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An Evaluation of Tailored Messages to Address Parental Questions About HPV Vaccination

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ClinicalTrials.gov Identifier: NCT03628885
Recruitment Status : Completed
First Posted : August 14, 2018
Results First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Indiana University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions Human Papilloma Virus Vaccines
Attitude to Health
Interventions Behavioral: Top Concern Tailored Intervention
Behavioral: All Concerns Tailored Intervention
Enrollment 908
Recruitment Details  
Pre-assignment Details  
Arm/Group Title General Vaccine Information Top Concern Tailored Intervention All Concerns Tailored Intervention
Hide Arm/Group Description Brief (47 second) animated informational video about vaccines recommended for all young adolescents.

Intervention includes the General Vaccine Information video plus a brief (< 50 sec) animated video address the parent's top ranked question or concern from the provided list of possible concerns: 1. "I need more information about the vaccine"; 2. "My child is too young"; 3. "I am concerned about the long-term health effects or safety of the vaccine"; 4. "My child's health care provider did not recommend it or said my child could wait"; 5. "The vaccine is not required for school"; 6. "Other / none of the above". For those indicating #6, they will receive the same video as those indicating #1 (need more information).

Top Concern Tailored Intervention: General Vaccine Information video plus a brief (< 50 sec) animated video address the parent's top ranked question or concern from the provided list of possible concerns.

Intervention includes the General Vaccine Information video plus one or more brief (< 50 sec) animated videos that address all of the parent's indicated question or concern from the provided list of possible concerns: 1. "I need more information about the vaccine"; 2. "My child is too young"; 3. "I am concerned about the long-term health effects or safety of the vaccine"; 4. "My child's health care provider did not recommend it or said my child could wait"; 5. "The vaccine is not required for school"; 6. "Other / none of the above".

All Concerns Tailored Intervention: General Vaccine Information video plus one or more brief (< 50 sec) animated videos that address all of the parent's indicated question or concern from the provided list of possible concerns.

Period Title: Overall Study
Started 306 299 303
Completed 267 252 243
Not Completed 39 47 60
Arm/Group Title General Vaccine Information Top Concern Tailored Intervention All Concerns Tailored Intervention Total
Hide Arm/Group Description Brief (47 second) animated informational video about vaccines recommended for all young adolescents.

Intervention includes the General Vaccine Information video plus a brief (< 50 sec) animated video address the parent's top ranked question or concern from the provided list of possible concerns: 1. "I need more information about the vaccine"; 2. "My child is too young"; 3. "I am concerned about the long-term health effects or safety of the vaccine"; 4. "My child's health care provider did not recommend it or said my child could wait"; 5. "The vaccine is not required for school"; 6. "Other / none of the above". For those indicating #6, they will receive the same video as those indicating #1 (need more information).

Top Concern Tailored Intervention: General Vaccine Information video plus a brief (< 50 sec) animated video address the parent's top ranked question or concern from the provided list of possible concerns.

Intervention includes the General Vaccine Information video plus one or more brief (< 50 sec) animated videos that address all of the parent's indicated question or concern from the provided list of possible concerns: 1. "I need more information about the vaccine"; 2. "My child is too young"; 3. "I am concerned about the long-term health effects or safety of the vaccine"; 4. "My child's health care provider did not recommend it or said my child could wait"; 5. "The vaccine is not required for school"; 6. "Other / none of the above".

All Concerns Tailored Intervention: General Vaccine Information video plus one or more brief (< 50 sec) animated videos that address all of the parent's indicated question or concern from the provided list of possible concerns.

Total of all reporting groups
Overall Number of Baseline Participants 306 299 303 908
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 306 participants 299 participants 303 participants 908 participants
21-25 years old
0
   0.0%
1
   0.3%
1
   0.3%
2
   0.2%
25-30 years old
15
   4.9%
13
   4.3%
12
   4.0%
40
   4.4%
31-35 years old
72
  23.5%
64
  21.4%
55
  18.2%
191
  21.0%
36-40 years old
84
  27.5%
72
  24.1%
67
  22.1%
223
  24.6%
41-45 years old
63
  20.6%
75
  25.1%
70
  23.1%
208
  22.9%
46-50 years old
39
  12.7%
38
  12.7%
41
  13.5%
118
  13.0%
51-55 years old
16
   5.2%
16
   5.4%
23
   7.6%
55
   6.1%
56-60 years old
5
   1.6%
5
   1.7%
11
   3.6%
21
   2.3%
61-65 years old
2
   0.7%
3
   1.0%
1
   0.3%
6
   0.7%
66-70 years old
2
   0.7%
2
   0.7%
1
   0.3%
5
   0.6%
70-75 years old
0
   0.0%
1
   0.3%
1
   0.3%
2
   0.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Female Number Analyzed 306 participants 299 participants 303 participants 908 participants
Female
306
 100.0%
299
 100.0%
303
 100.0%
908
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 306 participants 299 participants 303 participants 908 participants
Non-Hispanic White
217
  70.9%
225
  75.3%
233
  76.9%
675
  74.3%
Non-Hispanic Black
31
  10.1%
16
   5.4%
20
   6.6%
67
   7.4%
Non-Hispanic Other
28
   9.2%
33
  11.0%
37
  12.2%
98
  10.8%
Hispanic
30
   9.8%
25
   8.4%
13
   4.3%
68
   7.5%
Child's Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 306 participants 299 participants 303 participants 908 participants
Females
153
  50.0%
152
  50.8%
155
  51.2%
460
  50.7%
Males
153
  50.0%
147
  49.2%
148
  48.8%
448
  49.3%
Child's Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 306 participants 299 participants 303 participants 908 participants
12.28  (1.12) 12.33  (1.15) 12.60  (1.15) 12.40  (1.15)
1.Primary Outcome
Title Intention to Vaccinate Against HPV in the Next 12 Months
Hide Description Each parent will be asked to respond to this question. The response will be scaled from 1-10 in terms of parental intent regarding vaccination, with higher scores meaning greater parental intent to vaccinate children.
Time Frame Immediately after video intervention has been administered
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title General Vaccine Information Top Concern Tailored Intervention All Concerns Tailored Intervention
Hide Arm/Group Description:
Brief (47 second) animated informational video about vaccines recommended for all young adolescents.

Intervention includes the General Vaccine Information video plus a brief (< 50 sec) animated video address the parent's top ranked question or concern from the provided list of possible concerns: 1. "I need more information about the vaccine"; 2. "My child is too young"; 3. "I am concerned about the long-term health effects or safety of the vaccine"; 4. "My child's health care provider did not recommend it or said my child could wait"; 5. "The vaccine is not required for school"; 6. "Other / none of the above". For those indicating #6, they will receive the same video as those indicating #1 (need more information).

Top Concern Tailored Intervention: General Vaccine Information video plus a brief (< 50 sec) animated video address the parent's top ranked question or concern from the provided list of possible concerns.

Intervention includes the General Vaccine Information video plus one or more brief (< 50 sec) animated videos that address all of the parent's indicated question or concern from the provided list of possible concerns: 1. "I need more information about the vaccine"; 2. "My child is too young"; 3. "I am concerned about the long-term health effects or safety of the vaccine"; 4. "My child's health care provider did not recommend it or said my child could wait"; 5. "The vaccine is not required for school"; 6. "Other / none of the above".

All Concerns Tailored Intervention: General Vaccine Information video plus one or more brief (< 50 sec) animated videos that address all of the parent's indicated question or concern from the provided list of possible concerns.

Overall Number of Participants Analyzed 267 252 243
Mean (95% Confidence Interval)
Unit of Measure: score on a scale
3.49
(3.2 to 3.8)
3.87
(3.6 to 4.2)
4.16
(3.8 to 4.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection General Vaccine Information, Top Concern Tailored Intervention, All Concerns Tailored Intervention
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.02
Comments Adjusted for mother's educational level, which differed across groups. A priori threshold for statistical significance = P<.05
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection General Vaccine Information, Top Concern Tailored Intervention
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =.07
Comments Adjusted for mother's educational level, which differed across groups. A priori threshold for statistical significance = P<.05
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection General Vaccine Information, All Concerns Tailored Intervention
Comments Adjusted for mother's educational level, which differed across groups. A priori threshold for statistical significance = P<.05
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.01
Comments Adjusted for mother's educational level, which differed across groups. A priori threshold for statistical significance = P<.05
Method ANOVA
Comments [Not Specified]
Time Frame 20 minutes
Adverse Event Reporting Description This study involved participants completing a 20 minute online survey. Therefore, there was zero risk for either mortality or serious adverse events.
 
Arm/Group Title General Vaccine Information Top Concern Tailored Intervention All Concerns Tailored Intervention
Hide Arm/Group Description Brief (47 second) animated informational video about vaccines recommended for all young adolescents.

Intervention includes the General Vaccine Information video plus a brief (< 50 sec) animated video address the parent's top ranked question or concern from the provided list of possible concerns: 1. "I need more information about the vaccine"; 2. "My child is too young"; 3. "I am concerned about the long-term health effects or safety of the vaccine"; 4. "My child's health care provider did not recommend it or said my child could wait"; 5. "The vaccine is not required for school"; 6. "Other / none of the above". For those indicating #6, they will receive the same video as those indicating #1 (need more information).

Top Concern Tailored Intervention: General Vaccine Information video plus a brief (< 50 sec) animated video address the parent's top ranked question or concern from the provided list of possible concerns.

Intervention includes the General Vaccine Information video plus one or more brief (< 50 sec) animated videos that address all of the parent's indicated question or concern from the provided list of possible concerns: 1. "I need more information about the vaccine"; 2. "My child is too young"; 3. "I am concerned about the long-term health effects or safety of the vaccine"; 4. "My child's health care provider did not recommend it or said my child could wait"; 5. "The vaccine is not required for school"; 6. "Other / none of the above".

All Concerns Tailored Intervention: General Vaccine Information video plus one or more brief (< 50 sec) animated videos that address all of the parent's indicated question or concern from the provided list of possible concerns.

All-Cause Mortality
General Vaccine Information Top Concern Tailored Intervention All Concerns Tailored Intervention
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
Show Serious Adverse Events Hide Serious Adverse Events
General Vaccine Information Top Concern Tailored Intervention All Concerns Tailored Intervention
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
General Vaccine Information Top Concern Tailored Intervention All Concerns Tailored Intervention
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/306 (0.00%)   0/299 (0.00%)   0/303 (0.00%) 
A limitation of this trial is that the outcome is intention to vaccinate, rather than actual vaccination.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Gregory Zimet
Organization: Indiana University
Phone: 3172748812
EMail: gzimet@iu.edu
Layout table for additonal information
Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT03628885     History of Changes
Other Study ID Numbers: 1807664964
First Submitted: August 7, 2018
First Posted: August 14, 2018
Results First Submitted: December 20, 2018
Results First Posted: April 2, 2019
Last Update Posted: April 2, 2019