Trial Outcomes & Findings for Increasing Men's Engagement in Preventive Healthcare Through an Enhanced Cocoon Vaccination Strategy (NCT NCT06437834)
NCT ID: NCT06437834
Last Updated: 2026-06-05
Results Overview
Aggregate number of influenza vaccinations provided in the birthing center utilizing pharmacy records
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
176 participants
Primary outcome timeframe
Up to 7 weeks
Results posted on
2026-06-05
Participant Flow
Participant milestones
| Measure |
Vaccination Offer Only
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
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.
Information Sheet: Information sheet describing the importance of vaccines and preventive care as well as contact information for patient navigators.
|
Offer of Bedside Vaccines Plus High-touch Connection
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.
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
80
|
42
|
54
|
|
Overall Study
COMPLETED
|
80
|
42
|
54
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Individuals in the birthing center were informed via an info sheet. Due to the nature of labor/delivery and the volume, a full waiver of consent was granted. Male-identifying visitors during the implementation of the study were considered enrolled. The number of enrolled participants is based on the total number of birthing patients seen during the study, assuming a one-to-one ratio of male-visitors to every patient giving birth. Age and race were not collected on any participants.
Baseline characteristics by cohort
| Measure |
Vaccination Offer Only
n=80 Participants
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
n=42 Participants
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.
Information Sheet: Information sheet describing the importance of vaccines and preventive care as well as contact information for patient navigators.
|
Offer of Bedside Vaccines Plus High-touch Connection
n=54 Participants
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.
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.
|
Total
n=176 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
—
|
—
|
—
|
0 Participants
Individuals in the birthing center were informed via an info sheet. Due to the nature of labor/delivery and the volume, a full waiver of consent was granted. Male-identifying visitors during the implementation of the study were considered enrolled. The number of enrolled participants is based on the total number of birthing patients seen during the study, assuming a one-to-one ratio of male-visitors to every patient giving birth. Age and race were not collected on any participants.
|
|
Age, Categorical
Between 18 and 65 years
|
—
|
—
|
—
|
0 Participants
Individuals in the birthing center were informed via an info sheet. Due to the nature of labor/delivery and the volume, a full waiver of consent was granted. Male-identifying visitors during the implementation of the study were considered enrolled. The number of enrolled participants is based on the total number of birthing patients seen during the study, assuming a one-to-one ratio of male-visitors to every patient giving birth. Age and race were not collected on any participants.
|
|
Age, Categorical
>=65 years
|
—
|
—
|
—
|
0 Participants
Individuals in the birthing center were informed via an info sheet. Due to the nature of labor/delivery and the volume, a full waiver of consent was granted. Male-identifying visitors during the implementation of the study were considered enrolled. The number of enrolled participants is based on the total number of birthing patients seen during the study, assuming a one-to-one ratio of male-visitors to every patient giving birth. Age and race were not collected on any participants.
|
|
Sex: Female, Male
Female
|
0 Participants
n=80 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=176 Participants
|
|
Sex: Female, Male
Male
|
80 Participants
n=80 Participants
|
42 Participants
n=42 Participants
|
54 Participants
n=54 Participants
|
176 Participants
n=176 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Up to 7 weeksAggregate number of influenza vaccinations provided in the birthing center utilizing pharmacy records
Outcome measures
| Measure |
Vaccination Offer Only
n=80 Participants
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
n=42 Participants
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.
Information Sheet: Information sheet describing the importance of vaccines and preventive care as well as contact information for patient navigators.
|
Offer of Bedside Vaccines Plus High-touch Connection
n=54 Participants
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.
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.
|
|---|---|---|---|
|
Number of Male-identifying Individuals Who Received Influenza Vaccine
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 7 weeksAggregate number of Tdap vaccinations provided in the birthing center utilizing pharmacy records
Outcome measures
| Measure |
Vaccination Offer Only
n=80 Participants
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
n=42 Participants
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.
Information Sheet: Information sheet describing the importance of vaccines and preventive care as well as contact information for patient navigators.
|
Offer of Bedside Vaccines Plus High-touch Connection
n=54 Participants
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.
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.
|
|---|---|---|---|
|
Number of Male-identifying Individuals Who Received TDap Vaccine
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 7 weeksPopulation: Aggregate results on the number of men enrolling in the men's health center duirng the time periods of each of the three arms were assessed.
Enrollment in Men's Health Center that includes patient navigation from records from the Men's Health Center
Outcome measures
| Measure |
Vaccination Offer Only
n=80 Participants
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
n=42 Participants
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.
Information Sheet: Information sheet describing the importance of vaccines and preventive care as well as contact information for patient navigators.
|
Offer of Bedside Vaccines Plus High-touch Connection
n=54 Participants
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.
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.
|
|---|---|---|---|
|
Number of Participant Who Enrolled in Patient Navigation
|
14 Participants
|
6 Participants
|
5 Participants
|
Adverse Events
Vaccination Offer Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Offer of Bedside Vaccines Plus Information
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Offer of Bedside Vaccines Plus High-touch Connection
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place