The Impact of Community and Patient Engagement Practices on Vaccine Confidence in the United States

NCT06374134 | Not Yet Recruiting

• 1 other identifier: STUDY00004835
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this study is to demonstrate an empirical relationship between community- engagement practices, and between patient-centric clinical trial design, execution and communication practices, and vaccine adoption experience. Our hypothesis is that patient-centric clinical trial activity, and community engagement in late-stage clinical trials and early-stage commercialization, reduces vaccine hesitancy and increases vaccine confidence among health care providers overall and within diverse patient communities and ultimately drives faster vaccine adoption.

Conditions

Vaccine Hesitancy

Keywords

Patient Engagement; Community Engagement; Patient-Centric; Vaccine Adoption; Vaccine Confidence

Outcome Measures

Primary Outcomes (1)

• Units of Vaccine Dispensed

  Per Month

Interventions

Community Engagement Practice BEHAVIORAL

Community engagement includes pre- and post-approval clinical trials that partnered and engaged with diverse public and patient communities; trusted community leaders; local advocacy groups; faith-based and civic organizations; community influencers; community health and government health communities.

Patient-Centric Protocol Element BEHAVIORAL

Patient-centric clinical trial designs include those that solicited patient, investigative site and community input into protocol design and clinical trial feasibility; offered solutions that improved patient participation convenience and access; and that more fully and effectively communicated clinical trial knowledge to diverse public and patient communities, health care providers and community influencers.

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population for the quantitative analysis will include all US citizens.

You may qualify if:

• Qualitative Interviews
• Based in the US
• Healthcare provider, subject matter expert, or community representative/influencer

Sponsors & Collaborators

• Tufts University: lead
• Merck Sharp & Dohme LLC: collaborator

MeSH Terms

Conditions

Vaccination Hesitancy; Patient Participation

Condition Hierarchy (Ancestors)

Vaccination Refusal; Treatment Refusal; Treatment Adherence and Compliance; Health Behavior; Behavior; Patient Acceptance of Health Care

Study Officials

• Kenneth Getz, MBA

  Tufts Center for the Study of Drug Development

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 18, 2024
• Study Start: June 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: February 1, 2025
• Last Updated: April 18, 2024

Record last verified: 2024-04