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

Not Applicable

Completed

• Conditions: GARDASIL Vaccination
• Interventions: Behavioral: Computer reminder system

• Registration Number: NCT01343485
• Lead Sponsor: Planned Parenthood Federation of America

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-26
• Study First Submitted QC: 2011-04-27
• Study First Posted: 2011-04-28
• Study Start: 2011-09
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Results First Submitted: 2013-09-30
• Results First Submitted QC: 2013-09-30
• Results First Posted: 2013-12-02
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-03
• Last Update Posted: 2018-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 365

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention, computer reminder system	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.

Primary Outcome Measures

Name	Time	Method
On-time Completion of the Human Papillomavirus Vaccine Series	32 weeks after receipt of initial vaccine

Trial Locations

Locations (7)

Family Planning Clinic of the John H. Stroger Jr. Hospital of Cook County; 🇺🇸 Chicago, Illinois, United States

Planned Parenthood Association of Utah; 🇺🇸 South Jordan, Utah, United States

Planned Parenthood of North Carolina; 🇺🇸 Charlotte, North Carolina, United States

Planned Parenthood of Greater Northwest; 🇺🇸 Seattle, Washington, United States

Planned Parenthood of Central North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States

Planned Parenthood of Rocky Mountains; 🇺🇸 Denver, Colorado, United States

Planned Parenthood of Arizona; 🇺🇸 Glendale, Arizona, United States