Girls OnGuard: HPV Vaccination Uptake Among African American Adolescent Females
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- GARDASIL vaccination uptake and compliance with second and third doses [ Time Frame: measured at 7 months post-randomization ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 280 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | June 2013 |
| 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 |
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| 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 |
More Information
No publications provided
| Responsible Party: | Ralph J. DiClemente, Professor, Emory University |
| ClinicalTrials.gov Identifier: | NCT00813319 History of Changes |
| Other Study ID Numbers: | Merck - Emory UPN 08042902 |
| Study First Received: | December 22, 2008 |
| Last Updated: | January 3, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Emory University:
|
GARDASIL HPV Vaccination |
ClinicalTrials.gov processed this record on June 17, 2013