Girls OnGuard: HPV Vaccination Uptake Among African American Adolescent Females
Condition: Vaccination
Intervention: Girls OnGuard
Intervention description: 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.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 216.0
Sex: Female
Minimum age: 13 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: GARDASIL; HPV; Vaccination

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.
    

Eligibility 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