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Virtual PrEP Delivery for HIV Prevention (VPrEP Trial)
Phase 4
Waitlist Available
Led By Darrell HS Tan, MD,FRCPC,PhD
Research Sponsored by Unity Health Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No symptoms of acute HIV seroconversion (fever, myalgias, arthralgias, malaise, headache, rash, pharyngitis and/or diarrhea that is otherwise unexplained)
Age ≥16
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 weeks
Awards & highlights
VPrEP Trial Summary
This trial is testing a new way to deliver PrEP (a medication to prevent HIV) to people who are at high risk for HIV. The new method uses a mobile app and web-based system instead of in-person visits. The goal is to provide a scalable model for remote PrEP delivery that is attractive to both patients and providers.
Who is the study for?
This trial is for gay, bisexual men and transgender women over 16 years old at high risk of HIV who can use the internet and speak English. They must be HIV negative, willing to take daily oral PrEP (TAF/FTC), and not pregnant or allergic to TAF/FTC.Check my eligibility
What is being tested?
The study compares traditional in-person PrEP delivery with a web-based mobile health model called Freddie® for delivering daily oral TAF/FTC PrEP. Participants are randomly assigned to one of the two methods for 72 weeks.See study design
What are the potential side effects?
PrEP medications like TDF/FTC or TAF/FTC may cause side effects such as nausea, headache, stomach pain, weight loss, fatigue, and sometimes more serious effects on kidney function or bone density.
VPrEP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I do not have symptoms like fever, muscle pain, joint pain, tiredness, headache, rash, sore throat, or diarrhea without a known cause.
Select...
I am 16 years old or older.
Select...
My kidney function is good.
VPrEP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 72 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
'Final Visit Questionnaire' will be used to determine participants' stated preference for either the standard of care or the mHealth-based model of care.
Secondary outcome measures
Dried blood spot will be collected at week 36 and 72 will be used to determine PrEP adherence.
Hair Samples will be collected at week 36 and 72 will be used to determine PrEP adherence.
Interview administered questionnaires will be used to comparison of the average amount of participant time required for PrEP follow-up activities by model of care
+8 moreVPrEP Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Standard model of careExperimental Treatment2 Interventions
Delivery of PrEP care through the local standard of care.
Group II: mHealth model of careActive Control2 Interventions
Delivery of PrEP care through the Freddie® mobile Health (mHealth) platform.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tenofovir alafenamide
FDA approved
Find a Location
Who is running the clinical trial?
Gilead SciencesIndustry Sponsor
1,085 Previous Clinical Trials
848,143 Total Patients Enrolled
CIHR Canadian HIV Trials NetworkNETWORK
40 Previous Clinical Trials
6,437 Total Patients Enrolled
Unity Health TorontoLead Sponsor
545 Previous Clinical Trials
450,470 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot or will not perform self-collected throat or rectal swabs.I am eligible for or already on PrEP and willing to switch to the study's PrEP regimen.I do not have symptoms like fever, muscle pain, joint pain, tiredness, headache, rash, sore throat, or diarrhea without a known cause.I am 16 years old or older.My kidney function is good.I identify as a gay, bisexual man, or a transgender woman.
Research Study Groups:
This trial has the following groups:- Group 1: Standard model of care
- Group 2: mHealth model of care
Awards:
This trial has 5 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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