HIV - Human Immunodeficiency VirusPhase 4OAT-PrEPNCT07160075
HIV Prevention With PrEP Among People on Opioid Replacement Therapy
A Phase 4 study testing Simultaneous administration of OAT and oral PrEP at existing pharmacy-based programs in people with HIV - Human Immunodeficiency Virus, run by Cara Spence at 6 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV - Human Immunodeficiency Virus
- What is being tested?
- Simultaneous administration of OAT and oral PrEP at existing pharmacy-based programs
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 6 sitesCanada
- Study dates
- 28 Aug 2025to 1 Sep 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Canada6 sites, 6 recruiting
- Not yet recruiting
Sheldon M Chumir Health Centre
Calgary, Alberta, T2R 0X7
Caley Shukalek, MD, MPH, 403-210-6093, cbshukal@ucalgary.ca
Caley Shukalek, MD, MPH
- Not yet recruiting
Queen City Wellness Pharmacy
Regina, Saskatchewan, S4P 0H7
Sarah Kozusko, BScPharm, 306-522-2266, skozusko@rubiconpharmacies.com
Cara Spence, PhD
- Recruiting
Mayfair Drugs Pharmacy
Saskatoon, Saskatchewan, S7L 0V8
Christine McDougall, RN, 306-370-2320, mcdougall.christine@gmail.com
Chantelle Wong, BSc., chw454@usask.ca
- Recruiting
Pharmasave Riversdale Pharmacy
Saskatoon, Saskatchewan, S7M 0Y2
Christine McDougall, RN, 1-306-370-2320, mcdougall.christine@gmail.com
Chantelle Wong, BSc., chw454@usask.ca
- Recruiting
The Medicine Shoppe Pharmacy
Saskatoon, Saskatchewan, S7M 0Z7
Christine McDougall, RN, 306-370-2320, mcdougall.christine@gmail.com
Chantelle Wong, BSc., chw454@usask.ca
- Recruiting
Meadowgreen Pharmacy
Saskatoon, Saskatchewan, S7M 4R5
Christine McDougall, RN, 306-370-2320, mcdougall.christine@gmail.com
Chantelle Wong, BSc., chw454@usask.ca
About this study
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
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.
Read the 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.
- Conditions
- HIV - Human Immunodeficiency Virus
- Being tested
- Simultaneous administration of OAT and oral PrEP at existing pharmacy-based programs
- Keywords
- PrEP, OAT, Opioid Agonist Therapy, HIV
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| PrEP Group | Experimental | Participants who have agreed to be on PrEP Receives: Behavioral: Simultaneous administration of OAT and oral PrEP at existing pharmacy-based programs |
| Non-PrEP Group | No intervention | Participants who have declined PrEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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: 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
PrEP adherence data will be collected via self-report and dispensing records (daily direct observed therapy and pill count for home supply).
Unit of measure for PrEP adherence: Number of weeks in which PrEP prescription was filled.
The proportion of participants adhering to PrEP will be compared between the PrEP and non-PrEP arms.
Measured: 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
OAT adherence through self-report and dispensing records (daily direct observed therapy and pill count for home supply)
Measured: 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
Overall persistence, i.e.: PrEP taken at least once per week
Measured: 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
Overall persistence, i.e.: OAT taken at least once per week
Measured: 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
Measured: 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
Measured: 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
Comparing the number of individuals lost to follow-up between both groups
Measured: 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
Qualitative measures assessed in all patient participants at baseline, 1, 3, 6, 9, and 12 months: HIV PrEP Stigma Scale (HPSS-12)
Higher total scores reflect a higher level of perceived HIV-related stigma. Total scores range from 12 to 48.
Measured: 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
Qualitative measures assessed in all patient participants at baseline, 1, 3, 6, 9, and 12 months: Depression Scale (PHQ-9)
Total scores range from 0 to 27. 0-4 indicates minimal or no depression, 5-9 suggests mild depression, 10-14 indicates moderate depression, 15-19 represents moderately severe depression, and 20-27 signifies severe depression.
Measured: 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
Qualitative measures assessed in all patient participants at baseline, 1, 3, 6, 9, and 12 months: Generalized Anxiety Disorder (GAD-7)
Total scores are interpreted on a scale from 0 to 21, with higher scores indicating more severe anxiety.
Measured: 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
Qualitative measures will be assessed at baseline by interviewing OAT provider participants with questions regarding awareness of PrEP, barriers and facilitators of PrEP use, preferences for and acceptability of long-acting injectable options.
Interview questions at Baseline visit:
- Before this study, how often would you recommend PrEP to patients at risk of HIV?
- What do you think most of your patients' understanding of PrEP is?
- Based on your estimates, what proportion of patients with HIV exposure are on PrEP in this community?
- Why do you think is/are the reason(s) an eligible patient would decline PrEP?
- In your experience, what are some effective ways to encourage eligible patients to take PrEP?
- Do you believe health system barriers limit the uptake of PrEP in patients at risk of HIV? If so, what are they?
- What are your opinions on prescribing a long-acting injectable option for PrEP over the oral version?
Measured: 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
Qualitative measures will be assessed at 1, 3, 6, 9, and 12 months, by interviewing OAT provider participants with questions regarding awareness of PrEP, barriers and facilitators of PrEP use, preferences for and acceptability of long-acting injectable options.
Interview questions at Follow-up visit:
- Do you think your patients' understanding of PrEP has changed since the study began? If so, how?
- Do you think your patients' attitudes towards PrEP has changed since the study began? If so, how?
- What proportion of your patients do you predict will continue taking PrEP after the study ends? Why?
- Have your opinions changed on prescribing long-acting injectables for PrEP over the oral version? If so, what is your current opinion and why?
- Since the last questionnaire, do you have any additional comments on the patient-level and health system-level barriers and facilitators for PrEP uptake in this community?
Measured: 1, 3, 6, 9, and 12 months after initiation of PrEP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start28 Aug 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV - Human Immunodeficiency VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cara Spence
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor-investigator, Cara Spence, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07160075
- Sponsor's protocol ID
- Bio 5418
- Acronym
- OAT-PrEP
- Status last verified
- Aug 2025
- First submitted
- 18 Aug 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07160075
- Acronym / sponsor ID
- OAT-PrEP / Bio 5418
- Conditions
- HIV - Human Immunodeficiency Virus
- Keywords
- PrEP, OAT, Opioid Agonist Therapy, HIV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Cara SpenceUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 28 Aug 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PrEP Group | Experimental | Behavioral: Simultaneous administration of OAT and oral PrEP at existing pharmacy-based programsParticipants who have agreed to be on PrEP |
| Non-PrEP Group | No intervention | –Participants who have declined PrEP |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simultaneous administration of OAT and oral PrEP at existing pharmacy-based programsSimultaneous administration of OAT and oral PrEP (direct observed therapy or home supply) at existing pharmacy-based programs | Behavioural | PrEP Group |
Primary outcome
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
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)
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
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Simultaneous administration of OAT and oral PrEP at existing pharmacy-based programs in people with HIV - Human Immunodeficiency Virus, run by Cara Spence at 6 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.