Increasing Men's Engagement in Preventive Healthcare Through an Enhanced Cocoon Vaccination Strategy
NCT ID: NCT06437834
Last Updated: 2025-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
176 participants
INTERVENTIONAL
2025-08-15
2025-09-30
Brief Summary
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Does access to vaccinations and overall health education for men lead to increased uptake of vaccines? Does access to vaccinations and overall health education for men lead to increased engagement in overall healthcare of male identifying support persons.
Researchers will compare three arms (one that receives an offer of vaccines at bedside in the birthing clinic, one that receives an information flyer about the importance of preventive care in addition to the offer of vaccines and a third one that receives higher level of engagement from patient liaisons as well as the offer of vaccines at bedside) to see if there is a difference in vaccine uptake and engagement in healthcare.
Outcomes will be measured by aggregate number of men receiving vaccines weekly in each arm and aggregate number of men enrolling in a men's health care center in each arm. Men will also be invited to complete a survey and a portion will be invited to complete and interview.
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Detailed Description
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Aim 1: Assess the effectiveness of cocoon vaccination interventions on a continuum of minimum to high-touch in terms of vaccination completion and healthcare engagement. After refinement of the intervention materials and study materials based on engagement with community members, representatives of the priority population, interested parties including birthing parents, the initiative will roll out in three randomly timed clusters, one that includes bedside vaccinations, another that includes bedside vaccinations in addition to low-touch informational flyer, and a third that includes bedside vaccinations and high-touch connection to the UH Cutler Center for Men through the Joe Team. Vaccination completion will be assessed utilizing records from the Pharmacy department delivering the vaccinations. Health care engagement will be assessed utilizing records from the UH Cutler Center for Men on enrollment in the center. Male-identifying individuals will also be recruited and enrolled to complete a survey at baseline to assess healthcare engagement.
Aim 2: Examine the factors that impact uptake of vaccination and healthcare engagement after a cocoon vaccination intervention. Factors that impact intervention uptake will be assessed through the survey and semi-structured interviews with a subsample of survey participants. Additionally, contextual factors related to the implementation of the intervention, such as hours of operation for high touch connections/vaccine distribution will be assessed. By understanding the factors that impact intervention uptake, we will assess the barriers and facilitators of this strategy.
Hypothesis. This pilot study will examine whether implementing a cocoon vaccination strategy that provides access to vaccinations and overall health education for men leads to increased uptake of vaccines and engagement in overall healthcare of male identifying support persons. Additionally, it will assess the factors that impact intervention uptake. We anticipate that vaccination rates and engagement with healthcare will be highest among male visitors at the Ahuja Medical Center who receive the vaccination offer at bedside and the high-touch healthcare navigation information relative to those who are only offered offered bedside vaccines only.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Vaccination Offer only
all male-identifying visitors in the birthing center will receive the offer of influenza and Tdap vaccinations at the bedside only.
No interventions assigned to this group
Offer of Bedside Vaccines plus Information
All male-identifying visitors in the birthing center at the birthing center will receive an information sheet about vaccinations and preventive healthcare, and will be offered influenza and Tdap vaccinations at bedside in the birthing center.
Information Sheet
Information sheet describing the importance of vaccines and preventive care as well as contact information for patient navigators.
Offer of Bedside Vaccines plus High-touch connection
All male-identifying visitors in the birthing center will receive the information sheet, and will be offered influenza and Tdap vaccinations at bedside in the birthing center, as well as a high-touch connection to healthcare navigation supports.
Information Sheet
Information sheet describing the importance of vaccines and preventive care as well as contact information for patient navigators.
High-touch connect
Engagement with a patient navigator.
Interventions
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Information Sheet
Information sheet describing the importance of vaccines and preventive care as well as contact information for patient navigators.
High-touch connect
Engagement with a patient navigator.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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University Hospitals Cleveland Medical Center
OTHER
National Center for Advancing Translational Sciences (NCATS)
NIH
Case Western Reserve University
OTHER
Responsible Party
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Principal Investigators
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Randy Vince, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center
Locations
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University Hospitals
Cleveland, Ohio, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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STUDY20240985
Identifier Type: -
Identifier Source: org_study_id
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