Recruiting

PrEP & OAT

Sponsor:

Cara Spence

Code:

NCT07160075

Conditions

HIV - Human Immunodeficiency Virus

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Accepted

Interventions

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

Study Details

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 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.

Conditions

HIV - Human Immunodeficiency Virus

Study ID

NCT07160075

Start date

Aug 28, 2025

Status verified date

Aug, 2025

Completion date

Sep 1, 2027

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

350 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: PrEP Group

Participants who have agreed to be on PrEP

no intervention: Non-PrEP Group

Participants who have declined PrEP

Interventions

Simultaneous 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

Primary outcome measure

  • 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 [ Time Frame: 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 [ Time Frame: From the time that PrEP was offered to the acceptance of PrEP or the end of the 6-month recruitment period ]

Central Contacts and Locations

Locations

Mayfair Drugs Pharmacy

Recruiting

Saskatoon, Saskatchewan, Canada, S7L 0V8

Contacts

Christine McDougall, RN

306-370-2320mcdougall.christine@gmail.com

Chantelle Wong, BSc.

chw454@usask.ca

Principal Investigator:

Cara Spence, PhD

Pharmasave Riversdale Pharmacy

Recruiting

Saskatoon, Saskatchewan, Canada, S7M 0Y2

Contacts

Christine McDougall, RN

1-306-370-2320mcdougall.christine@gmail.com

Chantelle Wong, BSc.

chw454@usask.ca

Principal Investigator:

Cara Spence, PhD

The Medicine Shoppe Pharmacy

Recruiting

Saskatoon, Saskatchewan, Canada, S7M 0Z7

Contacts

Christine McDougall, RN

306-370-2320mcdougall.christine@gmail.com

Chantelle Wong, BSc.

chw454@usask.ca

Principal Investigator:

Cara Spence, PhD

Meadowgreen Pharmacy

Recruiting

Saskatoon, Saskatchewan, Canada, S7M 4R5

Contacts

Christine McDougall, RN

306-370-2320mcdougall.christine@gmail.com

Chantelle Wong, BSc.

chw454@usask.ca

Principal Investigator:

Cara Spence, PhD

More Information

Sponsor

Cara Spence

Last update posted

Oct 7, 2025

Last verified

Aug, 2025

Keywords

  • PrEP
  • OAT
  • Opioid Agonist Therapy
  • HIV

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cara Spence on 2025-10-07.