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OpenTrials
Completed

NCT Number: NCT06437834

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals

Cleveland, Ohio, 44106, United States

About this study

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. 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Information Sheet

Other

Information sheet describing the importance of vaccines and preventive care as well as contact information for patient navigators.

High-touch connect

Other

Engagement with a patient navigator.

Primary outcomes

  1. Number of Male-identifying Individuals Who Received Influenza Vaccine

    Time frame: Up to 7 weeks

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

Secondary outcomes

  1. Number of Male-identifying Individuals Who Received TDap Vaccine

    Time frame: Up to 7 weeks

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

  2. Number of Participant Who Enrolled in Patient Navigation

    Time frame: Up to 7 weeks

    Enrollment in Men's Health Center that includes patient navigation from records from the Men's Health Center

Sponsors and collaborators

Lead sponsor

Case Western Reserve University

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)
  • University Hospitals Cleveland Medical Center

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 31, 2024
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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