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Developing a Dyadic Intervention for Sexually Transmitted Infection (STI)/HIV Prevention in Youth

Developing a Dyadic Intervention for STI/HIV Prevention in Youth

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03275168
Enrollment
68
Registered
2017-09-07
Start date
2018-01-15
Completion date
2021-10-01
Last updated
2025-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exposure to Sexually Transmissible Disorder (Event)

Brief summary

This pilot project will evaluate the feasibility, acceptability, and preliminary effectiveness of a couples-based behavioral intervention \[COUPLES\] that augments individual evidence-based interventions with joint health education counseling for STI-affected AYA dyads within a primary care setting.

Detailed description

While public health programs have demonstrated modest success in reducing the adolescent and young adult (AYA) risk for STI/HIV, significant health disparities remain. The risk of STI/HIV is not uniform among AYA. AYA residing in segregated urban communities with high STI prevalence and complicated sexual networks face even greater risk for disease and associated complications. Additional supports designed to increase engagement in care and reduce STI acquisition and transmissions are urgently needed to meet the sexual health and reproductive health goals for the nation. Overwhelmingly, AYA STI prevention interventions have targeted individuals and individual-level factors. While effective, these interventions do not adequately address other important influences affecting AYA risk for STI/HIV, such as partner or relationship influences on sexual decision-making and behavior. Partner notification and treatment is a key strategy for disease control and has previously been tested among adults for STI/HIV prevention work but has yet to be evaluated for AYA. Our prior research demonstrates that AYAs with complicated STIs are likely to notify their partners to seek treatment (88-92%); however, AYAs receiving brief behavioral interventions, relative to those receiving standard of care were 3 times more likely to be successful in arranging for their partner's treatment. Thus, partner interventions may hold promise for harnessing the power of relationship dynamics to enhance sexual decision-making, communication, and subsequent health behaviors. The investigators propose to pilot test an intervention designed to change sexual health outcomes by understanding partners and the learning environment related to sex \[COUPLES\] by simultaneously delivering two evidence-based STI/HIV prevention interventions Sister-to-Sister Teen and Focus on the Future. The simultaneous delivery of effective interventions will be augmented with a joint partner health education counseling session focused on enhancing communication and negotiation of safe sexual practices within the relationship. If successful, this pilot will support the development of a larger trial designed to evaluate the effectiveness of this approach in the busy primary care setting by providing evidence that AYA can and will safely engage their partners in a supportive primary care setting that integrates high quality treatment with evidence-based STI/HIV prevention interventions delivered by health educator teams.

Interventions

BEHAVIORALIntervention

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).

BEHAVIORALIndividual 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.

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

Single blind

Eligibility

Sex/Gender
ALL
Age
16 Years to 30 Years
Healthy volunteers
Yes

Inclusion criteria

The index patient must be * 16-25 years * Engage in male-female \[heterosexual\] intercourse * Permanently reside in the Greater Baltimore Metropolitan Area (GBMA) * Willing to recruit their main sexual partner for the study * Willing to participate in a single individual session with a health educator followed by a joint debriefing session together * Willing to be contacted in 6-8 weeks for a telephone interview The partner must be * 16-30 years * Engage in male-female \[heterosexual\] intercourse with the index patient * Permanently reside in the greater Baltimore Metropolitan Area * Willing to participate in a single individual session with a health educator followed by a joint debriefing session together * Willing to be contacted in 6-8 weeks for a telephone interview

Exclusion criteria

* Index participants and partners who are unable to communicate with staff or participate in study procedures due to cognitive, mental, or language difficulties will not be eligible for recruitment into the study. * Dyads will also be excluded if in same-sex main partnership or a member of the couple is currently enrolled in another sexual behavior study, one or both partners has a known concurrent HIV infection, one or more partners has a pending incarceration, there is more than five years age difference between the two partners and one partner is \<16 years of age, or there is evidence of intimate partner violence (IPV) in the relationship. * Individuals who screen positive for IPV will be referred to local resources for assistance.

Design outcomes

Primary

MeasureTime frameDescription
Feasibility as Assessed by the Number of Participants Who Are Enrolled With a Partner24 monthsRecruitment (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.

Secondary

MeasureTime frameDescription
Acceptability as Assessed by Number of Participants Available for Week 6-8 Interview6-8 weeksRetention for the 6-8 week interview will also be calculated as a measure of acceptability.

Countries

United States

Participant flow

Pre-assignment details

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.

Participants by arm

ArmCount
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.
34
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).
34
Total68

Baseline characteristics

CharacteristicInterventionTotalControl
Age, Categorical
<=18 years
1 Participants7 Participants6 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
33 Participants61 Participants28 Participants
Age, Continuous23.5 years
STANDARD_DEVIATION 2.4
22.3 years
STANDARD_DEVIATION 2.5
21.3 years
STANDARD_DEVIATION 2.6
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
34 Participants68 Participants34 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
United States
34 Participants68 Participants34 Participants
Sex: Female, Male
Female
17 Participants33 Participants16 Participants
Sex: Female, Male
Male
17 Participants35 Participants18 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 330 / 33
other
Total, other adverse events
0 / 330 / 33
serious
Total, serious adverse events
0 / 330 / 33

Outcome results

Primary

Feasibility as Assessed by the Number of Participants Who Are Enrolled With a Partner

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.

Time frame: 24 months

Population: The population for analysis is the number of those who were eligible to enroll, not the number who were enrolled.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ControlFeasibility as Assessed by the Number of Participants Who Are Enrolled With a Partner17 Participants
InterventionFeasibility as Assessed by the Number of Participants Who Are Enrolled With a Partner17 Participants
Secondary

Acceptability as Assessed by Number of Participants Available for Week 6-8 Interview

Retention for the 6-8 week interview will also be calculated as a measure of acceptability.

Time frame: 6-8 weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ControlAcceptability as Assessed by Number of Participants Available for Week 6-8 Interview27 Participants
InterventionAcceptability as Assessed by Number of Participants Available for Week 6-8 Interview25 Participants

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026