Human Papillomavirus
Conditions
Keywords
Human Papillomavirus
Brief summary
The purpose of this study is to evaluate the impact of a school-based Human Papillomavirus (HPV) vaccination program to determine if the combination of increased disease and vaccine education coupled with the removal of barriers will positively impact the HPV vaccination uptake and completion rates among students.
Detailed description
The purpose of this study is to evaluate the impact of a school-based HPV vaccination program. The intervention will consists of: provision of HPV vaccine information and consent forms for parents delivered in the back-to-school packets; school-nurse delivered student education; removal of barriers (scheduling, transportation and parental presence); changing of social norms; and the provision of free HPV vaccine.
Interventions
OTHERHPV Vaccine and HPV-related Health Education
Increased education of HPV-related diseases and HPV vaccine
OTHERReduction of barriers
Eliminate structural and financial barriers to being vaccinated
Sponsors
Merck Sharp & Dohme LLC
Lake Cumberland District Health Department
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 20 Years
Healthy volunteers
Yes
Inclusion criteria
* Must have not completed three dose series of HPV vaccine * Must be a student at Wayne County or Monticello High School in KY
Exclusion criteria
* Completed three dose series * Pregnant * Contraindication to vaccine ingredients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Students Who Initiated the HPV Vaccine Series as a Result of the School-based Program | August 2012-June 2013 | Number of students who returned a parental consent form and ultimately initiated the HPV vaccine series as a result of the school-based program |
| Number of Students Who Completed HPV Vaccination as a Result of the School-based Program | August 2012 -- June 2013 | Number of students who returned a parental consent form and ultimately completed the full HPV vaccination series as a result of the school-based program |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 511 |
| Total | 511 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of returned parental consent form | 424 |
Baseline characteristics
| Characteristic | Intervention School |
|---|---|
| Age, Customized Ages 12-20 | 511 participants |
| Grade 10th grade | 128 participants |
| Grade 11th grade | 116 participants |
| Grade 12th grade | 124 participants |
| Grade 9th grade | 142 participants |
| Grade missing | 1 participants |
| Insurance Status Insured | 114 participants |
| Insurance Status Medicaid/KCHIP | 182 participants |
| Insurance Status No Insurance | 22 participants |
| Insurance Status Underinsured | 28 participants |
| Insurance Status Unknown | 165 participants |
| Prior doses (baseline) 0 | 447 participants |
| Prior doses (baseline) 1 | 9 participants |
| Prior doses (baseline) 2 | 5 participants |
| Prior doses (baseline) 3 | 50 participants |
| Sex: Female, Male Female | 240 Participants |
| Sex: Female, Male Male | 271 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 511 |
| serious Total, serious adverse events | 0 / 511 |
Outcome results
Primary
Number of Students Who Completed HPV Vaccination as a Result of the School-based Program
Number of students who returned a parental consent form and ultimately completed the full HPV vaccination series as a result of the school-based program
Time frame: August 2012 -- June 2013
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention School | Number of Students Who Completed HPV Vaccination as a Result of the School-based Program | 288 participants |
Primary
Number of Students Who Initiated the HPV Vaccine Series as a Result of the School-based Program
Number of students who returned a parental consent form and ultimately initiated the HPV vaccine series as a result of the school-based program
Time frame: August 2012-June 2013
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention School | Number of Students Who Initiated the HPV Vaccine Series as a Result of the School-based Program | 315 participants |