Clinical trial Recruiting at 4 sites Phase 4 Interventional Ages 16 and up

PrEP given with opioid replacement therapy at community pharmacies

Official title: 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

Run by University of Saskatchewan · NCT07160075 · Data updated 2026-11-12

This project will test whether giving daily oral PrEP together with opioid agonist therapy at community pharmacies is practical and acceptable for HIV-negative people on opioid replacement therapy who are at risk.

Quick facts

PhasePhase 4
Study typeInterventional
Ages16 Years and up
SexAll
Enrollment350 (estimated)
SponsorUniversity of Saskatchewan
Academic / other
Locations6 sites (Calgary, Alberta and 5 other locations)
StatusRecruiting
StartedAugust 28, 2025
Main results expectedSeptember 1, 2026
Study endsSeptember 1, 2027
Registry record updatedOctober 7, 2025
Trial IDNCT07160075 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are HIV-negative adults in Alberta or Saskatchewan who are regularly receiving opioid agonist therapy (at least three days per week), have ongoing behaviors that risk HIV exposure, and are willing to attend follow-up visits.

Probably not a fit

People with significant kidney dysfunction or other contraindications to tenofovir-based PrEP, those requiring HIV post-exposure prophylaxis at screening, or those who recently took PrEP will likely not benefit from this program.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In Alberta and Saskatchewan the program offers oral PrEP alongside ongoing opioid agonist therapy through existing pharmacy-based OAT programs to see if co-delivery is practical. HIV-negative participants who are regularly engaged in OAT (at least three days per week) and report behaviors that could expose them to HIV will be enrolled and followed. The study will collect data on preferences, adherence, and persistence with oral PrEP and will ask about interest in long-acting injectable PrEP options. Safety exclusions include significant renal impairment or other contraindications to tenofovir-based PrEP.

Why it matters

Potential benefit: If successful, this approach could increase PrEP uptake and adherence among people who inject drugs by making HIV prevention easier to access where they already get opioid treatment.

How similar studies have gone: Programs that integrated PrEP into addiction treatment or pharmacy services have shown improved uptake in some settings, and long-acting injectable PrEP has proven effective in clinical trials but is less studied specifically in people who inject drugs.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Mayfair Drugs Pharmacy
    Saskatoon, Saskatchewan, Canada
    Recruiting
  • Pharmasave Riversdale Pharmacy
    Saskatoon, Saskatchewan, Canada
    Recruiting
  • The Medicine Shoppe Pharmacy
    Saskatoon, Saskatchewan, Canada
    Recruiting
  • Meadowgreen Pharmacy
    Saskatoon, Saskatchewan, Canada
    Recruiting
  • Sheldon M Chumir Health Centre
    Calgary, Alberta, Canada
    Not yet recruiting
  • Queen City Wellness Pharmacy
    Regina, Saskatchewan, Canada
    Not yet recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.