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Virtual PrEP Delivery for HIV Prevention (VPrEP Trial)

Phase 4

Recruiting

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 below

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I do not have symptoms like fever, muscle pain, joint pain, tiredness, headache, rash, sore throat, or diarrhea without a known cause.

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I am 16 years old or older.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 weeks for reporting.

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 more

VPrEP 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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Gilead SciencesIndustry Sponsor

1,082 Previous Clinical Trials

842,557 Total Patients Enrolled

CIHR Canadian HIV Trials NetworkNETWORK

40 Previous Clinical Trials

6,437 Total Patients Enrolled

Unity Health TorontoLead Sponsor

537 Previous Clinical Trials

447,397 Total Patients Enrolled

Media Library

mHealth Model of Care Clinical Trial Eligibility Overview. Trial Name: NCT05159531 — Phase 4

Human Immunodeficiency Virus Infection Research Study Groups: Standard model of care, mHealth model of care

Human Immunodeficiency Virus Infection Clinical Trial 2023: mHealth Model of Care Highlights & Side Effects. Trial Name: NCT05159531 — Phase 4

mHealth Model of Care 2023 Treatment Timeline for Medical Study. Trial Name: NCT05159531 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you elucidate the potential risks associated with PrEP?

"Prep has been approved and is therefore given a 3 rating on the scale of 1 to 3, according to our team at Power."

Answered by AI

For what kind of conditions is PrEP typically prescribed?

"Prep has been clinically verified to treat human immunodeficiency virus type 1 (HIV-1), stifle HIV infections, and impede the transmission of the infectious agent."

Answered by AI

At how many sites is this research endeavor being conducted?

"The trial is currently running across 5 different clinical sites, including those in Calgary, Hamilton and Winnipeg. To cut down on travel requirements should you choose to take part, it would be prudent to select the closest location for your needs."

Answered by AI

Have additional experiments been carried out with Pre-Exposure Prophylaxis (PrEP)?

"Presently, there are 98 clinical trials centered on Prep utilization, with 22 in the third stage of testing. Primarily based out of Boylston, Massachusetts, these experiments have stretched to 1,610 different sites across the globe."

Answered by AI

What is the current number of participants in this research project?

"This clinical trial is not accepting participants anymore, as the last update was made on December 6th 2021. However, if you are looking for other medical studies related to HIV infections or Prep (Pre-Exposure Prophylaxis), there are 484 and 98 trials respectively that remain open for enrollment."

Answered by AI

Is this trial currently open for enrollment?

"The clinicaltrials.gov registry indicates that this trial, which opened on December 18th 2021 and was last updated on December 6th of the same year, is not enrolling participants presently. However, there are 582 other medical studies recruiting patients at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Virtual PrEP: Rendering PrEP Delivery More Efficient

2023. "Virtual PrEP: Rendering PrEP Delivery More Efficient". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05159531.

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