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

Vaccines Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06437834
• Other study ID #: STUDY20240200
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2024
• Est. completion date: June 2025

Study information

• Verified date: May 2024
• Source: University Hospitals Cleveland Medical Center
• Contact: Sarah Koopman Gonzalez, PhD
• Phone: 216-368-5755
• Email: sjk98[@]case.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information only, one that receives information and an offer of vaccines at bedside, and 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.

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 low-touch information only, another that includes bedside vaccinations in addition to the low-touch information, and a third that includes bedside vaccinations and high-touch connection to the UH Cutler Center for Men through the Joe Team. Male-identifying individuals will be recruited and enrolled to complete two surveys, one at baseline and another four weeks after enrollment) to assess vaccination completion and 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 information on health care or those who are offered bedside vaccines and information.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 450
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Preventive Medicine
• Vaccines

Intervention

Other:
• 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.

Drug:
• Vaccines
Offer of receiving TDap and Influenza vaccine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Randy Vince, MD

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who received Influenza Vaccine	Self-report of receipt of Influenza vaccine	One-month post consent
Secondary	Number of participants who received TDap Vaccine	Self-report of receipt of TDap vaccine	One-month post consent
Secondary	Number of participant who enrolled in Patient Navigation	Self-report of enrollment in Men's Health Center that includes patient navigation	One-month post consent