HIV Prevention With PrEP Among People on Opioid Replacement Therapy (OAT-PrEP)

Cara Spence

Status and phase: Enrolling; Phase 4

Conditions: HIV - Human Immunodeficiency Virus

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07160075

Bio 5418

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 350 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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350 participants in 2 patient groups

PrEP Group

Experimental group

Description:

Participants who have agreed to be on PrEP

Treatment:

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

Non-PrEP Group

No Intervention group

Description:

Participants who have declined PrEP