N/A
Completed N=365
Innovative Tool to Increase Completion of Human Papillomavirus (HPV) Vaccine Series
GARDASIL Vaccination
Source: ClinicalTrials.gov NCT01343485 ↗
Enrolled (actual)
365
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcomePrimary: On-time Completion of the Human Papillomavirus Vaccine Series — 36; 31 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY On-time Completion of the Human Papillomavirus Vaccine Series |
36; 31 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01343485). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.