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An HPV Vaccine Provider Intervention in Safety Net Clinics

Primary Purpose

Human Papillomavirus, Uterine Cervical Neoplasms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational materials
Sponsored by
Meharry Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Human Papillomavirus focused on measuring Human papillomavirus (HPV) vaccine, Cervical cancer screening, Provider intervention

Eligibility Criteria

9 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Meharry Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Educational materials

Usual care

Arm Description

5-minute video and information sheet with a list of suggested questions to ask the provider

Usual care

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 16, 2016
Last Updated
September 12, 2016
Sponsor
Meharry Medical College
Collaborators
Vanderbilt University, Matthew Walker Comprehensive Health Center, Memphis Health Center, Southside/Dodson Avenue Community Health Centers
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1. Study Identification

Unique Protocol Identification Number
NCT02808832
Brief Title
An HPV Vaccine Provider Intervention in Safety Net Clinics
Official Title
Development of an HPV Vaccine and Cervical Cancer Screening Provider Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meharry Medical College
Collaborators
Vanderbilt University, Matthew Walker Comprehensive Health Center, Memphis Health Center, Southside/Dodson Avenue Community Health Centers

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papillomavirus, Uterine Cervical Neoplasms
Keywords
Human papillomavirus (HPV) vaccine, Cervical cancer screening, Provider intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
806 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Educational materials
Arm Type
Experimental
Arm Description
5-minute video and information sheet with a list of suggested questions to ask the provider
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Behavioral
Intervention Name(s)
Educational materials
Intervention Description
5-minute video and information sheet with a list of suggested questions to ask the provider
Primary Outcome Measure Information:
Title
Number of children participants who completed the 3-dose HPV vaccine series
Description
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 Outcome Measure Information:
Title
Number of mother participants who received appropriate cervical cancer screening
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maureen Sanderson, PhD
Organizational Affiliation
Meharry Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meharry Medical College
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37208
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28153042
Citation
Sanderson M, Canedo JR, Khabele D, Fadden MK, Harris C, Beard K, Burress M, Pinkerton H, Jackson C, Mayo-Gamble T, Hargreaves MK, Hull PC. Pragmatic trial of an intervention to increase human papillomavirus vaccination in safety-net clinics. BMC Public Health. 2017 Feb 2;17(1):158. doi: 10.1186/s12889-017-4094-1.
Results Reference
derived

Learn more about this trial

An HPV Vaccine Provider Intervention in Safety Net Clinics

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