Trial Outcomes & Findings for Vax Facts Human Papillomavirus (HPV): Study of a Computer-based Tailoring System and Mothers' Intentions to Vaccinate Their Daughters Against HPV (NCT NCT01143142)

Last Updated: 2014-12-22

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

70 participants

Primary outcome timeframe

Date of intervention (one day)

Results posted on

2014-12-22

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	36	34
Overall Study COMPLETED	36	34
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tailoring n=36 Participants 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.	Untailored Information n=34 Participants 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.	Total n=70 Participants Total of all reporting groups
Age, Continuous	40 years n=5 Participants	40 years n=7 Participants	40 years n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	34 Participants n=7 Participants	70 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants	22 Participants n=7 Participants	47 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	36 participants n=5 Participants	34 participants n=7 Participants	70 participants n=5 Participants

PRIMARY outcome

Timeframe: Date of intervention (one day)

Outcome measures

Outcome measures
Measure	Tailoring n=36 Participants 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.	Untailored Information n=34 Participants 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.
Mother's Intention to Vaccinate Daughter Against HPV	1.53 units on a scale Interval 1.31 to 1.83	1.29 units on a scale Interval 1.09 to 1.79

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Tailoring n=36 Participants 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.	Untailored Information n=34 Participants 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.
Vaccination of Daughter	1 participants	2 participants

Adverse Events

Tailoring

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Untailored Information

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Amanda Dempsey

University of Colorado

Phone: 303-724-6679

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place