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

Last updated: June 18, 2025
Sponsor: Case Western Reserve University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vaccines

Treatment

Vaccines

High-touch connect

Information Sheet

Clinical Study ID

NCT06437834
STUDY20240985
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Participants will complete two survey and one interview.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult Partner of birthing person at a birthing center who identifies asmale-identifying

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 450
Treatment Group(s): 3
Primary Treatment: Vaccines
Phase:
Study Start date:
July 15, 2025
Estimated Completion Date:
October 31, 2025

Study Description

The goal of this project is to understand whether the combination of vaccination access and connection to services tailored for men improves vaccination rates among men and engagement in healthcare. Additionally, this project aims to understand variations in effectiveness between low-touch and high-touch approaches. To achieve these goals, the project has two specific aims:

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. Male-identifying individuals will also be recruited and enrolled to complete two surveys, one at baseline and another four weeks after enrollment) 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 two surveys 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.

Connect with a study center

  • University Hospitals

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

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