NCT04372875

Brief Summary

We will compare differences in sexually transmitted infection (STI) detection rates between sexual health survey (SHS)-derived electronic clinical decision support (CDS) versus usual care (e.g. no provision of CDS) using an interrupted time series design. We hypothesize that population-based STI detection rates will be higher when SHS-derived electronic CDS is provided compared to usual care. Secondary analysis will include a comparison of STI detection rates by sexual risk strata (high risk vs. at risk) and race/ethnicity.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18,500

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Mar 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress82%
Mar 2023Jan 2027

First Submitted

Initial submission to the registry

April 30, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 4, 2020

Completed
2.8 years until next milestone

Study Start

First participant enrolled

March 8, 2023

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2027

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

3.8 years

First QC Date

April 30, 2020

Last Update Submit

March 16, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Chlamydia trachomatis (CT) / Neisseria gonorrhoeae (GC) detection rates

    Proportion of encounters during which patients test positive for CT/GC; measured by urine-based nucleic acid amplification tests.

    3-7 days after emergency department (ED) visit

Secondary Outcomes (1)

  • STI rates by race/ethnicity

    3-7 days after ED visit

Study Arms (2)

SHS-derived CDS

EXPERIMENTAL

All adolescents seen in the emergency department that meet eligibility criteria will be offered the sexual health survey (SHS) during the pragmatic trial.

Behavioral: SHS-derived CDS

Usual care

NO INTERVENTION

All adolescents seen in the emergency department that meet eligibility criteria prior to implementation of SHS-derived CDS.

Interventions

SHS-derived CDSBEHAVIORAL

This intervention will provide electronic clinical decision support for adolescents who screen at risk or at high risk of an STI.

SHS-derived CDS

Eligibility Criteria

Age15 Years - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Adolescents aged 15-21 years seeking care in the emergency department

You may not qualify if:

  • Patients will be excluded if unable to understand English, are critically ill, cognitively impaired, or otherwise unable to provide consent for completion of the sexual health survey (SHS) and STI screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's National Hospital

Washington D.C., District of Columbia, 20010, United States

RECRUITING

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics and Emergency Medicine

Study Record Dates

First Submitted

April 30, 2020

First Posted

May 4, 2020

Study Start

March 8, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

January 15, 2027

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations