Trial Outcomes & Findings for HPV Message Testing and Social Media Campaign (NCT NCT03747302)

NCT ID: NCT03747302

Last Updated: 2022-09-14

Results Overview

Change in Attitudes about HPV vaccine: Pre to post test comparison of summated 9 items measured on a 7-point scale of HPV vaccine attitudes. Scores range from a minimum of 9 to a maximum of 63. Higher scores indicated more positive attitudes toward HPV vaccination. Change was calculated from two time points, the later time point(\<1 hour post messaging intervention) minus value at baseline.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1043 participants

Primary outcome timeframe

Post test completed < 1 hour post messaging intervention

Results posted on

2022-09-14

Participant Flow

1713 prospective participants responded to a social media or MTurk posting about the study between 12/12/18 to 04/15/19. 39 declined to consent. Of the remaining 1674 participants: 631 had no child and were deemed ineligible,.1043 people were eligible and consented to be in the study. Of that, 45 dropped before random assignment. As such, 998 people were eligible, provided a consent, and completed a baseline survey.

Eligible, consented participants completed a pre-test survey prior to assignment to an arm.

Participant milestones

Participant milestones
Measure
HPV Messaging
834 Subjects were randomized to receive an experimental message about HPV vaccination.
Control Messaging
164 Subjects received a control message.
Overall Study
STARTED
834
164
Overall Study
COMPLETED
833
162
Overall Study
NOT COMPLETED
1
2

Reasons for withdrawal

Reasons for withdrawal
Measure
HPV Messaging
834 Subjects were randomized to receive an experimental message about HPV vaccination.
Control Messaging
164 Subjects received a control message.
Overall Study
Withdrawal by Subject
1
2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
HPV Messaging
n=834 Participants
834 Subjects are randomized to receive one of five messages on one of the five themes about HPV vaccination.(165-167/group) Social Media Message about HPV and HPV vaccine: Messages educate parents with facts about HPV vaccination.
Control Message
n=164 Participants
164 Subjects are randomized to receive one of five messages about electronic cigarettes. Social media message about risk of electronic cigarettes.: Messages educate parents with facts about electronic cigarettes. This is an attention control group without outcomes obtained.
Total
n=998 Participants
Total of all reporting groups
Age, Continuous
38.05 years
STANDARD_DEVIATION 10.75 • n=834 Participants
37.33 years
STANDARD_DEVIATION 10.88 • n=164 Participants
37.93 years
STANDARD_DEVIATION 10.77 • n=998 Participants
Sex: Female, Male
Female
520 Participants
n=834 Participants
96 Participants
n=164 Participants
616 Participants
n=998 Participants
Sex: Female, Male
Male
314 Participants
n=834 Participants
68 Participants
n=164 Participants
382 Participants
n=998 Participants
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.
Prior knowledge of HPV
730 Participants
n=834 Participants
142 Participants
n=164 Participants
872 Participants
n=998 Participants
HPV Vaccine in prevents Cervical Cancer
2.53 units on a scale
STANDARD_DEVIATION 1.58 • n=834 Participants
2.48 units on a scale
STANDARD_DEVIATION 1.50 • n=164 Participants
2.52 units on a scale
STANDARD_DEVIATION 1.56 • n=998 Participants
HPV Vaccine in prevents Throat Cancer
2.26 units on a scale
STANDARD_DEVIATION 1.80 • n=834 Participants
2.08 units on a scale
STANDARD_DEVIATION 1.81 • n=164 Participants
2.23 units on a scale
STANDARD_DEVIATION 1.80 • n=998 Participants

PRIMARY outcome

Timeframe: Post test completed < 1 hour post messaging intervention

Population: 1 participant in the experimental group and 2 participants in the control group withdrew from the study and are not included in the analysis.

Change in Attitudes about HPV vaccine: Pre to post test comparison of summated 9 items measured on a 7-point scale of HPV vaccine attitudes. Scores range from a minimum of 9 to a maximum of 63. Higher scores indicated more positive attitudes toward HPV vaccination. Change was calculated from two time points, the later time point(\<1 hour post messaging intervention) minus value at baseline.

Outcome measures

Outcome measures
Measure
HPV Messaging
n=833 Participants
834 Subjects were randomized to receive one of 25 experimental messages about HPV vaccination
Control Messaging
n=162 Participants
164 Subjects received a control message not about HPV vaccination.
Change in Attitudes About HPV Vaccine
.16 units on a scale
Standard Deviation .92
-.08 units on a scale
Standard Deviation .91

SECONDARY outcome

Timeframe: Ore test immediately before viewing message and post- test immediately after viewing message. Approximately one hour.

Population: A sub-group of parents of 9-14 year old children who had not been vaccinated were asked on pre- and post-test: How likely is it that she/he will receive the HPV vaccine in the next 12 months? Responses range form 1 (very likely) to 5 (not very likely).

A sub-group of parents of 9-14 year old children who had not been vaccinated were asked on pre- and post-test: How likely is it that she/he will receive the HPV vaccine in the next 12 months? Responses range form 1 (very likely) to 5 (not very likely). HPV vaccination behavioral intent change scores were calculated by subtracting pre- and post- test values. It is a negative-value scale, in which smaller values indicate more positive attitude change after exposure to the viewed message.

Outcome measures

Outcome measures
Measure
HPV Messaging
n=155 Participants
834 Subjects were randomized to receive one of 25 experimental messages about HPV vaccination
Control Messaging
n=34 Participants
164 Subjects received a control message not about HPV vaccination.
Behavioral Intention to Vaccinate Their Child With HPV Vaccine
-.022 units on a scale
Standard Deviation .81
-.06 units on a scale
Standard Deviation .92

Adverse Events

HPV Messaging

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control Message

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

Dr. Ardis Olson

Norris Cotton Cancer Center

Phone: 603-643-2385

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place