NCT07160075 HIV Prevention With PrEP Among People on Opioid Replacement Therapy
| NCT ID | NCT07160075 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Cara Spence |
| Condition | HIV - Human Immunodeficiency Virus |
| Study Type | INTERVENTIONAL |
| Enrollment | 350 participants |
| Start Date | 2025-08-28 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 350 participants in total. It began in 2025-08-28 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Frequently Asked Questions
Who can join the NCT07160075 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying HIV - Human Immunodeficiency Virus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07160075 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07160075 currently recruiting?
Yes, NCT07160075 is actively recruiting participants. Visit ClinicalTrials.gov or contact Cara Spence to inquire about joining.
Where is the NCT07160075 trial being conducted?
This trial is being conducted at Calgary, Canada, Regina, Canada, Saskatoon, Canada, Saskatoon, Canada and 2 additional locations.
Who is sponsoring the NCT07160075 clinical trial?
NCT07160075 is sponsored by Cara Spence. The trial plans to enroll 350 participants.
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