Girls OnGuard: HPV Vaccination Uptake Among African American Adolescent Females

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Ralph J. DiClemente, Emory University
ClinicalTrials.gov Identifier:
NCT00813319
First received: December 22, 2008
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

African American adolescent females seeking treatment for STIs are an underserved population at increased risk for HPV infection. While GARDASIL is an effective preventive vaccine, vaccination rates are low. Given the risk for HPV infection among this subgroup and the negative health effects associated with HPV, enhancing uptake of GARDASIL is necessary. The goal of this project is to promote GARDASIL vaccination through the development of a new multi-component, culturally-appropriate, interactive DVD.

We propose to recruit 280 unmarried African American adolescent females, 13-18 years of age, from participating clinic sites in Atlanta, Georgia. While seeking clinical services, adolescents will be contacted and invited to participate in the proposed study. Eligible adolescents will be required to provide written assent/consent prior to participation. Adolescents who are eligible and willing to participate in the project will complete a short survey on a laptop computer. The survey is designed to assess adolescents' risk taking and preventive behaviors. After they complete the survey, adolescents will be assigned at random to one of two groups. In one group, adolescents will watch a short (10 min), interactive DVD designed to promote HPV awareness and initial GARDASIL vaccination and receive a keepsake to help them remember to return to the clinic for their second and third vaccine doses. In the second group, adolescents will watch an equally short (10 min) DVD on healthy lifestyles and behaviors. All adolescents are eligible to receive the GARDASIL vaccine at participating study clinics as part of their routine standard of care.

With the help of clinic staff, participant medical records will be reviewed over a 7 month period to assess vaccination rates. Vaccination rates from adolescents who received the interactive HPV/GARDASIL awareness DVD will be compared to the group of adolescents who received the healthy lifestyles DVD. It is hypothesized that study participants receiving the interactive DVD intervention that promotes HPV awareness will have higher vaccination rates over time.


Condition Intervention Phase
Vaccination
Behavioral: Girls OnGuard
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Overcoming Barriers to Vaccination With GARDASIL in Underserved Girls and Adolescents

Further study details as provided by Emory University:

Primary Outcome Measures:
  • GARDASIL Vaccination Uptake and Compliance With Second and Third Doses [ Time Frame: measured at 7 months post-randomization ] [ Designated as safety issue: No ]
    Number of participants who received at least 1 dose, 2 doses, 3 doses

  • Total Doses Received of HPV Vaccine [ Time Frame: measured at 7-months post randomization ] [ Designated as safety issue: No ]
    As an additional primary outcome, we assessed the total number of vaccine doses received


Secondary Outcome Measures:
  • STD Incidence [ Time Frame: 7 months post randomization ] [ Designated as safety issue: No ]
    Number of participants who tested positive for any STD 7 months post randomization, information was gathered via medical chart abstraction


Enrollment: 216
Study Start Date: October 2009
Study Completion Date: March 2014
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 - Girls OnGuard/HPV awareness
Adolescents will watch a short (10 min), interactive DVD designed to promote HPV awareness and initial GARDASIL vaccination and receive a keepsake to help them remember to return to the clinic for their second and third vaccine doses.
Behavioral: Girls OnGuard
Using the Information-Motivation-Behavioral Skills Model (IMB) as a framework, Girls OnGuard is an interactive,culturally-appropriate, computer-delivered program design to enhance initial uptake of GARDASIL by addressing three major components: (1) information about GARDASIL; (2) motivation to obtain GARDASIL vaccination; and (3) behavioral skills to enhance self-efficacy of obtaining GARDASIL vaccination.
No Intervention: 2 - General health promotion
Adolescents will watch an equally short (10 min) DVD on healthy lifestyles and behaviors. HPV awareness and vaccination will not be addressed.

  Eligibility

Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • African American
  • Female
  • Age 13-18 years
  • Seeking reproductive/STI services at participating clinic
  • Ability to give written informed consent or assent

Exclusion Criteria:

  • Pregnant
  • Married
  • Already received the HPV vaccine
  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: NCT00813319

Locations
United States, Georgia
Fulton County Department of Health and Wellness
Atlanta, Georgia, United States, 30303
DeKalb County Health Department
Decatur, Georgia, United States, 30034
Sponsors and Collaborators
Emory University
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Ralph J. DiClemente, PhD Emory University Rollins School of Public Health
  More Information

No publications provided

Responsible Party: Ralph J. DiClemente, Professor, Emory University
ClinicalTrials.gov Identifier: NCT00813319     History of Changes
Other Study ID Numbers: IRB00015576, Merck - Emory UPN 08042902
Study First Received: December 22, 2008
Results First Received: June 10, 2014
Last Updated: August 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
GARDASIL
HPV
Vaccination

ClinicalTrials.gov processed this record on October 20, 2014