Recruiting

HIV Screening

Sponsor:

Westat

Code:

NCT07728123

Conditions

HIV Infections

Eligibility Criteria

Sex: All

Age: 14 - 24

Healthy Volunteers: Accepted

Interventions

HIV screening strategies

Study Details

Brief 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 and link adolescents seeking care in the ED to HIV Pre-Exposure Prophylaxis (PrEP)/Antiretroviral treatment (ART).

Conditions

HIV Infections

Study ID

NCT07728123

Start date

Jun 16, 2026

Status verified date

Aug, 2026

Completion date

Oct 31, 2028

Anticipated

Primary completion date

Oct 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 24

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Design

Enrollment

84000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

other: 1. Universally offered opt-in > Universally offered opt-out > Targeted

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: 2. Universally offered opt-out > Universally offered opt-in > Targeted

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: 3. Universally offered opt-in > Targeted > Universally offered opt-out

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: 4. Universally offered opt-out > Targeted > Universally offered opt-in

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: 5. Targeted > Universally offered opt-out > Universally offered opt-in

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: 6. Targeted > Universally offered opt-in > Universally offered opt-out

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.

Interventions

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Erin Ricketts

240-453-2786erinricketts@westat.com

Nancy Liu

718-980-3937NancyLiu@westat.com

Locations

University of South Florida

Recruiting

Tampa, Florida, United States, 33612

Contacts

Elizabeth Enriquez-Bruce

813-250-2574enriquezbruce@usf.edu

Principal Investigator:

Carina Rodriguez, MD

Emory Atlanta Adolescent Consortium

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Kaylin Dance

404-727-5642kaylin.dance@emory.edu

Principal Investigator:

Andres Camacho-Gonzalez, MD

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Jessica Coleman-Lewis, MD

3013854868jcolem52@jh.edu

Principal Investigator:

Errol Fields, MD

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38015

Contacts

Jamie Russell

901-595-8300jamie.russell@stjude.org

Principal Investigator:

Aditya Gaur, MD

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Litty Koshy

832-822-1038Litty.Koshy@bcm.edu

Principal Investigator:

Mary Paul, MD

More Information

Sponsor

Westat

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Keywords

  • HIV
  • adolescents
  • emergency department
  • preventive care
  • mHealth
  • PrEP

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Westat on 2026-08-17.