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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Simultaneous administration of OAT and oral PrEP at existing pharmacy-based programs
BehavioralSimultaneous administration of OAT and oral PrEP (direct observed therapy or home supply) at existing pharmacy-based programs
Treatment groups
350 Participants
are divided into 2 treatment groupsGroup A: PrEP GroupExperimental treatment 1 intervention
Group B: Non-PrEP GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Oral PrEP use in an OAT setting at 6 months follow-up: Review data from participant screening and clinical follow-up, and compare it to baseline PrEP use to assess uptake
The proportion of participants: * Using PrEP within the clinical programs at baseline * Who initiate PrEP (take one dose) when approached for study enrollment and 1, 3, and 6 months from study initiation * Maintained on PrEP at 6 months (have taken PrEP at least once a week)
Time frame
Start of 6-month recruitment period to 6 months following the end of the recruitment period2
Oral PrEP use in an OAT setting at 6 months follow-up: Record the time from offer to acceptance of PrEP
Time frame
From the time that PrEP was offered to the acceptance of PrEP or the end of the 6-month recruitment periodSecondary outcomes
1
Compare usage and clinical outcomes between individuals who initiate PrEP and those who do not at 1, 3, 6, 9, and 12 months
PrEP adherence data will be collected via self-report and dispensing records (daily direct observed therapy and pill count for home supply). Unit of measure for PrEP adherence: Number of weeks in which PrEP prescription was filled. The proportion of participants adhering to PrEP will be compared between the PrEP and non-PrEP arms.
Time frame
From initiation of PrEP to 1, 3, 6, 9, and 12 months after initiation2
Compare usage and clinical outcomes between individuals who initiate PrEP and those who do not at 1, 3, 6, 9, and 12 months
OAT adherence through self-report and dispensing records (daily direct observed therapy and pill count for home supply)
Time frame
From initiation of PrEP to 1, 3, 6, 9, and 12 months after initiation3
Compare usage and clinical outcomes between individuals who initiate PrEP and those who do not at 1, 3, 6, 9, and 12 months
Overall persistence, i.e.: PrEP taken at least once per week
Time frame
From initiation of PrEP to 1, 3, 6, 9, and 12 months after initiation4
Compare usage and clinical outcomes between individuals who initiate PrEP and those who do not at 1, 3, 6, 9, and 12 months
Overall persistence, i.e.: OAT taken at least once per week
Time frame
From initiation of PrEP to 1, 3, 6, 9, and 12 months after initiationSponsors and contacts
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Source ClinicalTrials.gov