Trial Outcomes & Findings for We Prevent: A Dyadic Approach to HIV Prevention and Care Among Young Male Couples (NCT NCT03551938)
NCT ID: NCT03551938
Last Updated: 2023-06-18
Results Overview
Anal or vaginal intercourse without condoms or PrEP that occurs with a person of known positive or unknown serostatus during follow-up period.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
318 participants
Primary outcome timeframe
The number of participants who report sexual risk behavior at 3 months.
Results posted on
2023-06-18
Participant Flow
Participant milestones
| Measure |
Control
Receive only the standard HIV Counseling, Testing, and Referral or Couples HIV Testing and Counseling (CHTC) Session.
|
Intervention
Receive one 45-minute Relationship skills session for YMSM individuals and couples (the intervention) as an addition to the standard HIV Counseling, Testing, and Referral (CTR) or Couples HIV Testing and Counseling (CHTC) Session.
Relationship skills session for YMSM partnered-individuals and couples: Relationship skills session as an addition to the current CTR and CHTC intervention for 15-24 year old YMSM and their partners.
|
|---|---|---|
|
3-Month Follow Up
STARTED
|
160
|
158
|
|
3-Month Follow Up
COMPLETED
|
121
|
120
|
|
3-Month Follow Up
NOT COMPLETED
|
39
|
38
|
|
6-Month Follow Up
STARTED
|
160
|
158
|
|
6-Month Follow Up
COMPLETED
|
114
|
116
|
|
6-Month Follow Up
NOT COMPLETED
|
46
|
42
|
|
9-Month Follow Up
STARTED
|
160
|
158
|
|
9-Month Follow Up
COMPLETED
|
116
|
115
|
|
9-Month Follow Up
NOT COMPLETED
|
44
|
43
|
Reasons for withdrawal
| Measure |
Control
Receive only the standard HIV Counseling, Testing, and Referral or Couples HIV Testing and Counseling (CHTC) Session.
|
Intervention
Receive one 45-minute Relationship skills session for YMSM individuals and couples (the intervention) as an addition to the standard HIV Counseling, Testing, and Referral (CTR) or Couples HIV Testing and Counseling (CHTC) Session.
Relationship skills session for YMSM partnered-individuals and couples: Relationship skills session as an addition to the current CTR and CHTC intervention for 15-24 year old YMSM and their partners.
|
|---|---|---|
|
3-Month Follow Up
Lost to Follow-up
|
39
|
38
|
|
6-Month Follow Up
Lost to Follow-up
|
46
|
42
|
|
9-Month Follow Up
Lost to Follow-up
|
44
|
43
|
Baseline Characteristics
We Prevent: A Dyadic Approach to HIV Prevention and Care Among Young Male Couples
Baseline characteristics by cohort
| Measure |
Control
n=160 Participants
Receive only the standard HIV Counseling, Testing, and Referral or Couples HIV Testing and Counseling (CHTC) Session.
|
Intervention
n=158 Participants
Receive one 45-minute Relationship skills session for YMSM individuals and couples (the intervention) as an addition to the standard HIV Counseling, Testing, and Referral (CTR) or Couples HIV Testing and Counseling (CHTC) Session.
Relationship skills session for YMSM partnered-individuals and couples: Relationship skills session as an addition to the current CTR and CHTC intervention for 15-24 year old YMSM and their partners.
|
Total
n=318 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
22 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
138 Participants
n=99 Participants
|
137 Participants
n=107 Participants
|
275 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
21 years
n=99 Participants
|
21 years
n=107 Participants
|
21 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
160 Participants
n=99 Participants
|
158 Participants
n=107 Participants
|
318 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
27 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
133 Participants
n=99 Participants
|
135 Participants
n=107 Participants
|
268 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
89 Participants
n=99 Participants
|
95 Participants
n=107 Participants
|
184 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
33 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
27 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
160 participants
n=99 Participants
|
158 participants
n=107 Participants
|
318 participants
n=206 Participants
|
|
Sexual Risk Behavior
|
6 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
HIV Communication
|
4.5 units on a scale
STANDARD_DEVIATION 1.1 • n=99 Participants
|
4.4 units on a scale
STANDARD_DEVIATION 0.9 • n=107 Participants
|
4.5 units on a scale
STANDARD_DEVIATION 1.0 • n=206 Participants
|
|
PrEP use
|
14 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
HIV Testing
|
105 Participants
n=99 Participants
|
107 Participants
n=107 Participants
|
212 Participants
n=206 Participants
|
|
STI Testing
|
83 Participants
n=99 Participants
|
101 Participants
n=107 Participants
|
184 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: The number of participants who report sexual risk behavior at 3 months.Population: Self-report of participants who reported sexual risk behavior.
Anal or vaginal intercourse without condoms or PrEP that occurs with a person of known positive or unknown serostatus during follow-up period.
Outcome measures
| Measure |
Control
n=121 Participants
Receive only the standard HIV Counseling, Testing, and Referral or Couples HIV Testing and Counseling (CHTC) Session.
|
Intervention
n=120 Participants
Receive one 45-minute Relationship skills session for YMSM individuals and couples (the intervention) as an addition to the standard HIV Counseling, Testing, and Referral (CTR) or Couples HIV Testing and Counseling (CHTC) Session.
Relationship skills session for YMSM partnered-individuals and couples: Relationship skills session as an addition to the current CTR and CHTC intervention for 15-24 year old YMSM and their partners.
|
|---|---|---|
|
Sexual Risk Behavior
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: The number of participants who report sexual risk behavior at 6 months.Population: Self-report of participants who reported sexual risk behavior.
Anal or vaginal intercourse without condoms or PrEP that occurs with a person of known positive or unknown serostatus during follow-up period.
Outcome measures
| Measure |
Control
n=114 Participants
Receive only the standard HIV Counseling, Testing, and Referral or Couples HIV Testing and Counseling (CHTC) Session.
|
Intervention
n=116 Participants
Receive one 45-minute Relationship skills session for YMSM individuals and couples (the intervention) as an addition to the standard HIV Counseling, Testing, and Referral (CTR) or Couples HIV Testing and Counseling (CHTC) Session.
Relationship skills session for YMSM partnered-individuals and couples: Relationship skills session as an addition to the current CTR and CHTC intervention for 15-24 year old YMSM and their partners.
|
|---|---|---|
|
Sexual Risk Behavior
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: The number of participants who report sexual risk behavior at 9 months.Population: Self-report of participants who reported sexual risk behavior.
Anal or vaginal intercourse without condoms or PrEP that occurs with a person of known positive or unknown serostatus during follow-up period.
Outcome measures
| Measure |
Control
n=116 Participants
Receive only the standard HIV Counseling, Testing, and Referral or Couples HIV Testing and Counseling (CHTC) Session.
|
Intervention
n=115 Participants
Receive one 45-minute Relationship skills session for YMSM individuals and couples (the intervention) as an addition to the standard HIV Counseling, Testing, and Referral (CTR) or Couples HIV Testing and Counseling (CHTC) Session.
Relationship skills session for YMSM partnered-individuals and couples: Relationship skills session as an addition to the current CTR and CHTC intervention for 15-24 year old YMSM and their partners.
|
|---|---|---|
|
Sexual Risk Behavior
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Mean at 3 monthsPopulation: Self-report to scale
Participants completed the 9-item Couples Efficacy to Reduce HIV Threat scale .Participants responded to each item on 5-point Likert scale ranging from (1) strongly disagree to (5) strongly agree. The items were mean centered such that higher scores indicate that participants perceive that they can effectively communicate with their partner about HIV prevention strategies (range 1 to 5).
Outcome measures
| Measure |
Control
n=101 Participants
Receive only the standard HIV Counseling, Testing, and Referral or Couples HIV Testing and Counseling (CHTC) Session.
|
Intervention
n=97 Participants
Receive one 45-minute Relationship skills session for YMSM individuals and couples (the intervention) as an addition to the standard HIV Counseling, Testing, and Referral (CTR) or Couples HIV Testing and Counseling (CHTC) Session.
Relationship skills session for YMSM partnered-individuals and couples: Relationship skills session as an addition to the current CTR and CHTC intervention for 15-24 year old YMSM and their partners.
|
|---|---|---|
|
HIV Communication
|
4.6 score on a scale
Standard Deviation 1
|
4.6 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Mean at 6 monthsPopulation: Self-report on a scale
Participants completed the 9-item Couples Efficacy to Reduce HIV Threat scale. Participants responded to each item on 5-point Likert scale ranging from (1) strongly disagree to (5) strongly agree. The items were mean centered such that higher scores indicate that participants perceive that they can effectively communicate with their partner about HIV prevention strategies (range 1 to 5).
Outcome measures
| Measure |
Control
n=88 Participants
Receive only the standard HIV Counseling, Testing, and Referral or Couples HIV Testing and Counseling (CHTC) Session.
|
Intervention
n=89 Participants
Receive one 45-minute Relationship skills session for YMSM individuals and couples (the intervention) as an addition to the standard HIV Counseling, Testing, and Referral (CTR) or Couples HIV Testing and Counseling (CHTC) Session.
Relationship skills session for YMSM partnered-individuals and couples: Relationship skills session as an addition to the current CTR and CHTC intervention for 15-24 year old YMSM and their partners.
|
|---|---|---|
|
HIV Communication
|
4.5 score on a scale
Standard Deviation 0.8
|
4.9 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Mean at 9 monthsPopulation: Self-report on a scale
Participants completed the 9-item Couples Efficacy to Reduce HIV Threat scale. Participants responded to each item on 5-point Likert scale ranging from (1) strongly disagree to (5) strongly agree. The items were mean centered such that higher scores indicate that participants perceive that they can effectively communicate with their partner about HIV prevention strategies (range 1 to 5).
Outcome measures
| Measure |
Control
n=86 Participants
Receive only the standard HIV Counseling, Testing, and Referral or Couples HIV Testing and Counseling (CHTC) Session.
|
Intervention
n=77 Participants
Receive one 45-minute Relationship skills session for YMSM individuals and couples (the intervention) as an addition to the standard HIV Counseling, Testing, and Referral (CTR) or Couples HIV Testing and Counseling (CHTC) Session.
Relationship skills session for YMSM partnered-individuals and couples: Relationship skills session as an addition to the current CTR and CHTC intervention for 15-24 year old YMSM and their partners.
|
|---|---|---|
|
HIV Communication
|
4.8 score on a scale
Standard Deviation 0.8
|
5.0 score on a scale
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: The number of participants at 3 monthsPopulation: Self-report of participants who reported that they were currently taking PrEP.
Current PrEP use, which a self-report measure of whether the participant is currently using PrEP (yes/no).
Outcome measures
| Measure |
Control
n=121 Participants
Receive only the standard HIV Counseling, Testing, and Referral or Couples HIV Testing and Counseling (CHTC) Session.
|
Intervention
n=120 Participants
Receive one 45-minute Relationship skills session for YMSM individuals and couples (the intervention) as an addition to the standard HIV Counseling, Testing, and Referral (CTR) or Couples HIV Testing and Counseling (CHTC) Session.
Relationship skills session for YMSM partnered-individuals and couples: Relationship skills session as an addition to the current CTR and CHTC intervention for 15-24 year old YMSM and their partners.
|
|---|---|---|
|
PrEP Use
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: The number of participants at 6 monthsPopulation: Self-report of participants who reported that they were currently taking PrEP.
Current PrEP use, which a self-report measure of whether the participant is currently using PrEP (yes/no)
Outcome measures
| Measure |
Control
n=114 Participants
Receive only the standard HIV Counseling, Testing, and Referral or Couples HIV Testing and Counseling (CHTC) Session.
|
Intervention
n=116 Participants
Receive one 45-minute Relationship skills session for YMSM individuals and couples (the intervention) as an addition to the standard HIV Counseling, Testing, and Referral (CTR) or Couples HIV Testing and Counseling (CHTC) Session.
Relationship skills session for YMSM partnered-individuals and couples: Relationship skills session as an addition to the current CTR and CHTC intervention for 15-24 year old YMSM and their partners.
|
|---|---|---|
|
PrEP Use
|
9 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: The number of participants at 9 monthsPopulation: Self-report of participants who self-reported that they were currently taking PrEP.
Current PrEP use, which a self-report measure of whether the participant is currently using PrEP (yes/no)
Outcome measures
| Measure |
Control
n=116 Participants
Receive only the standard HIV Counseling, Testing, and Referral or Couples HIV Testing and Counseling (CHTC) Session.
|
Intervention
n=115 Participants
Receive one 45-minute Relationship skills session for YMSM individuals and couples (the intervention) as an addition to the standard HIV Counseling, Testing, and Referral (CTR) or Couples HIV Testing and Counseling (CHTC) Session.
Relationship skills session for YMSM partnered-individuals and couples: Relationship skills session as an addition to the current CTR and CHTC intervention for 15-24 year old YMSM and their partners.
|
|---|---|---|
|
PrEP Use
|
14 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: The number of participants at 3-monthsPopulation: Self-report of participants who had an HIV test in the past 3 months.
Self-reported HIV testing in the past 3 months
Outcome measures
| Measure |
Control
n=121 Participants
Receive only the standard HIV Counseling, Testing, and Referral or Couples HIV Testing and Counseling (CHTC) Session.
|
Intervention
n=120 Participants
Receive one 45-minute Relationship skills session for YMSM individuals and couples (the intervention) as an addition to the standard HIV Counseling, Testing, and Referral (CTR) or Couples HIV Testing and Counseling (CHTC) Session.
Relationship skills session for YMSM partnered-individuals and couples: Relationship skills session as an addition to the current CTR and CHTC intervention for 15-24 year old YMSM and their partners.
|
|---|---|---|
|
HIV Testing
|
73 Participants
|
70 Participants
|
SECONDARY outcome
Timeframe: The number of participants at 6 monthsPopulation: Self-report of participants who had an HIV test in the past 3 months.
Self-reported HIV testing in the past 3 months
Outcome measures
| Measure |
Control
n=114 Participants
Receive only the standard HIV Counseling, Testing, and Referral or Couples HIV Testing and Counseling (CHTC) Session.
|
Intervention
n=116 Participants
Receive one 45-minute Relationship skills session for YMSM individuals and couples (the intervention) as an addition to the standard HIV Counseling, Testing, and Referral (CTR) or Couples HIV Testing and Counseling (CHTC) Session.
Relationship skills session for YMSM partnered-individuals and couples: Relationship skills session as an addition to the current CTR and CHTC intervention for 15-24 year old YMSM and their partners.
|
|---|---|---|
|
HIV Testing
|
33 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: The number of participants at 9 monthsPopulation: Self-report of participants who reported that they had an HIV test in the past 3 months.
Self-reported HIV testing in the past 3 months
Outcome measures
| Measure |
Control
n=116 Participants
Receive only the standard HIV Counseling, Testing, and Referral or Couples HIV Testing and Counseling (CHTC) Session.
|
Intervention
n=115 Participants
Receive one 45-minute Relationship skills session for YMSM individuals and couples (the intervention) as an addition to the standard HIV Counseling, Testing, and Referral (CTR) or Couples HIV Testing and Counseling (CHTC) Session.
Relationship skills session for YMSM partnered-individuals and couples: Relationship skills session as an addition to the current CTR and CHTC intervention for 15-24 year old YMSM and their partners.
|
|---|---|---|
|
HIV Testing
|
43 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: The number of participants at 3 monthsPopulation: Self-report of participants who reported that they had an STI test in the past 3 months.
Any self-reported STI testing in the past 3 months
Outcome measures
| Measure |
Control
n=121 Participants
Receive only the standard HIV Counseling, Testing, and Referral or Couples HIV Testing and Counseling (CHTC) Session.
|
Intervention
n=120 Participants
Receive one 45-minute Relationship skills session for YMSM individuals and couples (the intervention) as an addition to the standard HIV Counseling, Testing, and Referral (CTR) or Couples HIV Testing and Counseling (CHTC) Session.
Relationship skills session for YMSM partnered-individuals and couples: Relationship skills session as an addition to the current CTR and CHTC intervention for 15-24 year old YMSM and their partners.
|
|---|---|---|
|
STI Testing
|
32 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: The number of participants at 6 monthsPopulation: Self-report of participants who had an STI test in the past 3 months.
Any self-reported STI testing in the past 3 months
Outcome measures
| Measure |
Control
n=114 Participants
Receive only the standard HIV Counseling, Testing, and Referral or Couples HIV Testing and Counseling (CHTC) Session.
|
Intervention
n=116 Participants
Receive one 45-minute Relationship skills session for YMSM individuals and couples (the intervention) as an addition to the standard HIV Counseling, Testing, and Referral (CTR) or Couples HIV Testing and Counseling (CHTC) Session.
Relationship skills session for YMSM partnered-individuals and couples: Relationship skills session as an addition to the current CTR and CHTC intervention for 15-24 year old YMSM and their partners.
|
|---|---|---|
|
STI Testing
|
20 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: The number of participants at 9 monthsPopulation: Self-report of participants who reported that they had an STI test in the past 3 months.
Any self-reported STI testing in the past 3 months
Outcome measures
| Measure |
Control
n=116 Participants
Receive only the standard HIV Counseling, Testing, and Referral or Couples HIV Testing and Counseling (CHTC) Session.
|
Intervention
n=115 Participants
Receive one 45-minute Relationship skills session for YMSM individuals and couples (the intervention) as an addition to the standard HIV Counseling, Testing, and Referral (CTR) or Couples HIV Testing and Counseling (CHTC) Session.
Relationship skills session for YMSM partnered-individuals and couples: Relationship skills session as an addition to the current CTR and CHTC intervention for 15-24 year old YMSM and their partners.
|
|---|---|---|
|
STI Testing
|
28 Participants
|
35 Participants
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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