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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peter A. Vanable, Syracuse University
ClinicalTrials.gov Identifier:
NCT00680147
First received: May 15, 2008
Last updated: May 19, 2015
Last verified: May 2015
  Purpose

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


Condition Intervention Phase
HPV
Behavioral: brief informational intervention to promote HPV vaccine acceptance
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: HPV Vaccination Acceptance by African-American Parents: Identifying Psychosocial Barriers

Further study details as provided by Syracuse University:

Primary Outcome Measures:
  • completed vaccination with Gardasil [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • assessed cross-sectionally, at time of initial enrollment [ Time Frame: assessed at time of baseline assessment ] [ Designated as safety issue: No ]

Enrollment: 614
Study Start Date: July 2008
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: brief informational intervention to promote HPV vaccine acceptance
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.

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.

  Eligibility

Ages Eligible for Study:   11 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00680147

Locations
United States, New York
Center for Health and Behavior, Syracuse University
Syracuse, New York, United States, 13244
Sponsors and Collaborators
Syracuse University
  More Information

Additional Information:
No publications provided

Responsible Party: Peter A. Vanable, Professor, Syracuse University
ClinicalTrials.gov Identifier: NCT00680147     History of Changes
Other Study ID Numbers: IISP ID# 33546
Study First Received: May 15, 2008
Last Updated: May 19, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Syracuse University:
HPV
Gardasil
African-American
adolescent
health behavior
sexually transmitted infections
This will enroll 300 mothers of teenage girls and boys to identify barriers to HPV vaccination among low-income, African-American teens.

ClinicalTrials.gov processed this record on July 30, 2015