## Protocol Section
### Identification Module
**NCT ID:** NCT06437834

**Brief Title:** Increasing Men's Engagement in Preventive Healthcare Through an Enhanced Cocoon Vaccination Strategy

**Official Title:** Increasing Men's Engagement in Preventive Healthcare Through an Enhanced Cocoon Vaccination Strategy

#### Organization Study ID Info
**ID:** STUDY20240200
#### Organization
**Class:** OTHER
**Full Name:** University Hospitals Cleveland Medical Center
### Status Module
#### Completion Date
**Date:** 2025-06

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-24

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-10

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Randy Vince, MD

#### Responsible Party

**Investigator Affiliation:** University Hospitals Cleveland Medical Center

**Investigator Full Name:** Randy Vince, MD

**Investigator Title:** Physician

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 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.

**Detailed 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.

### Conditions Module

**Conditions:**

- Vaccines

- Preventive Medicine

**Keywords:**

- cocoon vaccination

- men's health

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** HEALTH_SERVICES_RESEARCH

#### Enrollment Info

**Count:** 450

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** all male-identifying visitors in the birthing center will receive an information sheet about the importance of vaccinations and preventive healthcare for men.

**Intervention Names:**

- Other: Information Sheet

**Label:** Information-Only

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** all male-identifying visitors in the birthing center at the birthing center will receive the information sheet about vaccinations and preventive healthcare, and the offer of influenza and Tdap vaccinations at bedside in the birthing center.

**Intervention Names:**

- Other: Information Sheet

- Drug: Vaccines

**Label:** Bedside Vaccines plus Information

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** all male-identifying visitors in the birthing center will receive the information sheet, the offer to receive influenza and Tdap vaccinations at bedside in the birthing center, as well as a high-touch connection to healthcare navigation supports.

**Intervention Names:**

- Other: Information Sheet

- Other: High-touch connect

- Drug: Vaccines

**Label:** Bedside Vaccines plus High-touch connection

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Bedside Vaccines plus High-touch connection

- Bedside Vaccines plus Information

- Information-Only

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

**Name:** Information Sheet

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Bedside Vaccines plus High-touch connection

**Description:** Engagement with a patient navigator.

**Name:** High-touch connect

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- Bedside Vaccines plus High-touch connection

- Bedside Vaccines plus Information

**Description:** Offer of receiving TDap and Influenza vaccine

**Name:** Vaccines

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Self-report of receipt of Influenza vaccine

**Measure:** Number of participants who received Influenza Vaccine

**Time Frame:** One-month post consent

#### Secondary Outcomes

**Description:** Self-report of receipt of TDap vaccine

**Measure:** Number of participants who received TDap Vaccine

**Time Frame:** One-month post consent

**Description:** Self-report of enrollment in Men's Health Center that includes patient navigation

**Measure:** Number of participant who enrolled in Patient Navigation

**Time Frame:** One-month post consent

### Eligibility Module

**Eligibility Criteria:** 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.

**Gender Based:** True

**Gender Description:** Identifies as Male

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** sjk98@case.edu

**Name:** Sarah Koopman Gonzalez, PhD

**Phone:** 216-368-5755

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** University Hospitals Cleveland Medical Center

**Name:** Randy Vince, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M17360

- Name: Vaccines

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
