Girls OnGuard: HPV Vaccination Uptake Among African American Adolescent Females

NCT00813319 | Completed Phase 3 Results DMC

• 2 other identifiers: IRB00015576Merck - Emory UPN 08042902
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 2

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.

Conditions

Vaccination

Keywords

GARDASIL; HPV; Vaccination

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• STD Incidence

  7 months post randomization

Study Arms (2)

1 - Girls OnGuard/HPV awareness

EXPERIMENTAL

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

2 - General health promotion

NO INTERVENTION

Adolescents will watch an equally short (10 min) DVD on healthy lifestyles and behaviors. HPV awareness and vaccination will not be addressed.

Interventions

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.

1 - Girls OnGuard/HPV awareness

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• African American
• Female
• Age 13-18 years
• Seeking reproductive/STI services at participating clinic
• Ability to give written informed consent or assent

You may not qualify if:

• Pregnant
• Married
• Already received the HPV vaccine

Sponsors & Collaborators

• Emory University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (2)

Fulton County Department of Health and Wellness

Atlanta, Georgia, 30303, United States

Location

DeKalb County Health Department

Decatur, Georgia, 30034, United States

Location

Limitations and Caveats

Limited sample size; Brevity of the computer-administered intervention; Substantial variability between and within clinics with respect to patient-provider interactions; Lack of a follow-up assessment.

Results Point of Contact

• Title: Dr. Ralph DiClemente, Principal Investigator
• Organization: Emory University Rollins School of Public Health

rdiclem@emory.edu

404-727-0237

Study Officials

• Ralph J. DiClemente, PhD

  Emory University Rollins School of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 22, 2008
• First Posted: December 23, 2008
• Study Start: October 1, 2009
• Primary Completion: November 1, 2012
• Study Completion: March 1, 2014
• Last Updated: August 12, 2014
• Results First Posted: August 12, 2014

Record last verified: 2014-08

Locations

US (2)