An HPV Vaccine Provider Intervention in Safety Net Clinics

NCT02808832CompletedNAINTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Meharry Medical College

Enrollment

806

Start Date

2010-09-01

Completion Date

2016-03-01

Study Type

INTERVENTIONAL

Official Title

Development of an HPV Vaccine and Cervical Cancer Screening Provider Intervention

Interventions

Educational materials

Conditions

Human PapillomavirusUterine Cervical Neoplasms

Eligibility

Age Range

9 Years+

Sex

ALL

Inclusion Criteria:

* Being seen as a pediatric patient at a study clinic on the day of enrollment
* Self-identified African American or Hispanic
* Aged 9-18 years (mother accompanying child to clinic visit had no age limit)
* Had received no doses of HPV vaccine or received one shot and was overdue for the second dose (three or more months after the first dose was given) prior to the clinic visit

Exclusion Criteria:

* Already having received two or more doses of HPV vaccine
* Mother or female guardian (referred to as "mother" henceforth) not accompanying the child
* Plans to move away from the clinic catchment area within the next 12 months
* Not completing the baseline assessment prior to entering the exam room
* Mother not providing or unable to give consent
* Child not giving assent.

Outcome Measures

Primary Outcomes

Number of children participants who completed the 3-dose HPV vaccine series

Although completion of the 3-dose HPV vaccine series is recommended within 6 months, the investigators measured completion within 12 months.

Time frame: 12 months

Secondary Outcomes

Number of mother participants who received appropriate cervical cancer screening

Cervical cancer screening is no longer recommended annually so the investigators measured receipt of a Pap smear as needed within a 12 month period.

Time frame: 12 months

Locations

Meharry Medical College, Nashville, United States

An HPV Vaccine Provider Intervention in Safety Net Clinics