TelePrEP for HIV Prevention
Trial Summary
What is the purpose of this trial?
Youth represent the largest proportion of new HIV infections in Colorado, reflective of their inadequate access and uptake of pre-exposure prophylaxis(PrEP)for HIV prevention. Colorado's 2019 HIV/AIDS Prevention Program state-wide review of PrEP barriers showed PrEP eligible individuals do not access PrEP services due to lack of interest, not wanting referral to a navigator, and low estimation of HIV risk. The overall goal is to provide youth at higher risk for HIV with an effective youth informed telemedicine delivery of PrEP (TelePrEP) that addresses PrEP barriers and contributes to ending the HIV epidemic in Colorado. The primary objective will be proportion of youth retained on PrEP 12 months after initiation. The hypotheses are that a TelePrEP model for youth will be acceptable and feasible and will result in successful initiation, persistence and retention on oral PrEP.
Will I have to stop taking my current medications?
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 data supports the effectiveness of the TelePrEP treatment for HIV prevention?
Is TelePrEP for HIV prevention safe for humans?
Pre-exposure prophylaxis (PrEP), which includes the use of medications like tenofovir disoproxil fumarate/emtricitabine, has been shown to have a good safety profile in clinical trials. Common side effects are mild to moderate nausea, vomiting, and diarrhea, and regular monitoring is recommended to prevent long-term effects on liver, kidneys, and bones.12678
How is the TelePrEP treatment for HIV prevention different from other treatments?
Eligibility Criteria
This trial is for young individuals assigned male at birth, who have had male sex partners in the past 6 months and are HIV negative. They must be eligible for PrEP based on CDC guidance, agree to TelePrEP visits, and willing to use or obtain insurance coverage. It's not for pregnant individuals, those with HIV or acute HIV concerns until ruled out, cisgender women, transgender men, or persons whose only risk is from injection drug use.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
PrEP Initiation
Participants undergo a PrEP initiation visit with a provider, which may be in-person or via telemedicine. Recommended laboratory testing, including HIV testing, is conducted.
TelePrEP Follow-up
TelePrEP visits are conducted by a skilled multidisciplinary team one month after initiation and then every three months.
Follow-up
Participants are monitored for retention on PrEP at week 48, including PrEP clinic visits or prescription refills.
Treatment Details
Interventions
- TelePrEP
TelePrEP is already approved in United States, European Union, Canada for the following indications:
- HIV prevention
- HIV prevention
- HIV prevention
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor
Gilead Sciences
Industry Sponsor
Daniel O'Day
Gilead Sciences
Chief Executive Officer since 2019
MBA from Columbia University
Dietmar Berger
Gilead Sciences
Chief Medical Officer
MD and PhD from Albert-Ludwigs University School of Medicine