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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06437834
Other study ID # STUDY20240200
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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