Human Papilloma Virus (HPV) Vaccination Among Rural African American Primary Caregivers and Daughters

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Steve Kogan, University of Georgia
ClinicalTrials.gov Identifier:
NCT00937287
First received: July 9, 2009
Last updated: August 12, 2013
Last verified: August 2013
  Purpose

African American women living in the rural South are twice as likely as Caucasian women to develop cervical cancer and die of invasive cervical cancer at a higher rate than any other racial/ethnic group in the US (1). Reasons for low HPV vaccination rates among rural African Americans are not well understood. HPV vaccination compliance is likely influenced by barriers to health care access, misinformation regarding vaccinations, religious beliefs related to sexual health and behaviors, and mistrust of the medical community (2, 3). Because the vaccination of minors requires primary caregiver consent, vaccination commitment and compliance is strongly influenced by family beliefs and communication regarding health and sexuality. To date, little research has examined the cultural, familial, and intrapersonal influences on HPV vaccination compliance among rural African American women. This study will address these gaps in the literature and provide data needed to develop effective interventions and health promotion materials to encourage HPV vaccination among rural African American women.

From a pool of approximately 800 families who are participating in ongoing longitudinal research through the Center for Family Research at the University of Georgia, the investigators will recruit 200 rural female African American youth aged 13-17 who have not received the HPV vaccine and their primary caregivers (n=200) into an observational, prospective study on vaccination commitment and compliance. The investigators hypotheses are as follows:

  1. Sociocultural factors that rural African Americans experience, including discrimination, previous health care experience, religious beliefs, and community norms regarding HPV vaccination and adolescent sexual behavior, will forecast primary caregivers' HPV vaccination commitment and compliance for their daughters. The investigators also predict that primary caregivers' HPV-related knowledge and attitudes will mediate this association.
  2. Sociocultural factors will influence sexual health-related family communication and interaction, primary caregivers' and youths' HPV-related attitudes, and HPV vaccination commitment and compliance.
  3. Primary caregivers' attitudes, youths' attitudes, and family health communication will contribute to youths' and caregivers' vaccination commitment and compliance.
  4. Youths' sexual behavior will influence their attitudes, family health communication, and vaccination commitment and compliance.

Condition Intervention
Human Papillomavirus
Other: There is no intervention in this study.

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Understanding HPV Vaccination Among Rural African American Primary Caregivers and Daughters

Resource links provided by NLM:


Further study details as provided by University of Georgia:

Primary Outcome Measures:
  • HPV vaccination compliance [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 410
Study Start Date: July 2009
Study Completion Date: July 2012
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
youth and caregivers Other: There is no intervention in this study.
No intervention is provided in this study as it is exploratory.

  Eligibility

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

The sample will include rural, female African American youth aged 13-17 (n=200) and their primary caregivers (n=200) who reside in the same household.

Criteria

Inclusion Criteria:

  • Rural African American girls aged 13-17
  • Female parent or primary caregiver of participating daughter

Exclusion Criteria:

  • Girls can not be younger than age 13, or older than 17
  • The target's female parent or primary caregiver must also live in the same household and agree to participate
  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: NCT00937287

Locations
United States, Georgia
The Center for Family Research
Athens, Georgia, United States, 30602
Sponsors and Collaborators
University of Georgia
Investigators
Principal Investigator: Stephanie R. Burwell, PhD University of Georgia
  More Information

Publications:
Responsible Party: Steve Kogan, Principal Investigator, University of Georgia
ClinicalTrials.gov Identifier: NCT00937287     History of Changes
Other Study ID Numbers: MISP 36701
Study First Received: July 9, 2009
Last Updated: August 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Georgia:
HPV
African American
Rural

ClinicalTrials.gov processed this record on July 23, 2014