STI Screening Strategies for Emergency Department Visitors

(STI Trial)

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

70000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

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

Is STI screening in emergency departments safe for humans?

The research does not specifically address safety concerns related to STI screening in emergency departments, but it suggests that the process is generally acceptable to patients and clinicians, implying no significant safety issues have been identified. ^{1 2 3 4 5}

How does this STI screening strategy differ from other treatments for STIs?

This STI screening strategy is unique because it focuses on screening asymptomatic adolescents in emergency departments, which may be their only opportunity for STI testing. It integrates electronically-enhanced screening tools into the emergency department workflow, making it more efficient and accessible compared to traditional clinic-based screenings. ^{2 3 4 5 6}

What data supports the effectiveness of the treatment Targeted STI Screening, Universally Offered STI Screening for emergency department visitors?

Research shows that STI screening in emergency departments is highly accepted by patients, and implementing such programs is feasible and effective. Screening can help identify infections in adolescents who may not have other healthcare access, potentially reducing future emergency visits. ^{2 3 5 6 7}

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. United States pubmed.ncbi.nlm.nih.gov

Universal Screening for Sexually Transmitted Infections among Asymptomatic Adolescents in an Urban Emergency Department: High Acceptance but Low Prevalence of Infection. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Impact of Post-visit Contact on Emergency Department Utilization for Adolescent Women with a Sexually Transmitted Infection. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Implementing an HIV and sexually transmitted disease screening program in an emergency department. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Workflow Analysis Driven Recommendations for Integration of Electronically-Enhanced Sexually Transmitted Infection Screening Tools in Pediatric Emergency Departments. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Screening for Asymptomatic Gonorrhea and Chlamydia in the Pediatric Emergency Department. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of an urban emergency department call-back system in the successful linkage to treatment of sexually transmitted infections. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Adolescent Attitudes Toward Sexually Transmitted Infection Screening in the Emergency Department. [2023]