NCT01143142

Brief Summary

The goal of this study is to determine whether a two-page print brochure that delivers individually tailored educational messages about the Human papillomavirus (HPV) vaccine increases HPV vaccine-hesitant mothers' intentions to have their adolescent daughters vaccinated against HPV.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2010

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

Study Start

First participant enrolled

June 1, 2010

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 14, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

December 22, 2014

Completed
Last Updated

December 22, 2014

Status Verified

December 1, 2014

Enrollment Period

1.3 years

First QC Date

June 10, 2010

Results QC Date

December 8, 2014

Last Update Submit

December 15, 2014

Conditions

Human PapillomavirusPrevention

Keywords

Human papillomavirusHPVPreventionTailoringPersuasive communicationAdolescent

Outcome Measures

Primary Outcomes (1)

  • Mother's Intention to Vaccinate Daughter Against HPV

    Mother will rate her intention to have her daughter vaccinated against HPV using a Likert scale before and after the intervention. The scale ranges from 0-11 with higher numbers representing more positive intentions to vaccinate against HPV, and 5 being neutral intentions (i.e. neither positive nor negative). In this assessment we use this 11-point scale to assess vaccination before and after viewing the educational materials. The difference pre and post intervention in vaccination intention is calculated (min 0, max 11) and the mean of these differences are calculated for the control and intervention groups.

    Date of intervention (one day)

Secondary Outcomes (1)

  • Vaccination of Daughter

    Less than or equal to three months from the date of the intervention

Study Arms (2)

Tailoring

EXPERIMENTAL

Individuals assigned to the experimental group will receive a two-page brochure tailored based on their responses to the survey.

Behavioral: Computer-based tailoring system

Untailored information

ACTIVE COMPARATOR

Individuals assigned to the control group will receive the CDC vaccine information sheet that is standardly provided.

Behavioral: Computer-based tailoring system

Interventions

Computer-based tailoring systemBEHAVIORAL

Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure.

TailoringUntailored information

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mother is greater than or equal to 18 years of age
  • Mother has a daughter who is between the ages of 11-15 years
  • Daughter has not received any doses of the HPV vaccine
  • When asked to describe how she feels about getting her daughter vaccinated against HPV in the next six months, mother responds "I don't want her to get vaccinated" or "I'm unsure if I want her vaccinated."

You may not qualify if:

  • Cannot read/speak English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMHS Outpatient Pediatrics

Ann Arbor, Michigan, 48104, United States

Location

Related Publications (8)

  • Centers for Disease Control and Prevention (CDC). National, state, and local area vaccination coverage among adolescents aged 13-17 years--United States, 2008. MMWR Morb Mortal Wkly Rep. 2009 Sep 18;58(36):997-1001.

    PMID: 19763075BACKGROUND

  • Chesson HW, Blandford JM, Gift TL, Tao G, Irwin KL. The estimated direct medical cost of sexually transmitted diseases among American youth, 2000. Perspect Sex Reprod Health. 2004 Jan-Feb;36(1):11-9. doi: 10.1363/psrh.36.11.04.

    PMID: 14982672BACKGROUND

  • Dempsey AF, Abraham LM, Dalton V, Ruffin M. Understanding the reasons why mothers do or do not have their adolescent daughters vaccinated against human papillomavirus. Ann Epidemiol. 2009 Aug;19(8):531-8. doi: 10.1016/j.annepidem.2009.03.011. Epub 2009 Apr 25.

    PMID: 19394865BACKGROUND

  • Dempsey A, Cohn L, Dalton V, Ruffin M. Patient and clinic factors associated with adolescent human papillomavirus vaccine utilization within a university-based health system. Vaccine. 2010 Jan 22;28(4):989-95. doi: 10.1016/j.vaccine.2009.10.133. Epub 2009 Nov 17.

    PMID: 19925899BACKGROUND

  • Dempsey AF, Zimet GD, Davis RL, Koutsky L. Factors that are associated with parental acceptance of human papillomavirus vaccines: a randomized intervention study of written information about HPV. Pediatrics. 2006 May;117(5):1486-93. doi: 10.1542/peds.2005-1381.

    PMID: 16651301BACKGROUND

  • Gust D, Brown C, Sheedy K, Hibbs B, Weaver D, Nowak G. Immunization attitudes and beliefs among parents: beyond a dichotomous perspective. Am J Health Behav. 2005 Jan-Feb;29(1):81-92. doi: 10.5993/ajhb.29.1.7.

    PMID: 15604052BACKGROUND

  • Hawkins RP, Kreuter M, Resnicow K, Fishbein M, Dijkstra A. Understanding tailoring in communicating about health. Health Educ Res. 2008 Jun;23(3):454-66. doi: 10.1093/her/cyn004. Epub 2008 Mar 17.

    PMID: 18349033BACKGROUND

  • Markowitz LE, Dunne EF, Saraiya M, Lawson HW, Chesson H, Unger ER; Centers for Disease Control and Prevention (CDC); Advisory Committee on Immunization Practices (ACIP). Quadrivalent Human Papillomavirus Vaccine: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2007 Mar 23;56(RR-2):1-24.

    PMID: 17380109BACKGROUND

Results Point of Contact

Title
Amanda Dempsey
Organization
University of Colorado
amanda.dempsey@ucdenver.edu
303-724-6679

Study Officials

  • Amanda Dempsey, MD, PhD, MPH

    Child Health Evaluation and Research Unit

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics

Study Record Dates

First Submitted

June 10, 2010

First Posted

June 14, 2010

Study Start

June 1, 2010

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

December 22, 2014

Results First Posted

December 22, 2014

Record last verified: 2014-12

Locations

US(1)