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

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.

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Key information

Conditions

GARDASIL Vaccination Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

19 year–26 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Planned Parenthood of Arizona, Glendale, Arizona, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Computer reminder system

Behavioral

Intervention sites will receive computer kiosk with study specific software to assist in reminding study participants to return for HPV vaccine series

Primary outcomes

On-time Completion of the Human Papillomavirus Vaccine Series

Time frame: 32 weeks after receipt of initial vaccine

Sponsors and collaborators

Lead sponsor

Planned Parenthood Federation of America

Other

Collaborators

Merck Sharp & Dohme LLC

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Apr 28, 2011
Registry last updated: Jun 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed