Adolescent Sexually Transmitted Infection Screening in the Emergency Department

NCT03715335 | Completed Results DMC

• 2 other identifiers: CIN001-STI Screening1R01HD094213-01A1
• Study Type: interventional
• Target: 98,413
• Locations: 1 country
• Sites: 5

Brief Summary

Sexually transmitted infections (STIs) are highly prevalent among adolescents. Clinical practices related to screening, diagnosis, treatment, and prevention of STIs among adolescents are suboptimal. There is a need to expand our screening programs to nontraditional healthcare settings such as emergency departments (ED) and to determine the most efficient and cost-effective method for providing this screening. The goal of this study is to leverage our recent insights obtained from single center ED-based adolescent GC/CT screening research and apply them across a national pediatric ED research network to determine the most clinically effective and cost-effective screening approach for adolescents when implemented into a real-world clinical setting through a pragmatic trial. This will be accomplished through a network of children's hospital EDs with a track record of robust research collaboration (Pediatric Emergency Care Applied Research Network or PECARN). This intervention will rely on an innovative approach that electronically integrates patient-reported data to guide clinical decision support. The investigators will apply human factors modeling methods to perform ED workflow evaluations at each participating pediatric ED to determine the most efficient way to integrate the screening process into clinical care. The investigators will then conduct a comparative effectiveness pragmatic trial of targeted STI screening versus universally offered STI screening through electronic integration of patient reported data for provision of clinical decision support. The investigators will develop decision analytic models to evaluate the cost-effectiveness of targeted screening compared to universally offered screening.

Conditions

Gonorrhea; Chlamydia

Keywords

Screening; Emergency Department; Adolescents; Sexually Transmitted Infections; Sexually Transmitted Diseases; Cost Effectiveness; Pragmatic Trial

Outcome Measures

Primary Outcomes (1)

• GC/CT Detection Rates

  Our primary outcome measure is GC/CT detection rates per 1000 eligible patients.

  Through study completion, an average of 2 years

Study Arms (3)

Baseline

NO INTERVENTION

Current STI screening rates.

Targeted STI Screening

ACTIVE COMPARATOR

Data from the Sexual Health Screen (SHS) will be integrated into the Electronic Health Record (EHR) and will provide Clinical Decision Support (CDS) for GC/CT testing based on SHS-calculated STI risk. Patients will be classified as at high risk for STIs, at risk or low risk if they deny any history of sexual activity. When patients classify as at high risk, clinicians will receive CDS that STI testing is "highly recommended"; when they care for patients who classify as at risk, they will receive CDS that STI testing is "recommended"; when caring for patients who classify as at low risk, they will receive CDS that STI testing "is not necessary at this time." If the clinician chooses to follow the recommendation for screening based on patient's risk assessment, and the patient consents to testing on the tablet device, urine GC/CT testing will be performed.

Other: Targeted STI Screening

Universally Offered STI Screening

ACTIVE COMPARATOR

During the universally offered screening intervention, STI screening will be offered to all eligible adolescents, regardless of risk. All eligible patients will also complete the SHS, will be informed of the CDC GC/CT testing recommendations and then be given the option to decline STI testing using the tablet device. During this phase, the SHS results will not be available to the clinician. STI testing recommendations will be based only on the patient's decision to undergo GC/CT testing. Like the process followed in the targeted screening phase, if the clinician follows the CDS that informs the clinician that the patient agreed to GC/CT screening and consequently orders testing, urine GC/CT testing will be performed.

Other: Universally Offered STI Screening

Interventions

Targeted STI Screening OTHER

GC/CT screening will be offered to those who screen at risk or at high risk for STIs.

Targeted STI Screening

Universally Offered STI Screening OTHER

GC/CT screening will be offered to all patients who meet the age eligibility criteria.

Universally Offered STI Screening

Eligibility Criteria

• Age: 15 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years of age

You may not qualify if:

• unable to understand English
• critically ill
• cognitive impairment or altered mental status
• unable to provide consent for completion of the sexual health screen and STI screening.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• MedStar Health: collaborator
• Nationwide Children's Hospital: collaborator
• Children's National Research Institute: collaborator
• Children's Hospital of Philadelphia: collaborator
• Ann & Robert H Lurie Children's Hospital of Chicago: collaborator
• Children's Hospital and Health System Foundation, Wisconsin: collaborator
• Baylor College of Medicine: collaborator
• Children's Hospital Colorado: collaborator
• University of Cincinnati: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (5)

Colorado Children's Hospital

Aurora, Colorado, 80045, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Children's Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

• Reed JL, Palmer CA, Casper TC, Augustine EM, Cruz AT, Elsholz CL, Mollen CJ, Pickett ML, Schmidt SK, Stukus KS, Goyal MK. Gonorrhea and Chlamydia Screening for Adolescents and Young Adults in Emergency Departments. JAMA Pediatr. 2025 Dec 1;179(12):1343-1352. doi: 10.1001/jamapediatrics.2025.2139.

  PMID: 40920405 DERIVED

MeSH Terms

Conditions

Gonorrhea; Chlamydia Infections; Emergencies; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Communicable Diseases; Genital Diseases; Urogenital Diseases; Chlamydiaceae Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Jennifer Reed
• Organization: Cincinnati Children's Hospital Medical Center

jennifer.reed@cchmc.org

(513) 636-7966

Study Officials

• Jennifer L Reed, MD, MSCE

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Pediatrics, Attending Physician Division of Emergency Medicine

Model Details: A comparative effectiveness pragmatic trial using a stepped wedge crossover design will be conducted. A stepped wedge design involves the sequential roll-out of an intervention or a sequence of interventions to individuals or sites over multiple time periods. At the end of the study, all sites will have received all interventions, but the order in which sites are enrolled is randomly assigned. Once the final intervention is implemented, that intervention will continue until the end of the study.

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 23, 2018
• Study Start: July 20, 2020
• Primary Completion: September 25, 2022
• Study Completion: July 31, 2025
• Last Updated: November 6, 2025
• Results First Posted: November 6, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)