Comparing 4 approaches for vaccine preventable disease
Official title: Addressing Unfunded Vaccines Through a Co-payment Mechanism in Pharmacies
Addressing the Problem of Recommended But Unfunded Vaccines Through a Co-payment Mechanism in Pharmacies
Interventions
Co-payment Model - Step 1
Step 1 of the co-payment model: A pharmacy site from Nova Scotia and Ontario will be randomly assigned to this step where the study will cover the administration service fee (approximately $35.00) and the participant will pay 100% of the vaccine cost out-of-pocket for the eligible vaccine. The vaccines will include FluMist Quadrivalent, Shingrix, and Abrysvo or Arexvy.
Co-payment Model - Step 2
Step 2 of the co-payment model: A pharmacy site from Nova Scotia and Ontario will be randomly assigned to this step where the study will cover 50% of the vaccine cost plus the administration service fee and the participant will pay 50% of the vaccine cost out-of-pocket. The vaccines will include FluMist Quadrivalent, Shingrix, Abrysvo or Arexvy.
Co-payment Model - Step 3
Step 3 of the co-payment model: A pharmacy site from Nova Scotia and Ontario will be randomly assigned to this step where the study will cover 75% of the vaccine cost plus the administration service fee and the participant will pay 25% of the vaccine cost out-of-pocket. The vaccines will include FluMist Quadrivalent, Shingrix, and Abrysvo or Arexvy.
Co-payment Model - Step 4
Step 4 of the co-payment model: A pharmacy site from Nova Scotia and Ontario will be randomly assigned to this step where the study will cover 100% of the vaccine cost plus the administration service fee and the participant will pay 0% of the vaccine cost. The vaccines will include FluMist Quadrivalent, Shingrix, and Abrysvo or Arexvy.
Canadian Sites (2)
Dalhousie University
Halifax, Nova Scotia, Canada
University of Waterloo
Kitchener, Ontario, Canada
Eligibility Criteria
See who this study is looking for6 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Recommended but Unfunded Vaccines: FluMist Quadrivalent: An age-appropriate quadrivalent influenza should be used in children (2 to 17 years) without contraindications or precautions; Shingrix Vaccine: Adults 50 to 64 years of age in Nova Scotia or 50 years of age or older in Ontario without contraindications or adults 18 years of age or older if immunocompromised; and Abrysvo or Arexvy (RSV) vaccine: Adults 50 years of age or older (Arexvy) or 60 years of age and older (Abrysvo) who are at increased risk of severe RSV disease. Note: The eligibility criteriaEligibility criteriaThe full list of requirements for taking part in a study.Read more → for each vaccine product may be revised during the pilot study if there are any changes in vaccine recommendations and/or funding status in Nova Scotia or Ontario.
- +Community Pharmacy Sites: Inclusion criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more → for the selection of the community pharmacies will include volume of prescriptions (e.g., how busy the siteTrial siteA hospital or clinic where a study is actually run.Read more → it), stable pharmacy patients (e.g., patients who consistently use the same pharmacy), availability and interest of community pharmacies and community pharmacy professionals, sufficient numbers of pharmacy professionals qualified to provide vaccinations, and lack of substantial health care spill over to adjacent communities. Spill over is defined as a pattern of health-care utilization where the public regularly receive care at different regional health centres. Communities will be geographically separated to minimize potential spill over. Based on this inclusion criteria, one pharmacy from the four health zones in Nova Scotia will be selected to implement the co-payment model within their community pharmacy, while a mix of urban and rural pharmacies in Ontario will be selected to implement the co-payment model.
- +Members of the Public: The participating pilot pharmacies will recruit through targeted screeningScreeningThe checks done before joining, to see whether a study fits.Read more → members of the public who meet the vaccine-specific eligibility criteria or their substitute decision-makers for those who lack capacity to consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →. Any members of the public or the substitute decision-maker who consents to participate will be eligible until the maximum number of participants we aim to recruit has been achieved. Eligible members of the public will receive the vaccines based on NACI recommendations for each product as part of routine care.
Exclusion
- −FluMist Quadrivalent: should not be used in children or adolescents for whom it is contraindicated or for whom there are warnings and precautions; should not be used in children or adolescents already adequately immunized against influenza; not recommended for pregnant individuals, health care workers, and adult 18 to 59 years old with specific chronic health conditions; adults 60 to 64 and 65 years and old, as this vaccine is not authorized for use in these age groups; pediatric children (2 to 17 years) of the participating pharmacies who already have private insurance coverage to cover all (or most) of the FluMist vaccine will be excluded from taking part in this study.
- −Shingrix: Persons with active herpes zoster (HZ) should not be immunized with HZ vaccine; should not be used in individuals already adequately immunized against HZ; adults 65 years of age or older in Nova Scotia, as this vaccine is publicly funded for this age group; adults 65 to 70 years of age in Ontario, as this vaccine is publicly funded for this age group; and adults (50 to 64 years old in Nova Scotia and 50 years of age or older in Ontario) of the participating pharmacies who already have private insurance coverage to cover all (or most) of the Shingrix vaccine will be excluded from taking part in this study.
- −Abrysvo or Arexvy (RSV): Persons under the age 50 years should not be immunized with RSV vaccine (exception is use of Abrysvo in pregnancy), as it is not authorized for use in this age group; should not be used in individuals already adequately immunized against RSV; adults 60 years and older in Nova Scotia living in long-term care facilities or in hospital awaiting long-term care placement, as this vaccine is publicly funded for this age group; high-risk older adults (aged 60 years and older) in Ontario (e.g., residents of long-term care homes, Elder Care Lodges, or retirement homes; patients in hospital receiving alternate level of care; patients receiving hemodialysis or peritoneal dialysis; recipients of solid organ or hematopoietic stem cell transplants; individuals experiencing homelessness; and individuals who identify as First Nations, Inuit, or Métis); and adults (≥ 50 years of age (AREXVY) or 60 years of age (Abrysvo) at increased risk of severe RSV disease) of the participating pharmacies who already have private insurance coverage to cover all (or most) of the RSV vaccine will be excluded from taking part in this study.
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.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
What is being given or done in this study: Co-payment Model - Step 1, Co-payment Model - Step 2, Co-payment Model - Step 3, Co-payment Model - Step 4.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
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.
There are 4 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 2 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 600 people.
The study is currently expected to finish around December 2026.
The main measurement is taken over: 6 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Evaluating Acceptability of Implementing of a Co-Payment Model within Community Pharmacies through Surveys with Members of the Public and Community Pharmacy Providers — measured over 6 months.
Evaluating Feasibility of Implementing a Co-Payment Model within Community Pharmacies through Surveys with Members of the Public and Community Pharmacy Providers — measured over 6 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06489964 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 Co-payment Model - Step 1Other
Step 1 of the co-payment model: A pharmacy site from Nova Scotia and Ontario will be randomly assigned to this step where the study will cover the administration service fee (approximately $35.00) and the participant will pay 100% of the vaccine cost out-of-pocket for the eligible vaccine. The vaccines will include FluMist Quadrivalent, Shingrix, and Abrysvo or Arexvy.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About Co-payment Model - Step 2Other
Step 2 of the co-payment model: A pharmacy site from Nova Scotia and Ontario will be randomly assigned to this step where the study will cover 50% of the vaccine cost plus the administration service fee and the participant will pay 50% of the vaccine cost out-of-pocket. The vaccines will include FluMist Quadrivalent, Shingrix, Abrysvo or Arexvy.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About Co-payment Model - Step 3Other
Step 3 of the co-payment model: A pharmacy site from Nova Scotia and Ontario will be randomly assigned to this step where the study will cover 75% of the vaccine cost plus the administration service fee and the participant will pay 25% of the vaccine cost out-of-pocket. The vaccines will include FluMist Quadrivalent, Shingrix, and Abrysvo or Arexvy.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About Co-payment Model - Step 4Other
Step 4 of the co-payment model: A pharmacy site from Nova Scotia and Ontario will be randomly assigned to this step where the study will cover 100% of the vaccine cost plus the administration service fee and the participant will pay 0% of the vaccine cost. The vaccines will include FluMist Quadrivalent, Shingrix, and Abrysvo or Arexvy.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
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 2 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.
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.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 2 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: 6 months.
The study as a whole is currently expected to finish around 2026-12.
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 600 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 2 locations, including: Halifax, Nova Scotia, Canada; Kitchener, Ontario, 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 goal of this pilot demonstration and evaluation project is to determine the acceptability and feasibility of a co-payment model among the public and providers and assess whether a co-payment model in community pharmacies in Nova Scotia and Ontario increases the accessibility and uptake of recommended but unfunded vaccines. The research questions that guided the development of this study are: * What is the feasibility of implementing a co-payment model for recommended but unfunded vaccines in community pharmacies? * To what extent is a co-payment model for recommended but unfunded vaccines perceived as acceptable to community pharmacists and the public? A co-payment model will be piloted at a maximum of 8 select community pharmacy sites in Nova Scotia (n=4 sites) and Ontario (n=4 sites). Each community pharmacy site will be randomly assigned to pilot one of the steps of the co-payment model for the duration of the demonstration project. At the end of the pilot study, participating pharmacy providers will be asked to complete an online survey about their experiences in implementing the co-payment model into their pharmacy. As part of the co-payment model, recruited members of the public (participants) will choose to receive the vaccine (if eligible) at a reduced cost either for themselves or their dependent (e.g., incapable minor or adult), as part of routine care (following standard pharmacy practice). After receiving the vaccine, the participant will complete an online survey exploring their thoughts on the co-payment model, their satisfaction with the co-payment model, their perception on vaccines in general, and their demographics (such as gender, age, education, race/ethnicity).
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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.