Trial Outcomes & Findings for Young Men's Health Project Targeting HIV Risk Reduction and Substance Abuse (NCT NCT03577301)
NCT ID: NCT03577301
Last Updated: 2024-09-03
Results Overview
The self-reported number of illicit drug use days (not including marijuana) in the past 30 days
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
83 participants
Primary outcome timeframe
baseline, 3 months, 6 months, 9 months, 12 months
Results posted on
2024-09-03
Participant Flow
Participant milestones
| Measure |
Clinic-based Delivery
Participants will receive the intervention in person following HIV counseling and testing. The intervention involves completion of the 4 YMHP sessions and the delivery of pre-exposure prophylaxis (PrEP) information and navigation services to interested participants. This arm is closed to enrollment.
Clinic-based Delivery: A minimum of 2 community health workers (CHWs) will be trained to deliver clinic-based intervention sessions.
|
Remote Delivery
Participants will receive the intervention by remote delivery following HIV counseling and testing. Just as the clinic-based participants, he intervention involves completion of the 4 YMHP sessions and the delivery of pre-exposure prophylaxis (PrEP) information and navigation services to interested participants. This arm is closed to enrollment.
Remote Delivery: A minimum of 2 community health workers (CHWs) will be trained to deliver intervention sessions to the participant in a location remote from the clinic setting.
|
Multi-modal Delivery
A 4 session MI intervention. Session 1 is always delivered in person immediately after baseline. Session 2-4 can be delivered in person or remotely based upon youth preference. This arm is open to enrollment as of 11/15/2019.
Multi-modal Delivery: A minimum of 2 community health workers (CHWs) will be trained to deliver clinic-based or remote intervention sessions. First MI session is in person immediately after baseline. Sessions 2-4 can be delivered in person or remotely based on youth preference.
|
Treatment as Usual
Treatment as usual control = individual HIV testing with referrals and link age to care as provided by the sites under routine circumstances. This arm is open to enrollment as of 11/15/2019.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
24
|
21
|
16
|
22
|
|
Overall Study
COMPLETED
|
24
|
21
|
16
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Young Men's Health Project Targeting HIV Risk Reduction and Substance Abuse
Baseline characteristics by cohort
| Measure |
Clinic-based Delivery
n=24 Participants
Participants will receive the intervention in person following HIV counseling and testing. The intervention involves completion of the 4 YMHP sessions and the delivery of pre-exposure prophylaxis (PrEP) information and navigation services to interested participants. This arm is closed to enrollment.
Clinic-based Delivery: A minimum of 2 community health workers (CHWs) will be trained to deliver clinic-based intervention sessions.
|
Remote Delivery
n=21 Participants
Participants will receive the intervention by remote delivery following HIV counseling and testing. Just as the clinic-based participants, he intervention involves completion of the 4 YMHP sessions and the delivery of pre-exposure prophylaxis (PrEP) information and navigation services to interested participants. This arm is closed to enrollment.
Remote Delivery: A minimum of 2 community health workers (CHWs) will be trained to deliver intervention sessions to the participant in a location remote from the clinic setting.
|
Multi-modal Delivery
n=16 Participants
A 4 session MI intervention. Session 1 is always delivered in person immediately after baseline. Session 2-4 can be delivered in person or remotely based upon youth preference. This arm is open to enrollment as of 11/15/2019.
Multi-modal Delivery: A minimum of 2 community health workers (CHWs) will be trained to deliver clinic-based or remote intervention sessions. First MI session is in person immediately after baseline. Sessions 2-4 can be delivered in person or remotely based on youth preference.
|
Treatment as Usual
n=22 Participants
Treatment as usual control = individual HIV testing with referrals and link age to care as provided by the sites under routine circumstances. This arm is open to enrollment as of 11/15/2019.
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
21 Participants
n=7 Participants
|
71 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
83 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
31 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Latino
|
9 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
30 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other/Multiracial
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
|
Sexual Identity
Gay/Queer
|
18 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
64 Participants
n=31 Participants
|
|
Sexual Identity
Bisexual/Other
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
19 Participants
n=31 Participants
|
|
Site
Site 1
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
16 Participants
n=31 Participants
|
|
Site
Site 2
|
12 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
50 Participants
n=31 Participants
|
|
Site
Site 3
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
17 Participants
n=31 Participants
|
|
Relationship Status
Single
|
16 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
47 Participants
n=31 Participants
|
|
Relationship Status
Partnered
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
36 Participants
n=31 Participants
|
|
Education
4-Year College Degree or more
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=31 Participants
|
|
Education
Some college of Associates Degree
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
45 Participants
n=31 Participants
|
|
Education
Some High School
|
8 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
23 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: baseline, 3 months, 6 months, 9 months, 12 monthsPopulation: Intent to treat population
The self-reported number of illicit drug use days (not including marijuana) in the past 30 days
Outcome measures
| Measure |
Clinic-based Delivery
n=24 Participants
Participants will receive the intervention in person following HIV counseling and testing. The intervention involves completion of the 4 YMHP sessions and the delivery of pre-exposure prophylaxis (PrEP) information and navigation services to interested participants. This arm is closed to enrollment.
Clinic-based Delivery: A minimum of 2 community health workers (CHWs) will be trained to deliver clinic-based intervention sessions.
|
Remote Delivery
n=21 Participants
Participants will receive the intervention by remote delivery following HIV counseling and testing. Just as the clinic-based participants, he intervention involves completion of the 4 YMHP sessions and the delivery of pre-exposure prophylaxis (PrEP) information and navigation services to interested participants. This arm is closed to enrollment.
Remote Delivery: A minimum of 2 community health workers (CHWs) will be trained to deliver intervention sessions to the participant in a location remote from the clinic setting.
|
Multi-modal Delivery
n=16 Participants
A 4 session MI intervention. Session 1 is always delivered in person immediately after baseline. Session 2-4 can be delivered in person or remotely based upon youth preference. This arm is open to enrollment as of 11/15/2019.
Multi-modal Delivery: A minimum of 2 community health workers (CHWs) will be trained to deliver clinic-based or remote intervention sessions. First MI session is in person immediately after baseline. Sessions 2-4 can be delivered in person or remotely based on youth preference.
|
Treatment as Usual
n=22 Participants
Treatment as usual control = individual HIV testing with referrals and link age to care as provided by the sites under routine circumstances. This arm is open to enrollment as of 11/15/2019.
|
|---|---|---|---|---|
|
Illicit Drug Use Days
Use at 9 Months
|
1.58 Number of Days
Standard Deviation 3.70
|
3.46 Number of Days
Standard Deviation 8.35
|
7.45 Number of Days
Standard Deviation 23.09
|
10.93 Number of Days
Standard Deviation 34.99
|
|
Illicit Drug Use Days
Use at Baseline
|
3.17 Number of Days
Standard Deviation 4.10
|
3.10 Number of Days
Standard Deviation 7.37
|
3.25 Number of Days
Standard Deviation 5.99
|
2.86 Number of Days
Standard Deviation 6.76
|
|
Illicit Drug Use Days
Use at 3 Months
|
9.00 Number of Days
Standard Deviation 19.16
|
5.12 Number of Days
Standard Deviation 10.89
|
2.55 Number of Days
Standard Deviation 5.66
|
9.21 Number of Days
Standard Deviation 29.62
|
|
Illicit Drug Use Days
Use at 6 Months
|
9.64 Number of Days
Standard Deviation 24.38
|
5.93 Number of Days
Standard Deviation 16.04
|
3.23 Number of Days
Standard Deviation 9.03
|
2.64 Number of Days
Standard Deviation 6.17
|
|
Illicit Drug Use Days
Use at 12 Months
|
9.91 Number of Days
Standard Deviation 27.70
|
3.80 Number of Days
Standard Deviation 9.27
|
1.00 Number of Days
Standard Deviation 1.89
|
1.33 Number of Days
Standard Deviation 1.21
|
PRIMARY outcome
Timeframe: baseline, 3 months, 6 months, 9 months, 12 monthsPopulation: Intent to treat population
The self-reported number of condomless anal sex acts with male partners in the last 30 days prior to assessment point.
Outcome measures
| Measure |
Clinic-based Delivery
n=24 Participants
Participants will receive the intervention in person following HIV counseling and testing. The intervention involves completion of the 4 YMHP sessions and the delivery of pre-exposure prophylaxis (PrEP) information and navigation services to interested participants. This arm is closed to enrollment.
Clinic-based Delivery: A minimum of 2 community health workers (CHWs) will be trained to deliver clinic-based intervention sessions.
|
Remote Delivery
n=21 Participants
Participants will receive the intervention by remote delivery following HIV counseling and testing. Just as the clinic-based participants, he intervention involves completion of the 4 YMHP sessions and the delivery of pre-exposure prophylaxis (PrEP) information and navigation services to interested participants. This arm is closed to enrollment.
Remote Delivery: A minimum of 2 community health workers (CHWs) will be trained to deliver intervention sessions to the participant in a location remote from the clinic setting.
|
Multi-modal Delivery
n=16 Participants
A 4 session MI intervention. Session 1 is always delivered in person immediately after baseline. Session 2-4 can be delivered in person or remotely based upon youth preference. This arm is open to enrollment as of 11/15/2019.
Multi-modal Delivery: A minimum of 2 community health workers (CHWs) will be trained to deliver clinic-based or remote intervention sessions. First MI session is in person immediately after baseline. Sessions 2-4 can be delivered in person or remotely based on youth preference.
|
Treatment as Usual
n=22 Participants
Treatment as usual control = individual HIV testing with referrals and link age to care as provided by the sites under routine circumstances. This arm is open to enrollment as of 11/15/2019.
|
|---|---|---|---|---|
|
Condomless Anal Sex Acts
Baseline
|
5.9 Acts in the past 30 days
Standard Deviation 4.91
|
4.5 Acts in the past 30 days
Standard Deviation 8.6
|
6.9 Acts in the past 30 days
Standard Deviation 8.98
|
10.0 Acts in the past 30 days
Standard Deviation 14.54
|
|
Condomless Anal Sex Acts
3 Month
|
3.1 Acts in the past 30 days
Standard Deviation 4.44
|
5.9 Acts in the past 30 days
Standard Deviation 12.81
|
6.8 Acts in the past 30 days
Standard Deviation 10.20
|
10.2 Acts in the past 30 days
Standard Deviation 20.20
|
|
Condomless Anal Sex Acts
6 Month
|
5.4 Acts in the past 30 days
Standard Deviation 8.18
|
4.4 Acts in the past 30 days
Standard Deviation 10.57
|
8.9 Acts in the past 30 days
Standard Deviation 13.74
|
10.6 Acts in the past 30 days
Standard Deviation 23.93
|
|
Condomless Anal Sex Acts
9 Month
|
11.0 Acts in the past 30 days
Standard Deviation 14.75
|
13.6 Acts in the past 30 days
Standard Deviation 30.07
|
13.2 Acts in the past 30 days
Standard Deviation 18.19
|
20.6 Acts in the past 30 days
Standard Deviation 48.34
|
|
Condomless Anal Sex Acts
12 Month
|
10.8 Acts in the past 30 days
Standard Deviation 18.30
|
2.3 Acts in the past 30 days
Standard Deviation 5.58
|
11.9 Acts in the past 30 days
Standard Deviation 16.98
|
1.2 Acts in the past 30 days
Standard Deviation 1.30
|
PRIMARY outcome
Timeframe: baseline, 3 months, 6 months, 9 months, 12 monthsPopulation: Intent to treat population
The self-reported number of marijuana use days in the past 30 days prior to assessment point.
Outcome measures
| Measure |
Clinic-based Delivery
n=24 Participants
Participants will receive the intervention in person following HIV counseling and testing. The intervention involves completion of the 4 YMHP sessions and the delivery of pre-exposure prophylaxis (PrEP) information and navigation services to interested participants. This arm is closed to enrollment.
Clinic-based Delivery: A minimum of 2 community health workers (CHWs) will be trained to deliver clinic-based intervention sessions.
|
Remote Delivery
n=21 Participants
Participants will receive the intervention by remote delivery following HIV counseling and testing. Just as the clinic-based participants, he intervention involves completion of the 4 YMHP sessions and the delivery of pre-exposure prophylaxis (PrEP) information and navigation services to interested participants. This arm is closed to enrollment.
Remote Delivery: A minimum of 2 community health workers (CHWs) will be trained to deliver intervention sessions to the participant in a location remote from the clinic setting.
|
Multi-modal Delivery
n=16 Participants
A 4 session MI intervention. Session 1 is always delivered in person immediately after baseline. Session 2-4 can be delivered in person or remotely based upon youth preference. This arm is open to enrollment as of 11/15/2019.
Multi-modal Delivery: A minimum of 2 community health workers (CHWs) will be trained to deliver clinic-based or remote intervention sessions. First MI session is in person immediately after baseline. Sessions 2-4 can be delivered in person or remotely based on youth preference.
|
Treatment as Usual
n=22 Participants
Treatment as usual control = individual HIV testing with referrals and link age to care as provided by the sites under routine circumstances. This arm is open to enrollment as of 11/15/2019.
|
|---|---|---|---|---|
|
Marijuana Use Days
Baseline
|
31.38 Number of Days
Standard Deviation 34.01
|
34.09 Number of Days
Standard Deviation 38.48
|
32.00 Number of Days
Standard Deviation 35.40
|
19.00 Number of Days
Standard Deviation 29.30
|
|
Marijuana Use Days
3 Month
|
40.00 Number of Days
Standard Deviation 37.21
|
32.75 Number of Days
Standard Deviation 36.56
|
26.00 Number of Days
Standard Deviation 32.66
|
20.16 Number of Days
Standard Deviation 28.71
|
|
Marijuana Use Days
6 Month
|
41.71 Number of Days
Standard Deviation 38.43
|
32.57 Number of Days
Standard Deviation 35.67
|
28.77 Number of Days
Standard Deviation 32.72
|
19.50 Number of Days
Standard Deviation 28.25
|
|
Marijuana Use Days
9 Month
|
42.00 Number of Days
Standard Deviation 41.60
|
33.08 Number of Days
Standard Deviation 35.44
|
22.27 Number of Days
Standard Deviation 30.05
|
24.71 Number of Days
Standard Deviation 34.73
|
|
Marijuana Use Days
12 Month
|
41.82 Number of Days
Standard Deviation 36.61
|
37.20 Number of Days
Standard Deviation 38.60
|
34.80 Number of Days
Standard Deviation 38.01
|
18.50 Number of Days
Standard Deviation 24.07
|
SECONDARY outcome
Timeframe: baseline, 3 months, 6 months, 9 months, 12 monthsPopulation: Intent to treat population
The self-reported number of alcohol use days in the past 30 days
Outcome measures
| Measure |
Clinic-based Delivery
n=24 Participants
Participants will receive the intervention in person following HIV counseling and testing. The intervention involves completion of the 4 YMHP sessions and the delivery of pre-exposure prophylaxis (PrEP) information and navigation services to interested participants. This arm is closed to enrollment.
Clinic-based Delivery: A minimum of 2 community health workers (CHWs) will be trained to deliver clinic-based intervention sessions.
|
Remote Delivery
n=21 Participants
Participants will receive the intervention by remote delivery following HIV counseling and testing. Just as the clinic-based participants, he intervention involves completion of the 4 YMHP sessions and the delivery of pre-exposure prophylaxis (PrEP) information and navigation services to interested participants. This arm is closed to enrollment.
Remote Delivery: A minimum of 2 community health workers (CHWs) will be trained to deliver intervention sessions to the participant in a location remote from the clinic setting.
|
Multi-modal Delivery
n=16 Participants
A 4 session MI intervention. Session 1 is always delivered in person immediately after baseline. Session 2-4 can be delivered in person or remotely based upon youth preference. This arm is open to enrollment as of 11/15/2019.
Multi-modal Delivery: A minimum of 2 community health workers (CHWs) will be trained to deliver clinic-based or remote intervention sessions. First MI session is in person immediately after baseline. Sessions 2-4 can be delivered in person or remotely based on youth preference.
|
Treatment as Usual
n=22 Participants
Treatment as usual control = individual HIV testing with referrals and link age to care as provided by the sites under routine circumstances. This arm is open to enrollment as of 11/15/2019.
|
|---|---|---|---|---|
|
Alcohol Use Days
6 Month
|
18.78 Number of Days
Standard Deviation 18.63
|
9.78 Number of Days
Standard Deviation 10.49
|
10.15 Number of Days
Standard Deviation 11.01
|
17.36 Number of Days
Standard Deviation 15.96
|
|
Alcohol Use Days
Baseline
|
20.17 Number of Days
Standard Deviation 17.82
|
13.71 Number of Days
Standard Deviation 15.35
|
17.62 Number of Days
Standard Deviation 20.03
|
17.27 Number of Days
Standard Deviation 15.22
|
|
Alcohol Use Days
3 Month
|
20.60 Number of Days
Standard Deviation 17.52
|
12.06 Number of Days
Standard Deviation 12.54
|
13.45 Number of Days
Standard Deviation 13.57
|
16.89 Number of Days
Standard Deviation 15.49
|
|
Alcohol Use Days
9 Month
|
15.00 Number of Days
Standard Deviation 14.34
|
14.61 Number of Days
Standard Deviation 15.84
|
13.27 Number of Days
Standard Deviation 17.27
|
17.43 Number of Days
Standard Deviation 14.05
|
|
Alcohol Use Days
12 Month
|
20.91 Number of Days
Standard Deviation 23.34
|
13.50 Number of Days
Standard Deviation 22.15
|
22.33 Number of Days
Standard Deviation 18.49
|
15.30 Number of Days
Standard Deviation 23.76
|
Adverse Events
Clinic-based Delivery
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Remote Delivery
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Multi-modal Delivery
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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
Sylvie Naar, PhD; Distinguished Endowed Professor
Florida State University
Phone: 18506442334
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place