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

Planned Parenthood Federation of America

Status: Completed

Conditions: GARDASIL Vaccination

Treatments: Behavioral: Computer reminder system

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01343485

PPFA-Merck-38068

Details and patient eligibility

About

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.

Enrollment: 365 patients

Sex: Female

Ages: 19 to 26 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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365 participants in 2 patient groups

Control, standard care for HPV vaccine

No Intervention group

Description:

Study participants in control sites will receive standard care for HPV vaccine administration and follow-up per PPFA protocol

Intervention, computer reminder system

Experimental group

Description:

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.

Treatment:

Behavioral: Computer reminder system