An interventional study of HIV screening strategies in HIV Infections, sponsored by Westat. Recruiting at 5 sites in United States. Open to participants aged 14 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by Westat · Not applicable, Interventional, and Screening
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).
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.
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's planned enrollment of 84,000 is above the median of 80 across 3,489 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Westat is the lead sponsor of 23 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Other: HIV screening strategies
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.
Other: HIV screening strategies
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.
Other: HIV screening strategies
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.
Other: HIV screening strategies
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.
Other: HIV screening strategies
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.
Other: HIV screening strategies
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.
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.
Time frame: 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.
Time frame: 36 months
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.
Time frame: 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.
Time frame: 36 months
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Oct 2028, 28 months after the start.
Of 393 non-industry interventional studies with no phase under HIV Infections, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 45. This study's planned 28 months is close to that.
Counting every sponsor, half of 402 studies reached it within 28 months; a quarter within 16 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
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