- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00680147
Human Papillomavirus (HPV) Vaccination Acceptance by African-American Parents: Identifying Psychosocial Barriers
May 19, 2015 updated by: Peter A. Vanable, Syracuse University
HPV Vaccination Acceptance by African-American Parents: Identifying Psychosocial Barriers
This will enroll 300 mothers of teenage girls and boys to identify barriers to HPV vaccination among low-income, African-American teens.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The HPV vaccine offers hope that the incidence of cervical cancer can be greatly reduced in the U.S. and globally.
However, because the vaccine is recommended for children and early adolescents, vaccine awareness and acceptance among parents is critical to insuring vaccine uptake and public health benefit.
Although culturally specific concerns may reduce HPV vaccination among African-American youth, research has not addressed this possibility.
Accordingly, the proposed study will enroll 300 mothers in a study to identify barriers to HPV vaccination among low-income, African-American teens.
Surveys assessing culturally-specific barriers to HPV vaccination acceptance will be administered to both parents and their vaccine-eligible children.
Upon completion of the survey, parents with vaccine-eligible daughters will be invited to receive a free HPV vaccination for their child through a local, teen-friendly health clinic.
Outcome analyses will focus on identification of predictors of completed vaccinations among girls and barriers to vaccine acceptance among mothers of teenage sons.
Our study will provide critically important behavioral outcome data linking barriers to vaccination to subsequent vaccination decisions in a real-world, health care setting.
Study Type
Interventional
Enrollment (Actual)
614
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Syracuse, New York, United States, 13244
- Center for Health and Behavior, Syracuse University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Females parent or guardian with an African-American daughter or son between the ages of 11 and 17
- African-American adolescents between the ages of 11-17
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Brief HPV vaccine informational intervention
Because we anticipated that knowledge and awareness of the HPV vaccine would be low in our study population, our CASI survey included a brief, informational overview of key facts concerning HPV vaccination prior to assessing vaccine acceptance, perceived barriers to vaccination, and intentions to vaccinate.
The overview lasted approximately 3 minutes and consisted of a brief overview of key HPV vaccination facts that were presented visually (on the computer screen) and read aloud using a digital recording.
HPV and vaccine knowledge, awareness, and attitudes items were administered prior to participants hearing the informational overview.
|
Teen and parent participants will receive a brief informational intervention that provides basic facts about the HPV vaccine, including the health benefits and three-dose requirements, along with information regarding where to go to receive the vaccination.
A coupon for a free HPV vaccination will provided to the parent for use by their teenage daughter.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
completed vaccination with Gardasil
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
assessed cross-sectionally, at time of initial enrollment
Time Frame: assessed at time of baseline assessment
|
assessed at time of baseline assessment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Actual)
February 1, 2012
Study Completion (Actual)
February 1, 2012
Study Registration Dates
First Submitted
May 15, 2008
First Submitted That Met QC Criteria
May 16, 2008
First Posted (Estimate)
May 19, 2008
Study Record Updates
Last Update Posted (Estimate)
May 21, 2015
Last Update Submitted That Met QC Criteria
May 19, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HPV
-
Xiamen UniversityXiamen Innovax Biotech Co., Ltd; Xiamen Center for Disease Control and PreventionNot yet recruitingHPV Vaccination Rates | HPV Vaccine Awareness | HPV Vaccination Intention
-
Population Services InternationalFederal Democratic Republic of Ethiopia Ministry of Health; Addis Ababa University...Not yet recruitingAdolescent Health | HPV Vaccine Acceptability | HPV Vaccines | Integrated Community-based Intervention Package | Papillomavirus Vaccines | HPV Vaccine Attitudes | Adolescent Health Services | HPV Vaccinations | HPV Vaccine Knowledge
-
Xiamen UniversityXiamen Center for Disease Control and PreventionNot yet recruitingHPV Vaccination Rates | HPV Vaccine Awareness | HPV Vaccination Intention
-
H. Lee Moffitt Cancer Center and Research InstituteNational Cancer Institute (NCI)CompletedHPV Vaccine | HPVUnited States, Puerto Rico
-
University of PennsylvaniaWorld Bank GroupNot yet recruiting
-
Indiana UniversityMerck Sharp & Dohme LLCCompletedHPV Vaccine Attitudes | HPV Vaccine IntentionUnited States
-
Xijing HospitalEnrolling by invitationHPV Vaccination、HPV Related Diseases、Protective EfficacyChina
-
Global Alliance to Immunize Against AIDS Vaccine...Merck Sharp & Dohme LLCCompletedHPV-Related Cervical Carcinoma | HPV
-
Karolinska InstitutetNot yet recruitingHPV | HPV Vaccination | Vaccine Acceptance | Vaccine Decision Making
-
Centre Hospitalier Universitaire de la RéunionRecruiting
Clinical Trials on brief informational intervention to promote HPV vaccine acceptance
-
Boston Medical CenterCompletedCervical CancerUnited States
-
VA Office of Research and DevelopmentMinneapolis Veterans Affairs Medical Center; Central Arkansas Veterans Healthcare... and other collaboratorsCompletedCOVID-19 VaccinationUnited States
-
The University of Hong KongRecruitingMetabolic Syndrome | Primary Prevention of Atherosclerotic Cardiovascular DiseaseHong Kong