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Sponsors and Collaborators: |
Emory University Merck |
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Information provided by: | Emory University |
ClinicalTrials.gov Identifier: | NCT00813319 |
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. To address this need, the proposed study is an exciting opportunity to build upon a relationship previously formed between Planned Parenthood of Georgia and Emory University Rollins School of Public Health. 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 400 unmarried African American adolescent females, 13-18 years of age, from Planned Parenthood in Atlanta, Georgia. At Planned Parenthood, 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 Planned Parenthood as part of their routine standard of care.
With the help of clinic staff, participant medical records will be reviewed over a 6 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 |
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Vaccination |
Behavioral: Girls OnGuard |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Overcoming Barriers to Vaccination With GARDASIL in Underserved Girls and Adolescents |
Estimated Enrollment: | 400 |
Study Start Date: | October 2009 |
Estimated Study Completion Date: | November 2010 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1 - Girls OnGuard/HPV awareness: Experimental
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.
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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.
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2 - General health promotion: No Intervention
Adolescents will watch an equally short (10 min) DVD on healthy lifestyles and behaviors. HPV awareness and vaccination will not be addressed.
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Ages Eligible for Study: | 13 Years to 18 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Colleen C. Murray, DrPH, MPH | 404-727-9872 | ccritte@sph.emory.edu |
Contact: Jessica M. Sales, PhD | 404-727-6598 | jmcderm@emory.edu |
United States, Georgia | |
Planned Parenthood of Georgia | |
Atlanta, Georgia, United States, 30303 |
Principal Investigator: | Ralph J. DiClemente, PhD | Emory University Rollins School of Public Health |
Responsible Party: | Emory University ( Ralph J. DiClemente, PhD ) |
Study ID Numbers: | Merck - Emory UPN 08042902 |
Study First Received: | December 22, 2008 |
Last Updated: | August 11, 2009 |
ClinicalTrials.gov Identifier: | NCT00813319 History of Changes |
Health Authority: | United States: Institutional Review Board |
GARDASIL HPV Vaccination |