Clinical trial NCT00813319: Girls OnGuard: HPV Vaccination Uptake Among African American Adolescent Females
Official title: Overcoming Barriers to Vaccination With GARDASIL in Underserved Girls and Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vaccination
Keywords: GARDASIL
HPV
Vaccination
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2008-12-23
Enrollment: 216
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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

Primary outcomes:
measure: GARDASIL Vaccination Uptake and Compliance With Second and Third Doses
timeFrame: measured at 7 months post-randomization
measure: Total Doses Received of HPV Vaccine
timeFrame: measured at 7-months post randomization
Secondary outcomes:
measure: STD Incidence
timeFrame: 7 months post randomization
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Fulton County Department of Health and Wellness
state: Georgia
city: Decatur
country: United States
facility: DeKalb County Health Department
state: Georgia
Study officials:
affiliation: Emory University Rollins School of Public Health
name: Ralph J. DiClemente, PhD
role: PRINCIPAL_INVESTIGATOR
References: