NCT00937287

Brief Summary

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. 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. 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. 3.Primary caregivers' attitudes, youths' attitudes, and family health communication will contribute to youths' and caregivers' vaccination commitment and compliance.
  4. 4.Youths' sexual behavior will influence their attitudes, family health communication, and vaccination commitment and compliance.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
410

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 10, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

August 14, 2013

Status Verified

August 1, 2013

Enrollment Period

1.8 years

First QC Date

July 9, 2009

Last Update Submit

August 12, 2013

Conditions

Keywords

HPVAfrican AmericanRural

Outcome Measures

Primary Outcomes (1)

  • HPV vaccination compliance

    1 year

Study Arms (1)

youth and caregivers

Other: There is no intervention in this study.

Interventions

No intervention is provided in this study as it is exploratory.

youth and caregivers

Eligibility Criteria

Age13 Years - 17 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Center for Family Research

Athens, Georgia, 30602, United States

Location

Related Publications (3)

  • Saraiya M, Ahmed F, Krishnan S, Richards TB, Unger ER, Lawson HW. Cervical cancer incidence in a prevaccine era in the United States, 1998-2002. Obstet Gynecol. 2007 Feb;109(2 Pt 1):360-70. doi: 10.1097/01.AOG.0000254165.92653.e8.

    PMID: 17267837BACKGROUND
  • Brewer NT, Fazekas KI. Predictors of HPV vaccine acceptability: a theory-informed, systematic review. Prev Med. 2007 Aug-Sep;45(2-3):107-14. doi: 10.1016/j.ypmed.2007.05.013. Epub 2007 Jun 2.

    PMID: 17628649BACKGROUND
  • Cates JR, Brewer NT, Fazekas KI, Mitchell CE, Smith JS. Racial differences in HPV knowledge, HPV vaccine acceptability, and related beliefs among rural, southern women. J Rural Health. 2009 Winter;25(1):93-7. doi: 10.1111/j.1748-0361.2009.00204.x.

    PMID: 19166567BACKGROUND

Study Officials

  • Stephanie R. Burwell, PhD

    University of Georgia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 9, 2009

First Posted

July 10, 2009

Study Start

July 1, 2009

Primary Completion

April 1, 2011

Study Completion

July 1, 2012

Last Updated

August 14, 2013

Record last verified: 2013-08

Locations