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Virtual PrEP: Rendering PrEP Delivery More Efficient

NCT05159531 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2024-04-18

No results posted yet for this study

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

Interventions

DRUG

PrEP

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

OTHER

mHealth Model of Care

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.

OTHER

Standard of Care

Delivery of PrEP care through the local standard of care

Sponsors & Collaborators

  • CIHR Canadian HIV Trials Network

    collaborator NETWORK

  • Gilead Sciences

    collaborator INDUSTRY

  • Unity Health Toronto

    lead OTHER

Principal Investigators

  • Darrell HS Tan, MD,FRCPC,PhD · Unity Health Toronto

  • Kevin Woodward, MD,FRCPC · Hamilton PrEP Clinic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
16 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2023-06-08
Completion
2023-06-08

Countries

  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05159531 on ClinicalTrials.gov