Enhanced SexHealth Intervention to Improve Adolescent Outcomes

Not Applicable

Completed

• Conditions: Sexually Transmitted Diseases; Reproductive Behavior

• Registration Number: NCT03341975
• Lead Sponsor: Children's Mercy Hospital Kansas City

Brief 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.

Study Timeline

• Study First Submitted: 2017-11-06
• Study First Submitted QC: 2017-11-09
• Study First Posted: 2017-11-14
• Study Start: 2017-12-01
• Primary Completion: 2020-04-30
• Study Completion: 2020-05-01
• Results First Submitted: 2021-01-25
• Status Verified: 2021-02
• Results First Submitted QC: 2021-02-09
• Last Update Submitted: 2021-02-09
• Results First Posted: 2021-02-25
• Last Update Posted: 2021-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

• Aged 14-19 years old
• Reside within 30 minutes travel time
• Report previous sexual activity

Exclusion Criteria

• Subjects who are unable to provide consent (i.e., determined to be too ill by the ED team, have cognitive impairment due to chronic condition or acute medical concern)
• Subjects in police custody
• Subjects seeking care due to sexual assault or psychiatric emergency
• Subjects who do not speak English
• Subjects who are patients under the clinical care of a study investigator working in the ED

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Participants With Uptake of 1 or More Health Services	Index visit	Any 1 or more of the following services: Testing for pregnancy, gonorrhea/chlamydia, and/or HIV, hormonal birth control, condoms, emergency contraception (for immediate or future use), treatment for previously diagnosed (yet untreated) infection with gonorrhea/chlamydia, appointment for clinic referral.

Trial Locations

Locations (1)

Children's Mercy Hospital; 🇺🇸 Kansas City, Missouri, United States