NCT00807898

Brief Summary

Preventing cervical cancer is a public health concern. Since 2006 a quadrivalent vaccine for young women nine to twenty six years of age has been available to protect against the human papillomavirus (HPV) and to prevent some types of cervical cancer (Gardasil). The vaccine is an important health promotion tool to address the widespread prevalence of HPV and cervical cancer, but not all eligible young women receive the vaccine. The vaccine is most effective when administered to young women before their sexual debut. When the vaccine is given to young women less than 18 years of age, parental permission is required. This permission is usually provided by the young woman's mother. Understanding predictors of a mother's decision for her minor daughter to receive the HPV vaccine will inform interventions that seek to increase the number of young women who receive the vaccine. The study will focus on mothers and their adolescent daughters between 13-17 years of age. We hypothesize that the Expanded Theory of Planned Behavior will explain a mother's decision to choose the HPV vaccine for her daughter. Research Questions include: 1)What TPB variables predict a mother's decision to choose HPV vaccine for her daughter? 2)What variables predict the strength of a daughter's influence on the mother's decision to choose HPV vaccine for her daughter? 3) What are the relationships between the mothers' and daughters' scores on the variables related to the decision to choose HPV vaccine? 4) How do the mothers and daughters who chose to receive the HPV vaccine differ descriptively from those mothers and daughters who do not choose to receive the HPV vaccine?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 12, 2008

Completed
20 days until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

May 5, 2017

Status Verified

January 1, 2011

Enrollment Period

1.9 years

First QC Date

December 11, 2008

Last Update Submit

May 2, 2017

Conditions

Keywords

GardasilHPV vaccinedecision makingmotherdaughter

Eligibility Criteria

Age13 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Mother and daughter pairs (n =75) will be recruited.

You may qualify if:

  • Adolescent females 13-17 years of age
  • and adolescent's mother, any age
  • and adolescent not pregnant
  • and adolescent has not received vaccine for HPV

You may not qualify if:

  • Males
  • daughters younger than 13 yrs of age
  • daughters older than 17 yrs of age
  • pregnant daughters
  • daughters who have received the HPV vaccine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Louisville School of Nursing

Louisville, Kentucky, 40292, United States

Location

Related Publications (1)

  • Hertweck SP, LaJoie AS, Pinto MD, Flamini L, Lynch T, Logsdon MC. Health care decision making by mothers for their adolescent daughters regarding the quadrivalent HPV vaccine. J Pediatr Adolesc Gynecol. 2013 Apr;26(2):96-101. doi: 10.1016/j.jpag.2012.10.009.

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Mimia C Logsdon, DNS, ARNP, FAAN

    University of Louisville School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 11, 2008

First Posted

December 12, 2008

Study Start

January 1, 2009

Primary Completion

December 1, 2010

Study Completion

January 1, 2011

Last Updated

May 5, 2017

Record last verified: 2011-01

Locations