Virtual PrEP: Rendering PrEP Delivery More Efficient

NCT05159531 | Terminated Phase 4 DMC

• 1 other identifier: CTN 332
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 5

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.

Conditions

HIV Infections

Keywords

HIV; PrEP; HIV prevention

Outcome Measures

Primary Outcomes (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?"

  72 weeks

Secondary Outcomes (11)

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

  72 weeks

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

  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

  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

  72 weeks

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

  72 weeks

Study Arms (2)

Standard model of care

EXPERIMENTAL

Delivery of PrEP care through the local standard of care.

Drug: PrEP; Other: Standard of Care

mHealth model of care

ACTIVE COMPARATOR

Delivery of PrEP care through the Freddie® mobile Health (mHealth) platform.

Drug: PrEP; Other: mHealth Model of Care

Interventions

PrEP DRUG

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

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

Standard model of care; mHealth model of care

mHealth Model of Care OTHER

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.

Also known as: GoFreddie®

mHealth model of care

Standard of Care OTHER

Delivery of PrEP care through the local standard of care

Also known as: PrEP standard of care

Standard model of care

Eligibility Criteria

• Age: 16 Years+
• Gender Eligibility Details: Self-reported gay, bisexual or other man who has sex with men or transgender woman
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Unity Health Toronto: lead
• CIHR Canadian HIV Trials Network: collaborator
• Gilead Sciences: collaborator

Study Sites (5)

Sexually Transmitted Infection (STI) Clinic

Calgary, Alberta, T2R 0X7, Canada

Location

Nine Circles

Winnipeg, Manitoba, R3G 0X2, Canada

Location

Hamilton PrEP Clinic

Hamilton, Ontario, L8N 1Y2, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Maple Leaf Research

Toronto, Ontario, M5G 1K2, Canada

Location

MeSH Terms

Conditions

HIV Infections

Interventions

emtricitabine tenofovir alafenamide; Standard of Care

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Darrell HS Tan, MD,FRCPC,PhD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

• Kevin Woodward, MD,FRCPC

  Hamilton PrEP Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: December 16, 2021
• Study Start: May 1, 2023
• Primary Completion: June 8, 2023
• Study Completion: June 8, 2023
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5)