Status:
UNKNOWN
Optimizing the Delivery of HIV nPEP
Lead Sponsor:
Unity Health Toronto
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
CIHR Canadian HIV Trials Network
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Despite decades of traditional prevention efforts based on behavior change and condom use, Ontario has seen over 700 new HIV infections annually over the past 10 years. Post-exposure prophylaxis (PEP)...
Eligibility Criteria
Inclusion
- Be 18 years or older
- Be known or presumed to be HIV-uninfected at baseline
- Be initiated on PEP by a healthcare provider in the past six days for a sexual exposure to a known or suspected HIV-infected source
- STAGE 1 only: Own a mobile phone with text messaging capabilities on which they are willing to potentially receive messages from the text messaging service
- Be capable of communicating verbally and via text in English
- Be planning to continue their follow-up locally or be willing to have follow-up study visits conducted remotely; either by telephone or via an encrypted video conferencing system (such as Zoom for healthcare).
- Be referred to a sexual assault center and provided with necessary counselling and support services if presented for nPEP following sexual assault.
Exclusion
- Creatinine clearance \<30 mL/min (using Cockcroft-Gault formula)
- Enrolled in any other clinical trial of an HIV prevention intervention
- Prior participation in this clinical trial for a previous episode of nPEP
- Known co-infection with chronic hepatitis B at enrollment
- Current or planned pregnancy or breastfeeding
- Use of a medication whose co-administration with Biktarvy is contraindicated (dofetilide, carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, rifampicin, rifabutin, rifapentine, modafinil, dexamethasone, metformin, St. John's Wort)
- Concomitant use of HIV pre-exposure prophylaxis (PrEP)
- Stage 2 only: Concomitant use of any non-prescription medication, supplement, vitamin or natural remedy which the patient is unwilling to discontinue during Biktarvy® administration
Key Trial Info
Start Date :
November 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2023
Estimated Enrollment :
434 Patients enrolled
Trial Details
Trial ID
NCT03259698
Start Date
November 4 2021
End Date
August 1 2023
Last Update
November 22 2021
Active Locations (3)
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1
HIV Prevention Clinic (Toronto General Hospital)
Toronto, Ontario, Canada
2
Positive Care Clinic (St. Michael's Hospital)
Toronto, Ontario, Canada
3
Crossways Sexual Health Clinic (TPH)
Toronto, Canada