Increasing Men's Engagement in Preventive Healthcare Through an Enhanced Cocoon Vaccination Strategy

NCT06437834 | Completed

• 2 other identifiers: STUDY20240985UM1TR004528
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to understand if offering a high touch engagement with healthcare center catered to men and bedside vaccine access in a birthing center increases men's engagement in preventive healthcare. The main questions it aims to answer are: 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.

Conditions

Vaccines; Preventive Medicine

Keywords

cocoon vaccination; men's health

Outcome Measures

Primary Outcomes (1)

• Number of male-identifying individuals who received Influenza Vaccine

  Aggregate number of influenza vaccinations provided in the birthing center utilizing pharmacy records

  Up to 7 weeks

Secondary Outcomes (2)

• Number of male-identifying individuals who received TDap Vaccine

  Up to 7 weeks

• Number of participant who enrolled in Patient Navigation

  Up to 7 weeks

Study Arms (3)

Vaccination Offer only

NO INTERVENTION

all male-identifying visitors in the birthing center will receive the offer of influenza and Tdap vaccinations at the bedside only.

Offer of Bedside Vaccines plus Information

EXPERIMENTAL

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.

Other: Information Sheet

Offer of Bedside Vaccines plus High-touch connection

EXPERIMENTAL

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.

Other: Information Sheet; Other: High-touch connect

Interventions

Information Sheet OTHER

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; Offer of Bedside Vaccines plus Information

High-touch connect OTHER

Engagement with a patient navigator.

Offer of Bedside Vaccines plus High-touch connection

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Identifies as Male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Adult Partner of birthing person at a birthing center who identifies as male-identifying

You may not qualify if:

• Under the age of 18; does not identify as a man.

Sponsors & Collaborators

• Case Western Reserve University: lead
• University Hospitals Cleveland Medical Center: collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

University Hospitals

Cleveland, Ohio, 44106, United States

Location

Study Officials

• Randy Vince, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: May 31, 2024
• Study Start: August 15, 2025
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)