Recruiting

Digital Health

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT06003192

Conditions

HIV Infections

Eligibility Criteria

Sex: All

Age: 15 - 21

Healthy Volunteers: Accepted

Interventions

Universal Opt-out HIV Screening

Study Details

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.

Conditions

HIV Infections

Study ID

NCT06003192

Start date

Dec 16, 2024

Status verified date

Feb, 2025

Completion date

Mar 15, 2028

Anticipated

Primary completion date

Dec 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15 - 21

Healthy Volunteers: Accepted

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

Study Design

Enrollment

63000 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

other: Universal Opt-out HIV Screening

The intervention is offering universal opt-out HIV screening to all adolescents 15 to 21 years of age that are seeking care in the emergency department.

Interventions

Universal Opt-out HIV Screening

Using a tablet device, offering universal opt-out HIV screening to adolescents seeking care in a pediatric emergency department.

Primary outcome measure

  • HIV testing rates per 1000 eligible patients during each month [ Time Frame: 30 months ]
  • HIV infection rates per 1000 eligible patients during each month [ Time Frame: 30 months ]
  • Linkage of PrEP [ Time Frame: 30 months ]

Central Contacts and Locations

Central contacts

Tricia Cobb, MS

513-636-7966patricia.cobb@cchmc.org

Locations

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Kristin Stukus, MD

614-722-4385Kristin.Stukus@nationwidechildrens.org

Annie Truelove

614-355-5791annie.truelove@nationwidechildrens.org

Principal Investigator:

Kristin Stukus, MD

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

May 4, 2025

Last verified

Feb, 2025

Keywords

  • HIV
  • adolescents
  • emergency department
  • mHealth
  • preventive care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2025-05-04.