HIV InfectionsScreen SmartNCT06003192
Screen Smart: Using Digital Health to Improve HIV Screening and Prevention
A study testing Universal Opt-out HIV Screening in people with HIV Infections, run by Children's Hospital Medical Center, Cincinnati at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Universal Opt-out HIV Screening
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63,000 participants
- Where
- 4 sitesUnited States
- Study dates
- 16 Dec 2024to 15 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- All patients 15-21 years of age visiting a pediatric emergency department.
Who cannot join
- Unable to understand English
- Critically ill
- Cognitively impaired
- Altered mental status
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Kristin Stukus, MD, 614-722-4385, Kristin.Stukus@nationwidechildrens.org
Annie Truelove, 614-355-5791, annie.truelove@nationwidechildrens.org
- Not yet recruiting
Children's Wisconsin
Milwaukee, Wisconsin, 53226
Michelle Pickett, MD, MS, 414-460-0276, mpickett@mcw.edu
Danny Thomas, MD, 414-266-2625, dthomas@mcw.edu
- Not yet recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Cynthia Mollen, MD, MSCE, 215-590-4410, MOLLENC@chop.edu
Joe Zorc, MD, MSCE, 215-590-4410, ZORC@chop.edu
- Not yet recruiting
University of Utah
Salt Lake City, Utah, 84112
Charlie Casper, PhD, 8015816410, Charlie.Casper@hsc.utah.edu
Melissa Laws, BSN, 8015816410, Melissa.Laws@hsc.utah.edu
About this study
Official title: Screen Smart: Using Digital Health to Improve HIV Screening and Prevention for Adolescents in the Emergency Department
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:
- 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?
- What is the successful linkage to comprehensive HIV pre-exposure prophylaxis (PrEP) care using a novel, digital health platform? Participants will
- Complete the previously developed and validated computerized sexual health screen (cSHS) containing questions regarding their personal sexual health history
- Have the opportunity to opt-out of clinician-ordered HIV testing
- 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.
Read the detailed description
Using a previously developed tablet-based, broad scale gonorrhea and chlamydia screening process, the investigators will adapt, refine, and test this process with the aim of increasing universally offered, opt-out HIV screening in the pediatric ED through electronic integration of patient reported data for provision of clinical decision support for HIV screening and identification of PrEP candidacy. The investigators will then use mHealth to link patients to PrEP services. The goal of this study is to (1) adapt, refine, and test this previously implemented multi-center, ED-based, screening study with a goal of increasing universally offered, opt-out HIV screening among adolescents in the pediatric ED and (2) link at-risk adolescents to PrEP services and preventive care. This will be accomplished through a network of children's hospital EDs (Pediatric Emergency Care Applied Research Network or PECARN). This research will contribute to the evidence base for creating clinically effective and sustainable HIV screening programs that can be successfully implemented into the clinical workflow of the ED. It will also improve identification and linkage to PrEP care for at risk adolescents using mHealth strategies by first identifying adolescents and young adults (AYA) who are PrEP candidates based on their responses to a computerized sexual health screen (cSHS) and subsequently (1) providing clinical decision support to providers via the electronic health record and (2) direct text messaging from the cSHS to PrEP candidates providing educational content and connecting youth to a PrEP navigator. This intervention will rely on an innovative approach that electronically integrates patient-reported data to guide clinical decision support.
- Conditions
- HIV Infections
- Being tested
- Universal Opt-out HIV Screening
- Keywords
- HIV, adolescents, emergency department, mHealth, preventive care
- Medical subject headings
- HIV Infections, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Universal Opt-out HIV ScreeningOther
Using a tablet device, offering universal opt-out HIV screening to adolescents seeking care in a pediatric emergency department.
| Study group | Role | What they receive |
|---|---|---|
| Universal Opt-out HIV Screening | Other | 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. Receives: Other: Universal Opt-out HIV Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV testing rates per 1000 eligible patients during each month
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.
Measured: 30 months
HIV infection rates per 1000 eligible patients during each month
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
Measured: 30 months
Linkage of PrEP
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.
Measured: 30 months
Secondary outcomes (5)
Identification of PrEP eligible and interest in starting PrEP
The proportion of patients who are identified as PrEP eligible and who endorse interest in starting PrEP
Measured: 30 months
Demographics associated with PrEP eligibility
Sociodemographic and visit characteristics associated with PrEP eligibility.
Measured: 30 months
Demographics associated with PrEP linkage to care
Sociodemographic and visit characteristics associated with completion of PrEP care visit within 1 month of study enrollment.
Measured: 30 months
Demographics associated with HIV screening acceptance
Sociodemographic and visit characteristics associated with patient HIV screening acceptance
Measured: 30 months
HIV positivity rates in different sexual risk strata
Comparison of HIV positivity rates between patients in the different sexual risk strata (determined by patient entered cSHS)
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start16 Dec 2024
- Primary completion15 Dec 2027 (estimated)
- Study completion15 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Interrupted Times Series Model
- Masking
- None (open label)
- Enrolment
- 63,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- University of Utah
- Responsible party
- Sponsor
- Investigators
- Jennifer L Reed, MD, MS, Principal investigator, Children's Hospital Medical Center, CincinnatiMonika Goyal, MD, MSCE, Principal investigator, Children's National Research InstituteNadia Dowshen, MD, MSHP, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06003192
- Sponsor's protocol ID
- 1R01HD110321-01A1
- Acronym
- Screen Smart
- Status last verified
- Oct 2026
- First submitted
- 3 Aug 2023
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screen Smart: Using Digital Health to Improve HIV Screening and Prevention for Adolescents in the Emergency Department
- ClinicalTrials.gov ID
- NCT06003192
- Acronym / sponsor ID
- Screen Smart / 1R01HD110321-01A1
- Conditions
- HIV Infections
- Keywords
- HIV, adolescents, emergency department, mHealth, preventive care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 63,000 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- University of Utah
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 15 Mar 2028 (estimated)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- What is the successful linkage to comprehensive HIV pre-exposure prophylaxis (PrEP) care using a novel, digital health platform? Participants will
- Complete the previously developed and validated computerized sexual health screen (cSHS) containing questions regarding their personal sexual health history
- Have the opportunity to opt-out of clinician-ordered HIV testing
- 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.
Detailed description
Using a previously developed tablet-based, broad scale gonorrhea and chlamydia screening process, the investigators will adapt, refine, and test this process with the aim of increasing universally offered, opt-out HIV screening in the pediatric ED through electronic integration of patient reported data for provision of clinical decision support for HIV screening and identification of PrEP candidacy. The investigators will then use mHealth to link patients to PrEP services. The goal of this study is to (1) adapt, refine, and test this previously implemented multi-center, ED-based, screening study with a goal of increasing universally offered, opt-out HIV screening among adolescents in the pediatric ED and (2) link at-risk adolescents to PrEP services and preventive care. This will be accomplished through a network of children's hospital EDs (Pediatric Emergency Care Applied Research Network or PECARN). This research will contribute to the evidence base for creating clinically effective and sustainable HIV screening programs that can be successfully implemented into the clinical workflow of the ED. It will also improve identification and linkage to PrEP care for at risk adolescents using mHealth strategies by first identifying adolescents and young adults (AYA) who are PrEP candidates based on their responses to a computerized sexual health screen (cSHS) and subsequently (1) providing clinical decision support to providers via the electronic health record and (2) direct text messaging from the cSHS to PrEP candidates providing educational content and connecting youth to a PrEP navigator. This intervention will rely on an innovative approach that electronically integrates patient-reported data to guide clinical decision support.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Interrupted Times Series Model
| Arm | Type | Receives |
|---|---|---|
| Universal Opt-out HIV Screening | Other | Other: Universal Opt-out HIV ScreeningThe 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. |
Who may qualify
- Ages
- 15 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All patients 15-21 years of age visiting a pediatric emergency department.
Key exclusion criteria (4 listed)
- Unable to understand English
- Critically ill
- Cognitively impaired
- Altered mental status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Universal Opt-out HIV ScreeningUsing a tablet device, offering universal opt-out HIV screening to adolescents seeking care in a pediatric emergency department. | Other | Universal Opt-out HIV Screening |
Primary outcome
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.
5 secondary outcomes
Identification of PrEP eligible and interest in starting PrEP
Time frame: 30 months
Demographics associated with PrEP eligibility
Time frame: 30 months
Demographics associated with PrEP linkage to care
Time frame: 30 months
Demographics associated with HIV screening acceptance
Time frame: 30 months
HIV positivity rates in different sexual risk strata
Time frame: 30 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer L Reed, MD, MS principal investigator
Children's Hospital Medical Center, Cincinnati
Monika Goyal, MD, MSCE principal investigator
Children's National Research Institute
Nadia Dowshen, MD, MSHP principal investigator
Children's Hospital of Philadelphia
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Universal Opt-out HIV Screening in people with HIV Infections, run by Children's Hospital Medical Center, Cincinnati at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tricia Cobb, MS (513-636-7966, patricia.cobb@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV testing rates per 1000 eligible patients during each month (time frame: 30 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.