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STI Screening Strategies for Emergency Department Visitors (STI Trial)

N/A

Waitlist Available

Led By Jennifer L Reed, MD, MSCE

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

Must not have

Cognitive impairment or altered mental status

Unable to understand English

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 15 and 21 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have issues with my memory or thinking clearly.

Select...

I cannot understand English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 2 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

GC/CT testing rates

Secondary study objectives

Appropriate Treatment of Positive GC/CT Infections

Gas Chromatography

Positive GC/CT Rates by Risk Strata

Other study objectives

CDS recommendations followed

ED Length of Stay

Patients agreeing to testing

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Active Control

Group I: 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 II: 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 III: BaselineActive Control1 Intervention

Current STI screening rates.

0 / 3Eligibility criteria met