HIV Prevention With PrEP Among People on Opioid Replacement Therapy
NCT ID: NCT07160075
Last Updated: 2025-10-07
Study Results
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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RECRUITING
PHASE4
350 participants
INTERVENTIONAL
2025-08-28
2027-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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PrEP Group
Participants who have agreed to be on PrEP
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
Non-PrEP Group
Participants who have declined PrEP
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
16 Years
ALL
Yes
Sponsors
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Gilead Sciences
INDUSTRY
Cara Spence
OTHER
Responsible Party
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Cara Spence
Lead Principal Investigator in Saskatchewan, Canada
Locations
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Sheldon M Chumir Health Centre
Calgary, Alberta, Canada
Queen City Wellness Pharmacy
Regina, Saskatchewan, Canada
Mayfair Drugs Pharmacy
Saskatoon, Saskatchewan, Canada
Pharmasave Riversdale Pharmacy
Saskatoon, Saskatchewan, Canada
The Medicine Shoppe Pharmacy
Saskatoon, Saskatchewan, Canada
Meadowgreen Pharmacy
Saskatoon, Saskatchewan, Canada
Countries
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Facility Contacts
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Other Identifiers
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Bio 5418
Identifier Type: -
Identifier Source: org_study_id
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