250 Participants NeededMy employer runs this trial

PrEP for HIV Prevention

(PrEP ED Trial)

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Texas Southwestern Medical Center
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 aims to increase awareness and use of PrEP, a medication that helps prevent HIV, among visitors to the Parkland Memorial Hospital Emergency Department in Dallas, TX. The trial focuses on providing a quick start of PrEP medication at the hospital and setting up a follow-up appointment for ongoing care. Individuals who have tested negative for HIV, are interested in starting PrEP, have had an STI (sexually transmitted infection), or are referred by their ED clinician as likely benefiting from PrEP are suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to access PrEP quickly and conveniently while contributing to important research on its implementation in emergency settings.

Do I have to stop taking my current medications for the PrEP trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this PrEP protocol is safe for HIV prevention?

Research has shown that PrEP, the medication used to prevent HIV, is generally safe for most people. Studies have found that side effects are usually mild, including nausea, diarrhea, and headaches, and most people manage them easily.

In rare cases, PrEP can affect the kidneys, so doctors often perform kidney tests before and during treatment to monitor this. A large study found that serious problems from taking PrEP are uncommon. Most people who experience side effects report that they are mild and resolve quickly.

Overall, PrEP is well-tolerated, and many people take it without major issues.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a rapid start of HIV Pre-Exposure Prophylaxis (PrEP) in the Emergency Department (ED). This approach is different because it aims to initiate PrEP quickly for at-risk individuals right when they seek emergency care, potentially increasing accessibility and adherence. Unlike the usual initiation process that may involve delays and multiple visits, this rapid-start method could significantly reduce the time to protection and make it easier for people to start and stay on PrEP. This could lead to better prevention outcomes in populations who might otherwise face barriers to timely PrEP initiation.

What evidence suggests that PrEP is effective for HIV prevention?

Studies have shown that HIV Pre-Exposure Prophylaxis (PrEP) effectively prevents HIV. Research indicates that taking PrEP as prescribed can reduce the risk of contracting HIV from sex by about 99%. It also lowers the risk for people who inject drugs by at least 74%. In real-world settings, adherence to the PrEP routine can lead to a 93% reduction in the risk of HIV infection. Overall, when taken correctly, PrEP serves as a powerful tool for preventing HIV.678910

Are You a Good Fit for This Trial?

This trial is for adults in the Dallas area who are at risk for HIV, test negative on a rapid HIV test, and want or need PrEP. Participants must be able to give consent and plan to follow up at Parkland clinic. Pregnant/breastfeeding women, people under 18, prisoners, those already on PrEP recently, or with known allergies to PrEP can't join.

Inclusion Criteria

Able to comprehend and provide signed, written informed consent prior to initiation of study procedures
Negative HIV rapid test
I am at high risk for HIV or have asked my doctor about PrEP.
See 1 more

Exclusion Criteria

Adults unable to consent, women who are known to be pregnant or breast feeding at time of study enrollment
I am 18 years or older and I am not a prisoner.
Positive HIV rapid test
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Immediate
1 visit (in-person)

PrEP Initiation

Participants receive immediate PrEP prescribing in the Emergency Department with linkage to PrEP clinic

Immediate
1 visit (in-person)

Follow-up

Participants are monitored for PrEP persistence and adherence, with clinic visits every 3 months

12 months
4 visits (in-person)

Final Assessment

Final survey administered to assess tolerability, satisfaction, and quality of life related to PrEP

At 12-month visit

What Are the Treatments Tested in This Trial?

Interventions

  • HIV Pre-Exposure Prophylaxis (PrEP)

Trial Overview

The study tests starting oral PrEP right away in the emergency department versus usual care. Patients get a prescription before leaving and help connecting to ongoing care; they can later choose between pill or injectable forms of PrEP.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Participants who decide to receive PrEP (rapid start)Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials
1,102
Recruited
1,077,000+

Gilead Sciences

Industry Sponsor

Trials
1,150
Recruited
878,000+
Daniel O'Day profile image

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger profile image

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine

Citations

Oral pre-exposure prophylaxis (PrEP) to prevent HIV - PMC

PrEP is effective in preventing HIV acquisition in serodiscordant couples with a rate reduction of 75%. HIV infection: heterosexual transmission, all clinical ...

Progress Toward UNAIDS Global HIV Pre-Exposure ...

Oral pre-exposure prophylaxis (PrEP) reduces HIV acquisition from sex by 99% and from injection drug use by ≥74% when taken as recommended (1).

Real-world effectiveness of pre-exposure prophylaxis in ...

We found that PrEP use was associated with an overall 60% reduction in the risk of HIV infection, reaching 93% for a high amount of PrEP consumption, and 86% if ...

Pre-Exposure Prophylaxis (PrEP)

PrEP reduces the risk of getting HIV from sex by about 99% when taken as prescribed. Among people who inject drugs, it reduces the risk by at least 74% when ...

Preexposure Prophylaxis for the Prevention of HIV ...

Eleven trials in the 2019 review found oral PrEP associated with decreased HIV infection risk vs placebo or no PrEP (n = 18 172; relative risk [RR], 0.46 [95% ...

Pre-Exposure Prophylaxis for HIV Prevention: Safety Concerns

The main adverse effects observed with PrEP are gastrointestinal related; basically mild to moderate nausea, vomiting and diarrhea. Other ...

Side effects of Pre-Exposure Prophylaxis (PrEP)

Very few people taking PrEP have serious problems. PrEP can sometimes affect your kidneys. This is why kidney tests are done before and during treatment. PrEP ...

Large study finds complications from HIV PrEP uncommon

PrEP is associated with general side effects such as headache, nausea, rash and diarrhea. In the vast majority of users who develop such side ...

Preventing HIV with PrEP

PrEP is safe to take. Some people experience side effects like diarrhea, nausea, headache, fatigue, and stomach pain. These side effects usually ...

10.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39284166/

Reported Side Effects and Adherence of Daily HIV Pre ...

In total, 175 participants (29%) ever reported experiencing side effects: most commonly diarrhea (7.5% of study visits), and most were of mild severity. Lower ...