RecruitingPhase 4

HIV Prevention With PrEP Among People on Opioid Replacement Therapy

Canada350 participantsStarted 2025-08-28

Plain-language summary

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.

Who can participate

Age range16 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

What they're measuring

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

Timeframe: Start of 6-month recruitment period to 6 months following the end of the recruitment period

Oral PrEP use in an OAT setting at 6 months follow-up: Record the time from offer to acceptance of PrEP

Timeframe: From the time that PrEP was offered to the acceptance of PrEP or the end of the 6-month recruitment period

Trial details

NCT IDNCT07160075

SponsorCara Spence

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-01

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