Human Papillomavirus (HPV) Vaccination Acceptance by African-American Parents: Identifying Psychosocial Barriers

May 19, 2015 updated by: Peter A. Vanable, Syracuse University

HPV Vaccination Acceptance by African-American Parents: Identifying Psychosocial Barriers

This will enroll 300 mothers of teenage girls and boys to identify barriers to HPV vaccination among low-income, African-American teens.

Study Overview

Detailed Description

The HPV vaccine offers hope that the incidence of cervical cancer can be greatly reduced in the U.S. and globally. However, because the vaccine is recommended for children and early adolescents, vaccine awareness and acceptance among parents is critical to insuring vaccine uptake and public health benefit. Although culturally specific concerns may reduce HPV vaccination among African-American youth, research has not addressed this possibility. Accordingly, the proposed study will enroll 300 mothers in a study to identify barriers to HPV vaccination among low-income, African-American teens. Surveys assessing culturally-specific barriers to HPV vaccination acceptance will be administered to both parents and their vaccine-eligible children. Upon completion of the survey, parents with vaccine-eligible daughters will be invited to receive a free HPV vaccination for their child through a local, teen-friendly health clinic. Outcome analyses will focus on identification of predictors of completed vaccinations among girls and barriers to vaccine acceptance among mothers of teenage sons. Our study will provide critically important behavioral outcome data linking barriers to vaccination to subsequent vaccination decisions in a real-world, health care setting.

Study Type

Interventional

Enrollment (Actual)

614

Phase

  • Phase 2

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

    • New York
      • Syracuse, New York, United States, 13244
        • Center for Health and Behavior, Syracuse University

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

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

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Females parent or guardian with an African-American daughter or son between the ages of 11 and 17
  • African-American adolescents between the ages of 11-17

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Brief HPV vaccine informational intervention
Because we anticipated that knowledge and awareness of the HPV vaccine would be low in our study population, our CASI survey included a brief, informational overview of key facts concerning HPV vaccination prior to assessing vaccine acceptance, perceived barriers to vaccination, and intentions to vaccinate. The overview lasted approximately 3 minutes and consisted of a brief overview of key HPV vaccination facts that were presented visually (on the computer screen) and read aloud using a digital recording. HPV and vaccine knowledge, awareness, and attitudes items were administered prior to participants hearing the informational overview.
Teen and parent participants will receive a brief informational intervention that provides basic facts about the HPV vaccine, including the health benefits and three-dose requirements, along with information regarding where to go to receive the vaccination. A coupon for a free HPV vaccination will provided to the parent for use by their teenage daughter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
completed vaccination with Gardasil
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
assessed cross-sectionally, at time of initial enrollment
Time Frame: assessed at time of baseline assessment
assessed at time of baseline assessment

Collaborators and Investigators

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

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

July 1, 2008

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

May 15, 2008

First Submitted That Met QC Criteria

May 16, 2008

First Posted (Estimate)

May 19, 2008

Study Record Updates

Last Update Posted (Estimate)

May 21, 2015

Last Update Submitted That Met QC Criteria

May 19, 2015

Last Verified

May 1, 2015

More Information

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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