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
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||216 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Overcoming Barriers to Vaccination With GARDASIL in Underserved Girls and Adolescents|
|Study Start Date :||October 2009|
|Primary Completion Date :||November 2012|
|Study Completion Date :||March 2014|
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.
- 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
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00813319
|United States, Georgia|
|Fulton County Department of Health and Wellness|
|Atlanta, Georgia, United States, 30303|
|DeKalb County Health Department|
|Decatur, Georgia, United States, 30034|
|Principal Investigator:||Ralph J. DiClemente, PhD||Emory University Rollins School of Public Health|