Trial Outcomes & Findings for Prevention and Risk: Treatment With a New Emphasis on Relationships (NCT NCT03396367)
NCT ID: NCT03396367
Last Updated: 2025-10-29
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
196 participants
Primary outcome timeframe
Baseline, 3-Month, 6-Month, 9-Month, 12-Month
Results posted on
2025-10-29
Participant Flow
Participant milestones
| Measure |
Partner Intervention
The PATRNER intervention addresses, drug use, PrEP uptake/adherence, and HIV transmission risk by enhancing communication skills by integrating motivational interviewing and video-based communication skills training.
|
Education Intervention
The Education intervention consists of a 4-session health education intervention that addresses sexual risk and substance use through a lecture and question and answer format.
|
|---|---|---|
|
Overall Study
STARTED
|
94
|
102
|
|
Overall Study
COMPLETED
|
94
|
102
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prevention and Risk: Treatment With a New Emphasis on Relationships
Baseline characteristics by cohort
| Measure |
Education Intervention
n=102 Participants
The Education intervention consists of a 4-session health education intervention that addresses sexual risk and substance use through a lecture and question and answer format.
|
Total
n=196 Participants
Total of all reporting groups
|
Partner Intervention
n=94 Participants
The PATRNER intervention addresses, drug use, PrEP uptake/adherence, and HIV transmission risk by enhancing communication skills by integrating motivational interviewing and video-based communication skills training.
|
|---|---|---|---|
|
Age, Continuous
|
27 years
STANDARD_DEVIATION 2.8 • n=7 Participants
|
26.9 years
STANDARD_DEVIATION 2.8 • n=5 Participants
|
26.8 years
STANDARD_DEVIATION 2.8 • n=5 Participants
|
|
Sex/Gender, Customized
Cisgender Male
|
102 Participants
n=7 Participants
|
196 Participants
n=5 Participants
|
94 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
47 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
53 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Latino or Hispanic
|
31 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian, Pacific Islander
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiracial or another identity
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
6 Participants
n=5 Participants
|
|
Sexual Identity
Gay
|
88 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
70 Participants
n=5 Participants
|
|
Sexual Identity
Bisexual
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
10 Participants
n=5 Participants
|
|
Sexual Identity
Queer or another Identity
|
5 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
13 Participants
n=5 Participants
|
|
Sexual Identity
unknown
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
|
Region of Residence
Northeast
|
95 Participants
n=7 Participants
|
178 Participants
n=5 Participants
|
83 Participants
n=5 Participants
|
|
Region of Residence
Elsewhere in the US
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
11 Participants
n=5 Participants
|
|
Education
Less than a 4 year degree
|
24 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
19 Participants
n=5 Participants
|
|
Education
4 year degree or higher
|
77 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
74 Participants
n=5 Participants
|
|
Education
unknown
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
|
PrEP status
Not taking PrEP
|
44 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
44 Participants
n=5 Participants
|
|
PrEP status
Current PrEP perscription
|
58 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
50 Participants
n=5 Participants
|
|
Interpersonal Communication Communication Competence Scale
|
44.4 units on a scale
STANDARD_DEVIATION 5.9 • n=7 Participants
|
43.8 units on a scale
STANDARD_DEVIATION 5.9 • n=5 Participants
|
43.3 units on a scale
STANDARD_DEVIATION 5.9 • n=5 Participants
|
|
Approximation to an Ideal subscale of the Multiple Determinants of Relationship Commitment Inventory
|
15.4 units on a scale
STANDARD_DEVIATION 3.1 • n=7 Participants
|
15.2 units on a scale
STANDARD_DEVIATION 3.4 • n=5 Participants
|
15.1 units on a scale
STANDARD_DEVIATION 3.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3-Month, 6-Month, 9-Month, 12-MonthPopulation: intent-to-treat population
The self-reported number of illicit drug use days (not including marijuana) in the past 30 days
Outcome measures
| Measure |
Partner Intervention
n=94 Participants
The PATRNER intervention addresses, drug use, PrEP uptake/adherence, and HIV transmission risk by enhancing communication skills by integrating motivational interviewing and video-based communication skills training.
|
Education Intervention
n=102 Participants
The Education intervention consists of a 4-session health education intervention that addresses sexual risk and substance use through a lecture and question and answer format.
|
|---|---|---|
|
Illicit Drug Use Days
Baseline
|
1.49 days
Standard Deviation 5.37
|
.80 days
Standard Deviation 2.14
|
|
Illicit Drug Use Days
3-month
|
1.16 days
Standard Deviation 3.83
|
0.83 days
Standard Deviation 2.3
|
|
Illicit Drug Use Days
6-month
|
.67 days
Standard Deviation 1.79
|
.56 days
Standard Deviation 1.29
|
|
Illicit Drug Use Days
9-month
|
1.08 days
Standard Deviation 3.62
|
.81 days
Standard Deviation 2.30
|
|
Illicit Drug Use Days
12-month
|
.66 days
Standard Deviation 1.49
|
.67 days
Standard Deviation 1.55
|
PRIMARY outcome
Timeframe: Baseline, 3-Month, 6-Month, 9-Month, 12-MonthPopulation: intent-to-treat population
The self-reported number of cannabis drug use days in the past 30 days
Outcome measures
| Measure |
Partner Intervention
n=94 Participants
The PATRNER intervention addresses, drug use, PrEP uptake/adherence, and HIV transmission risk by enhancing communication skills by integrating motivational interviewing and video-based communication skills training.
|
Education Intervention
n=102 Participants
The Education intervention consists of a 4-session health education intervention that addresses sexual risk and substance use through a lecture and question and answer format.
|
|---|---|---|
|
Cannabis Use Days
Baseline
|
9.68 days
Standard Deviation 11.25
|
7.59 days
Standard Deviation 10.64
|
|
Cannabis Use Days
3-Month
|
9.28 days
Standard Deviation 11.58
|
7.49 days
Standard Deviation 10.33
|
|
Cannabis Use Days
6-Month
|
9.13 days
Standard Deviation 11.63
|
7.27 days
Standard Deviation 10.39
|
|
Cannabis Use Days
9-Month
|
10.04 days
Standard Deviation 12.24
|
6.88 days
Standard Deviation 10.73
|
|
Cannabis Use Days
12-Month
|
10.04 days
Standard Deviation 12.55
|
6.61 days
Standard Deviation 10.64
|
PRIMARY outcome
Timeframe: Baseline, 3-Month, 6-Month, 9-Month, 12-MonthPopulation: intent-to-treat population
The percentage of participants in each condition reporting sexual HIV transmission risk with a casual partner (any condomless sex with a casual partner in the absence of PrEP).
Outcome measures
| Measure |
Partner Intervention
n=94 Participants
The PATRNER intervention addresses, drug use, PrEP uptake/adherence, and HIV transmission risk by enhancing communication skills by integrating motivational interviewing and video-based communication skills training.
|
Education Intervention
n=102 Participants
The Education intervention consists of a 4-session health education intervention that addresses sexual risk and substance use through a lecture and question and answer format.
|
|---|---|---|
|
Number (Proportion) of Participants Who Report Sexual HIV Transmission Risk With Casual Partners
Baseline
|
16 Participants
|
16 Participants
|
|
Number (Proportion) of Participants Who Report Sexual HIV Transmission Risk With Casual Partners
3-Month
|
8 Participants
|
10 Participants
|
|
Number (Proportion) of Participants Who Report Sexual HIV Transmission Risk With Casual Partners
6-Month
|
5 Participants
|
5 Participants
|
|
Number (Proportion) of Participants Who Report Sexual HIV Transmission Risk With Casual Partners
9-Month
|
6 Participants
|
6 Participants
|
|
Number (Proportion) of Participants Who Report Sexual HIV Transmission Risk With Casual Partners
12-Month
|
11 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3-Month, 6-Month, 9-Month, 12-Month,Population: intent-to-treat population
The percentage participants in each condition who report having a current PrEP prescription at the time of follow-up.
Outcome measures
| Measure |
Partner Intervention
n=94 Participants
The PATRNER intervention addresses, drug use, PrEP uptake/adherence, and HIV transmission risk by enhancing communication skills by integrating motivational interviewing and video-based communication skills training.
|
Education Intervention
n=102 Participants
The Education intervention consists of a 4-session health education intervention that addresses sexual risk and substance use through a lecture and question and answer format.
|
|---|---|---|
|
The Number (Proportion) of Participants Reporting Pre-Exposure Prophylaxis (PrEP) Uptake
9-Month
|
52 Participants
|
45 Participants
|
|
The Number (Proportion) of Participants Reporting Pre-Exposure Prophylaxis (PrEP) Uptake
Baseline
|
50 Participants
|
58 Participants
|
|
The Number (Proportion) of Participants Reporting Pre-Exposure Prophylaxis (PrEP) Uptake
3-Month
|
42 Participants
|
51 Participants
|
|
The Number (Proportion) of Participants Reporting Pre-Exposure Prophylaxis (PrEP) Uptake
6-Month
|
50 Participants
|
47 Participants
|
|
The Number (Proportion) of Participants Reporting Pre-Exposure Prophylaxis (PrEP) Uptake
12-Month
|
43 Participants
|
46 Participants
|
Adverse Events
PARTNER Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Education Intervention
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