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 groupsSponsors and collaborators
Source ClinicalTrials.gov