Virtual PrEP: Rendering PrEP Delivery More Efficient (VPrEP)

Unity Health Toronto

Status and phase: Terminated; Phase 4

Conditions: HIV Infections

Treatments: Other: Standard of Care; Other: mHealth Model of Care; Drug: PrEP

Study type: Interventional

Funder types: Other; NETWORK; Industry

Identifiers

NCT05159531

CTN 332

Details and patient eligibility

About

Gay, bisexual and other men who have sex with men (GBM) account for over half of new HIV infections in Canada each year, and have a 131-fold higher risk of HIV than other Canadian men. HIV pre-exposure prophylaxis (PrEP) using regular oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) or tenofovir alafenamide/emtricitabine (TAF/FTC) is an effective and safe HIV prevention option.

Despite growing interest, awareness and willingness to use PrEP there has been numerous challenges to the broader rollout of PrEP. This study will address some of these challenges by assessing participant satisfaction,feasibility and clinical outcomes associated with a web-based mobile health (mHealth) model of care for daily oral TAF/FTC PrEP compared to standard of care delivery of TAF/FTC PrEP in Canadian GBM/TGW, in the era of COVID-19.

The ultimate goal of this study is to provide a scalable model for remote PrEP delivery that minimizes the need for in-person interactions; respects guideline recommendations regarding how to optimally monitor patients; and is attractive to both patients and providers.

This study is a 1:1 open-label, pragmatic randomized controlled trial using a AB:BA crossover design, comparing the standard of care to an mHealth based model of care (Freddie® ) for TAF/FTC PrEP delivery over 72 weeks.

Enrollment: 2 patients

Sex: Male

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Self-reported gay, bisexual or other man who has sex with men (inclusive of transgender men) or transgender woman
2. Age ≥16
3. HIV seronegative, as documented by a 4th generation HIV antigen/antibody combination test performed within 14 days of baseline
4. No symptoms of acute HIV seroconversion (fever, myalgias, arthralgias, malaise, headache, rash, pharyngitis and/or diarrhea that is otherwise unexplained)
5. Meets clinical criteria for PrEP according to the prescribing clinician. Patients can be enrolled into the study regardless of whether they will be newly initiating PrEP, or are already receiving PrEP; those already receiving PrEP can be using any regimen (eg. daily TDF/FTC, on-demand TDF/FTC, daily TAF/FTC) as long as they are willing to transition to the study regimen of daily, oral TAF/FTC.
6. eGFR >30ml/min
7. Has adequate access to the internet to permit use of the mHealth platform
8. Adequate facility in English to communicate with their provider

Exclusion criteria

1. Known hypersensitivity/allergy to TAF/FTC
2. Actively participating in another interventional trial related to the delivery of PrEP or sexual health-related care
3. Being unwilling or unable to perform self-collected pharyngeal and/or rectal swabs as part of routine PrEP care
4. Potential to become pregnant
5. Currently living in, or planning to move to a location that would render standard of care or ad hoc in-person visits to the study site impractical during the study period.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

Standard model of care

Experimental group

Description:

Delivery of PrEP care through the local standard of care.

Treatment:

Drug: PrEP

Other: Standard of Care

mHealth model of care

Active Comparator group

Description:

Delivery of PrEP care through the Freddie® mobile Health (mHealth) platform.

Treatment:

Drug: PrEP

Other: mHealth Model of Care