responders.
|
Received Low Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 2
The low-intensity frontline intervention consisted of 6 weeks of CM, followed by 6 weeks of GE. Participants who did not respond to Stage 1 were randomized and received the Matrix + CM intervention in Stage 2, attending 12 weekly Matrix group counseling sessions plus 12 weeks of CM. This intervention was a Stage 2 add-on intervention for Stage 1 non-responders.
|
|---|---|---|---|---|
|
Adherence to ART if HIV-positive: High- vs. Low-Intensity Frontline Intervention With SMS in Stage 2
Week 24 · Non-adherence to ART
|
1 Participants
|
4 Participants
|
—
|
—
|
|
Adherence to ART if HIV-positive: High- vs. Low-Intensity Frontline Intervention With SMS in Stage 2
Baseline · Adherence to ART
|
38 Participants
|
41 Participants
|
—
|
—
|
|
Adherence to ART if HIV-positive: High- vs. Low-Intensity Frontline Intervention With SMS in Stage 2
Baseline · Non-adherence to ART
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Adherence to ART if HIV-positive: High- vs. Low-Intensity Frontline Intervention With SMS in Stage 2
Week 24 · Adherence to ART
|
37 Participants
|
37 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (start of Stage 1) and week 24 (end of Stage 2)Population: Only participants classified as Stage 1 non-responders who completed the Week 24 assessment and received ART were included in this analysis.
This information will be collected using the study questionnaire at baseline, weeks 12th and 24th. People who adhered to ART was defined as currently on ART and either (1) within 4 days they never forgot to take HIV medication or (2) never took HIV medication later 2 hours than required or (3) forgot to take their HIV medication at the weekend. This outcome measure reports ART adherence at baseline (Week 0) and Week 24 in order to evaluate change in ART adherence following completion of the full intervention period.
Outcome measures
| Measure |
Received High Intensity Frontline Intervention in Stage 1 and SMS in Stage 2
n=7 Participants
The high-intensity frontline intervention consisted of 12 weeks of Contingency Management (CM), delivered through rewards for methamphetamine-negative urine samples. Participants who responded to Stage 1 continued to receive SMS reminders in Stage 2. SMS consisted of two daily reminders plus one weekly self-monitoring assessment, delivered for 12 weeks. This intervention was a Stage 2 add-on intervention for Stage 1 responders.
|
Received Low Intensity Frontline Intervention in Stage 1 and SMS in Stage 2
n=12 Participants
The low-intensity frontline intervention consisted of 6 weeks of CM, followed by 6 weeks of Group Education (GE). Participants who responded to Stage 1 continued to receive SMS reminders in Stage 2, consisting of two daily reminders plus one weekly self-monitoring assessment delivered for 12 weeks. This intervention was a Stage 2 add-on intervention for Stage 1 responders.
|
Received High Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 2
n=6 Participants
The high-intensity frontline intervention consisted of 12 weeks of CM. Participants who did not respond to Stage 1 were randomized and received the Matrix + CM intervention in Stage 2, attending 12 weekly Matrix group counseling sessions plus 12 weeks of CM. This intervention was a Stage 2 add-on intervention for Stage 1 non-responders.
|
Received Low Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 2
n=12 Participants
The low-intensity frontline intervention consisted of 6 weeks of CM, followed by 6 weeks of GE. Participants who did not respond to Stage 1 were randomized and received the Matrix + CM intervention in Stage 2, attending 12 weekly Matrix group counseling sessions plus 12 weeks of CM. This intervention was a Stage 2 add-on intervention for Stage 1 non-responders.
|
|---|---|---|---|---|
|
Adherence to ART if HIV-positive: High- vs. Low-Intensity Frontline Intervention With Matrix/Matrix + CM in Stage 2
Baseline · Adherence to ART
|
6 Participants
|
12 Participants
|
6 Participants
|
10 Participants
|
|
Adherence to ART if HIV-positive: High- vs. Low-Intensity Frontline Intervention With Matrix/Matrix + CM in Stage 2
Baseline · Non-adherence to ART
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adherence to ART if HIV-positive: High- vs. Low-Intensity Frontline Intervention With Matrix/Matrix + CM in Stage 2
Week 24 · Non-adherence to ART
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adherence to ART if HIV-positive: High- vs. Low-Intensity Frontline Intervention With Matrix/Matrix + CM in Stage 2
Week 24 · HIV seroconversion by Week 24 / ART discontinuation by Week 24
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Adherence to ART if HIV-positive: High- vs. Low-Intensity Frontline Intervention With Matrix/Matrix + CM in Stage 2
Baseline · HIV seroconversion by Week 24 / ART discontinuation by Week 24
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Adherence to ART if HIV-positive: High- vs. Low-Intensity Frontline Intervention With Matrix/Matrix + CM in Stage 2
Week 24 · Adherence to ART
|
7 Participants
|
11 Participants
|
6 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Week 12 (end of Stage 1) and Week 24 (end of Stage 2)Population: Only participants classified as Stage 1 responders with completed assessments at week 12 and week 24 and HIV-negative were included in the analysis
HIV testing will be assessed based on whether HIV-negative participants received HIV testing services at each assessment point
Outcome measures
| Measure |
Received High Intensity Frontline Intervention in Stage 1 and SMS in Stage 2
n=181 Participants
The high-intensity frontline intervention consisted of 12 weeks of Contingency Management (CM), delivered through rewards for methamphetamine-negative urine samples. Participants who responded to Stage 1 continued to receive SMS reminders in Stage 2. SMS consisted of two daily reminders plus one weekly self-monitoring assessment, delivered for 12 weeks. This intervention was a Stage 2 add-on intervention for Stage 1 responders.
|
Received Low Intensity Frontline Intervention in Stage 1 and SMS in Stage 2
n=149 Participants
The low-intensity frontline intervention consisted of 6 weeks of CM, followed by 6 weeks of Group Education (GE). Participants who responded to Stage 1 continued to receive SMS reminders in Stage 2, consisting of two daily reminders plus one weekly self-monitoring assessment delivered for 12 weeks. This intervention was a Stage 2 add-on intervention for Stage 1 responders.
|
Received High Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 2
The high-intensity frontline intervention consisted of 12 weeks of CM. Participants who did not respond to Stage 1 were randomized and received the Matrix + CM intervention in Stage 2, attending 12 weekly Matrix group counseling sessions plus 12 weeks of CM. This intervention was a Stage 2 add-on intervention for Stage 1 non-responders.
|
Received Low Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 2
The low-intensity frontline intervention consisted of 6 weeks of CM, followed by 6 weeks of GE. Participants who did not respond to Stage 1 were randomized and received the Matrix + CM intervention in Stage 2, attending 12 weekly Matrix group counseling sessions plus 12 weeks of CM. This intervention was a Stage 2 add-on intervention for Stage 1 non-responders.
|
|---|---|---|---|---|
|
Frequency of HIV Testing if HIV-negative: High- vs. Low-Intensity Frontline Intervention With SMS in Stage 2
Week 12
|
181 Participants
|
148 Participants
|
—
|
—
|
|
Frequency of HIV Testing if HIV-negative: High- vs. Low-Intensity Frontline Intervention With SMS in Stage 2
Week 24
|
179 Participants
|
149 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12 (end of Stage 1) and Week 24 (end of Stage 2)Population: Only participants classified as Stage 1 non-responders with completed assessments at week 12 and week 24 and HIV-negative were included in the analysis
HIV testing will be assessed based on whether HIV-negative participants received HIV testing services at each assessment point
Outcome measures
| Measure |
Received High Intensity Frontline Intervention in Stage 1 and SMS in Stage 2
n=26 Participants
The high-intensity frontline intervention consisted of 12 weeks of Contingency Management (CM), delivered through rewards for methamphetamine-negative urine samples. Participants who responded to Stage 1 continued to receive SMS reminders in Stage 2. SMS consisted of two daily reminders plus one weekly self-monitoring assessment, delivered for 12 weeks. This intervention was a Stage 2 add-on intervention for Stage 1 responders.
|
Received Low Intensity Frontline Intervention in Stage 1 and SMS in Stage 2
n=52 Participants
The low-intensity frontline intervention consisted of 6 weeks of CM, followed by 6 weeks of Group Education (GE). Participants who responded to Stage 1 continued to receive SMS reminders in Stage 2, consisting of two daily reminders plus one weekly self-monitoring assessment delivered for 12 weeks. This intervention was a Stage 2 add-on intervention for Stage 1 responders.
|
Received High Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 2
n=35 Participants
The high-intensity frontline intervention consisted of 12 weeks of CM. Participants who did not respond to Stage 1 were randomized and received the Matrix + CM intervention in Stage 2, attending 12 weekly Matrix group counseling sessions plus 12 weeks of CM. This intervention was a Stage 2 add-on intervention for Stage 1 non-responders.
|
Received Low Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 2
n=44 Participants
The low-intensity frontline intervention consisted of 6 weeks of CM, followed by 6 weeks of GE. Participants who did not respond to Stage 1 were randomized and received the Matrix + CM intervention in Stage 2, attending 12 weekly Matrix group counseling sessions plus 12 weeks of CM. This intervention was a Stage 2 add-on intervention for Stage 1 non-responders.
|
|---|---|---|---|---|
|
Frequency of HIV Testing if HIV-negative: High- vs. Low-Intensity Frontline Intervention With Matrix/Matrix + CM in Stage 2
Week 24
|
26 Participants
|
52 Participants
|
35 Participants
|
44 Participants
|
|
Frequency of HIV Testing if HIV-negative: High- vs. Low-Intensity Frontline Intervention With Matrix/Matrix + CM in Stage 2
Week 12
|
25 Participants
|
52 Participants
|
35 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: Week 12 (end of Stage 1) and Week 24 (end of Stage 2)Population: Only participants classified as Stage 1 responders with completed assessments at week 12 and week 24 were included in the analysis
Opioid overdose will be assessed in the past 3 months through participant self-report using the question: "In the past 3 months, how many times have you had an opioid/heroin overdose?". Overdose is defined as an acute event due to heroin or other opioid use that required assistance from another person to recover (e.g., ambulance call, resuscitation, being awakened by others). This definition excludes episodes where the participant "just slept it off." Both non-fatal and fatal overdoses are included, and intentional overdoses (suicidal attempts) are also counted. For analysis, participants reporting at least one overdose in the past 3 months will be categorized as "Yes" for having experienced an overdose.
Outcome measures
| Measure |
Received High Intensity Frontline Intervention in Stage 1 and SMS in Stage 2
n=222 Participants
The high-intensity frontline intervention consisted of 12 weeks of Contingency Management (CM), delivered through rewards for methamphetamine-negative urine samples. Participants who responded to Stage 1 continued to receive SMS reminders in Stage 2. SMS consisted of two daily reminders plus one weekly self-monitoring assessment, delivered for 12 weeks. This intervention was a Stage 2 add-on intervention for Stage 1 responders.
|
Received Low Intensity Frontline Intervention in Stage 1 and SMS in Stage 2
n=192 Participants
The low-intensity frontline intervention consisted of 6 weeks of CM, followed by 6 weeks of Group Education (GE). Participants who responded to Stage 1 continued to receive SMS reminders in Stage 2, consisting of two daily reminders plus one weekly self-monitoring assessment delivered for 12 weeks. This intervention was a Stage 2 add-on intervention for Stage 1 responders.
|
Received High Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 2
The high-intensity frontline intervention consisted of 12 weeks of CM. Participants who did not respond to Stage 1 were randomized and received the Matrix + CM intervention in Stage 2, attending 12 weekly Matrix group counseling sessions plus 12 weeks of CM. This intervention was a Stage 2 add-on intervention for Stage 1 non-responders.
|
Received Low Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 2
The low-intensity frontline intervention consisted of 6 weeks of CM, followed by 6 weeks of GE. Participants who did not respond to Stage 1 were randomized and received the Matrix + CM intervention in Stage 2, attending 12 weekly Matrix group counseling sessions plus 12 weeks of CM. This intervention was a Stage 2 add-on intervention for Stage 1 non-responders.
|
|---|---|---|---|---|
|
Frequency of Opioid Overdose: High- vs. Low-Intensity Frontline Intervention With SMS in Stage 2
Week 12
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Frequency of Opioid Overdose: High- vs. Low-Intensity Frontline Intervention With SMS in Stage 2
Week 24
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12 (end of Stage 1) and Week 24 (end of Stage 2)Population: Only participants classified as Stage 1 non-responders with completed assessments at week 12 and week 24 were included in the analysis
Opioid overdose will be assessed in the past 3 months through participant self-report using the question: "In the past 3 months, how many times have you had an opioid/heroin overdose?". Overdose is defined as an acute event due to heroin or other opioid use that required assistance from another person to recover (e.g., ambulance call, resuscitation, being awakened by others). This definition excludes episodes where the participant "just slept it off." Both non-fatal and fatal overdoses are included, and intentional overdoses (suicidal attempts) are also counted. For analysis, participants reporting at least one overdose in the past 3 months will be categorized as "Yes" for having experienced an overdose.
Outcome measures
| Measure |
Received High Intensity Frontline Intervention in Stage 1 and SMS in Stage 2
n=31 Participants
The high-intensity frontline intervention consisted of 12 weeks of Contingency Management (CM), delivered through rewards for methamphetamine-negative urine samples. Participants who responded to Stage 1 continued to receive SMS reminders in Stage 2. SMS consisted of two daily reminders plus one weekly self-monitoring assessment, delivered for 12 weeks. This intervention was a Stage 2 add-on intervention for Stage 1 responders.
|
Received Low Intensity Frontline Intervention in Stage 1 and SMS in Stage 2
n=64 Participants
The low-intensity frontline intervention consisted of 6 weeks of CM, followed by 6 weeks of Group Education (GE). Participants who responded to Stage 1 continued to receive SMS reminders in Stage 2, consisting of two daily reminders plus one weekly self-monitoring assessment delivered for 12 weeks. This intervention was a Stage 2 add-on intervention for Stage 1 responders.
|
Received High Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 2
n=41 Participants
The high-intensity frontline intervention consisted of 12 weeks of CM. Participants who did not respond to Stage 1 were randomized and received the Matrix + CM intervention in Stage 2, attending 12 weekly Matrix group counseling sessions plus 12 weeks of CM. This intervention was a Stage 2 add-on intervention for Stage 1 non-responders.
|
Received Low Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 2
n=56 Participants
The low-intensity frontline intervention consisted of 6 weeks of CM, followed by 6 weeks of GE. Participants who did not respond to Stage 1 were randomized and received the Matrix + CM intervention in Stage 2, attending 12 weekly Matrix group counseling sessions plus 12 weeks of CM. This intervention was a Stage 2 add-on intervention for Stage 1 non-responders.
|
|---|---|---|---|---|
|
Frequency of Opioid Overdose: High- vs. Low-Intensity Frontline Intervention With Matrix/Matrix + CM in Stage 2
Week 12
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Opioid Overdose: High- vs. Low-Intensity Frontline Intervention With Matrix/Matrix + CM in Stage 2
Week 24
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (start of Stage 1) and week 24 (end of Stage 2)Population: Only participants classified as Stage 1 responders with completed assessments at week 24 were included in the analysis
Quality of life will be assessed using the EQ-5D-5L instrument, which includes five health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with five levels of severity. Responses will be converted into a single utility index score using the Vietnamese value set (https://doi.org/10.1007/s11136-020-02469-7), ranging from 0-1, where higher scores indicate better health-related quality of life. In addition, participants will rate their overall health on the EQ Visual Analogue Scale (VAS), ranging from 0 ("worst imaginable health") to 100 ("best imaginable health"), with higher scores reflecting better perceived health. Both the EQ-5D-5L utility index and the VAS score will be analyzed as continuous outcomes.
Outcome measures
| Measure |
Received High Intensity Frontline Intervention in Stage 1 and SMS in Stage 2
n=222 Participants
The high-intensity frontline intervention consisted of 12 weeks of Contingency Management (CM), delivered through rewards for methamphetamine-negative urine samples. Participants who responded to Stage 1 continued to receive SMS reminders in Stage 2. SMS consisted of two daily reminders plus one weekly self-monitoring assessment, delivered for 12 weeks. This intervention was a Stage 2 add-on intervention for Stage 1 responders.
|
Received Low Intensity Frontline Intervention in Stage 1 and SMS in Stage 2
n=192 Participants
The low-intensity frontline intervention consisted of 6 weeks of CM, followed by 6 weeks of Group Education (GE). Participants who responded to Stage 1 continued to receive SMS reminders in Stage 2, consisting of two daily reminders plus one weekly self-monitoring assessment delivered for 12 weeks. This intervention was a Stage 2 add-on intervention for Stage 1 responders.
|
Received High Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 2
The high-intensity frontline intervention consisted of 12 weeks of CM. Participants who did not respond to Stage 1 were randomized and received the Matrix + CM intervention in Stage 2, attending 12 weekly Matrix group counseling sessions plus 12 weeks of CM. This intervention was a Stage 2 add-on intervention for Stage 1 non-responders.
|
Received Low Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 2
The low-intensity frontline intervention consisted of 6 weeks of CM, followed by 6 weeks of GE. Participants who did not respond to Stage 1 were randomized and received the Matrix + CM intervention in Stage 2, attending 12 weekly Matrix group counseling sessions plus 12 weeks of CM. This intervention was a Stage 2 add-on intervention for Stage 1 non-responders.
|
|---|---|---|---|---|
|
Changes in Quality of Life: High- vs. Low-Intensity Frontline Intervention With SMS in Stage 2
Baseline EQ-5D-5L value
|
0.9 score on a scale
Standard Deviation 0.1
|
0.9 score on a scale
Standard Deviation 0.1
|
—
|
—
|
|
Changes in Quality of Life: High- vs. Low-Intensity Frontline Intervention With SMS in Stage 2
Baseline VAS
|
74.8 score on a scale
Standard Deviation 14.7
|
74.4 score on a scale
Standard Deviation 14.9
|
—
|
—
|
|
Changes in Quality of Life: High- vs. Low-Intensity Frontline Intervention With SMS in Stage 2
Week 24 EQ-5D-5L value
|
1.0 score on a scale
Standard Deviation 0.1
|
1.0 score on a scale
Standard Deviation 0.1
|
—
|
—
|
|
Changes in Quality of Life: High- vs. Low-Intensity Frontline Intervention With SMS in Stage 2
Week 24 VAS
|
78.2 score on a scale
Standard Deviation 12.5
|
75.9 score on a scale
Standard Deviation 14.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (start of Stage 1) and week 24 (end of Stage 2)Population: Only participants classified as Stage 1 non-responders with completed assessments at week 24 were included in the analysis
Quality of life will be assessed using the EQ-5D-5L instrument, which includes five health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with five levels of severity. Responses will be converted into a single utility index score using the Vietnamese value set (https://doi.org/10.1007/s11136-020-02469-7) ranging from 0-1, where higher scores indicate better health-related quality of life. In addition, participants will rate their overall health on the EQ Visual Analogue Scale (VAS), ranging from 0 ("worst imaginable health") to 100 ("best imaginable health"), with higher scores reflecting better perceived health. Both the EQ-5D-5L utility index and the VAS score will be analyzed as continuous outcomes.
Outcome measures
| Measure |
Received High Intensity Frontline Intervention in Stage 1 and SMS in Stage 2
n=33 Participants
The high-intensity frontline intervention consisted of 12 weeks of Contingency Management (CM), delivered through rewards for methamphetamine-negative urine samples. Participants who responded to Stage 1 continued to receive SMS reminders in Stage 2. SMS consisted of two daily reminders plus one weekly self-monitoring assessment, delivered for 12 weeks. This intervention was a Stage 2 add-on intervention for Stage 1 responders.
|
Received Low Intensity Frontline Intervention in Stage 1 and SMS in Stage 2
n=66 Participants
The low-intensity frontline intervention consisted of 6 weeks of CM, followed by 6 weeks of Group Education (GE). Participants who responded to Stage 1 continued to receive SMS reminders in Stage 2, consisting of two daily reminders plus one weekly self-monitoring assessment delivered for 12 weeks. This intervention was a Stage 2 add-on intervention for Stage 1 responders.
|
Received High Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 2
n=41 Participants
The high-intensity frontline intervention consisted of 12 weeks of CM. Participants who did not respond to Stage 1 were randomized and received the Matrix + CM intervention in Stage 2, attending 12 weekly Matrix group counseling sessions plus 12 weeks of CM. This intervention was a Stage 2 add-on intervention for Stage 1 non-responders.
|
Received Low Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 2
n=56 Participants
The low-intensity frontline intervention consisted of 6 weeks of CM, followed by 6 weeks of GE. Participants who did not respond to Stage 1 were randomized and received the Matrix + CM intervention in Stage 2, attending 12 weekly Matrix group counseling sessions plus 12 weeks of CM. This intervention was a Stage 2 add-on intervention for Stage 1 non-responders.
|
|---|---|---|---|---|
|
Changes in Quality of Life: High- vs. Low-Intensity Frontline Intervention With Matrix/Matrix + CM in Stage 2
Week 24 EQ-5D-5L value
|
1.0 score on a scale
Standard Deviation 0.1
|
0.9 score on a scale
Standard Deviation 0.1
|
0.9 score on a scale
Standard Deviation 0.1
|
0.9 score on a scale
Standard Deviation 0.2
|
|
Changes in Quality of Life: High- vs. Low-Intensity Frontline Intervention With Matrix/Matrix + CM in Stage 2
Baseline EQ-5D-5L value
|
1.0 score on a scale
Standard Deviation 0.1
|
0.9 score on a scale
Standard Deviation 0.1
|
0.9 score on a scale
Standard Deviation 0.1
|
0.9 score on a scale
Standard Deviation 0.1
|
|
Changes in Quality of Life: High- vs. Low-Intensity Frontline Intervention With Matrix/Matrix + CM in Stage 2
Baseline VAS
|
73.8 score on a scale
Standard Deviation 16.4
|
74.4 score on a scale
Standard Deviation 15.6
|
73.5 score on a scale
Standard Deviation 14.7
|
73.3 score on a scale
Standard Deviation 16.0
|
|
Changes in Quality of Life: High- vs. Low-Intensity Frontline Intervention With Matrix/Matrix + CM in Stage 2
Week 24 VAS
|
74.6 score on a scale
Standard Deviation 16.4
|
71.4 score on a scale
Standard Deviation 17.6
|
72.6 score on a scale
Standard Deviation 15.1
|
75.1 score on a scale
Standard Deviation 16.9
|
Adverse Events
Low Intensity Frontline + SMS Reminders
Serious events: 5 serious events
Other events: 3 other events
Deaths: 1 deaths
Low Intensity Frontline + Matrix Only
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Low Intensity Frontline + Matrix + Contingency Management
Serious events: 3 serious events
Other events: 1 other events
Deaths: 1 deaths
High Intensity Frontline + SMS Reminders
Serious events: 14 serious events
Other events: 1 other events
Deaths: 1 deaths
High Intensity Frontline + Matrix Only
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
High Intensity Frontline + Matrix + Contingency Management
Serious events: 5 serious events
Other events: 0 other events
Deaths: 2 deaths
High Intensity Frontline Intervention
Serious events: 7 serious events
Other events: 2 other events
Deaths: 2 deaths
Low Intensity Frontline Intervention
Serious events: 9 serious events
Other events: 4 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Low Intensity Frontline + SMS Reminders
n=198 participants at risk
Participants who receive the low intensity frontline intervention and SMS reminders in the adaptive phase
|
Low Intensity Frontline + Matrix Only
n=68 participants at risk
Participants who receive the low intensity frontline intervention and Matrix in the adaptive phase
|
Low Intensity Frontline + Matrix + Contingency Management
n=62 participants at risk
Participants who receive the low intensity frontline intervention and Matrix plus contingency management in the adaptive phase
|
High Intensity Frontline + SMS Reminders
n=230 participants at risk
Participants who receive the high intensity frontline intervention and SMS reminders in the adaptive phase
|
High Intensity Frontline + Matrix Only
n=40 participants at risk
Participants who receive the high intensity frontline intervention and Matrix in the adaptive phase
|
High Intensity Frontline + Matrix + Contingency Management
n=45 participants at risk
Participants who receive the high intensity frontline intervention and Matrix plus contingency management in the adaptive phase
|
High Intensity Frontline Intervention
n=328 participants at risk
Participants randomized to the high intensity frontline intervention arm (12 weeks of contingency management)
|
Low Intensity Frontline Intervention
n=337 participants at risk
Participants randomized into the low intensity frontline intervention arm (6 weeks of contingency management plus 6 weeks of group education0
|
|---|---|---|---|---|---|---|---|---|
|
Social circumstances
Incarceration
|
1.0%
2/198 • Number of events 2 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
2.9%
2/68 • Number of events 2 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
3.2%
2/62 • Number of events 2 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
1.7%
4/230 • Number of events 4 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
5.0%
2/40 • Number of events 2 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
0.00%
0/45 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
1.2%
4/328 • Number of events 4 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
1.2%
4/337 • Number of events 4 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
|
Social circumstances
Sent to compulsory drug rehabilitation programs
|
1.5%
3/198 • Number of events 3 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
5.9%
4/68 • Number of events 4 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
1.6%
1/62 • Number of events 1 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
3.9%
9/230 • Number of events 9 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
7.5%
3/40 • Number of events 3 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
6.7%
3/45 • Number of events 3 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
0.61%
2/328 • Number of events 2 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
0.59%
2/337 • Number of events 2 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
|
Psychiatric disorders
Hospitalization
|
0.00%
0/198 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
0.00%
0/68 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
0.00%
0/62 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
0.00%
0/230 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
2.5%
1/40 • Number of events 1 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
2.2%
1/45 • Number of events 1 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
0.30%
1/328 • Number of events 1 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
0.00%
0/337 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
|
Gastrointestinal disorders
Hospitalization
|
0.00%
0/198 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
0.00%
0/68 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
0.00%
0/62 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
0.43%
1/230 • Number of events 1 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
2.5%
1/40 • Number of events 1 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
0.00%
0/45 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
0.00%
0/328 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
0.89%
3/337 • Number of events 3 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
|
Surgical and medical procedures
Hospitalization
|
0.00%
0/198 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
0.00%
0/68 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
0.00%
0/62 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
0.00%
0/230 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
0.00%
0/40 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
2.2%
1/45 • Number of events 1 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
0.00%
0/328 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
0.00%
0/337 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
Other adverse events
| Measure |
Low Intensity Frontline + SMS Reminders
n=198 participants at risk
Participants who receive the low intensity frontline intervention and SMS reminders in the adaptive phase
|
Low Intensity Frontline + Matrix Only
n=68 participants at risk
Participants who receive the low intensity frontline intervention and Matrix in the adaptive phase
|
Low Intensity Frontline + Matrix + Contingency Management
n=62 participants at risk
Participants who receive the low intensity frontline intervention and Matrix plus contingency management in the adaptive phase
|
High Intensity Frontline + SMS Reminders
n=230 participants at risk
Participants who receive the high intensity frontline intervention and SMS reminders in the adaptive phase
|
High Intensity Frontline + Matrix Only
n=40 participants at risk
Participants who receive the high intensity frontline intervention and Matrix in the adaptive phase
|
High Intensity Frontline + Matrix + Contingency Management
n=45 participants at risk
Participants who receive the high intensity frontline intervention and Matrix plus contingency management in the adaptive phase
|
High Intensity Frontline Intervention
n=328 participants at risk
Participants randomized to the high intensity frontline intervention arm (12 weeks of contingency management)
|
Low Intensity Frontline Intervention
n=337 participants at risk
Participants randomized into the low intensity frontline intervention arm (6 weeks of contingency management plus 6 weeks of group education0
|
|---|---|---|---|---|---|---|---|---|
|
General disorders
COVID-19 infection (mild to moderate)
|
1.0%
2/198 • Number of events 2 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
0.00%
0/68 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
0.00%
0/62 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
0.00%
0/230 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
0.00%
0/40 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
0.00%
0/45 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
0.61%
2/328 • Number of events 2 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
1.2%
4/337 • Number of events 4 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
|
Musculoskeletal and connective tissue disorders
Accidents and injuries
|
0.51%
1/198 • Number of events 1 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
0.00%
0/68 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
1.6%
1/62 • Number of events 1 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
0.43%
1/230 • Number of events 1 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
0.00%
0/40 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
0.00%
0/45 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
0.00%
0/328 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
0.00%
0/337 • Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.
Adverse events in this trial are defined as medical issues that do not require hospitalization. Serious adverse events are defined as life-threatening events such (e.g., suicide, opioid overdose) or other events that have a negative impact on participants' life such as incarceration or compulsory drug rehabilitation.
|
Additional Information
Le Minh Giang - Principal Investigator
Hanoi Medical University
Phone: +84913281842
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place