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HIV InfectionsPhase 4VPrEPNCT05159531

Virtual PrEP: Rendering PrEP Delivery More Efficient

A Phase 4 study testing PrEP and mHealth Model of Care in people with HIV Infections, run by Unity Health Toronto at 5 sites in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 16 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
HIV Infections
What is being tested?
PrEP and mHealth Model of Care
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
5 sitesCanada
Study dates
1 May 2023to 8 Jun 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • Men only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Self-reported gay, bisexual or other man who has sex with men (inclusive of transgender men) or transgender woman
  • Age ≥16
  • HIV seronegative, as documented by a 4th generation HIV antigen/antibody combination test performed within 14 days of baseline
  • No symptoms of acute HIV seroconversion (fever, myalgias, arthralgias, malaise, headache, rash, pharyngitis and/or diarrhea that is otherwise unexplained)
  • 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.
  • eGFR >30ml/min
  • Has adequate access to the internet to permit use of the mHealth platform
  • Adequate facility in English to communicate with their provider

Who cannot join

  • Known hypersensitivity/allergy to TAF/FTC
  • Actively participating in another interventional trial related to the delivery of PrEP or sexual health-related care
  • Being unwilling or unable to perform self-collected pharyngeal and/or rectal swabs as part of routine PrEP care
  • Potential to become pregnant
  • 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 locations and contacts

5 sites in 1 country.

5 sites in 1 country

Canada5 sites

  • Sexually Transmitted Infection (STI) Clinic

    Calgary, Alberta, T2R 0X7

  • Hamilton PrEP Clinic

    Hamilton, Ontario, L8N 1Y2

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

  • Maple Leaf Research

    Toronto, Ontario, M5G 1K2

  • Nine Circles

    Winnipeg, Manitoba, R3G 0X2

Other trials in Canada

About this study

Official title: Virtual PrEP: Rendering PrEP Delivery More Efficient Using an mHealth Intervention and TAF/FTC

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.

Read more

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.

Conditions
HIV Infections
Being tested
PrEP, mHealth Model of Care, Standard of Care
Keywords
HIV, PrEP, HIV prevention
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PrEPDrug

    Also called Descovy® 200/25mg (DIN= 02454424), TAF/FTC, tenofovir alafenamide/emtricitabine

    Participants will receive Descovy® 200/25mg 1 tablet once daily for 72 weeks.

  • mHealth Model of CareOther

    Also called GoFreddie®

    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 CareOther

    Also called PrEP standard of care

    Delivery of PrEP care through the local standard of care

Study groups in NCT05159531
Study groupRoleWhat they receive
Standard model of careExperimentalDelivery of PrEP care through the local standard of care.
Receives: Drug: PrEP; Other: Standard of Care
mHealth model of careActive comparatorDelivery of PrEP care through the Freddie® mobile Health (mHealth) platform.
Receives: Drug: PrEP; Other: mHealth Model of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 'Final Visit Questionnaire' will be used to determine participants' stated preference for either the standard of care or the mHealth-based model of care.

    The primary outcome will be defined using the response to the following question:

    "During this study, your PrEP care was provided through the Freddie platform for part of the study period, and through your clinic's standard procedures for part of the study period. Which of these did you prefer?"

    Measured: 72 weeks

Secondary outcomes (11)

  1. Study visit attendance will be used to compare the number of missed visits by model of care

    Measured by study visit attendance (defined as: occasions on which the patient and provider fail to connect for a quarterly follow-up in the pre-planned fashion)

    Measured: 72 weeks

  2. Quantity of missing laboratory questionnaires will be used to compare the number of missed laboratory evaluations by model of care.

    Missed laboratory evaluations (secondary outcome B) will be defined as any occasion on which a participant fails to complete their clinically indicated laboratory tests (HIV serology, STI screening, creatinine) by the end of the 9th week of each 12-weekly follow-up cycle.

    Measured: 72 weeks

  3. 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

    Measure of time required for PrEP follow-up activities per quarter will be calculated as the sum (in minutes) of all time spent by the participant on activities related to receiving PrEP care per 12-week follow-up interval, as reported by the participant during study interviews.

    Measured: 72 weeks

  4. Questionnaires administered to clinicians will be used to compare of the average amount of clinician time required for PrEP follow-up by activities per model of care

    Measured by total number of minutes spent by the clinician on activities related to delivering PrEP care per 12-week follow-up interval.

    Measured: 72 weeks

  5. Study visit attendance will be followed to compare of the total number of participant visits by model of care

    measured from study visit attendance

    Measured: 72 weeks

  6. PrEP adherence questionnaire administered at week 36 and 72 will be used to determine PrEP adherence.

    PrEP adherence refers to the degree to which participants take their daily TAF/FTC as prescribed. PrEP adherence questionnaire will include questions of the number of days per week on which PrEP was taken.

    Measured: 72 weeks

  7. Dried blood spot will be collected at week 36 and 72 will be used to determine PrEP adherence.

    PrEP adherence refers to the degree to which participants take their daily TAF/FTC as prescribed. Samples will be analyzed for drug levels as this outcome is mapped onto pharmacokinetic outcomes.

    Measured: 72 weeks

  8. Hair Samples will be collected at week 36 and 72 will be used to determine PrEP adherence.

    PrEP adherence refers to the degree to which participants take their daily TAF/FTC as prescribed. Samples will be analyzed for drug levels as this outcome is mapped onto pharmacokinetic outcomes.

    Measured: 72 weeks

  9. Participant visit logs will be used to assess retention in PrEP care by model of care.

    Measurement of patients' continued engagement in PrEP care, regardless of whether continuing to take PrEP medication.

    Measured: 72 weeks

  10. Interview administered questionnaires will be used to qualitatively learn about the preferences of patients and providers about the mHealth model of care.

    Questions assessing pros and cons of each model of care will allow for participants to provide insight about preferences in PrEP care models.

    Measured: 72 weeks

  11. Satisfaction questionnaires will be used to compare participant satisfaction with their PrEP care by model of care.

    Measured by questionnaire responses at weeks 4, 12, 36, 48, 60 and at final study visit.

    Measured: 72 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2021
  2. Study start1 May 2023
  3. Primary completion8 Jun 2023
  4. Study completion8 Jun 2023

Why it stopped: Funding withdrawn

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Model description
1:1 open-label RCT using a AB:BA crossover design, comparing the standard of care to an mHealth-based model of care for TAF/FTC PrEP delivery over 72 weeks.
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05159531
Sponsor's protocol ID
CTN 332
Acronym
VPrEP
Status last verified
Apr 2024
First submitted
3 Nov 2021
Last updated
18 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing PrEP and mHealth Model of Care in people with HIV Infections, run by Unity Health Toronto at 5 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Funding withdrawn). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

'Final Visit Questionnaire' will be used to determine participants' stated preference for either the standard of care or the mHealth-based model of care. (time frame: 72 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05159531.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.

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