Trial Outcomes & Findings for Examining Community-based Effectiveness of a Substance Use and HIV Risk Reduction Intervention for Young Men of Color (NCT NCT03488914)
NCT ID: NCT03488914
Last Updated: 2024-05-08
Results Overview
The self-reported number of illicit drug use days (not including marijuana) in the past 90 days
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
86 participants
Primary outcome timeframe
Baseline, 3-Month, 6-Month, 9-Month, 12-Month, 15-Month
Results posted on
2024-05-08
Participant Flow
Participant milestones
| Measure |
Intervention
The YMHP intervention is a 4 session Motivational Interviewing (MI) intervention. In session 1, youth will choose which behavior to discuss first (substance use or sexual risk behavior), and the Health Educator counselor will elicit the client's view of the problem using standard MI techniques, building motivation for change by eliciting and reinforcing change talk, and clarifying the youth's own personal goals for maintaining their sexual health/considering changes in their substance use. The second session follows the same format for the second target behavior. In the subsequent two sessions, the counselor will discuss Pre-exposure Prophylaxis (PrEP) uptake as part of a change plan, continue to elicit and reinforce change talk, problem-solve barriers, consolidate commitment, and consider strategies to maintain behavior change.
YMHP Intervention
|
Enhanced Treatment as Usual
The Enhanced Treatment as Usual arm involves referring youth to standard of care services available at the community based organization for substance use and sexual health. This includes available services for Pre-exposure prophylaxis.
Enhanced Treatment as Usual
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
39
|
|
Overall Study
COMPLETED
|
47
|
39
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Examining Community-based Effectiveness of a Substance Use and HIV Risk Reduction Intervention for Young Men of Color
Baseline characteristics by cohort
| Measure |
Intervention
n=47 Participants
The YMHP intervention is a 4 session Motivational Interviewing (MI) intervention. In session 1, youth will choose which behavior to discuss first (substance use or sexual risk behavior), and the Health Educator counselor will elicit the client's view of the problem using standard MI techniques, building motivation for change by eliciting and reinforcing change talk, and clarifying the youth's own personal goals for maintaining their sexual health/considering changes in their substance use. The second session follows the same format for the second target behavior. In the subsequent two sessions, the counselor will discuss Pre-exposure Prophylaxis (PrEP) uptake as part of a change plan, continue to elicit and reinforce change talk, problem-solve barriers, consolidate commitment, and consider strategies to maintain behavior change.
YMHP Intervention
|
Enhanced Treatment as Usual
n=39 Participants
The Enhanced Treatment as Usual arm involves referring youth to standard of care services available at the community based organization for substance use and sexual health. This includes available services for Pre-exposure prophylaxis.
Enhanced Treatment as Usual
|
Total
n=86 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
24.5 years
STANDARD_DEVIATION 3.37 • n=5 Participants
|
24.3 years
STANDARD_DEVIATION 3.21 • n=7 Participants
|
24.4 years
STANDARD_DEVIATION 3.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black
|
10 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Latino
|
22 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Site
Study Site 1
|
33 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Site
Study Site 2
|
14 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Relationship Status
Single
|
37 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Relationship Status
Partnered
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Education
4-Year College Degree
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Education
Less than 4-Year Degree
|
26 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Education
Missing
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Employment
Part-time
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Employment
Full-time
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Employment
Missing
|
31 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3-Month, 6-Month, 9-Month, 12-Month, 15-MonthPopulation: Intent-to-treat population
The self-reported number of illicit drug use days (not including marijuana) in the past 90 days
Outcome measures
| Measure |
Intervention
n=47 Participants
The YMHP intervention is a 4 session Motivational Interviewing (MI) intervention. In session 1, youth will choose which behavior to discuss first (substance use or sexual risk behavior), and the Health Educator counselor will elicit the client's view of the problem using standard MI techniques, building motivation for change by eliciting and reinforcing change talk, and clarifying the youth's own personal goals for maintaining their sexual health/considering changes in their substance use. The second session follows the same format for the second target behavior. In the subsequent two sessions, the counselor will discuss Pre-exposure Prophylaxis (PrEP) uptake as part of a change plan, continue to elicit and reinforce change talk, problem-solve barriers, consolidate commitment, and consider strategies to maintain behavior change.
YMHP Intervention
|
Enhanced Treatment as Usual
n=39 Participants
The Enhanced Treatment as Usual arm involves referring youth to standard of care services available at the community based organization for substance use and sexual health. This includes available services for Pre-exposure prophylaxis.
Enhanced Treatment as Usual
|
|---|---|---|
|
Illicit Drug Use Days
Baseline
|
3.04 days
Standard Deviation 7.05
|
11.62 days
Standard Deviation 6.04
|
|
Illicit Drug Use Days
3-Month
|
2.00 days
Standard Deviation 5.03
|
6.04 days
Standard Deviation 11.10
|
|
Illicit Drug Use Days
6-Month
|
1.19 days
Standard Deviation 2.97
|
6.29 days
Standard Deviation 12.48
|
|
Illicit Drug Use Days
9-Month
|
3.81 days
Standard Deviation 8.19
|
3.77 days
Standard Deviation 9.08
|
|
Illicit Drug Use Days
12-Month
|
2.00 days
Standard Deviation 4.83
|
4.35 days
Standard Deviation 11.37
|
|
Illicit Drug Use Days
15-Month
|
2.08 days
Standard Deviation 5.25
|
6.19 days
Standard Deviation 11.30
|
PRIMARY outcome
Timeframe: Baseline, 3-Month, 6-Month, 9-Month, 12-Month, 15-MonthPopulation: intent-to-treat population
The self-reported number of condomless anal sex acts with male partners in the past 90 days
Outcome measures
| Measure |
Intervention
n=47 Participants
The YMHP intervention is a 4 session Motivational Interviewing (MI) intervention. In session 1, youth will choose which behavior to discuss first (substance use or sexual risk behavior), and the Health Educator counselor will elicit the client's view of the problem using standard MI techniques, building motivation for change by eliciting and reinforcing change talk, and clarifying the youth's own personal goals for maintaining their sexual health/considering changes in their substance use. The second session follows the same format for the second target behavior. In the subsequent two sessions, the counselor will discuss Pre-exposure Prophylaxis (PrEP) uptake as part of a change plan, continue to elicit and reinforce change talk, problem-solve barriers, consolidate commitment, and consider strategies to maintain behavior change.
YMHP Intervention
|
Enhanced Treatment as Usual
n=39 Participants
The Enhanced Treatment as Usual arm involves referring youth to standard of care services available at the community based organization for substance use and sexual health. This includes available services for Pre-exposure prophylaxis.
Enhanced Treatment as Usual
|
|---|---|---|
|
Condomless Anal Sex Acts
Baseline
|
10.38 acts
Standard Deviation 13.02
|
14.36 acts
Standard Deviation 15.59
|
|
Condomless Anal Sex Acts
3-Months
|
9.71 acts
Standard Deviation 17.5
|
9.47 acts
Standard Deviation 14.88
|
|
Condomless Anal Sex Acts
6-Months
|
3.38 acts
Standard Deviation 5.16
|
11.14 acts
Standard Deviation 16.49
|
|
Condomless Anal Sex Acts
9-Months
|
12.45 acts
Standard Deviation 15.28
|
10.92 acts
Standard Deviation 16.01
|
|
Condomless Anal Sex Acts
12-Months
|
7.3 acts
Standard Deviation 10.32
|
6.88 acts
Standard Deviation 11.83
|
|
Condomless Anal Sex Acts
15-Months
|
6.56 acts
Standard Deviation 9.02
|
10 acts
Standard Deviation 11.99
|
PRIMARY outcome
Timeframe: Baseline, 3-Month, 6-Month, 9-Month, 12-Month, 15-MonthPopulation: intent-to-treat population
The self-reported number of marijuana use days in the past 90 days
Outcome measures
| Measure |
Intervention
n=47 Participants
The YMHP intervention is a 4 session Motivational Interviewing (MI) intervention. In session 1, youth will choose which behavior to discuss first (substance use or sexual risk behavior), and the Health Educator counselor will elicit the client's view of the problem using standard MI techniques, building motivation for change by eliciting and reinforcing change talk, and clarifying the youth's own personal goals for maintaining their sexual health/considering changes in their substance use. The second session follows the same format for the second target behavior. In the subsequent two sessions, the counselor will discuss Pre-exposure Prophylaxis (PrEP) uptake as part of a change plan, continue to elicit and reinforce change talk, problem-solve barriers, consolidate commitment, and consider strategies to maintain behavior change.
YMHP Intervention
|
Enhanced Treatment as Usual
n=39 Participants
The Enhanced Treatment as Usual arm involves referring youth to standard of care services available at the community based organization for substance use and sexual health. This includes available services for Pre-exposure prophylaxis.
Enhanced Treatment as Usual
|
|---|---|---|
|
Marijuana Use Days
Baseline
|
33.11 days
Standard Deviation 32.59
|
46.15 days
Standard Deviation 36.14
|
|
Marijuana Use Days
3-Months
|
34.19 days
Standard Deviation 36.97
|
44.39 days
Standard Deviation 42.45
|
|
Marijuana Use Days
6-Months
|
35.81 days
Standard Deviation 39.4
|
24.50 days
Standard Deviation 32.86
|
|
Marijuana Use Days
9-Months
|
32.52 days
Standard Deviation 35.26
|
42 days
Standard Deviation 39.57
|
|
Marijuana Use Days
12-Months
|
37.75 days
Standard Deviation 36.93
|
29.24 days
Standard Deviation 39.22
|
|
Marijuana Use Days
15-Months
|
25.08 days
Standard Deviation 32.64
|
36.06 days
Standard Deviation 40.25
|
SECONDARY outcome
Timeframe: Baseline, 3-Month, 6-Month, 9-Month, 12-Month, 15-MonthThe self-reported number of alcohol use days in the past 90 days
Outcome measures
| Measure |
Intervention
n=47 Participants
The YMHP intervention is a 4 session Motivational Interviewing (MI) intervention. In session 1, youth will choose which behavior to discuss first (substance use or sexual risk behavior), and the Health Educator counselor will elicit the client's view of the problem using standard MI techniques, building motivation for change by eliciting and reinforcing change talk, and clarifying the youth's own personal goals for maintaining their sexual health/considering changes in their substance use. The second session follows the same format for the second target behavior. In the subsequent two sessions, the counselor will discuss Pre-exposure Prophylaxis (PrEP) uptake as part of a change plan, continue to elicit and reinforce change talk, problem-solve barriers, consolidate commitment, and consider strategies to maintain behavior change.
YMHP Intervention
|
Enhanced Treatment as Usual
n=39 Participants
The Enhanced Treatment as Usual arm involves referring youth to standard of care services available at the community based organization for substance use and sexual health. This includes available services for Pre-exposure prophylaxis.
Enhanced Treatment as Usual
|
|---|---|---|
|
Alcohol Use Days
12-Months
|
14.45 days
Standard Deviation 18.72
|
18.53 days
Standard Deviation 21.16
|
|
Alcohol Use Days
Baseline
|
20.26 days
Standard Deviation 22.15
|
30.10 days
Standard Deviation 27.14
|
|
Alcohol Use Days
3-Months
|
18.81 days
Standard Deviation 26.42
|
27.04 days
Standard Deviation 28.57
|
|
Alcohol Use Days
6-Months
|
9.94 days
Standard Deviation 11.64
|
20.29 days
Standard Deviation 21.88
|
|
Alcohol Use Days
9-Months
|
16.08 days
Standard Deviation 20.98
|
27.31 days
Standard Deviation 21.76
|
|
Alcohol Use Days
15-Months
|
11.35 days
Standard Deviation 14.05
|
17.75 days
Standard Deviation 20.52
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced Treatment as Usual
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place