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Recruiting NCT06003192

NCT06003192 Screen Smart: Using Digital Health to Improve HIV Screening and Prevention

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Clinical Trial Summary
NCT ID NCT06003192
Status Recruiting
Phase
Sponsor Children's Hospital Medical Center, Cincinnati
Condition HIV Infections
Study Type INTERVENTIONAL
Enrollment 63,000 participants
Start Date 2024-12-16
Primary Completion 2027-12-15

Eligibility & Interventions

Sex All sexes
Min Age 15 Years
Max Age 21 Years
Study Type INTERVENTIONAL
Interventions
Universal Opt-out HIV Screening

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 63,000 participants in total. It began in 2024-12-16 with a primary completion date of 2027-12-15.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

The goal of this interrupted time series quasi-experimental design study is to implement universal opt- out HIV testing and linkage to HIV preventive care in 15-21 year old adolescents visiting the pediatric emergency department (ED). The main question\[s\] it aims to answer are: 1. What is the uptake, reach and effectiveness of universally offered, opt-out HIV screening across pediatric EDs after implementing an adapted version of a tablet-based screening process? 2. What is the successful linkage to comprehensive HIV pre-exposure prophylaxis (PrEP) care using a novel, digital health platform? Participants will 1. Complete the previously developed and validated computerized sexual health screen (cSHS) containing questions regarding their personal sexual health history 2. Have the opportunity to opt-out of clinician-ordered HIV testing 3. Patients meeting CDC criteria for HIV PrEP will be given the opportunity to enroll in the digital health PrEP linkage platform and followed for 3 months after enrollment.

Eligibility Criteria

Inclusion Criteria: * All patients 15-21 years of age visiting a pediatric emergency department. Exclusion Criteria: * Unable to understand English * Critically ill * Cognitively impaired * Altered mental status

Contact & Investigator

Central Contact

Tricia Cobb, MS

✉ patricia.cobb@cchmc.org

📞 513-636-7966

Principal Investigator

Jennifer L Reed, MD, MS

PRINCIPAL INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Frequently Asked Questions

Who can join the NCT06003192 clinical trial?

This trial is open to participants of all sexes, aged 15 Years or older, up to 21 Years, studying HIV Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06003192 currently recruiting?

Yes, NCT06003192 is actively recruiting participants. Contact the research team at patricia.cobb@cchmc.org for enrollment information.

Where is the NCT06003192 trial being conducted?

This trial is being conducted at Columbus, United States, Philadelphia, United States, Salt Lake City, United States, Milwaukee, United States.

Who is sponsoring the NCT06003192 clinical trial?

NCT06003192 is sponsored by Children's Hospital Medical Center, Cincinnati. The principal investigator is Jennifer L Reed, MD, MS at Children's Hospital Medical Center, Cincinnati. The trial plans to enroll 63,000 participants.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: July 2026  ·  Data Methodology