Status:

RECRUITING

HIV Prevention With PrEP Among People on Opioid Replacement Therapy

Lead Sponsor:

Cara Spence

Collaborating Sponsors:

Gilead Sciences

Conditions:

HIV - Human Immunodeficiency Virus

Eligibility:

All Genders

16+ years

Phase:

PHASE4

Brief 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 pr...

Detailed Description

In Alberta and Saskatchewan, Canada, HIV acquisition is increasingly and predominantly seen in people who inject drugs (PWID). Less than 2% of this population are utilizing PrEP despite a high level o...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

August 28 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 1 2027

Estimated Enrollment :

350 Patients enrolled

Trial Details

Trial ID

NCT07160075

Start Date

August 28 2025

End Date

September 1 2027

Last Update

October 7 2025

Active Locations (6)

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Page 1 of 2 (6 locations)

1

Sheldon M Chumir Health Centre

Calgary, Alberta, Canada, T2R 0X7

2

Queen City Wellness Pharmacy

Regina, Saskatchewan, Canada, S4P 0H7

3

Mayfair Drugs Pharmacy

Saskatoon, Saskatchewan, Canada, S7L 0V8

4

Pharmasave Riversdale Pharmacy

Saskatoon, Saskatchewan, Canada, S7M 0Y2