Trial Outcomes & Findings for A Study to Compare the Impact of a School Based HPV Program on Vaccination Uptake and Completion Rates (NCT NCT01526551)
NCT ID: NCT01526551
Last Updated: 2015-03-06
Results Overview
Number of students who returned a parental consent form and ultimately initiated the HPV vaccine series as a result of the school-based program
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
935 participants
Primary outcome timeframe
August 2012-June 2013
Results posted on
2015-03-06
Participant Flow
Participant milestones
| Measure |
Intervention School
High school students attending Wayne County and Monticello Ind. schools will be given opportunity to receive HPV vaccination in school clinic
HPV Vaccine and Disease Education: Increased education of disease and vaccine
Reduction of barriers: eliminate barriers to being vaccinated
|
|---|---|
|
Overall Study
STARTED
|
935
|
|
Overall Study
COMPLETED
|
511
|
|
Overall Study
NOT COMPLETED
|
424
|
Reasons for withdrawal
| Measure |
Intervention School
High school students attending Wayne County and Monticello Ind. schools will be given opportunity to receive HPV vaccination in school clinic
HPV Vaccine and Disease Education: Increased education of disease and vaccine
Reduction of barriers: eliminate barriers to being vaccinated
|
|---|---|
|
Overall Study
Lack of returned parental consent form
|
424
|
Baseline Characteristics
A Study to Compare the Impact of a School Based HPV Program on Vaccination Uptake and Completion Rates
Baseline characteristics by cohort
| Measure |
Intervention School
n=511 Participants
High school students attending Wayne County and Monticello Ind. schools will be given opportunity to receive HPV vaccination in school clinic
HPV Vaccine and Disease Education: Increased education of disease and vaccine
Reduction of barriers: eliminate barriers to being vaccinated
|
|---|---|
|
Age, Customized
Ages 12-20
|
511 participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
240 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
271 Participants
n=93 Participants
|
|
Grade
9th grade
|
142 participants
n=93 Participants
|
|
Grade
10th grade
|
128 participants
n=93 Participants
|
|
Grade
11th grade
|
116 participants
n=93 Participants
|
|
Grade
12th grade
|
124 participants
n=93 Participants
|
|
Grade
missing
|
1 participants
n=93 Participants
|
|
Insurance Status
Insured
|
114 participants
n=93 Participants
|
|
Insurance Status
Medicaid/KCHIP
|
182 participants
n=93 Participants
|
|
Insurance Status
No Insurance
|
22 participants
n=93 Participants
|
|
Insurance Status
Underinsured
|
28 participants
n=93 Participants
|
|
Insurance Status
Unknown
|
165 participants
n=93 Participants
|
|
Prior doses (baseline)
0
|
447 participants
n=93 Participants
|
|
Prior doses (baseline)
1
|
9 participants
n=93 Participants
|
|
Prior doses (baseline)
2
|
5 participants
n=93 Participants
|
|
Prior doses (baseline)
3
|
50 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: August 2012-June 2013Number of students who returned a parental consent form and ultimately initiated the HPV vaccine series as a result of the school-based program
Outcome measures
| Measure |
Intervention School
n=511 Participants
High school students attending Wayne County and Monticello Ind. schools will be given opportunity to receive HPV vaccination in school clinic
HPV Vaccine and Disease Education: Increased education of disease and vaccine
Reduction of barriers: eliminate barriers to being vaccinated
|
|---|---|
|
Number of Students Who Initiated the HPV Vaccine Series as a Result of the School-based Program
|
315 participants
|
PRIMARY outcome
Timeframe: August 2012 -- June 2013Number of students who returned a parental consent form and ultimately completed the full HPV vaccination series as a result of the school-based program
Outcome measures
| Measure |
Intervention School
n=511 Participants
High school students attending Wayne County and Monticello Ind. schools will be given opportunity to receive HPV vaccination in school clinic
HPV Vaccine and Disease Education: Increased education of disease and vaccine
Reduction of barriers: eliminate barriers to being vaccinated
|
|---|---|
|
Number of Students Who Completed HPV Vaccination as a Result of the School-based Program
|
288 participants
|
Adverse Events
Intervention School
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. Robin Vanderpool
University of Kentucky College of Public Health
Phone: 859-218-2102
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place