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

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT06003192
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
15 Years - 21 Years
Healthy Volunteers
Accepted

Interventions

  • Universal Opt-out HIV Screening — OTHER
    Using a tablet device, offering universal opt-out HIV screening to adolescents seeking care in a pediatric emergency department.

Study Details

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.

Key Dates

Start date
Dec 16, 2024
Status verified
Feb 2025
Primary completion
Dec 15, 2027
Completion
Mar 15, 2028

Study Design

Enrollment
63,000 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING

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.

Primary Outcome Measure

HIV testing rates per 1000 eligible patients during each month [ Time Frame: 30 months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Nationwide Children's HospitalColumbusOhio43205
Kristin Stukus, MD
614-722-4385
Annie Truelove
614-355-5791
Kristin Stukus, MD (PRINCIPAL_INVESTIGATOR)
Megan Brundrett, MD (SUB_INVESTIGATOR)
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Cynthia Mollen, MD, MSCE
215-590-4410
Joe Zorc, MD, MSCE
215-590-4410
Cynthia Mollen, MD, MSCE (PRINCIPAL_INVESTIGATOR)
Marne Castillo, MEd, PhD (SUB_INVESTIGATOR)
Sarah Wood, MD, MSCE (SUB_INVESTIGATOR)
University of UtahSalt Lake CityUtah84112
Charlie Casper, PhD
8015816410
Melissa Laws, BSN
8015816410
Children's WisconsinMilwaukeeWisconsin53226
Michelle Pickett, MD, MS
414-460-0276
Danny Thomas, MD
414-266-2625
Michelle Pickett, MD, MS (PRINCIPAL_INVESTIGATOR)
Claudia Vicetti, MD, MS (SUB_INVESTIGATOR)

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