Innovative Tool to Increase Completion of Human Papillomavirus (HPV) Vaccine Series

Study Overview
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Brief Summary
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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.

Official Title
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Staying on Track: Increasing Completion of the HPV Vaccine Series With the Use of an Innovative Patient and Provider Information and Tracking Tool

Conditions
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GARDASIL Vaccination

Intervention / Treatment
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* Behavioral: Computer reminder system


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 26 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control, standard care for HPV vaccine<br>Study participants in control sites will receive standard care for HPV vaccine administration and follow-up per PPFA protocol | |
| Experimental: Intervention, computer reminder system<br>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. | Behavioral: Computer reminder system<br>* Intervention sites will receive computer kiosk with study specific software to assist in reminding study participants to return for HPV vaccine series<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| On-time Completion of the Human Papillomavirus Vaccine Series |  | 32 weeks after receipt of initial vaccine | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human papillomavirus (HPV) vaccine, Gardasil vaccine