NCT06003192 · Children's Hospital Medical Center, Cincinnati
Screen Smart: Using Digital Health to Improve HIV Screening and Prevention
(Screen Smart)
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
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 measures
HIV testing rates per 1000 eligible patients during each month
Time frame: 30 months
We will employ interrupted time series analyses to compare these rates between baseline (usual care) and upon implementation of universally offered, opt-out HIV screening strategy.
HIV infection rates per 1000 eligible patients during each month
Time frame: 30 months
We will employ interrupted time series analyses to compare these rates between baseline (usual care) and upon implementation of universally offered, opt-out HIV screening strategy
Linkage of PrEP
Time frame: 30 months
The number of PrEP eligible youth who are enrolled in the mHealth platform and complete a followup appointment in their comprehensive PrEP care medical home within 1 month of the ED visit.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Columbus, Ohio
- Philadelphia, Pennsylvania
- Salt Lake City, Utah
- Milwaukee, Wisconsin
Collaborators
University of Utah
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 4, 2025 · Source of record for eligibility and locations