HIV InfectionsS2PNCT07728123
Screen2Prevent (S2P)
A study testing HIV screening strategies in people with HIV Infections, run by Westat at 5 sites in United States.
Trial summary
Screen2Prevent is a study intended to improve HIV prevention and detection through implementation and evaluation of three different broad-scale HIV screening approaches a) targeted, b) universally offered opt-in, and c) universally offered opt-out in Emergency Departments (EDs) by leveraging digital health to identify… Read more about this study
- Who is it for?
- Ages 14 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- HIV screening strategies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84,000 participants
- Where
- 5 sitesUnited States
- Study dates
- 16 Jun 2026to 31 Oct 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 14 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 14-24 years, inclusive
- Present to the participating ED, regardless of chief complaint during the study period
Who cannot join
- None
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Emory Atlanta Adolescent Consortium
Atlanta, Georgia, 30322
Kaylin Dance, 404-727-5642, kaylin.dance@emory.edu
Andres Camacho-Gonzalez, MD
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21287
Jessica Coleman-Lewis, MD, 3013854868, jcolem52@jh.edu
Errol Fields, MD
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Litty Koshy, 832-822-1038, Litty.Koshy@bcm.edu
Mary Paul, MD
- Recruiting
St. Jude Children's Research Hospital
Memphis, Tennessee, 38015
Jamie Russell, 901-595-8300, jamie.russell@stjude.org
Aditya Gaur, MD
- Recruiting
University of South Florida
Tampa, Florida, 33612
Elizabeth Enriquez-Bruce, 813-250-2574, enriquezbruce@usf.edu
Carina Rodriguez, MD
About this study
Official title: Screen2Prevent (S2P): Using Digital Health to Improve HIV Screening and Prevention for Adolescents in the Emergency Department
Screen2Prevent is a study intended to improve HIV prevention and detection through implementation and evaluation of three different broad-scale HIV screening approaches a) targeted, b) universally offered opt-in, and c) universally offered opt-out in Emergency Departments (EDs) by leveraging digital health to identify and link adolescents seeking care in the ED to HIV Pre-Exposure Prophylaxis (PrEP)/Antiretroviral treatment (ART).
Read the detailed description
At each SC, each of the three screening strategies (targeted, universally offered opt-in, and universally offered opt-out) will be employed, one at a time, for a period of 8 months and a total study period of 24 months.
All patients 14-24 years of age that are seeking care in participating EDs during the study period will be given the opportunity to complete the computerized sexual health survey (cSHS) on a tablet. The cSHS asks patients to decide whether they want to be tested for HIV and contains questions based on the 2021 update to the CDC PrEP eligibility guidelines that stratify risk for HIV exposure and acquisition. The patient will agree (or not) to completing the cSHS on the tablet. The cSHS is not mandatory, so a patient may decline to use the tablet, and their parent or guardian may decline as well.
Throughout study activities (for all screening strategy phases), certain cSHS results will trigger real-time EHR-integrated decision support for clinicians on whether HIV testing should be ordered and whether counseling/prescription for PrEP should be provided. It also implements a text messaging platform with the patient for basic PrEP information and enrollment into a digital health PrEP linkage platform.
Additionally, all SCs will abstract baseline (plus 3 months) EHR data for all eligible patients to be used as a comparator in the analysis.
- Conditions
- HIV Infections
- Being tested
- HIV screening strategies
- Keywords
- HIV, adolescents, emergency department, preventive care, mHealth, PrEP
- 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.
HIV screening strategiesOther
The intervention includes three screening strategies (targeted, universally offered opt-in, and universally offered opt-out) which will each be employed, one at a time, for a period of 8 months.
A targeted screening approach is defined as screening those who are at increased likelihood for acquiring HIV. Alternatively, a universally offered screening approach is defined as screening all, regardless of behavior informing risk. There are two types of universally offered screening, opt-in and opt-out. With opt-in screening, all patients are offered screening, which they may then agree to undergo. Opt-out screening consists of notifying patients that the test will be conducted unless they explicitly decline.
Each screening strategy implements the cSHS, a text messaging platform, and Clinical Decision Support for identification of youth needing HIV treatment/prevention and linkage to services.
| Study group | Role | What they receive |
|---|---|---|
| 1. Universally offered opt-in > Universally offered opt-out > Targeted | Other | The intervention includes three screening strategies (targeted, universally offered opt-in, and universally offered opt-out) which will each be employed, one at a time, for a period of 8 months. Receives: Other: HIV screening strategies |
| 2. Universally offered opt-out > Universally offered opt-in > Targeted | Other | The intervention includes three screening strategies (targeted, universally offered opt-in, and universally offered opt-out) which will each be employed, one at a time, for a period of 8 months. Receives: Other: HIV screening strategies |
| 3. Universally offered opt-in > Targeted > Universally offered opt-out | Other | The intervention includes three screening strategies (targeted, universally offered opt-in, and universally offered opt-out) which will each be employed, one at a time, for a period of 8 months. Receives: Other: HIV screening strategies |
| 4. Universally offered opt-out > Targeted > Universally offered opt-in | Other | The intervention includes three screening strategies (targeted, universally offered opt-in, and universally offered opt-out) which will each be employed, one at a time, for a period of 8 months. Receives: Other: HIV screening strategies |
| 5. Targeted > Universally offered opt-out > Universally offered opt-in | Other | The intervention includes three screening strategies (targeted, universally offered opt-in, and universally offered opt-out) which will each be employed, one at a time, for a period of 8 months. Receives: Other: HIV screening strategies |
| 6. Targeted > Universally offered opt-in > Universally offered opt-out | Other | The intervention includes three screening strategies (targeted, universally offered opt-in, and universally offered opt-out) which will each be employed, one at a time, for a period of 8 months. Receives: Other: HIV screening strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monthly HIV detection rates per 1,000 eligible patients
Compare the rate of HIV detection between each screening strategy (targeted, universal opt-in, universal opt-out) to baseline using the all patients analysis set.
Measured: 36 months
Rapid PrEP/ART initiation (defined by prescription within 72 hours of ED discharge)
Compare the rates of rapid start of PrEP/ART, defined as PrEP/ART prescription within 72 hours of ED discharge, between adolescents and young adults who visit the ED prior to implementation of cSHS and those who visit after implementation of cSHS using the all patients analysis set.
Measured: 36 months
Secondary outcomes (2)
Cost per HIV case detected
Compare the cost per HIV case detected between each of the screening strategies and baseline using the all patients analysis set.
Measured: 36 months
Rapid PrEP/ART initiation (defined by prescription within 72 hours of ED discharge)
Compare the proportions of rapid start of PrEP/ART, defined as PrEP/ART prescription within 72 hours of ED discharge, among those who visit the ED during implementation of cSHS between those who engage in ScreenWell versus those who do not using the cSHS Analysis Set.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start16 Jun 2026
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Oct 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomizing ED departments to implement 3 screening strategies sequentially for 8 months each
- Masking
- None (open label)
- Enrolment
- 84,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Westat
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07728123
- Sponsor's protocol ID
- ATN164 (S2P)
- Acronym
- S2P
- Status last verified
- Aug 2026
- First submitted
- 22 Jul 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screen2Prevent (S2P): Using Digital Health to Improve HIV Screening and Prevention for Adolescents in the Emergency Department
- ClinicalTrials.gov ID
- NCT07728123
- Acronym / sponsor ID
- S2P / ATN164 (S2P)
- Conditions
- HIV Infections
- Keywords
- HIV, adolescents, emergency department, preventive care, mHealth, PrEP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84,000 participants (estimated)
- Lead sponsor
- WestatUniversity, hospital or other
- Study start
- 16 Jun 2026 (actual)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 27 Jul 2026 (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.
Screen2Prevent is a study intended to improve HIV prevention and detection through implementation and evaluation of three different broad-scale HIV screening approaches a) targeted, b) universally offered opt-in, and c) universally offered opt-out in Emergency Departments (EDs) by leveraging digital health to identify and link adolescents seeking care in the ED to HIV Pre-Exposure Prophylaxis (PrEP)/Antiretroviral treatment (ART).
Detailed description
At each SC, each of the three screening strategies (targeted, universally offered opt-in, and universally offered opt-out) will be employed, one at a time, for a period of 8 months and a total study period of 24 months.
All patients 14-24 years of age that are seeking care in participating EDs during the study period will be given the opportunity to complete the computerized sexual health survey (cSHS) on a tablet. The cSHS asks patients to decide whether they want to be tested for HIV and contains questions based on the 2021 update to the CDC PrEP eligibility guidelines that stratify risk for HIV exposure and acquisition. The patient will agree (or not) to completing the cSHS on the tablet. The cSHS is not mandatory, so a patient may decline to use the tablet, and their parent or guardian may decline as well.
Throughout study activities (for all screening strategy phases), certain cSHS results will trigger real-time EHR-integrated decision support for clinicians on whether HIV testing should be ordered and whether counseling/prescription for PrEP should be provided. It also implements a text messaging platform with the patient for basic PrEP information and enrollment into a digital health PrEP linkage platform.
Additionally, all SCs will abstract baseline (plus 3 months) EHR data for all eligible patients to be used as a comparator in the analysis.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Randomizing ED departments to implement 3 screening strategies sequentially for 8 months each
| Arm | Type | Receives |
|---|---|---|
| 1. Universally offered opt-in > Universally offered opt-out > Targeted | Other | Other: HIV screening strategiesThe intervention includes three screening strategies (targeted, universally offered opt-in, and universally offered opt-out) which will each be employed, one at a time, for a period of 8 months. |
| 2. Universally offered opt-out > Universally offered opt-in > Targeted | Other | Other: HIV screening strategiesThe intervention includes three screening strategies (targeted, universally offered opt-in, and universally offered opt-out) which will each be employed, one at a time, for a period of 8 months. |
| 3. Universally offered opt-in > Targeted > Universally offered opt-out | Other | Other: HIV screening strategiesThe intervention includes three screening strategies (targeted, universally offered opt-in, and universally offered opt-out) which will each be employed, one at a time, for a period of 8 months. |
| 4. Universally offered opt-out > Targeted > Universally offered opt-in | Other | Other: HIV screening strategiesThe intervention includes three screening strategies (targeted, universally offered opt-in, and universally offered opt-out) which will each be employed, one at a time, for a period of 8 months. |
| 5. Targeted > Universally offered opt-out > Universally offered opt-in | Other | Other: HIV screening strategiesThe intervention includes three screening strategies (targeted, universally offered opt-in, and universally offered opt-out) which will each be employed, one at a time, for a period of 8 months. |
| 6. Targeted > Universally offered opt-in > Universally offered opt-out | Other | Other: HIV screening strategiesThe intervention includes three screening strategies (targeted, universally offered opt-in, and universally offered opt-out) which will each be employed, one at a time, for a period of 8 months. |
Who may qualify
- Ages
- 14 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Age 14-24 years, inclusive
- Present to the participating ED, regardless of chief complaint during the study period
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| HIV screening strategiesThe intervention includes three screening strategies (targeted, universally offered opt-in, and universally offered opt-out) which will each be employed, one at a time, for a period of 8 months. A targeted screening approach is defined as screening those who are at increased likelihood for acquiring HIV. Alternatively, a universally offered screening approach is defined as screening all, regardless of behavior informing risk. There are two types of universally offered screening, opt-in and opt-out. With opt-in screening, all patients are offered screening, which they may then agree to undergo. Opt-out screening consists of notifying patients that the test will be conducted unless they explicitly decline. Each screening strategy implements the cSHS, a text messaging platform, and Clinical Decision Support for identification of youth needing HIV treatment/prevention and linkage to services. | Other | 1. Universally offered opt-in > Universally offered opt-out > Targeted, 2. Universally offered opt-out > Universally offered opt-in > Targeted, 3. Universally offered opt-in > Targeted > Universally offered opt-out, 4. Universally offered opt-out > Targeted > Universally offered opt-in, 5. Targeted > Universally offered opt-out > Universally offered opt-in, 6. Targeted > Universally offered opt-in > Universally offered opt-out |
Primary outcome
Monthly HIV detection rates per 1,000 eligible patients
Time frame: 36 months
Compare the rate of HIV detection between each screening strategy (targeted, universal opt-in, universal opt-out) to baseline using the all patients analysis set.
Rapid PrEP/ART initiation (defined by prescription within 72 hours of ED discharge)
Time frame: 36 months
Compare the rates of rapid start of PrEP/ART, defined as PrEP/ART prescription within 72 hours of ED discharge, between adolescents and young adults who visit the ED prior to implementation of cSHS and those who visit after implementation of cSHS using the all patients analysis set.
2 secondary outcomes
Cost per HIV case detected
Time frame: 36 months
Rapid PrEP/ART initiation (defined by prescription within 72 hours of ED discharge)
Time frame: 36 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 17 Aug 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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIV screening strategies in people with HIV Infections, run by Westat at 5 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 2 inclusion and 1 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 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 Erin Ricketts (240-453-2786, erinricketts@westat.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monthly HIV detection rates per 1,000 eligible patients (time frame: 36 months). The study lists 2 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 17 Aug 2026.