N/A
N=68
Developing a Dyadic Intervention for Sexually Transmitted Infection (STI)/HIV Prevention in Youth
Exposure to Sexually Transmissible Disorder (Event)
Bottom Line
View on ClinicalTrials.gov: NCT03275168 ↗Enrolled (actual)
68
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcome: Primary: Feasibility as Assessed by the Number of Participants Who Are Enrolled With a Partner — 17; 17 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intervention (Behavioral); Individual evidence-based STI/HIV prevention intervention (Behavioral)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility as Assessed by the Number of Participants Who Are Enrolled With a Partner |
17; 17 | — |
| SECONDARY Acceptability as Assessed by Number of Participants Available for Week 6-8 Interview |
27; 25 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03275168). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.