← Back to Search

STI Screening Strategies for Emergency Department Visitors (STI Trial)

N/A
Waitlist Available
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
15-21 years of age
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 2 years
Awards & highlights

STI Trial Summary

This trial will test whether targeted or universal screening for STIs is more effective in children's hospital EDs.

Who is the study for?
This trial is for adolescents aged 15-21 who visit the emergency department and can understand English. They must be able to consent to a sexual health screen and STI testing. Those with cognitive impairments, altered mental status, or critical illness cannot participate.Check my eligibility
What is being tested?
The study tests two methods of screening for sexually transmitted infections (STIs) in emergency departments: one that targets teens reporting high-risk behavior, and another that offers screening to all teens. The goal is to find the most effective and cost-efficient approach.See study design
What are the potential side effects?
There are no direct side effects from participating in this trial as it involves non-invasive STI screening procedures. However, there may be emotional or psychological impacts from receiving positive test results which will be handled according to best clinical practices.

STI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 15 and 21 years old.

STI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
GC/CT testing rates
Secondary outcome measures
Appropriate Treatment of Positive GC/CT Infections
Gas Chromatography
Positive GC/CT Rates by Risk Strata
Other outcome measures
CDS recommendations followed
ED Length of Stay
Patients agreeing to testing

STI Trial Design

3Treatment groups
Active Control
Group I: Targeted STI ScreeningActive Control1 Intervention
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.
Group II: Universally Offered STI ScreeningActive Control1 Intervention
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.
Group III: BaselineActive Control1 Intervention
Current STI screening rates.

Find a Location

Who is running the clinical trial?

Children's Hospital and Health System Foundation, WisconsinOTHER
55 Previous Clinical Trials
26,649 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,951 Previous Clinical Trials
2,590,786 Total Patients Enrolled
2 Trials studying Gonorrhea
2,107 Patients Enrolled for Gonorrhea
Baylor College of MedicineOTHER
997 Previous Clinical Trials
5,932,074 Total Patients Enrolled

Media Library

Gonorrhea Research Study Groups: Targeted STI Screening, Universally Offered STI Screening, Baseline
Gonorrhea Clinical Trial 2023: Targeted STI Screening Highlights & Side Effects. Trial Name: NCT03715335 — N/A
Targeted STI Screening 2023 Treatment Timeline for Medical Study. Trial Name: NCT03715335 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experimental research include senior citizens of 70 years and older?

"This study has a narrow age range of 15 to 21. Outside that, there are 60 trials specifically for minors and 190 studies accepting individuals above the pensionable age."

Answered by AI

Would I be eligible to participate in this research experiment?

"To qualify for this medical experiment, participants must have a diagnosis of gonorrhea and be within the age range of 15 to 21. In total, 70000 individuals are sought after by the research team."

Answered by AI

What is the participant enrollment for this experiment?

"Correct. The information located on clinicaltrials.gov shows that this healthcare trial is currently recruiting; it was first shared online on July 20th 2020 and has been updated most recently on July 22nd 2022. A total of 70,000 patients are needed to participate at one medical facility."

Answered by AI

Is enrollment for this trial still available?

"Affirmative. Clinicaltrials.gov records verify that this clinical study is recruiting candidates, having been initially posted on July 20th 2020 and last updated on July 22nd 2022. 70 000 patients are needed to be recruited from one medical site for the trial's completion."

Answered by AI
~15000 spots leftby Mar 2025