Enhanced SexHealth Intervention to Improve Adolescent Outcomes

Sexually Transmitted Diseases Clinical Trial

Official title:

Enhanced SexHealth Intervention to Improve Adolescent Outcomes: A Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03341975
• Other study ID #: 17010079
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: May 1, 2020

Study information

• Verified date: February 2021
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: May 1, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Reproductive Behavior
• Sexually Transmitted Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Children's Mercy Hospital	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Uptake of 1 or More Health Services	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.	Index visit