Trial Outcomes & Findings for Developing a Dyadic Intervention for Sexually Transmitted Infection (STI)/HIV Prevention in Youth (NCT NCT03275168)
NCT ID: NCT03275168
Last Updated: 2025-11-12
Results Overview
Recruitment (as a measure of feasibility) will be assessed by calculating the number of eligible patients who return with a partner to the study appointment and consent to participate in the study.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
68 participants
Primary outcome timeframe
24 months
Results posted on
2025-11-12
Participant Flow
44 participants were eligible for enrollment in the control arm and 45 participants were eligible for enrollment in the intervention arm. However, 34 in the control arm and 34 in the intervention arm (of the total eligible subjects) returned to be enrolled in the study.
Participant milestones
| Measure |
Control
Participants will receive individual evidence-based STI/HIV prevention intervention (Sister to Sister Teen for female participants and Focus on the Future for male participants) for STI prevention
Individual evidence-based STI/HIV prevention intervention: Sexual partners will receive individual evidence-based HIV/STI prevention counseling without partner debrief and/or practice negotiating condom use.
|
Intervention
Participants will receive individual evidence-based STI/HIV prevention intervention (Sister to Sister Teen for female participants and Focus on the Future for male participants) for STI prevention plus dyadic counseling and negotiation practice with partner
Intervention: Sexual partners will receive dyadic counseling and support for condom negotiation after receipt of individual evidence based HIV/STI prevention intervention (Sister-to-Sister (female) and Focus on the Future (male).
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
34
|
|
Overall Study
COMPLETED
|
27
|
25
|
|
Overall Study
NOT COMPLETED
|
7
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Developing a Dyadic Intervention for Sexually Transmitted Infection (STI)/HIV Prevention in Youth
Baseline characteristics by cohort
| Measure |
Control
n=34 Participants
Participants will receive individual evidence-based STI/HIV prevention intervention (Sister to Sister Teen for female participants and Focus on the Future for male participants) for STI prevention
Individual evidence-based STI/HIV prevention intervention: Sexual partners will receive individual evidence-based HIV/STI prevention counseling without partner debrief and/or practice negotiating condom use.
|
Intervention
n=34 Participants
Participants will receive individual evidence-based STI/HIV prevention intervention (Sister to Sister Teen for female participants and Focus on the Future for male participants) for STI prevention plus dyadic counseling and negotiation practice with partner
Intervention: Sexual partners will receive dyadic counseling and support for condom negotiation after receipt of individual evidence based HIV/STI prevention intervention (Sister-to-Sister (female) and Focus on the Future (male).
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
6 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
7 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=10 Participants
|
33 Participants
n=10 Participants
|
61 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Age, Continuous
|
21.3 years
STANDARD_DEVIATION 2.6 • n=10 Participants
|
23.5 years
STANDARD_DEVIATION 2.4 • n=10 Participants
|
22.3 years
STANDARD_DEVIATION 2.5 • n=20 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=10 Participants
|
17 Participants
n=10 Participants
|
33 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=10 Participants
|
17 Participants
n=10 Participants
|
35 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
34 Participants
n=10 Participants
|
34 Participants
n=10 Participants
|
68 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
34 Participants
n=10 Participants
|
34 Participants
n=10 Participants
|
68 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: The population for analysis is the number of those who were eligible to enroll, not the number who were enrolled.
Recruitment (as a measure of feasibility) will be assessed by calculating the number of eligible patients who return with a partner to the study appointment and consent to participate in the study.
Outcome measures
| Measure |
Control
n=44 Participants
Participants will receive individual evidence-based STI/HIV prevention intervention (Sister to Sister Teen for female participants and Focus on the Future for male participants) for STI prevention
Individual evidence-based STI/HIV prevention intervention: Sexual partners will receive individual evidence-based HIV/STI prevention counseling without partner debrief and/or practice negotiating condom use.
|
Intervention
n=45 Participants
Participants will receive individual evidence-based STI/HIV prevention intervention (Sister to Sister Teen for female participants and Focus on the Future for male participants) for STI prevention plus dyadic counseling and negotiation practice with partner
Intervention: Sexual partners will receive dyadic counseling and support for condom negotiation after receipt of individual evidence based HIV/STI prevention intervention (Sister-to-Sister (female) and Focus on the Future (male).
|
|---|---|---|
|
Feasibility as Assessed by the Number of Participants Who Are Enrolled With a Partner
|
17 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 6-8 weeksRetention for the 6-8 week interview will also be calculated as a measure of acceptability.
Outcome measures
| Measure |
Control
n=34 Participants
Participants will receive individual evidence-based STI/HIV prevention intervention (Sister to Sister Teen for female participants and Focus on the Future for male participants) for STI prevention
Individual evidence-based STI/HIV prevention intervention: Sexual partners will receive individual evidence-based HIV/STI prevention counseling without partner debrief and/or practice negotiating condom use.
|
Intervention
n=34 Participants
Participants will receive individual evidence-based STI/HIV prevention intervention (Sister to Sister Teen for female participants and Focus on the Future for male participants) for STI prevention plus dyadic counseling and negotiation practice with partner
Intervention: Sexual partners will receive dyadic counseling and support for condom negotiation after receipt of individual evidence based HIV/STI prevention intervention (Sister-to-Sister (female) and Focus on the Future (male).
|
|---|---|---|
|
Acceptability as Assessed by Number of Participants Available for Week 6-8 Interview
|
27 Participants
|
25 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