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

HPV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00680147
• Other study ID #: IISP ID# 33546
• Status: Completed
• Phase: Phase 2
• First received: May 15, 2008
• Last updated: May 19, 2015
• Start date: July 2008
• Est. completion date: February 2012

Study information

• Verified date: May 2015
• Source: Syracuse University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 614
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 11 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HPV

Intervention

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.

Locations

Country	Name	City	State
United States	Center for Health and Behavior, Syracuse University	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
Syracuse University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	completed vaccination with Gardasil		6 months	No
Secondary	assessed cross-sectionally, at time of initial enrollment		assessed at time of baseline assessment	No

External Links

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