Trial Outcomes & Findings for Enhancing Sexual Safety: Couples' Communication and HIV Testing Among YMSM (NCT NCT04289116)
NCT ID: NCT04289116
Last Updated: 2025-11-03
Results Overview
Self-reported Condomless anal sex with a casual partner
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
71 participants
Primary outcome timeframe
baseline, month 3, month 6
Results posted on
2025-11-03
Participant Flow
Participant milestones
| Measure |
We Test - Index Participants
Each individual who attended We Test received MI-CST + observation of ACT videos + CHTC. Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone.
We Test: This design tests the added benefits of adjunct intervention components delivered prior to receipt of CHTC-Assertive Communication Training (ACT) videos viewed by the couple separately and individually delivered Motivational Interviewing-based Communication Skills Training (MI-CST). These target the development of communication skills necessary to participate fully in HIV prevention and sexual safety discussions inherent to CHTC.
|
Individual HIV Testing and Counseling - Index Participants
Individual HIV Testing and Counseling (IHTC). Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone. This includes 1 index partner who completed the intervention with their partner.
IHTC: Individual HIV Testing and Counseling
|
Individual Counseling and Testing - Partner Participants
Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone. Only 1 couple chose this option. This couple attended the intervention together and received individual HIV testing and counseling.
|
|---|---|---|---|
|
Overall Study
STARTED
|
33
|
37
|
1
|
|
Overall Study
COMPLETED
|
33
|
37
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Enhancing Sexual Safety: Couples' Communication and HIV Testing Among YMSM
Baseline characteristics by cohort
| Measure |
We Test - Index Participants
n=33 Participants
Each individual who attended We Test received MI-CST + observation of ACT videos + CHTC. Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone.
We Test: This design tests the added benefits of adjunct intervention components delivered prior to receipt of CHTC-Assertive Communication Training (ACT) videos viewed by the couple separately and individually delivered Motivational Interviewing-based Communication Skills Training (MI-CST). These target the development of communication skills necessary to participate fully in HIV prevention and sexual safety discussions inherent to CHTC.
|
Individual HIV Testing and Counseling - Index Participants
n=37 Participants
Individual HIV Testing and Counseling (IHTC). Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone.
IHTC: Individual HIV Testing and Counseling
|
Individual Counseling and Testing - Partner Participants
n=1 Participants
Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone. Only 1 couple chose this option. This couple attended the intervention together and received individual HIV testing and counseling.
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
21.91 Years
STANDARD_DEVIATION 1.86 • n=15 Participants
|
22.38 Years
STANDARD_DEVIATION 1.77 • n=161 Participants
|
24.00 Years
n=100 Participants
|
22.18 Years
STANDARD_DEVIATION 1.82 • n=3 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=15 Participants
|
37 Participants
n=161 Participants
|
1 Participants
n=100 Participants
|
71 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Black
|
4 Participants
n=15 Participants
|
11 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
15 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Latino
|
13 Participants
n=15 Participants
|
9 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
22 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
White
|
13 Participants
n=15 Participants
|
12 Participants
n=161 Participants
|
1 Participants
n=100 Participants
|
26 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=15 Participants
|
5 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
8 Participants
n=3 Participants
|
|
Sexual Identity
Gay
|
23 Participants
n=15 Participants
|
25 Participants
n=161 Participants
|
1 Participants
n=100 Participants
|
49 Participants
n=3 Participants
|
|
Sexual Identity
Other/Queer
|
10 Participants
n=15 Participants
|
12 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
22 Participants
n=3 Participants
|
|
Gender Identity
Cisgender Male
|
26 Participants
n=15 Participants
|
30 Participants
n=161 Participants
|
1 Participants
n=100 Participants
|
57 Participants
n=3 Participants
|
|
Gender Identity
Transgender, gender nonconforming, or assigned male at birth
|
7 Participants
n=15 Participants
|
7 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
14 Participants
n=3 Participants
|
|
Employment
Yes
|
22 Participants
n=15 Participants
|
26 Participants
n=161 Participants
|
1 Participants
n=100 Participants
|
49 Participants
n=3 Participants
|
|
Employment
No
|
11 Participants
n=15 Participants
|
11 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
22 Participants
n=3 Participants
|
|
Health Insurance
No
|
5 Participants
n=15 Participants
|
5 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
10 Participants
n=3 Participants
|
|
Health Insurance
Yes, my own
|
14 Participants
n=15 Participants
|
16 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
30 Participants
n=3 Participants
|
|
Health Insurance
Yes, my guardian
|
14 Participants
n=15 Participants
|
16 Participants
n=161 Participants
|
1 Participants
n=100 Participants
|
31 Participants
n=3 Participants
|
|
Current PrEP Use
No
|
21 Participants
n=15 Participants
|
25 Participants
n=161 Participants
|
1 Participants
n=100 Participants
|
47 Participants
n=3 Participants
|
|
Current PrEP Use
Yes
|
12 Participants
n=15 Participants
|
12 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
24 Participants
n=3 Participants
|
|
Main Partner Age
|
25.45 Years
STANDARD_DEVIATION 7.89 • n=15 Participants
|
26.11 Years
STANDARD_DEVIATION 6.59 • n=161 Participants
|
24.00 Years
STANDARD_DEVIATION 0.00 • n=100 Participants
|
25.77 Years
STANDARD_DEVIATION 7.14 • n=3 Participants
|
|
Relationship Length (in months)
|
19.21 Months
STANDARD_DEVIATION 25.03 • n=15 Participants
|
21.14 Months
STANDARD_DEVIATION 26.56 • n=161 Participants
|
2.00 Months
STANDARD_DEVIATION 0.00 • n=100 Participants
|
19.97 Months
STANDARD_DEVIATION 25.59 • n=3 Participants
|
PRIMARY outcome
Timeframe: baseline, month 3, month 6Population: Intent to treat population. Analysis only includes participants who participated in the We Test - Index arm and Individual HIV Testing and Counseling - Index arm on their own.
Self-reported Condomless anal sex with a casual partner
Outcome measures
| Measure |
We Test - Index Participants
n=33 Participants
Each participant or couple will receive MI-CST + observation of ACT videos + CHTC. Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone.
We Test: This design tests the added benefits of adjunct intervention components delivered prior to receipt of CHTC-Assertive Communication Training (ACT) videos viewed by the couple separately and individually delivered Motivational Interviewing-based Communication Skills Training (MI-CST). These target the development of communication skills necessary to participate fully in HIV prevention and sexual safety discussions inherent to CHTC.
|
Individual HIV Testing and Counseling - Index Participants
n=37 Participants
Individual HIV Testing and Counseling (IHTC). Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone.
IHTC: Individual HIV Testing and Counseling
|
Individual Counseling and Testing - Partner Participants
n=1 Participants
Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone. Only 1 couple chose this option. This couple attended the intervention together and received individual HIV testing and counseling.
|
|---|---|---|---|
|
HIV Transmission Risk Behavior
Baseline
|
9 Participants
|
11 Participants
|
0 Participants
|
|
HIV Transmission Risk Behavior
3 month
|
4 Participants
|
8 Participants
|
0 Participants
|
|
HIV Transmission Risk Behavior
6 month
|
4 Participants
|
6 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: baseline, month 3, month 6Population: Intent to treat population. Analysis only includes participants who participated in the We Test - Index arm and Individual HIV Testing and Counseling - Index arm on their own.
Interpersonal Communication Competence Scale, higher scores are associated with better communication skills, range 0 - 150.
Outcome measures
| Measure |
We Test - Index Participants
n=33 Participants
Each participant or couple will receive MI-CST + observation of ACT videos + CHTC. Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone.
We Test: This design tests the added benefits of adjunct intervention components delivered prior to receipt of CHTC-Assertive Communication Training (ACT) videos viewed by the couple separately and individually delivered Motivational Interviewing-based Communication Skills Training (MI-CST). These target the development of communication skills necessary to participate fully in HIV prevention and sexual safety discussions inherent to CHTC.
|
Individual HIV Testing and Counseling - Index Participants
n=37 Participants
Individual HIV Testing and Counseling (IHTC). Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone.
IHTC: Individual HIV Testing and Counseling
|
Individual Counseling and Testing - Partner Participants
n=1 Participants
Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone. Only 1 couple chose this option. This couple attended the intervention together and received individual HIV testing and counseling.
|
|---|---|---|---|
|
Communication Skills
Baseline
|
123 Units on a scale
Standard Deviation 11.01
|
121.19 Units on a scale
Standard Deviation 12.78
|
129.00 Units on a scale
|
|
Communication Skills
3 month
|
125.04 Units on a scale
Standard Deviation 10.04
|
119.04 Units on a scale
Standard Deviation 12.97
|
—
|
|
Communication Skills
6 month
|
125.27 Units on a scale
Standard Deviation 12.81
|
117.68 Units on a scale
Standard Deviation 11.30
|
129.00 Units on a scale
|
Adverse Events
We Test - Index Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Individual HIV Testing and Counseling - Index Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Individual Counseling and Testing - Partner Participants
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