Girls OnGuard: HPV Vaccination Uptake Among African American Adolescent Females

Study Overview
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Brief Summary
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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.

Official Title
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Overcoming Barriers to Vaccination With GARDASIL in Underserved Girls and Adolescents

Conditions
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Vaccination

Intervention / Treatment
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* Behavioral: Girls OnGuard


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 - Girls OnGuard/HPV awareness<br>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<br>* 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.<br>|
| No Intervention: 2 - General health promotion<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GARDASIL, HPV, Vaccination