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

Human Papillomavirus Clinical Trial

Official title:

Understanding HPV Vaccination Among Rural African American Primary Caregivers and Daughters

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00937287
• Other study ID #: MISP 36701
• Status: Completed
• Phase: N/A
• First received: July 9, 2009
• Last updated: August 12, 2013
• Start date: July 2009
• Est. completion date: July 2012

Study information

• Verified date: August 2013
• Source: University of Georgia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 410
• Est. completion date: July 2012
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years to 17 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Human Papillomavirus

Intervention

Other:
• There is no intervention in this study.
No intervention is provided in this study as it is exploratory.

Locations

Country	Name	City	State
United States	The Center for Family Research	Athens	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
University of Georgia

Country where clinical trial is conducted

United States, 

References & Publications (3)

Brewer NT, Fazekas KI. Predictors of HPV vaccine acceptability: a theory-informed, systematic review. Prev Med. 2007 Aug-Sep;45(2-3):107-14. Epub 2007 Jun 2. Review. — View Citation

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. — View Citation

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. Erratum in: Obstet Gynecol. 2007 Apr;109(4):1002. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HPV vaccination compliance		1 year	No