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Recruiting NCT07728123

Screen2Prevent (S2P)

No phase Interventional HIV Infections

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HIV screening strategies.
Who it may be relevant to
Registry conditions: HIV Infections. Basic parameters: 14 years — 24 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Screen2Prevent (S2P): Using Digital Health to Improve HIV Screening and Prevention for Adolescents in the Emergency Department

Overview

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.

Interventions

  • 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-

Primary outcome measures

  • Monthly HIV detection rates per 1,000 eligible patients [Time frame: 36 months]
  • Rapid PrEP/ART initiation (defined by prescription within 72 hours of ED discharge) [Time frame: 36 months]
Secondary outcome measures (2)
  • 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]

Eligibility criteria

Inclusion criteria

  • Age 14-24 years, inclusive
  • Present to the participating ED, regardless of chief complaint during the study period

Exclusion criteria

  • None

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Screening

Study locations

United States · 5 centers
  • University of South Florida — Tampa
  • Emory Atlanta Adolescent Consortium — Atlanta
  • Johns Hopkins University — Baltimore
  • St. Jude Children's Research Hospital — Memphis
  • Baylor College of Medicine — Houston

Identifiers

NCT: NCT07728123 · ATN164 (S2P)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗