Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
2 participants
INTERVENTIONAL
2023-05-01
2023-06-08
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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Standard model of care
Delivery of PrEP care through the local standard of care.
PrEP
Participants will receive Descovy® 200/25mg 1 tablet once daily for 72 weeks.
Standard of Care
Delivery of PrEP care through the local standard of care
mHealth model of care
Delivery of PrEP care through the Freddie® mobile Health (mHealth) platform.
PrEP
Participants will receive Descovy® 200/25mg 1 tablet once daily for 72 weeks.
mHealth Model of Care
Freddie® allows for asynchronous contact between patients and care providers, meaning that it does not require both groups to be connected in real time, instead allowing communication over a number of days.
Interventions
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PrEP
Participants will receive Descovy® 200/25mg 1 tablet once daily for 72 weeks.
mHealth Model of Care
Freddie® allows for asynchronous contact between patients and care providers, meaning that it does not require both groups to be connected in real time, instead allowing communication over a number of days.
Standard of Care
Delivery of PrEP care through the local standard of care
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
16 Years
MALE
Yes
Sponsors
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CIHR Canadian HIV Trials Network
NETWORK
Gilead Sciences
INDUSTRY
Unity Health Toronto
OTHER
Responsible Party
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Principal Investigators
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Darrell HS Tan, MD,FRCPC,PhD
Role: PRINCIPAL_INVESTIGATOR
Unity Health Toronto
Kevin Woodward, MD,FRCPC
Role: PRINCIPAL_INVESTIGATOR
Hamilton PrEP Clinic
Locations
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Sexually Transmitted Infection (STI) Clinic
Calgary, Alberta, Canada
Nine Circles
Winnipeg, Manitoba, Canada
Hamilton PrEP Clinic
Hamilton, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Maple Leaf Research
Toronto, Ontario, Canada
Countries
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Other Identifiers
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CTN 332
Identifier Type: -
Identifier Source: org_study_id
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