Vax Facts Human Papillomavirus (HPV): Study of a Computer-based Tailoring System and Mothers' Intentions to Vaccinate Their Daughters Against HPV
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Human Papillomavirus Prevention |
Behavioral: Computer-based tailoring system |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
| Official Title: | Vax Facts HPV: Study of a Computer-based Tailoring System and Mothers' Intentions to Vaccinate Their Daughters Against HPV |
- Mother's intention to vaccinate daughter against HPV [ Time Frame: Date of intervention (one day) ] [ Designated as safety issue: No ]Mother will rate her intention to have her daughter vaccinated against HPV using a Likert scale before and after the intervention.
- Vaccination of daughter [ Time Frame: Less than or equal to three months from the date of the intervention ] [ Designated as safety issue: No ]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.
| Enrollment: | 70 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | October 2011 |
| Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Tailoring
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
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.
|
|
Active Comparator: Untailored information
Individuals assigned to the control group will receive the CDC vaccine information sheet that is standardly provided.
|
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.
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| United States, Michigan | |
| UMHS Outpatient Pediatrics | |
| Ann Arbor, Michigan, United States, 48104 | |
| Principal Investigator: | Amanda Dempsey, MD, PhD, MPH | Child Health Evaluation and Research Unit |
More Information
Publications:
| Responsible Party: | Amanda Dempsey, Child Health Evaluation and Research Unit |
| ClinicalTrials.gov Identifier: | NCT01143142 History of Changes |
| Other Study ID Numbers: | 149891, P50CA101451 |
| Study First Received: | June 10, 2010 |
| Last Updated: | July 12, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Michigan:
|
Human papillomavirus HPV Prevention |
Tailoring Persuasive communication Adolescent |
ClinicalTrials.gov processed this record on May 19, 2013