Recruiting

Observational Study

Sponsor:

Children's National Research Institute

Code:

NCT04372875

Conditions

Sexually Transmitted Diseases

Eligibility Criteria

Sex: All

Age: 15 - 21

Healthy Volunteers: Accepted

Interventions

SHS-derived CDS

Study Details

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.

Conditions

Sexually Transmitted Diseases

Study ID

NCT04372875

Start date

Mar 8, 2023

Status verified date

Mar, 2026

Completion date

Jan 15, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15 - 21

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

18500 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: SHS-derived CDS

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

no intervention: Usual care

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

Interventions

SHS-derived CDS

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

Primary outcome measure

  • Chlamydia trachomatis (CT) / Neisseria gonorrhoeae (GC) detection rates [ Time Frame: 3-7 days after emergency department (ED) visit ]

Central Contacts and Locations

Central contacts

Meleah Boyle

2024765388mdboyle@childrensnational.org

Monika Goyal, MD

12024762869mgoyal@cnmc.org

Locations

Children's National Hospital

Recruiting

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

Contacts

Monika Goyal, MD

12024762869mgoyal@cnmc.org

More Information

Sponsor

Children's National Research Institute

Last update posted

Mar 18, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's National Research Institute on 2026-03-18.