RecruitingPhase 4NCT07160075

HIV Prevention With PrEP Among People on Opioid Replacement Therapy

Improving Access to HIV Pre-exposure Prophylaxis: Implementation and Evaluation of Innovative HIV Prevention Services Among Persons on Opioid Replacement Therapy in Western Canada: Prospective, Implementation Study


Sponsor

Cara Spence

Enrollment

350 participants

Start Date

Aug 28, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 16 Years

Inclusion Criteria4

  • 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 Criteria3

  • 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

Interventions

BEHAVIORALSimultaneous administration of OAT and oral PrEP at existing pharmacy-based programs

Simultaneous administration of OAT and oral PrEP (direct observed therapy or home supply) at existing pharmacy-based programs


Locations(6)

Sheldon M Chumir Health Centre

Calgary, Alberta, Canada

Queen City Wellness Pharmacy

Regina, Saskatchewan, Canada

Mayfair Drugs Pharmacy

Saskatoon, Saskatchewan, Canada

Pharmasave Riversdale Pharmacy

Saskatoon, Saskatchewan, Canada

The Medicine Shoppe Pharmacy

Saskatoon, Saskatchewan, Canada

Meadowgreen Pharmacy

Saskatoon, Saskatchewan, Canada

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NCT07160075


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