Recruiting

Co-Payment Model

Sponsor:

Canadian Immunization Research Network

Code:

NCT06489964

Conditions

Preventable Disease, Vaccine

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Accepted

Interventions

Co-payment Model - Step 1

Co-payment Model - Step 2

Co-payment Model - Step 3

Co-payment Model - Step 4

Study Details

Brief summary:

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).

Conditions

Preventable Disease, Vaccine

Study ID

NCT06489964

Start date

Oct 23, 2025

Status verified date

Mar, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Community Pharmacy Sites: Inclusion criteria for the selection of the community pharmacies will include volume of prescriptions (e.g., how busy the site 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 screening members of the public who meet the vaccine-specific eligibility criteria or their substitute decision-makers for those who lack capacity to consent. 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.
  • 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 criteria 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

other: Community Pharmacy Sites (Step 1)

A pharmacy site in Nova Scotia and Ontario will be randomly assigned to pilot Step 1 of the co-payment model for the duration of the pilot study.

other: Community Pharmacy Sites (Step 2)

A pharmacy site in Nova Scotia and Ontario will be randomly assigned to pilot Step 2 of the co-payment model for the duration of the pilot study.

other: Community Pharmacy Sites (Step 3)

A pharmacy site in Nova Scotia and Ontario will be randomly assigned to pilot Step 3 of the co-payment model for the duration of the pilot study.

other: Community Pharmacy Sites (Step 4)

A pharmacy site in Nova Scotia and Ontario will be randomly assigned to pilot Step 4 of the co-payment model for the duration of the pilot study.

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.

Primary outcome measure

  • Evaluating Acceptability of Implementing of a Co-Payment Model within Community Pharmacies through Surveys with Members of the Public and Community Pharmacy Providers [ Time Frame: 6 months ]
  • Evaluating Feasibility of Implementing a Co-Payment Model within Community Pharmacies through Surveys with Members of the Public and Community Pharmacy Providers [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Melissa Kervin, MA

902-470-7583melissa.kervin@iwk.nshealth.ca

Emily Black, PharmD

902-494-2378Emily.Black@dal.ca

Locations

Dalhousie University

Recruiting

Halifax, Nova Scotia, Canada, B3H 4R2

Contacts

Melissa Kervin, MA

902-470-7583melissa.kervin@iwk.nshealth.ca

Emily Black, PharmD

902-494-2378Emily.Black@dal.ca

Principal Investigator:

Emily Black, PharmD

More Information

Sponsor

Canadian Immunization Research Network

Last update posted

Mar 19, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Canadian Immunization Research Network on 2026-03-19.