VaccinesNCT06437834
Increasing Men's Engagement in Preventive Healthcare Through an Enhanced Cocoon Vaccination Strategy
A study testing Information Sheet and High-touch connect in people with Vaccines and Preventive Medicine, run by Case Western Reserve University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vaccines, Preventive Medicine
- What is being tested?
- Information Sheet and High-touch connect
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2025to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult Partner of birthing person at a birthing center who identifies as male-identifying
Who cannot join
- -Under the age of 18; does not identify as a man.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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 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.
- Conditions
- Vaccines, Preventive Medicine
- Being tested
- Information Sheet, High-touch connect
- Keywords
- cocoon vaccination, men's health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Information SheetOther
Information sheet describing the importance of vaccines and preventive care as well as contact information for patient navigators.
High-touch connectOther
Engagement with a patient navigator.
| Study group | Role | What they receive |
|---|---|---|
| Vaccination Offer only | No intervention | all male-identifying visitors in the birthing center will receive the offer of influenza and Tdap vaccinations at the bedside only. |
| Offer of Bedside Vaccines plus Information | Experimental | All male-identifying visitors in the birthing center at the birthing center will receive an information sheet about vaccinations and preventive healthcare, and will be offered influenza and Tdap vaccinations at bedside in the birthing center. Receives: Other: Information Sheet |
| Offer of Bedside Vaccines plus High-touch connection | Experimental | All male-identifying visitors in the birthing center will receive the information sheet, and will be offered influenza and Tdap vaccinations at bedside in the birthing center, as well as a high-touch connection to healthcare navigation supports. Receives: Other: Information Sheet; Other: High-touch connect |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Male-identifying Individuals Who Received Influenza Vaccine
Aggregate number of influenza vaccinations provided in the birthing center utilizing pharmacy records
Measured: Up to 7 weeks
Secondary outcomes (2)
Number of Male-identifying Individuals Who Received TDap Vaccine
Aggregate number of Tdap vaccinations provided in the birthing center utilizing pharmacy records
Measured: Up to 7 weeks
Number of Participant Who Enrolled in Patient Navigation
Enrollment in Men's Health Center that includes patient navigation from records from the Men's Health Center
Measured: Up to 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start15 Aug 2025
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for VaccinesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals Cleveland Medical Center, National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Randy Vince, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06437834
- Sponsor's protocol ID
- STUDY20240985
- Other IDs
- UM1TR004528
- Status last verified
- May 2026
- First submitted
- 24 May 2024
- Last updated
- 5 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Men's Engagement in Preventive Healthcare Through an Enhanced Cocoon Vaccination Strategy
- ClinicalTrials.gov ID
- NCT06437834
- Acronym / sponsor ID
- STUDY20240985
- Conditions
- Vaccines, Preventive Medicine
- Keywords
- cocoon vaccination, men's health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- University Hospitals Cleveland Medical Center, National Center for Advancing Translational Sciences (NCATS)
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 31 May 2024 (actual)
- Results
- Posted 5 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vaccination Offer only | No intervention | –all male-identifying visitors in the birthing center will receive the offer of influenza and Tdap vaccinations at the bedside only. |
| Offer of Bedside Vaccines plus Information | Experimental | Other: Information SheetAll male-identifying visitors in the birthing center at the birthing center will receive an information sheet about vaccinations and preventive healthcare, and will be offered influenza and Tdap vaccinations at bedside in the birthing center. |
| Offer of Bedside Vaccines plus High-touch connection | Experimental | Other: Information Sheet, Other: High-touch connectAll male-identifying visitors in the birthing center will receive the information sheet, and will be offered influenza and Tdap vaccinations at bedside in the birthing center, as well as a high-touch connection to healthcare navigation supports. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult Partner of birthing person at a birthing center who identifies as male-identifying
Key exclusion criteria (1 listed)
- -Under the age of 18; does not identify as a man.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Information SheetInformation sheet describing the importance of vaccines and preventive care as well as contact information for patient navigators. | Other | Offer of Bedside Vaccines plus High-touch connection, Offer of Bedside Vaccines plus Information |
| High-touch connectEngagement with a patient navigator. | Other | Offer of Bedside Vaccines plus High-touch connection |
Primary outcome
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
2 secondary outcomes
Number of Male-identifying Individuals Who Received TDap Vaccine
Time frame: Up to 7 weeks
Number of Participant Who Enrolled in Patient Navigation
Time frame: Up to 7 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Randy Vince, MD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Information Sheet and High-touch connect in people with Vaccines and Preventive Medicine, run by Case Western Reserve University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Male-identifying Individuals Who Received Influenza Vaccine (time frame: Up to 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.