PrEP given with opioid replacement therapy at community pharmacies
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
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
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | University of Saskatchewan Academic / other |
| Locations | 6 sites (Calgary, Alberta and 5 other locations) |
| Trial ID | NCT07160075 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Calgary, Alberta and 5 other locations
- Sheldon M Chumir Health Centre — Calgary, Alberta, Canada (Not_yet_recruiting)
- Queen City Wellness Pharmacy — Regina, Saskatchewan, Canada (Not_yet_recruiting)
- 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)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.