HIV Prevention With PrEP Among People on Opioid Replacement Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Simultaneous administration of OAT and oral PrEP at existing pharmacy-based programs.
- Who it may be relevant to
- Registry conditions: HIV - Human Immunodeficiency Virus. Basic parameters: from 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Improving Access to HIV Pre-exposure Prophylaxis: Implementation and Evaluation of Innovative HIV Prevention Services Among Persons on Opioid Replacement Therapy in Western Canada: Prospective, Implementation Study
Overview
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
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.
Interventions
- Behavioral 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
Primary outcome measures
- 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 [Time frame: 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 [Time frame: From the time that PrEP was offered to the acceptance of PrEP or the end of the 6-month recruitment period]
Secondary outcome measures (12)
- Compare usage and clinical outcomes between individuals who initiate PrEP and those who do not at 1, 3, 6, 9, and 12 months [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: From initiation of PrEP to 1, 3, 6, 9, and 12 months after initiation]
- STI incidence between individuals who initiate PrEP and those who do not at 1, 3, 6, 9, and 12 months [Time frame: 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 [Time frame: From initiation of PrEP to 1, 3, 6, 9, and 12 months after initiation]
- To determine the barriers, facilitators, preferences, and contextual factors for uptake, adherence, and continuance of PrEP by participants, as well as patient-reported outcome (PRO) measures [Time frame: From initiation of PrEP to 1, 3, 6, 9, and 12 months after initiation]
- To determine the barriers, facilitators, preferences, and contextual factors for uptake, adherence, and continuance of PrEP by participants, as well as PRO measures [Time frame: From initiation of PrEP to 1, 3, 6, 9, and 12 months after initiation]
- To determine the barriers, facilitators, preferences, and contextual factors for uptake, adherence, and continuance of PrEP by participants, as well as PRO measures [Time frame: From initiation of PrEP to 1, 3, 6, 9, and 12 months after initiation]
- To determine the barriers, facilitators, preferences, and contextual factors for uptake, adherence, and continuance of PrEP by participants, as well as PRO measures [Time frame: At initiation of PrEP]
- To determine the barriers, facilitators, preferences, and contextual factors for uptake, adherence, and continuance of PrEP by participants, as well as PRO measures [Time frame: 1, 3, 6, 9, and 12 months after initiation of PrEP]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
Canada · 6 centers
- Sheldon M Chumir Health Centre — Calgary
- Queen City Wellness Pharmacy — Regina
- Mayfair Drugs Pharmacy — Saskatoon
- Pharmasave Riversdale Pharmacy — Saskatoon
- The Medicine Shoppe Pharmacy — Saskatoon
- Meadowgreen Pharmacy — Saskatoon
Identifiers
NCT: NCT07160075 · Bio 5418