STI Screening Strategies for Emergency Department Visitors

(STI Trial)

No longer recruiting at 4 trial locations

Overseen By Jennifer L Reed, MD, MS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Medical Center, Cincinnati

Disqualifiers: Critically ill, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve STI screening for adolescents in emergency departments by comparing two approaches: Universally Offered STI Screening, where everyone receives an STI test, and Targeted STI Screening, which focuses on those at higher risk based on a health questionnaire. The research seeks to identify the most effective and cost-efficient method for screening adolescents in emergency settings. Adolescents aged 15-21 who understand English and consent to participate may be suitable candidates. The goal is to make STI screening more accessible and effective for young people. As an unphased trial, this study allows participants to contribute to research that could enhance STI screening practices for adolescents.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these STI screening strategies are safe for adolescents?

Research shows that both targeted and universally offered STI (sexually transmitted infection) screenings are generally well-received by patients. Targeted screening focuses on individuals at higher risk for infections like gonorrhea and chlamydia. Studies have found that this method effectively identifies these individuals without causing significant side effects. It uses data to determine who should be tested, ensuring that those most in need are prioritized.

Universally offered screening, in contrast, is available to all eligible individuals, regardless of risk level. Research indicates that about 60% of adolescents agree to be screened, and this approach has identified STIs in about 5% of participants. It serves as a broad safety net, with no major safety concerns reported.

Both screening methods use simple urine tests, which are non-invasive and carry minimal risk of side effects. Overall, these strategies are safe and aid in early infection detection, which is crucial for treatment and prevention. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the STI screening strategies being tested because they offer a fresh approach to identifying and managing STIs in emergency department visitors. The "Universally Offered STI Screening" method ensures that all eligible adolescents are offered screening, regardless of their perceived risk, aiming for comprehensive detection. Meanwhile, the "Targeted STI Screening" leverages data from a Sexual Health Screen (SHS) to customize testing based on individual risk, using clinical decision support to guide clinicians. These strategies could lead to more personalized and widespread STI screening, improving early detection and treatment compared to current practices that may not systematically assess risk or offer universal testing.

What evidence suggests that this trial's screening strategies could be effective for STI detection in adolescents?

This trial will compare two STI screening strategies for emergency department visitors. Research has shown that focusing STI (sexually transmitted infection) screening on high-risk groups, as in the Targeted STI Screening arm of this trial, effectively identifies infections like gonorrhea and chlamydia in teenagers. Studies indicate that using information provided by patients helps identify those most at risk, leading to early detection.

In contrast, the Universally Offered STI Screening arm of this trial offers STI screening to everyone eligible, greatly increasing testing rates. This method detects infections even in asymptomatic individuals. Both targeted and universal screening are cost-effective ways to detect STIs compared to not screening at all. ^{6 7 8 9 10}

Who Is on the Research Team?

Jennifer L Reed, MD, MSCE

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am between 15 and 21 years old.

Exclusion Criteria

Unable to provide consent for completion of the sexual health screen and STI screening.

I have issues with my memory or thinking clearly.

I cannot understand English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Workflow Evaluations

ED workflow evaluations to determine integration of new processes using human factors workflow process mapping

4-8 weeks

Pragmatic Trial

Comparative effectiveness trial using a stepped wedge crossover design to evaluate targeted vs. universally offered STI screening

2 years

Cost-effectiveness Analysis

Evaluation of the cost-effectiveness of targeted vs. universally offered screening strategies

Concurrent with Pragmatic Trial

Follow-up

Participants are monitored for safety and effectiveness after the trial interventions

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Targeted STI Screening
• Universally Offered STI Screening

Trial Overview 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.

How Is the Trial Designed?

Group I: Universally Offered STI Screening Active Control 1 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 Screening Active Control 1 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: Baseline Active Control 1 Intervention

Current STI screening rates.

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

Nationwide Children's Hospital

Collaborator

Trials

354

Recruited

5,228,000+

Baylor College of Medicine

Collaborator

Trials

1,044

Recruited

6,031,000+

Children's National Research Institute

Collaborator

Trials

227

Recruited

258,000+

Ann & Robert H Lurie Children's Hospital of Chicago

Collaborator

Trials

275

Recruited

5,182,000+

Children's Hospital of Philadelphia

Collaborator

Trials

749

Recruited

11,400,000+

University of Cincinnati

Collaborator

Trials

442

Recruited

639,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

MedStar Health

Collaborator

Trials

9

Recruited

76,100+

Children's Hospital and Health System Foundation, Wisconsin

Collaborator

Trials

56

Recruited

93,300+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10648282/

Impact of Risk-based Sexually Transmitted Infection ... Sexually transmitted infections (STI), including chlamydia, gonorrhea, and human immunodeficiency virus pose a significant health burden in adolescents.

2. jamanetwork.com jamanetwork.com/journals/jamapediatrics/article-abstract/2838300

Gonorrhea and Chlamydia Screening for Adolescents and ... This comparative effectiveness trial evaluates screening approaches for gonorrhea and chlamydia in US emergency departments.

3. academic.oup.com academic.oup.com/ofid/article/11/9/ofae490/7743295

Opt-Out Emergency Department Screening Intervention Leads ... Post-intervention, 23.6% of PAI were tested for a urogenital sexually transmitted infection (STI) in the ED and 9.0% presented with symptoms of ...

4. publications.aap.org publications.aap.org/pediatrics/article/156/4/e2024068574/203461/STI-Testing-in-Adolescent-Males-Presenting-to-an

STI Testing in Adolescent Males Presenting to an ... The current standard of care recommends testing for all sexually active patients that have symptoms suggestive of an STI or with known exposure.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1083318814002484

Impact of Post-visit Contact on Emergency Department ... Of 922 women with STI testing at their initial ED visit, 216 (23%) were STI positive. One-third (315/922) returned to the ED, 15% (141/922) returned and had STI ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7046152/

Impact of Post-visit Contact on Emergency Department ... Of 922 women with STI testing at their initial ED visit, 216 (23%) were STI positive. One-third (315/922) returned to the ED, 15% (141/922) returned and had STI ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S221133552400192X

Testing trends and co-testing patterns for HIV, hepatitis C ... We explored national ED testing trends and co-testing patterns for HIV, hepatitis C, and sexually transmitted infections (STIs).

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11112655/

Sexually Transmitted Infection Co-testing in a Large Urban ... In this study, we aimed to describe the prevalence of co-testing and co-infection of HIV, hepatitis C virus (HCV), syphilis, gonorrhea, and chlamydia, in a ...

9. frontiersin.org frontiersin.org/journals/health-services/articles/10.3389/frhs.2025.1493318/full

Leading the way in pediatric sexual health screenings Introduction: Emergency department (ED) encounters offer strategic opportunities for sexually transmitted infection (STI) screening, prevention, ...

10. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2782338

Comparison of HIV Screening Strategies in the Emergency ... Of the 25 639 patients allocated to traditional targeted screening, 7099 (27.7%) were identified as having increased risk for HIV, of whom 4164 ...