Vax Facts Human Papillomavirus (HPV): Study of a Computer-based Tailoring System and Mothers' Intentions to Vaccinate Their Daughters Against HPV

Prevention Clinical Trial

Official title:

Vax Facts HPV: Study of a Computer-based Tailoring System and Mothers' Intentions to Vaccinate Their Daughters Against HPV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01143142
• Other study ID #: 149891
• Secondary ID: P50CA101451
• Status: Completed
• Phase: N/A
• First received: June 10, 2010
• Last updated: December 15, 2014
• Start date: June 2010
• Est. completion date: October 2011

Study information

• Verified date: December 2014
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

This will be a randomized controlled intervention trial for HPV vaccine-hesitant mothers of adolescent (ages 11-15 years old) girls. Mothers will complete a three-item measure that assesses their baseline intentions for having their adolescent daughter vaccinated against HPV. Mothers will then fill out a short, computer-based survey that assesses demographic factors, prior experience with HPV-associated illnesses and views about a variety of potential barriers to HPV vaccination. Following the survey, the intervention group (40 mothers) will receive a two-page print brochure that uses their survey data to generate the brochure such that it addresses each mother's top three concerns about the HPV vaccine. The control group (40 mothers) will receive a generic, two-page brochure that is similar in appearance to the intervention, but contains only untailored, generic information about the vaccine. HPV vaccination intention will be assessed a second time after reading the brochure, using the same three-item measure as before the survey. The vaccine administration records of the adolescent daughters of these mothers will be accessed three months after mothers' participation in the study to assess whether any HPV vaccine doses were provided.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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."

Exclusion Criteria:

• Cannot read/speak English

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Human Papillomavirus
• Prevention

Intervention

Behavioral:
• Computer-based tailoring system
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.

Locations

Country	Name	City	State
United States	UMHS Outpatient Pediatrics	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Vaccination of Daughter	With mother's consent, daughter's University of Michigan vaccination record will be accessed to determine whether daughter has received any doses of the HPV vaccine. If the University of Michigan vaccination record does not document a visit three months after the intervention, with mother's consent, research staff will call mother at home to determine whether daughter has received any doses of the HPV vaccine.	Less than or equal to three months from the date of the intervention	No