Testing Simultaneous administration of OAT and for HIV - human immunodeficiency virus
Official title: HIV Prevention With PrEP Among People on Opioid Replacement Therapy
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
- Phase 4
- 2 groups
- Sites in Calgary, Regina and 1 more city
- Recruiting
Interventions
- Behavioural therapy
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
Canadian Sites (6)
4 of 6 recruiting
- Recruiting
Mayfair Drugs Pharmacy
Saskatoon, Saskatchewan
- Recruiting
Pharmasave Riversdale Pharmacy
Saskatoon, Saskatchewan
- Recruiting
The Medicine Shoppe Pharmacy
Saskatoon, Saskatchewan
- Recruiting
Meadowgreen Pharmacy
Saskatoon, Saskatchewan
- Not yet recruiting
Sheldon M Chumir Health Centre
Calgary, Alberta
- Not yet recruiting
Queen City Wellness Pharmacy
Regina, Saskatchewan
Eligibility Criteria
See who this study is looking for7 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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-upFollow-upContinued check-ins after the treatment part is finished.Read more → visits
Exclusion
- −Deemed appropriate by a clinician for HIV Post-Exposure Prophylaxis at the time of screeningScreeningThe checks done before joining, to see whether a study fits.Read more → or enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →
- −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
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is looking at how care is delivered and organised, rather than at a treatment itself.
Phase 4Phase 4A study of a treatment that is already approved and in use.Read more → — a study of a treatment already approved for use, following it in everyday practice.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Simultaneous administration of OAT and oral PrEP at existing pharmacy-based programs.
Registry label: A: PrEP Group
Group B receives no study treatment and is followed for comparison.
Registry label: B: Non-PrEP Group
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Groups are assigned by the study team using set rules, rather than by chance.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives no study treatment at all, and is followed for comparison.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 16 years, with no upper limit given.
The study is open to people of any sex.
The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 350 people.
The study is currently expected to finish around September 2027.
The main measurement is taken over: Start of 6-month recruitment period to 6 months following the end of the recruitment period.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Oral PrEP use in an OAT setting at 6 months follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →: Review data from participant screeningScreeningThe checks done before joining, to see whether a study fits.Read more → and clinical follow-up, and compare it to baselineBaselineYour starting measurements, taken before treatment begins.Read more → PrEP use to assess uptake — measured over 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 — measured over From the time that PrEP was offered to the acceptance of PrEP or the end of the 6-month recruitment period.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07160075 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Simultaneous administration of OAT and oral PrEP at existing pharmacy-based programsBehavioural
Simultaneous administration of OAT and oral PrEP (direct observed therapy or home supply) at existing pharmacy-based programs
From the trial registry — its own words, unedited.
What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 16 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives no study treatment and is followed for comparison.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Groups are assigned by the study team using set rules, rather than by chance.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 16 years, with no upper limit given.
It is open to people of any sex.
It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Start of 6-month recruitment period to 6 months following the end of the recruitment period.
The study as a whole is currently expected to finish around 2027-09-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 350 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 3 locations, including: Calgary, Alberta, Canada; Regina, Saskatchewan, Canada; Saskatoon, Saskatchewan, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.