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An HPV Vaccine Provider Intervention in Safety Net Clinics

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ClinicalTrials.gov Identifier: NCT02808832
Recruitment Status : Completed
First Posted : June 22, 2016
Last Update Posted : September 14, 2016
Sponsor:
Collaborators:
Vanderbilt University
Matthew Walker Comprehensive Health Center
Memphis Health Center
Southside/Dodson Avenue Community Health Centers
Information provided by (Responsible Party):
Meharry Medical College

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Human Papillomavirus Uterine Cervical Neoplasms Behavioral: Educational materials Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 806 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Development of an HPV Vaccine and Cervical Cancer Screening Provider Intervention
Study Start Date : September 2010
Actual Primary Completion Date : March 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
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

No Intervention: Usual care
Usual care



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02808832


Locations
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United States, Tennessee
Meharry Medical College
Nashville, Tennessee, United States, 37208
Sponsors and Collaborators
Meharry Medical College
Vanderbilt University
Matthew Walker Comprehensive Health Center
Memphis Health Center
Southside/Dodson Avenue Community Health Centers
Investigators
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Principal Investigator: Maureen Sanderson, PhD Meharry Medical College

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Meharry Medical College
ClinicalTrials.gov Identifier: NCT02808832     History of Changes
Other Study ID Numbers: U54CA153708 ( U.S. NIH Grant/Contract )
First Posted: June 22, 2016    Key Record Dates
Last Update Posted: September 14, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Meharry Medical College:
Human papillomavirus (HPV) vaccine
Cervical cancer screening
Provider intervention
Additional relevant MeSH terms:
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Uterine Cervical Diseases
Vaccines
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Immunologic Factors
Physiological Effects of Drugs