Decision Support Tool for HIV Prevention

Not yet recruiting at 1 trial location

Overseen By Amanda D Castel

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: George Washington University

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This project will explore the development of a personalized decision support tool to assist with pre-exposure prophylaxis (PrEP) initiation and persistence among patients identified in the emergency department (ED) and urgent care settings as PrEP eligible. First, the investigators will use a sequence of validated implementation science methodologies to develop and validate a decision support tool designed to optimize PrEP persistence by strengthening self-efficacy by addressing the multifaceted medical and social needs of the individual patient. The investigators will then test the preliminary effectiveness of this tool through a pilot stepped wedge implementation trial in two EDs and an urgent care in Baltimore, MD and Washington, DC among 120 PrEP eligible patients to determine PrEP initiation, linkage to care, persistence, and adherence rates.

Are You a Good Fit for This Trial?

This trial is for individuals identified in emergency departments and urgent care settings as eligible for PrEP, a medication that helps prevent HIV. The study aims to help these patients start and continue taking PrEP by using a decision support tool tailored to their personal medical and social needs.

Inclusion Criteria

Medically stable ED/UC patients (defined as a triage category level 3, 4, 5 using Emergency Severity Index for ED patients only)

English-speaking

Self-report being HIV negative (GWU sites) or are found to be HIV rapid test negative (JHH ED)

Exclusion Criteria

I have conditions that make it unsafe to use TDF/FTC or TAF/FTC.

Pregnant

Have a comorbid medical or psychiatric condition that would make PrEP adherence or ongoing follow-up care difficult

What Are the Treatments Tested in This Trial?

Interventions

• Decision Support Tool

Trial Overview The trial is testing a personalized decision support tool designed to improve the initiation and persistence of PrEP treatment among patients. It will be conducted in two emergency departments and an urgent care center through a pilot stepped wedge implementation trial with 120 participants.

How Is the Trial Designed?

Group I: ED-PrEP + DST Experimental Treatment 2 Interventions

In Phase 2 (Post-DST) PrEP Champions will integrate the DST into all patient encounters, facilitating the use of the DST as well as the provision of any identified resources.

Group II: ED-PrEP Active Control 1 Intervention

In Phase 1 (Pre-DST) PrEP eligible patients who have agreed to PrEP will receive a PrEP prescription facilitated by a PrEP Champion; there will be no structured engagement intervention (i.e., the DST).

Who Is Running the Clinical Trial?

George Washington University

Lead Sponsor

Trials

263

Recruited

476,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+