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Enhanced SexHealth Intervention to Improve Adolescent Outcomes

Primary Purpose

Sexually Transmitted Diseases, Reproductive Behavior

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SexHealth
Sponsored by
Children's Mercy Hospital Kansas City
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Sexually Transmitted Diseases

Eligibility Criteria

14 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Children's Mercy Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

They will receive the same pamphlet as controls and the enhanced ED SexHealth intervention with the educator. Based on behaviors, CDS system recommendations (generated from screening survey responses only for intervention participants), and discussions, participants may be offered 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, and a scheduled appointment at Adolescent Clinic (for ongoing care, including repeat STI/HIV testing if needed). All services will be provided at point of care, costs will be covered by the study.

They will receive a printed health pamphlet and a list of local resources with the phone number for Adolescent Clinic. Participants will then be referred back to their ED provider, who will provide their standard care.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 6, 2017
Last Updated
February 9, 2021
Sponsor
Children's Mercy Hospital Kansas City
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1. Study Identification

Unique Protocol Identification Number
NCT03341975
Brief Title
Enhanced SexHealth Intervention to Improve Adolescent Outcomes
Official Title
Enhanced SexHealth Intervention to Improve Adolescent Outcomes: A Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
May 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Mercy Hospital Kansas City

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexually Transmitted Diseases, Reproductive Behavior

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
They will receive the same pamphlet as controls and the enhanced ED SexHealth intervention with the educator. Based on behaviors, CDS system recommendations (generated from screening survey responses only for intervention participants), and discussions, participants may be offered 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, and a scheduled appointment at Adolescent Clinic (for ongoing care, including repeat STI/HIV testing if needed). All services will be provided at point of care, costs will be covered by the study.
Arm Title
Control
Arm Type
No Intervention
Arm Description
They will receive a printed health pamphlet and a list of local resources with the phone number for Adolescent Clinic. Participants will then be referred back to their ED provider, who will provide their standard care.
Intervention Type
Behavioral
Intervention Name(s)
SexHealth
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Uptake of 1 or More Health Services
Description
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.
Time Frame
Index visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa Miller, MD
Organizational Affiliation
Children's Mercy Hospital Kansas City
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34144031
Citation
Miller MK, Catley D, Adams A, Staggs VS, Dowd MD, Stancil SL, Miller E, Satterwhite CL, Bauermeister J, Goggin K. Brief Motivational Intervention to Improve Adolescent Sexual Health Service Uptake: A Pilot Randomized Controlled Trial in the Emergency Department. J Pediatr. 2021 Oct;237:250-257.e2. doi: 10.1016/j.jpeds.2021.06.007. Epub 2021 Jun 16.
Results Reference
derived

Learn more about this trial

Enhanced SexHealth Intervention to Improve Adolescent Outcomes

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