HIV Screening Strategies for HIV Infection
(S2P Trial)

Recruiting at 4 trial locations

Overseen ByNancy Liu

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Westat

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks to identify the most effective method for screening HIV among young people in emergency departments. It evaluates three approaches: targeted screening, universally offered opt-in (where patients choose to participate), and universally offered opt-out (where participation is automatic unless declined). The trial aims to enhance HIV prevention and connect those in need to treatments like PrEP or ART. Teens and young adults aged 14-24 who visit a participating emergency department for any reason may qualify for this study.

As an unphased trial, it provides participants the chance to contribute to significant research that could improve HIV prevention strategies for young people.

What prior data suggests that these HIV screening strategies are safe?

Research has shown that HIV screening tests are very safe and reliable, designed to accurately detect HIV. Studies indicate that these tests can correctly identify HIV in 99.76% to 100% of cases, making them nearly perfect at finding the virus when present.

These tests are a regular part of health care and are recommended for everyone aged 13 to 64 at least once. The testing process is simple and carries no major risks. A small bruise might occur if blood is drawn for the test, but otherwise, these screening procedures are easy to handle and have no significant side effects reported.¹ ² ³ ⁴ ⁵

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores different strategies for HIV screening that could potentially improve early detection rates. Unlike traditional methods, which might rely heavily on targeted testing or patient-initiated opt-in approaches, this study evaluates universally offered strategies, both opt-in and opt-out, alongside targeted screening. By rotating these strategies over time, the trial aims to determine the most effective method for catching infections early, which can lead to better management and treatment outcomes. This innovative approach could reshape how HIV screenings are conducted, making them more accessible and efficient.

What evidence suggests that this trial's HIV screening strategies could be effective?

This trial will evaluate different HIV screening strategies to determine their effectiveness in early detection and reducing late diagnoses. Research has shown that HIV screening helps find infections early, reduces late diagnoses, and lowers deaths related to HIV. Studies have found that regular HIV testing in healthcare settings can be cost-effective, especially in areas where more than 0.1% of people have undiagnosed HIV. HIV tests are highly accurate, correctly identifying those with HIV 99.76% to 100% of the time and those without it 99% of the time. Additionally, more frequent testing can shorten the time to diagnose HIV by about 14 months. These strategies aim to make HIV testing more common and accessible, enabling people to get tested and start treatment if needed.⁶ ⁷ ⁸ ⁹ ¹⁰

Are You a Good Fit for This Trial?

This trial is for adolescents who visit the emergency department and may be at risk for HIV. It aims to include young people seeking care, regardless of why they are there, to improve HIV screening and prevention.

Inclusion Criteria

Present to the participating ED, regardless of chief complaint during the study period

I am between 14 and 24 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

24 months

Continuous screening in EDs

Intervention

Implementation of three different HIV screening strategies: targeted, universally offered opt-in, and universally offered opt-out, each for 8 months

24 months

Continuous engagement in EDs

Follow-up

Participants are monitored for HIV detection rates and cost-effectiveness of screening strategies

12 months

What Are the Treatments Tested in This Trial?

Interventions

HIV screening strategies

Trial Overview

The study compares three ways of offering HIV tests in emergency departments: only to those at higher risk (targeted), offered to everyone with a choice (opt-in), or automatically unless declined (opt-out). Digital tools help connect participants to prevention or treatment if needed.

How Is the Trial Designed?

Treatment groups

Experimental Treatment

Group I: 6. Targeted > Universally offered opt-in > Universally offered opt-outExperimental Treatment1 Intervention