Girls OnGuard: HPV Vaccination Uptake Among African American Adolescent Females (Girls OnGuard)

Overcoming Barriers to Vaccination With GARDASIL in Underserved Girls and Adolescents

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.

Study Overview

• Status: Completed
• Conditions: Vaccination
• Intervention / Treatment: Behavioral: Girls OnGuard

• Study Type: Interventional
• Enrollment (Actual): 216
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Fulton County Department of Health and Wellness
    • Decatur, Georgia, United States, 30034
      • DeKalb County Health Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GARDASIL Vaccination Uptake and Compliance With Second and Third Doses	Number of participants who received at least 1 dose, 2 doses, 3 doses	measured at 7 months post-randomization
Total Doses Received of HPV Vaccine	As an additional primary outcome, we assessed the total number of vaccine doses received	measured at 7-months post randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
STD Incidence	Number of participants who tested positive for any STD 7 months post randomization, information was gathered via medical chart abstraction	7 months post randomization

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Ralph J. DiClemente, PhD, Emory University Rollins School of Public Health

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: December 22, 2008
• First Submitted That Met QC Criteria: December 22, 2008
• First Posted (Estimate): December 23, 2008

Study Record Updates

• Last Update Posted (Estimate): August 12, 2014
• Last Update Submitted That Met QC Criteria: August 11, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Vaccination; HPV; GARDASIL
• Other Study ID Numbers: IRB00015576; Merck - Emory UPN 08042902 (Other Identifier: Other)