Girls OnGuard: HPV Vaccination Uptake Among African American Adolescent

Status Completed

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.

Clinical Trial Description

n/a

Study Design

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

Related Conditions & MeSH terms

Vaccination

Clinical Trial Details

NCT number	NCT00813319
Study type	Interventional
Source	Emory University
Contact
Status	Completed
Phase	Phase 3
Start date	October 2009
Completion date	March 2014

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05009251` - Using Explainable AI Risk Predictions to Nudge Influenza Vaccine Uptake	N/A
Completed	`NCT03284515` - Vaccination In Pregnancy Gene Signature: VIP Signature Study
Completed	`NCT05012163` - Lottery Incentive Nudges to Increase Influenza Vaccinations	N/A
Recruiting	`NCT05996549` - Cost-effectiveness of the Influenza Vaccination	Phase 4
Completed	`NCT04323137` - Encouraging Flu Vaccination Among High-Risk Patients Identified by ML	N/A
Completed	`NCT01224301` - School Influenza Vaccine vs Standard of Care With Nested Trial of 2 Parent Notification Intensities	N/A
Completed	`NCT00169858` - Long Term Immunogenicity Study of Engerix-B Vaccine in 10 Year Old Children and the Effect of Booster Injections	Phase 4
Completed	`NCT05509283` - Nudging Flu Vaccination in Patients at Moderately High Risk for Flu and Flu-related Complications	N/A
Completed	`NCT02907580` - Influenza Vaccine Attitudes, Intent, and Receipt: Pediatric	N/A
Recruiting	`NCT06160999` - Improving Uptake of Pediatric Vaccines Through Religious Conferences and Vaccines-in-a-van in Aceh, Indonesia	N/A
Recruiting	`NCT03875703` - Post-Vaccination Biological Collection
Completed	`NCT03287830` - Flu2Text: Text Message Reminders for 2nd Dose of Influenza Vaccine	N/A
Completed	`NCT02907645` - Influenza Vaccine Randomized Educational Trial: Adult	N/A
Completed	`NCT03220555` - Efficacy of the Buzzy® Device on the Prevention of Health Care Induced Pediatric Pain in a Vaccination Center	N/A
Withdrawn	`NCT05023512` - Understanding Public Attitudes Towards the COVID-19 Vaccination	N/A
Recruiting	`NCT02937428` - To Look or Not to Look at the Needle During Vaccination	Phase 3
Completed	`NCT03104790` - Assessment of Viral Shedding in Children Previously in Receipt of Multiple Doses of Live Attenuated Influenza Vaccine (LAIV) Compared to Influenza Vaccine-naïve Controls	Phase 4
Completed	`NCT04780867` - Psychological and Lifestyle Factors on Health Outcomes	N/A
Completed	`NCT03239795` - Promoting Influenza Vaccination In General Practice Waiting Rooms	N/A
Recruiting	`NCT05078905` - Vaccine Responses to SARS-CoV-2 and Other Emerging Infectious Diseases

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Girls OnGuard: HPV Vaccination Uptake Among African American Adolescent Females — Girls OnGuard

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms