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NCT Number: NCT07728123

Screen2Prevent (S2P)

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).

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Disease Attributes Emergencies Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

14 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of South Florida, Tampa, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

HIV screening strategies

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.

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Cost per HIV case detected

    Time frame: 36 months

    Compare the cost per HIV case detected between each of the screening strategies and baseline using the all patients analysis set.

  2. Rapid PrEP/ART initiation (defined by prescription within 72 hours of ED discharge)

    Time frame: 36 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Erin Ricketts

CONTACT

[email protected]

240-453-2786

Nancy Liu

CONTACT

[email protected]

718-980-3937

Sponsors and collaborators

Lead sponsor

Westat

Other

Registry information

Official study title

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

Acronym: S2P

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 27, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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