What side effects are associated with this type of intervention?

Common side effects of TAF/FTC PrEP (tenofovir alafenamide/emtricitabine) include gastrointestinal issues such as nausea and diarrhea, headache, and fatigue. More serious but less common side effects can include kidney problems and bone density loss. General side effects of antiretroviral therapy (ART) can also include liver toxicity, lipid abnormalities, and potential cardiovascular issues. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment and prevention of HIV infection, including those used for pre-exposure prophylaxis (PrEP). Notably, tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) was one of the first combinations approved for PrEP. More recently, tenofovir alafenamide/emtricitabine (TAF/FTC) has been approved as a safer alternative with fewer side effects. These drugs work by inhibiting the reverse transcriptase enzyme, preventing HIV from replicating in the body. The approval of these medications has significantly advanced HIV prevention strategies, particularly among high-risk populations.

What other types of research exist?

Promising novel alternatives to TAF/FTC PrEP for HIV prevention include long-acting injectable cabotegravir, which has shown high efficacy in clinical trials. Another alternative is the dapivirine vaginal ring, which provides a monthly option for women. Additionally, islatravir, an oral medication with a long half-life, is being investigated for its potential use in PrEP regimens.

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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

Must not have

Being unwilling or unable to perform self-collected pharyngeal and/or rectal swabs as part of routine PrEP care

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 72 weeks

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial tests a web-based system for delivering HIV prevention pills to gay, bisexual men, and transgender women in Canada. The goal is to see if this remote method is as effective and satisfactory as traditional in-person care. The study aims to make it easier for patients to get their medication without regular clinic visits.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot or will not perform self-collected throat or rectal swabs.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

'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 study objectives

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

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

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.

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 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for HIV infection, such as those involving tenofovir alafenamide/emtricitabine (TAF/FTC), work by inhibiting the virus's ability to replicate. TAF and FTC are nucleoside reverse transcriptase inhibitors (NRTIs) that block the reverse transcriptase enzyme, which is essential for converting viral RNA into DNA, a critical step in the HIV life cycle. By preventing this conversion, these drugs reduce the viral load in the body, helping to maintain immune function and prevent the progression to AIDS. This mechanism is crucial for HIV patients as it helps to manage the infection, reduce the risk of transmission, and improve overall health outcomes.

A Comprehensive Development Agenda on Tenofovir Alafenamide in Clinical Practice.Emtricitabine/tenofovir disoproxil fumarate: a review of its use in HIV-1 pre-exposure prophylaxis.