ATN 164: S2P

Study Summary:

The CDC recommends routine, universal opt-out HIV screening for individuals ≥ 13 years of age in all healthcare settings, including Emergency Departments (EDs). However, in the United States, only half of youth and young adults living with HIV are aware of their diagnosis. Many youth and young adults do not have a primary care doctor or receive yearly check-ups, but they often use EDs for their non-urgent care. This study, Screen 2 Prevent (S2P), will focus on increasing HIV screening in pediatric EDs and finding the best way to do so. It will also use digital health tools (mHealth), such as text messaging and apps, to help identify youth who are eligible for HIV Pre-exposure Prophylaxis (PrEP) and who are living with HIV, and to link them to prevention and treatment services.

What is the study trying to discover?

S2P is trying to identify the best way to screen youth for HIV in pediatric EDs and link them to HIV prevention and treatment services when needed.

Why is this study important?

S2P is an important step in getting more young people tested for HIV and started on HIV prevention or treatment. This research has the potential to improve the health of the millions of adolescents and young adults who access EDs as their only source of health care and to impact national policies related to youth HIV prevention, detection, and treatment.

Who is this study for?   

This study is for adolescents and young adults ages 14 to 24 years who are patients in participating pediatric EDs.

What happens during the study?

Eligible ED patients will be offered a tablet to complete a survey. During the targeted screening phase, responses to the survey will be used to electronically notify the ED doctor if a participant is at risk for HIV and testing is recommended. During the universally offered screening phase, participants will either decline (opt-out screening approach) or request (opt-in screening approach) to be tested for HIV as part of the survey, and their decision will be relayed to the ED clinician through the electronic medical record.

If a participant is eligible based on their survey responses, at the end of the survey they will be offered the opportunity to enroll in a text messaging-based digital health platform to learn more about PrEP, a medication to prevent HIV, and be linked to care or treatment, if needed.

Study Details:

Protocol Status:

Protocol under development

Study Purpose: 

The main goals of S2P are to increase HIV screening rates in pediatric EDs and identify the most clinically effective, cost-effective, and sustainable approach for implementation of broad-scale screening. S2P also aims to improve HIV prevention and treatment outcomes for youth beyond screening by using computerized patient-reported data to efficiently assess PrEP candidacy. Finally, it aims to provide rapid or same-day PrEP/ART (antiretroviral therapy) start and linkage-to-care for youth, regardless of HIV status.

Study Design:

2 parts:

  1. Comparative effectiveness pragmatic trial to determine the most clinically effective and cost-effective HIV screening approach
  2. Nested prospective cohort study to (1) identify participants who are eligible for PrEP/ART and (2) increase rates of rapid start and linkage-to-care for PrEP/ART

Study Population:

English- and Spanish-speaking youth and young adults ages 14 to 24 years who are patients in participating pediatric EDs

Sample Size:

Approximately 84,000 ED patients

Study Duration:

3 years

Screening Strategies:

2 parts:

  1. Completion of the survey to identify those who agree to HIV screening (during universally offered opt-in/opt-out phases) and those who screen “high-risk” or “at-risk” for HIV followed by clinical decision support for HIV testing (during targeted screening phase)
  2. Completion of the survey to determine PrEP eligibility

Primary Objectives:

  1. To compare the clinical- and cost-effectiveness of three evidence-based, broad-scale HIV screening approaches in the ED setting: a) targeted, b) universally offered opt-in, and c) universally offered opt-out at five sites in “End the HIV Epidemic in the US (EHE)” priority geographic areas using a pragmatic comparative effectiveness trial
  2. To compare the number of youth who (1) initiate PrEP and (2) test positive for HIV and are linked to care with implementation of same-day mHealth ART/PrEP start (SMART) using a pre-post design

Secondary Objectives:

  1. To compare rates of HIV between patients in the different sexual risk strata (determined by the patient’s survey responses) and sociodemographic factors such as gender identity, race/ethnicity, age, insurance status, sexual orientation, chief complaint, and ED diagnosis
  2. To compare sociodemographic and visit characteristics associated with PrEP eligibility and initiation within 72 hours of ED discharge

In development

Participating Site Consortiums

Baylor College of Medicine

Johns Hopkins University

St. Jude Children’s Research Hospital

University of South Florida

Emory Atlanta Adolescent Consortium

Protocol Co-Chairs

Nadia Dowshen
dowshenn@chop.edu

Monika Goyal
mgoyal@childrensnational.org

Jennifer Reed
jennifer.reed@cchmc.org

Study Manager

Erin Ricketts
erinricketts@westat.com