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

• ClinicalTrials.gov Identifier: NCT00813319
• Recruitment Status: Completed
• First Posted: December 23, 2008
• Results First Posted: August 12, 2014
• Last Update Posted: August 12, 2014
• Sponsor: Emory University
• Collaborator: Merck Sharp & Dohme Corp.
• Information provided by (Responsible Party): Ralph J. DiClemente, Emory University

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Vaccination	Behavioral: Girls OnGuard	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 216 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Overcoming Barriers to Vaccination With GARDASIL in Underserved Girls and Adolescents
• Study Start Date: October 2009
• Actual Primary Completion Date: November 2012
• Actual Study Completion Date: March 2014

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. STD Incidence [ Time Frame: 7 months post randomization ]
   Number of participants who tested positive for any STD 7 months post randomization, information was gathered via medical chart abstraction

Eligibility Criteria

• Ages Eligible for Study: 13 Years to 18 Years (Child, Adult)
• Sexes 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

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

• Responsible Party: Ralph J. DiClemente, Professor, Emory University
• ClinicalTrials.gov Identifier: NCT00813319
• Other Study ID Numbers: IRB00015576; Merck - Emory UPN 08042902 ( Other Identifier: Other )
• First Posted: December 23, 2008
• Results First Posted: August 12, 2014
• Last Update Posted: August 12, 2014
• Last Verified: August 2014

Keywords provided by Ralph J. DiClemente, Emory University:

GARDASIL; HPV; Vaccination