Back to resultsVirtual PrEP: Rendering PrEP Delivery More Efficient (VPrEP)
Primary Purpose
HIV Infections
Status
Recruiting
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
PrEP
mHealth Model of Care
Standard of Care
Sponsored by
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring HIV, PrEP, HIV prevention
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Sexually Transmitted Infection (STI) Clinic
- Nine Circles
- Hamilton PrEP Clinic
- St. Michael's HospitalRecruiting
- Maple Leaf Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Standard model of care
mHealth model of care
Arm Description
Delivery of PrEP care through the local standard of care.
Delivery of PrEP care through the Freddie® mobile Health (mHealth) platform.
Outcomes
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.
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?"
Secondary Outcome Measures
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)
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.
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.
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.
Study visit attendance will be followed to compare of the total number of participant visits by model of care
measured from study visit attendance
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05159531
First Posted
November 3, 2021
Last Updated
May 5, 2023
Sponsor
Unity Health Toronto
Collaborators
CIHR Canadian HIV Trials Network, Gilead Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05159531
Brief Title
Virtual PrEP: Rendering PrEP Delivery More Efficient
Acronym
VPrEP
Official Title
Virtual PrEP: Rendering PrEP Delivery More Efficient Using an mHealth Intervention and TAF/FTC
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto
Collaborators
CIHR Canadian HIV Trials Network, Gilead Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, PrEP, HIV prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
142 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard model of care
Arm Type
Experimental
Arm Description
Delivery of PrEP care through the local standard of care.
Arm Title
mHealth model of care
Arm Type
Active Comparator
Arm Description
Delivery of PrEP care through the Freddie® mobile Health (mHealth) platform.
Intervention Type
Drug
Intervention Name(s)
PrEP
Other Intervention Name(s)
Descovy® 200/25mg (DIN= 02454424), TAF/FTC, tenofovir alafenamide/emtricitabine
Intervention Description
Participants will receive Descovy® 200/25mg 1 tablet once daily for 72 weeks.
Intervention Type
Other
Intervention Name(s)
mHealth Model of Care
Other Intervention Name(s)
GoFreddie®
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard of Care
Other Intervention Name(s)
PrEP standard of care
Intervention Description
Delivery of PrEP care through the local standard of care
Primary Outcome Measure Information:
Title
'Final Visit Questionnaire' will be used to determine participants' stated preference for either the standard of care or the mHealth-based model of care.
Description
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?"
Time Frame
72 weeks
Secondary Outcome Measure Information:
Title
Study visit attendance will be used to compare the number of missed visits by model of care
Description
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)
Time Frame
72 weeks
Title
Quantity of missing laboratory questionnaires will be used to compare the number of missed laboratory evaluations by model of care.
Description
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.
Time Frame
72 weeks
Title
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
Description
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.
Time Frame
72 weeks
Title
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
Description
Measured by total number of minutes spent by the clinician on activities related to delivering PrEP care per 12-week follow-up interval.
Time Frame
72 weeks
Title
Study visit attendance will be followed to compare of the total number of participant visits by model of care
Description
measured from study visit attendance
Time Frame
72 weeks
Title
PrEP adherence questionnaire administered at week 36 and 72 will be used to determine PrEP adherence.
Description
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.
Time Frame
72 weeks
Title
Dried blood spot will be collected at week 36 and 72 will be used to determine PrEP adherence.
Description
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.
Time Frame
72 weeks
Title
Hair Samples will be collected at week 36 and 72 will be used to determine PrEP adherence.
Description
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.
Time Frame
72 weeks
Title
Participant visit logs will be used to assess retention in PrEP care by model of care.
Description
Measurement of patients' continued engagement in PrEP care, regardless of whether continuing to take PrEP medication.
Time Frame
72 weeks
Title
Interview administered questionnaires will be used to qualitatively learn about the preferences of patients and providers about the mHealth model of care.
Description
Questions assessing pros and cons of each model of care will allow for participants to provide insight about preferences in PrEP care models.
Time Frame
72 weeks
Title
Satisfaction questionnaires will be used to compare participant satisfaction with their PrEP care by model of care.
Description
Measured by questionnaire responses at weeks 4, 12, 36, 48, 60 and at final study visit.
Time Frame
72 weeks
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Self-reported gay, bisexual or other man who has sex with men or transgender woman
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Darrell HS TAN, MD, FRCPC, PhD
Phone
416-864-5568
Email
darrell.tan@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Reva Persaud, MD
Phone
4168646060
Ext
77105
Email
reva.persaud@unityhealth.to
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darrell HS TAN, MD, FRCPC, PhD
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kevin Woodward, MD, FRCPC
Organizational Affiliation
Hamilton PrEP Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sexually Transmitted Infection (STI) Clinic
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2R 0X7
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caley Shukalek, MD, MPH
Facility Name
Nine Circles
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3G 0X2
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justin Lys
Phone
204-940-6000
Email
jlys@ninecircles.ca
First Name & Middle Initial & Last Name & Degree
Laurie Ireland, MD
Facility Name
Hamilton PrEP Clinic
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1Y2
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Puri
Phone
905-522-1155
Ext
33998
First Name & Middle Initial & Last Name & Degree
Kevin Woodward, MD, FRCPC
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shreya Shah, MD
Phone
4168646060
Ext
77312
Email
shreya.shah@unityhealth.to
First Name & Middle Initial & Last Name & Degree
Ishana Maini
Phone
4168646060
Ext
49612
Email
ishana.maini@unityhealth.to
First Name & Middle Initial & Last Name & Degree
Darrell Tan, MD FRCPC, PhD
Facility Name
Maple Leaf Research
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1K2
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Knox, MD, CCFP, AAHIVS
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Virtual PrEP: Rendering PrEP Delivery More Efficient
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