Last reviewed · How we verify
Adolescent Sexually Transmitted Infection Screening in the Emergency Department
NA trial testing Targeted STI Screening in Gonorrhea in 98,413 participants. Completed in 31 July 2025.
| Lead sponsor | Children's Hospital Medical Center, Cincinnati |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | screening |
| Enrollment | 98,413 |
| Start date | 20 July 2020 |
| Primary completion | 25 September 2022 |
| Estimated completion | 31 July 2025 |
| Sites | 5 locations across United States |
Children's Hospital Medical Center, Cincinnati
Adults 15 to 21, any sex, with Gonorrhea or Chlamydia. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Our primary outcome measure is GC/CT detection rates per 1000 eligible patients.
| Group | Value | 95% CI |
|---|---|---|
| Baseline | 15.2 | 12.7 – 17.9 |
| Targeted STI Screening | 12.1 | 9.5 – 14.8 |
| Universally Offered STI Screening | 11 | 9.3 – 13.6 |
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.
3 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03715335.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing