Clinical trial NCT05159531: Virtual PrEP: Rendering PrEP Delivery More Efficient
Official title: Virtual PrEP: Rendering PrEP Delivery More Efficient Using an mHealth Intervention and TAF/FTC
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: HIV Infections
Keywords: HIV
PrEP
HIV prevention
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: CIHR Canadian HIV Trials Network
name: Gilead Sciences
First posted: 2021-12-16
Enrollment: 2
Sex: MALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
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.
timeFrame: 72 weeks
Secondary outcomes:
measure: Study visit attendance will be used to compare the number of missed visits by model of care
timeFrame: 72 weeks
measure: Quantity of missing laboratory questionnaires will be used to compare the number of missed laboratory evaluations by model of care.
timeFrame: 72 weeks
measure: 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
timeFrame: 72 weeks
measure: 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
timeFrame: 72 weeks
measure: Study visit attendance will be followed to compare of the total number of participant visits by model of care
timeFrame: 72 weeks
measure: PrEP adherence questionnaire administered at week 36 and 72 will be used to determine PrEP adherence.
timeFrame: 72 weeks
measure: Dried blood spot will be collected at week 36 and 72 will be used to determine PrEP adherence.
timeFrame: 72 weeks
measure: Hair Samples will be collected at week 36 and 72 will be used to determine PrEP adherence.
timeFrame: 72 weeks
measure: Participant visit logs will be used to assess retention in PrEP care by model of care.
timeFrame: 72 weeks
measure: Interview administered questionnaires will be used to qualitatively learn about the preferences of patients and providers about the mHealth model of care.
timeFrame: 72 weeks
measure: Satisfaction questionnaires will be used to compare participant satisfaction with their PrEP care by model of care.
timeFrame: 72 weeks
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Sexually Transmitted Infection (STI) Clinic
state: Alberta
city: Winnipeg
country: Canada
facility: Nine Circles
state: Manitoba
city: Hamilton
country: Canada
facility: Hamilton PrEP Clinic
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Maple Leaf Research
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Darrell HS Tan, MD,FRCPC,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hamilton PrEP Clinic
name: Kevin Woodward, MD,FRCPC
role: PRINCIPAL_INVESTIGATOR
References: