NCT03341975

Enhanced SexHealth Intervention to Improve Adolescent Outcomes

Enhanced SexHealth Intervention to Improve Adolescent Outcomes: A Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: Children's Mercy Hospital Kansas City · Academic / Other
• Sex: All
• Age: 14 Years – 19 Years
• Healthy volunteers: Accepted

Summary

This is an adaptive trial with an initial Formative Revision Process followed by a Randomized Controlled Trial (RCT). Up to 500 adolescents will be consented into this study to achieve 6 completed subjects for the formative process and 86 completed subjects for the RCT.

Detailed description

In a randomized controlled trial at a pediatric emergency department, sexually active adolescents will receive the control (i.e., printed materials) or intervention (i.e., motivationally-guided facilitation) arm delivered by a health educator. The tablet-based, interactive intervention includes motivational techniques to promote risk reduction, condom skills training, and tailored service recommendations. The primary outcome is uptake of ≥1 service at the index visit (i.e., counseling, condoms, emergency contraception for immediate or future use, pregnancy/sexually transmitted infection (STI)/HIV testing, STI treatment, and clinic referral). We assess feasibility (i.e., intervention completion, recommendations discussed, and satisfaction). Participants report sexual risk and care-seeking behaviors at 2, 4, and 6 months. We compare uptake between arms using Fisher exact tests.

Conditions

• Sexually Transmitted Diseases
• Reproductive Behavior

Interventions

Type	Name	Description
BEHAVIORAL	SexHealth	To enhance and test our ED SexHealth intervention that provides risk reduction counseling and point-of-care services as well as connections to sustainable, non-episodic sources of care.

Timeline

• Start date: 2017-12-01
• Primary completion: 2020-04-30
• Completion: 2020-05-01
• First posted: 2017-11-14
• Last updated: 2021-02-25
• Results posted: 2021-02-25

Locations

1 site across 1 country: United States