Addressing Unfunded Vaccines Through a Co-payment Mechanism in Pharmacies

NCT06489964 | Recruiting

• 1 other identifier: SH37
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (2)

• Evaluating Acceptability of Implementing of a Co-Payment Model within Community Pharmacies through Surveys with Members of the Public and Community Pharmacy Providers

  After choosing to receive a vaccine at a reduced cost either for themselves or their dependent (e.g., incapable minor or adult) as part of the co-payment model, participants will be asked to complete an online survey about their participation in the co-payment model. At the end of the pilot study, pharmacy providers who take part in the study will be asked to complete an online survey about implementing the co-payment model within their pharmacy practice. The surveys have been developed based on the Theoretical Framework of Acceptability and include questions on the acceptability of the co-payment model. To evaluate acceptability of implementing a co-payment model within community pharmacies, data from the public and provider surveys will be analyzed using basic descriptive statistics. Factors that may influence acceptability of the co-payment model (e.g. geography, gender, age, socioeconomic status, ethnicity, and cost) will also be assessed.

  6 months

• Evaluating Feasibility of Implementing a Co-Payment Model within Community Pharmacies through Surveys with Members of the Public and Community Pharmacy Providers

  After choosing to receive a vaccine at a reduced cost either for themselves or their dependent (e.g., incapable minor or adult) as part of the co-payment model, participants will be asked to complete an online survey about their participation in the co-payment model. At the end of the pilot study, pharmacy providers who take part in the study will be asked to complete an online survey about implementing the co-payment model within their pharmacy practice. The surveys have been developed based on the Theoretical Framework of Acceptability and include questions on the feasibility of the co-payment model. To evaluate the feasibility of implementing a co-payment model within community pharmacies, data from the public and provider surveys will be analyzed using basic descriptive statistics. Factors that may influence feasibility of the co-payment model such as geography (urban vs. rural), gender, age, socioeconomic status, ethnicity, and cost to the patient will also be assessed.

  6 months

Secondary Outcomes (1)

• Descriptively report on the number of vaccines administered at participating community pharmacy sites before and during implementation of the co-payment model

  30 months

Study Arms (4)

Community Pharmacy Sites (Step 1)

OTHER

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: Co-payment Model - Step 1

Community Pharmacy Sites (Step 2)

OTHER

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: Co-payment Model - Step 2

Community Pharmacy Sites (Step 3)

OTHER

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: Co-payment Model - Step 3

Community Pharmacy Sites (Step 4)

OTHER

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.

Other: Co-payment Model - Step 4

Interventions

Co-payment Model - Step 1 OTHER

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.

Community Pharmacy Sites (Step 1)

Co-payment Model - Step 2 OTHER

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.

Community Pharmacy Sites (Step 2)

Co-payment Model - Step 3 OTHER

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.

Community Pharmacy Sites (Step 3)

Co-payment Model - Step 4 OTHER

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.

Community Pharmacy Sites (Step 4)

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Canadian Immunization Research Network: lead
• Dalhousie University: collaborator
• AstraZeneca: collaborator
• GlaxoSmithKline: collaborator
• Canadian Center for Vaccinology: collaborator

Study Sites (2)

Dalhousie University

Halifax, Nova Scotia, B3H 4R2, Canada

RECRUITING

University of Waterloo

Kitchener, Ontario, N2G 1C5, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Vaccine-Preventable Diseases

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Emily Black, PharmD

  Dalhousie University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa Kervin, MA

CONTACT

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

Emily Black, PharmD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: July 8, 2024
• Study Start: October 23, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)