PrEP Choice for HIV Prevention
(CHOOSE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method to help young people start and maintain HIV prevention medication called PrEP. Researchers aim to determine if a smartphone package called PrEP Choice can simplify and reduce the cost of PrEP usage for young people. The trial will also assess the acceptance and use of another prevention method, DoxyPEP, among young participants. Individuals aged 13-24 who have had anal sex with a male, own a smartphone, and are not currently on PrEP may be suitable for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in HIV prevention.
Do I have to stop taking my current medications for the 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 team to get a clear answer.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that PrEP (pre-exposure prophylaxis) is a safe and effective method for preventing HIV. Studies have found that HIV-negative individuals taking PrEP do not experience major health issues, even after up to 5 years of use.
Some individuals might experience mild side effects, but serious problems remain rare. This is reassuring for those considering participation in a trial with PrEP Choice, as it builds on existing PrEP treatments. The safety of PrEP has been well-documented in various groups, such as men who have sex with men and people who inject drugs.
Although this trial is in an earlier stage, which typically focuses on safety, the existing data on PrEP's safety is encouraging.12345Why are researchers excited about this trial?
Researchers are excited about PrEP Choice for HIV prevention because it offers a personalized approach that could enhance adherence and effectiveness compared to standard PrEP options like daily oral tablets. PrEP Choice allows participants to select from multiple formulations and schedules, potentially improving user satisfaction and adherence. This flexibility could address individual preferences and lifestyle needs, making HIV prevention more accessible and effective for diverse populations.
What evidence suggests that PrEP Choice might be an effective treatment for HIV prevention?
This trial will compare two approaches to using PrEP Choice for HIV prevention. Studies have shown that pre-exposure prophylaxis (PrEP) effectively prevents HIV. Research indicates that consistent use of PrEP can lower the risk of contracting HIV by up to 93%. In everyday life, individuals using PrEP experience significantly reduced infection rates, dropping to as low as 0.2%. It's important to remember that while PrEP is highly effective, its success relies on regular, prescribed use. Overall, PrEP serves as a powerful tool for preventing HIV when used correctly.678910
Who Is on the Research Team?
Lisa Hightow-Weidman, MD, MPH
Principal Investigator
Florida State University
Sybil Hosek, PhD
Principal Investigator
University of Illinois at Chicago
Susan Buchbinder
Principal Investigator
San Francisco Department of Public Health
Albert Liu
Principal Investigator
San Francisco Department of Public Health
Are You a Good Fit for This Trial?
This trial is for young people ages 13-24 who are not living with HIV, have had anal sex with a male, are interested in learning about PrEP, own a smartphone, weigh at least 35 kg (about 77 lbs), can speak English, and are willing to get care from the study clinic.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive PrEP and DoxyPEP, with PrEP Choice package provided to intervention arm at enrollment and to control arm at 9 months
Follow-up
Participants are monitored for PrEP and DoxyPEP adherence, uptake, and acceptability
Open-label extension (optional)
Participants may continue to receive PrEP and DoxyPEP beyond the initial study period
What Are the Treatments Tested in This Trial?
Interventions
- PrEP Choice
Trial Overview
The study compares two ways of offering HIV prevention: one group gets standard care plus access to an mHealth tool called PrEP Choice right away; the other gets standard care first and then PrEP Choice after nine months. The goal is to see if this tool helps more young people start and stick with PrEP.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants randomized to the intervention arm will be onboarded PrEP Choice at their Enrollment Visit.
Participants randomized to the delayed arm will be onboarded to PrEP Choice at their Month 9 study visit.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Westat
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
National Institute on Drug Abuse (NIDA)
Collaborator
National Institute of Mental Health (NIMH)
Collaborator
National Institutes of Health (NIH)
Collaborator
Florida State University
Collaborator
The Emmes Company, LLC
Industry Sponsor
Peter Ronco
The Emmes Company, LLC
Chief Executive Officer since 2023
BSc from Nottingham University
Dr. Joe Sliman
The Emmes Company, LLC
Chief Medical Officer since 2020
MD from Uniformed Services University of the Health Sciences, MPH from Johns Hopkins University, BSc in Molecular and Cell Biology from Pennsylvania State University
Citations
the potential of PrEP choice and innovation to transform HIV ...
The potential of pre‐exposure prophylaxis (PrEP), as a highly effective and empowering HIV prevention intervention, has not yet been realized.
Effectiveness of Pre-exposure Prophylaxis (PrEP) in the ... - PMC
Pre-exposure prophylaxis (PrEP) has high biological efficacy, but real-world effectiveness varies due to adherence, access, and delivery barriers. This review ...
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 ...
A Systematic Review and Meta-Analysis of Real-World Studies
PrEP was highly effective in these real-world settings, with lower HIV-1 prevalence rates reported in PrEP users (0.2%) compared with the ...
Preexposure Prophylaxis (PrEP) for HIV
HIV prevention efficacy increased to 92% (95% CI, 40%-99%) among those with detectable plasma tenofovir levels (eTable in the Supplement). In a ...
HIV prevention: better choice for better coverage - PMC
Antiretroviral‐based pre‐exposure prophylaxis (PrEP) is today an established, effective and safe method of HIV prevention used in multiple countries worldwide.
Preventing HIV with PrEP
For receptive vaginal sex and injection drug use, PrEP pills reach maximum protection at about 21 days of daily use. No data are available for ...
Comparing Prep Choices: Efficacy, Safety, and What's New
Safety, tolerability, and acceptability of long-acting injectable cabotegravir for HIV prevention in cisgender female adolescents (HPTN 084 ...
9.
hiv.gov
hiv.gov/hiv-basics/hiv-prevention/using-hiv-medication-to-reduce-risk/pre-exposure-prophylaxisPre-Exposure Prophylaxis (PrEP)
PrEP is safe. No significant health effects have been seen in people who are HIV-negative and have taken PrEP for up to 5 years. Some people taking PrEP may ...
PrEP for HIV Prevention: Evidence, Global Scale-up, and ...
Antiretroviral pre-exposure prophylaxis (PrEP) for the prevention of HIV infection was demonstrated to be efficacious and safe earlier this decade from pivotal ...
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