Staying on Track: Increasing Completion of the HPV Vaccine Series With the Use of an Innovative Patient and Provider Information and Tracking Tool
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 365
- Locations
- 16
- Primary Endpoint
- On-time Completion of the Human Papillomavirus Vaccine Series
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 26 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
- •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.
Arms & Interventions
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.
Intervention: Computer reminder system (Behavioral)
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
Outcomes
Primary Outcomes
On-time Completion of the Human Papillomavirus Vaccine Series
Time Frame: 32 weeks after receipt of initial vaccine
Secondary Outcomes
No secondary outcomes reported
Investigators
Johanna Morfesis
Director of Research
Planned Parenthood Federation of America