HIV Prevention With PrEP Among People on Opioid Replacement Therapy
ConditionHIV - Human Immunodeficiency Virus
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age16+
SponsorCara Spence
About this trial
The purpose of this study is to assess the feasibility and acceptability of providing oral pre-exposure prophylaxis (PrEP) and opioid agonist therapy (OAT) simultaneously in existing pharmacy-based programs operating in Alberta and Saskatchewan, to collect preference, adherence, and persistence data on oral PrEP, and to assess interest / acceptability of long-lasting injectable options for human immunodeficiency virus (HIV) prevention.
Eligibility criteria
Qualifiers
HIV negative
Ongoing behaviors with potential HIV exposure as assessed by a clinician
Regularly engaged with their respective OAT program at least 3 days a week for the past 2 weeks
Report willingness to return for follow-up visits
Disqualifiers
Creatine clearance <30 mL/min or any medical condition or medication known to be contraindicated with the use of Emtricitabine/Tenofovir Alafenamide (F/TAF) or Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF)
Taken PrEP within the last 24 hours at the time of screening or enrollment
Deemed appropriate by a clinician for HIV Post-Exposure Prophylaxis at the time of screening or enrollment
Trial design
Treatments tested in this trial
- Simultaneous administration of OAT and oral PrEP at existing pharmacy-based programs
Treatment groups
350 Participants
are divided into 2 treatment groupsLocations
6Sheldon M Chumir Health CentreT2R 0X7, CalgaryAlberta, Canada
Queen City Wellness PharmacyS4P 0H7, ReginaSaskatchewan, Canada
Mayfair Drugs PharmacyS7L 0V8, SaskatoonSaskatchewan, Canada
Meadowgreen PharmacyS7M 4R5, SaskatoonSaskatchewan, Canada
Sponsors and collaborators
Cara Spence
Lead sponsor
University of Saskatchewan
Sponsor institution
Gilead Sciences
Collaborator
Source ClinicalTrials.gov