Trial Outcomes & Findings for Men's Beliefs About Associations Between HPV, Cancers, and HPV Vaccination (NCT NCT00799474)

Results Overview

Measured participants' willingness to receive HPV vaccine. Participants were asked how willing they would be to get HPV vaccine if it were approved for use in males. A 5-point scale ranging from "definitely not willing" to "definitely willing" was used to meausure willingness.

Recruitment status

COMPLETED

Target enrollment

609 participants

Primary outcome timeframe

at time of interview

Results posted on

2016-03-24

Participant Flow

Data was collected for this cross-sectional study through an online survey. Of the 874 men invited to participate, 609 (70%) completed the online survey. A pilot test was conducted between December 29, 2008 and January 4, 2009, and the main survey was conducted between January 6, 2009 and January 26, 2009.

Participant milestones

Participant milestones
Measure	Study Participants All study participants, this observational study was not a trial that involved multiple arms
Overall Study STARTED	609
Overall Study COMPLETED	609
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Men's Beliefs About Associations Between HPV, Cancers, and HPV Vaccination

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Participants n=609 Participants All study participants, this observational study was not a trial that involved multiple arms
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	609 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	44.5 years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	609 Participants n=5 Participants
Region of Enrollment United States	609 participants n=5 Participants

PRIMARY outcome

Timeframe: at time of interview

Population: One man reported having received human papillomavirus (HPV) vaccine so he was not asked willingness items which made the analytic sample size n=608

Measured participants' willingness to receive HPV vaccine. Participants were asked how willing they would be to get HPV vaccine if it were approved for use in males. A 5-point scale ranging from "definitely not willing" to "definitely willing" was used to meausure willingness.

Outcome measures

Outcome measures
Measure	Study Participants n=608 Participants All study participants, this observational study was not a trial that involved multiple arms
Willingness to Receive the Human Papillomavirus (HPV) Vaccine	338 Participants

SECONDARY outcome

Timeframe: At time of interview

Measured if participants had heard of HPV vaccine prior to survey. Participants were asked if they had heard to HPV vaccine prior to the survey and had response options of "yes", "no", and "I don't know".

Outcome measures

Outcome measures
Measure	Study Participants n=609 Participants All study participants, this observational study was not a trial that involved multiple arms
Awareness of HPV Vaccine	415 Participants

SECONDARY outcome

Timeframe: At time of interview

Population: HPV knowledge items were only asked to those men who had heard of HPV prior to survey (n=430)

Assessed participants' knowledge of HPV by summing correct responses to nine HPV knowledge items. Questions addressed what diseases are associated with HPV, how HPV is transmitted, and how common HPV infection is. For each item, participants were classified as having answered the item correctly or incorrectly.

Outcome measures

Outcome measures
Measure	Study Participants n=430 Participants All study participants, this observational study was not a trial that involved multiple arms
Knowledge of HPV	4.01 Correct Responses Standard Deviation 2.42

Adverse Events

Study Participants

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

Dr. Noel Brewer, PhD

The University of North Carolina at Chapel Hill, Gillings School of Global Public Health

Phone: 919-966-3282

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60