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OpenTrials
Completed

NCT Number: NCT00813319

Girls OnGuard: HPV Vaccination Uptake Among African American Adolescent Females

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.

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Key information

Conditions

Age range

13 year–18 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Fulton County Department of Health and Wellness, Atlanta, Georgia, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Girls OnGuard

Behavioral

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.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

Overcoming Barriers to Vaccination With GARDASIL in Underserved Girls and Adolescents

Acronym: Girls OnGuard

Important dates

Study start
2009
Primary completion
2012
Study completion
2014
First posted
Dec 23, 2008
Registry last updated
Aug 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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