GARDASIL Vaccination
Conditions
Keywords
Human papillomavirus (HPV) vaccine, Gardasil vaccine
Brief summary
Planned Parenthood Federation of America's (PPFA) Medical Affairs Division will conduct a prospective, cluster randomized trial to determine which factors influence the acquisition of the second and third human papillomavirus (HPV) vaccine doses among young women ages 19 to 26. This descriptive and interventional study will provide data to assess impact of a computerized tool upon HPV vaccine series completion. The interventional aspect of this study includes determination of patient assistance and provider support programs applicable to each woman's situation as well as the implementation of a computer software system for customized patient reminders.
Interventions
BEHAVIORALComputer reminder system
Intervention sites will receive computer kiosk with study specific software to assist in reminding study participants to return for HPV vaccine series
Sponsors
Merck Sharp & Dohme LLC
Planned Parenthood Federation of America
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 26 Years
Healthy volunteers
Yes
Inclusion criteria
* Female; * Age 19-26; * Fluent in English; * Seeking services for anything except pregnancy or abortion on the day of the visit * No previous vaccinations for HPV * No contraindication for HPV vaccine (includes a severe allergic reaction to yeast, amorphous aluminum hydroxyphosphate sulfate, and polysorbate 80.) * Access to phone, text, mail, email, or facebook * Not wanting to become pregnant in the next 8 months; * Not planning on moving from the area in the next 8 months * Willing to be contacted for follow-up over the next 8 months.
Exclusion criteria
* Women below 19 or above 26. * Male * Women who have one or more of HPV vaccination. * Women who have a contraindication for HPV vaccine. * Women who do not have access by phone, mail, email, Twitter or Facebook for follow up. * Women who are not fluent in English * Pregnant women or those intending on becoming pregnant during the study period. * Women who will be moving from the area and unable to return for follow up over the course of the study (approximately 8 months). * Severe mental impairment and unable to give Informed Consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| On-time Completion of the Human Papillomavirus Vaccine Series | 32 weeks after receipt of initial vaccine |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control, Standard Care for HPV Vaccine Study participants in control sites will receive standard care for HPV vaccine administration and follow-up per PPFA protocol | 185 |
| Intervention, Computer Reminder System Study participants in the intervention sites will receive standard care for HPV vaccine administration per PPFA protocol, reminder messages for subsequent vaccination appointments, and real-time determination of financial assistance for HPV vaccine.
Computer reminder system : Intervention sites will receive computer kiosk with study specific software to assist in reminding study participants to return for HPV vaccine series | 180 |
| Total | 365 |
Baseline characteristics
| Characteristic | Intervention, Computer Reminder System | Control, Standard Care for HPV Vaccine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 180 Participants | 185 Participants | 365 Participants |
| Age, Continuous | 23.17 years STANDARD_DEVIATION 2.18 | 23.64 years STANDARD_DEVIATION 2.15 | 23.41 years STANDARD_DEVIATION 2.18 |
| Region of Enrollment United States | 180 participants | 185 participants | 365 participants |
| Sex: Female, Male Female | 180 Participants | 185 Participants | 365 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 180 | 0 / 185 |
| serious Total, serious adverse events | 0 / 185 | 0 / 180 |
Outcome results
Primary
On-time Completion of the Human Papillomavirus Vaccine Series
Time frame: 32 weeks after receipt of initial vaccine
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control, Standard Care for HPV Vaccine | On-time Completion of the Human Papillomavirus Vaccine Series | 36 participants |
| Intervention, Computer Reminder System | On-time Completion of the Human Papillomavirus Vaccine Series | 31 participants |