HIV Prevention With PrEP Among People on Opioid Replacement Therapy

NCT ID: NCT07160075

Last Updated: 2025-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-28

Study Completion Date

2027-09-01

Brief Summary

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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.

Detailed Description

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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 of new infections. The purpose of this study is to assess the feasibility and acceptability of providing oral PrEP and 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 and acceptability of long-lasting injectable options for HIV prevention.

Conditions

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HIV - Human Immunodeficiency Virus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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PrEP Group

Participants who have agreed to be on PrEP

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

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

Non-PrEP Group

Participants who have declined PrEP

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role collaborator

Cara Spence

OTHER

Sponsor Role lead

Responsible Party

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Cara Spence

Lead Principal Investigator in Saskatchewan, Canada

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Sheldon M Chumir Health Centre

Calgary, Alberta, Canada

Site Status NOT_YET_RECRUITING

Queen City Wellness Pharmacy

Regina, Saskatchewan, Canada

Site Status NOT_YET_RECRUITING

Mayfair Drugs Pharmacy

Saskatoon, Saskatchewan, Canada

Site Status RECRUITING

Pharmasave Riversdale Pharmacy

Saskatoon, Saskatchewan, Canada

Site Status RECRUITING

The Medicine Shoppe Pharmacy

Saskatoon, Saskatchewan, Canada

Site Status RECRUITING

Meadowgreen Pharmacy

Saskatoon, Saskatchewan, Canada

Site Status RECRUITING

Countries

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Canada

Facility Contacts

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Caley Shukalek, MD, MPH

Role: primary

403-210-6093

Sarah Kozusko, BScPharm

Role: primary

306-522-2266

Christine McDougall, RN

Role: primary

306-370-2320

Chantelle Wong, BSc.

Role: backup

Christine McDougall, RN

Role: primary

1-306-370-2320

Chantelle Wong, BSc.

Role: backup

Christine McDougall, RN

Role: primary

306-370-2320

Chantelle Wong, BSc.

Role: backup

Christine McDougall, RN

Role: primary

306-370-2320

Chantelle Wong, BSc.

Role: backup

Other Identifiers

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Bio 5418

Identifier Type: -

Identifier Source: org_study_id

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