Virtual PrEP: Rendering PrEP Delivery More Efficient

Study Overview
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Brief Summary
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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.

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

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: PrEP
* Other: mHealth Model of Care
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard model of care<br>Delivery of PrEP care through the local standard of care. | Drug: PrEP<br>* Participants will receive Descovy® 200/25mg 1 tablet once daily for 72 weeks.<br>* Other names: tenofovir alafenamide/emtricitabine;Other: Standard of Care<br>* Delivery of PrEP care through the local standard of care<br>* Other names: PrEP standard of care;|
| Active Comparator: mHealth model of care<br>Delivery of PrEP care through the Freddie® mobile Health (mHealth) platform. | Drug: PrEP<br>* Participants will receive Descovy® 200/25mg 1 tablet once daily for 72 weeks.<br>* Other names: tenofovir alafenamide/emtricitabine;Other: mHealth Model of Care<br>* 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.<br>* Other names: GoFreddie®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| '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? | 72 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 72 weeks | 
| 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. | 72 weeks | 
| 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. | 72 weeks | 
| 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. | 72 weeks | 
| Study visit attendance will be followed to compare of the total number of participant visits by model of care | measured from study visit attendance | 72 weeks | 
| 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. | 72 weeks | 
| 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. | 72 weeks | 
| 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. | 72 weeks | 
| 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. | 72 weeks | 
| 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. | 72 weeks | 
| 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. | 72 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, PrEP, HIV prevention