Enhanced SexHealth Intervention to Improve Adolescent Outcomes

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2020-05-01

Brief Summary

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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.

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Detailed Description

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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

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Sexually Transmitted Diseases Reproductive Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention

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.

Group Type EXPERIMENTAL

SexHealth

Intervention Type BEHAVIORAL

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.

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

14 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes