HIV Prevention With PrEP Among People on Opioid Replacement Therapy

NCT07160075 | Recruiting Phase 4

• 1 other identifier: Bio 5418
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 6

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

Keywords

PrEP; OAT; Opioid Agonist Therapy; HIV

Outcome Measures

Primary Outcomes (2)

• 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

  The proportion of participants: * Using PrEP within the clinical programs at baseline * Who initiate PrEP (take one dose) when approached for study enrollment and 1, 3, and 6 months from study initiation * Maintained on PrEP at 6 months (have taken PrEP at least once a week)

  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

  From the time that PrEP was offered to the acceptance of PrEP or the end of the 6-month recruitment period

Secondary Outcomes (12)

• Compare usage and clinical outcomes between individuals who initiate PrEP and those who do not at 1, 3, 6, 9, and 12 months

  From initiation of PrEP to 1, 3, 6, 9, and 12 months after initiation

• Compare usage and clinical outcomes between individuals who initiate PrEP and those who do not at 1, 3, 6, 9, and 12 months

  From initiation of PrEP to 1, 3, 6, 9, and 12 months after initiation

• Compare usage and clinical outcomes between individuals who initiate PrEP and those who do not at 1, 3, 6, 9, and 12 months

  From initiation of PrEP to 1, 3, 6, 9, and 12 months after initiation

• Compare usage and clinical outcomes between individuals who initiate PrEP and those who do not at 1, 3, 6, 9, and 12 months

  From initiation of PrEP to 1, 3, 6, 9, and 12 months after initiation

• HIV incidence between individuals who initiate PrEP and those who do not at 1, 3, 6, 9, and 12 months

  From initiation of PrEP to 1, 3, 6, 9, and 12 months after initiation

Study Arms (2)

PrEP Group

EXPERIMENTAL

Participants who have agreed to be on PrEP

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

Non-PrEP Group

NO INTERVENTION

Participants who have declined PrEP

Interventions

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

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

PrEP Group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cara Spence: lead
• Gilead Sciences: collaborator

Study Sites (6)

Sheldon M Chumir Health Centre

Calgary, Alberta, T2R 0X7, Canada

NOT YET RECRUITING

Queen City Wellness Pharmacy

Regina, Saskatchewan, S4P 0H7, Canada

NOT YET RECRUITING

Mayfair Drugs Pharmacy

Saskatoon, Saskatchewan, S7L 0V8, Canada

RECRUITING

Pharmasave Riversdale Pharmacy

Saskatoon, Saskatchewan, S7M 0Y2, Canada

RECRUITING

The Medicine Shoppe Pharmacy

Saskatoon, Saskatchewan, S7M 0Z7, Canada

RECRUITING

Meadowgreen Pharmacy

Saskatoon, Saskatchewan, S7M 4R5, Canada

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lead Principal Investigator in Saskatchewan, Canada

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: September 8, 2025
• Study Start: August 28, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: October 7, 2025

Record last verified: 2025-08

Locations

CA (6)