Human Papillomavirus, Prevention
Conditions
Keywords
Human papillomavirus, HPV, Prevention, Tailoring, Persuasive communication, Adolescent
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.
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.
Interventions
BEHAVIORALComputer-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.
Sponsors
National Cancer Institute (NCI)
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mother's Intention to Vaccinate Daughter Against HPV | Date of intervention (one day) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vaccination of Daughter | Less than or equal to three months from the date of the intervention | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tailoring Individuals assigned to the experimental group will receive a two-page brochure tailored based on their responses to the survey.
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. | 36 |
| Untailored Information Individuals assigned to the control group will receive the CDC vaccine information sheet that is standardly provided.
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. | 34 |
| Total | 70 |
Baseline characteristics
| Characteristic | Tailoring | Total | Untailored Information |
|---|---|---|---|
| Age, Continuous | 40 years | 40 years | 40 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 18 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) White | 25 Participants | 47 Participants | 22 Participants |
| Region of Enrollment United States | 36 participants | 70 participants | 34 participants |
| Sex: Female, Male Female | 36 Participants | 70 Participants | 34 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 36 | 0 / 34 |
| serious Total, serious adverse events | 0 / 36 | 0 / 34 |
Outcome results
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.
Time frame: Date of intervention (one day)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Tailoring | Mother's Intention to Vaccinate Daughter Against HPV | 1.53 units on a scale |
| Untailored Information | Mother's Intention to Vaccinate Daughter Against HPV | 1.29 units on a scale |
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.
Time frame: Less than or equal to three months from the date of the intervention
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tailoring | Vaccination of Daughter | 1 participants |
| Untailored Information | Vaccination of Daughter | 2 participants |