An HPV Vaccine Provider Intervention in Safety Net Clinics

September 12, 2016 updated by: Meharry Medical College

Development of an HPV Vaccine and Cervical Cancer Screening Provider Intervention

The purpose of this study is to develop, deliver and evaluate a provider intervention for mothers and their children to encourage receipt of the human papillomavirus (HPV) vaccine in the children and appropriate cervical cancer screening in the mothers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this study the investigators utilized Community Based Participatory Research approaches in combination with our previous and ongoing research, patient and provider education materials available from professional organizations, and qualitative information obtained from provider in-depth interviews and parent/daughter focus groups to develop a provider intervention to encourage receipt of the HPV vaccine, and appropriate cancer screening in African Americans and Hispanics. A focus of the study was the formation of a Community Advisory Board (CAB) which provided input into the development and modification of the provider intervention. Safety net clinics in Nashville and Memphis served as intervention sites, and in Chattanooga and Nashville (Meharry) served as control sites. Mothers and children at the intervention sites viewed a 5-minute video in the exam room during any visit type before seeing the provider, and received an information sheet with a list of suggested questions to ask the provider. Mothers and children at the control sites received usual care. The selected study sites identified cervical cancer screening as a priority area based on the needs assessments conducted as part of the Meharry Medical College Community Health Center-Community Network Program (CHC-CNP). The investigators conducted pre- and post-intervention quantitative surveys with mothers and their children to evaluate whether the provider intervention was effective in improving HPV vaccination coverage, and cervical cancer screening rates. The investigators abstracted medical records and have indicated this in the HIPAA privacy form. After conducting pre- and post-intervention surveys and abstracting medical records, the investigators found that increasing HPV vaccine uptake requires more intensive, multicomponent interventions.

Study Type

Interventional

Enrollment (Actual)

806

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37208
        • Meharry Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual care
Experimental: Educational materials
5-minute video and information sheet with a list of suggested questions to ask the provider
Behavioral: Educational materials
5-minute video and information sheet with a list of suggested questions to ask the provider

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of children participants who completed the 3-dose HPV vaccine series
Time Frame: 12 months
Although completion of the 3-dose HPV vaccine series is recommended within 6 months, the investigators measured completion within 12 months.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of mother participants who received appropriate cervical cancer screening
Time Frame: 12 months
Cervical cancer screening is no longer recommended annually so the investigators measured receipt of a Pap smear as needed within a 12 month period.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meharry Medical College

Collaborators

Vanderbilt University
Memphis Health Center
Matthew Walker Comprehensive Health Center
Southside/Dodson Avenue Community Health Centers

Investigators

  • Principal Investigator: Maureen Sanderson, PhD, Meharry Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

June 16, 2016

First Submitted That Met QC Criteria

June 17, 2016

First Posted (Estimate)

June 22, 2016

Study Record Updates

Last Update Posted (Estimate)

September 14, 2016

Last Update Submitted That Met QC Criteria

September 12, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U54CA153708 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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