Girls OnGuard: HPV Vaccination Uptake Among African American Adolescent Females

Vaccination Clinical Trial

— Girls OnGuard  

Official title:

Overcoming Barriers to Vaccination With GARDASIL in Underserved Girls and Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00813319
• Other study ID #: IRB00015576
• Secondary ID: Merck - Emory UP
• Status: Completed
• Phase: Phase 3
• First received: December 22, 2008
• Last updated: August 11, 2014
• Start date: October 2009
• Est. completion date: March 2014

Study information

• Verified date: August 2014
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: March 2014
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Vaccination

Intervention

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.

Locations

Country	Name	City	State
United States	Fulton County Department of Health and Wellness	Atlanta	Georgia
United States	DeKalb County Health Department	Decatur	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No