Trial Outcomes & Findings for Educational Intervention to Minimize Disparities in Humanpapillomavirus Vaccination (NCT NCT02145156)

Results Overview

This outcome describes the number of young adult participants between the ages of 18-26 who received any dose of the HPV vaccine during the study period.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1294 participants

Primary outcome timeframe

16 months

Results posted on

2017-06-26

Participant Flow

Parent and young adult participants were recruited between June of 2014 and September of 2015 from one of five family health care clinics. Enrollment for the study was facilitated by 1) self-referral (passive recruitment), and 2) approach by research assistants (active recruitment).

Eligibility: 1. Parents of an adolescent between the ages of 9-17; OR a young adult patient between the ages of 18-26; 2. Adolescent/young adult has not yet received all three doses of the HPV vaccine; 3. Parent/young adult can read and converse in either English or Spanish

Participant milestones

Participant milestones
Measure	Tailored Intervention Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey. Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented.	Untailored Intervention Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers. Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV "Vaccine Information Sheet" that has been created by the Centers for Disease Control and Prevention.	Usual Care Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey. Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed.
Overall Study STARTED	430	425	439
Overall Study COMPLETED	370	373	398
Overall Study NOT COMPLETED	60	52	41

Reasons for withdrawal

Reasons for withdrawal
Measure	Tailored Intervention Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey. Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented.	Untailored Intervention Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers. Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV "Vaccine Information Sheet" that has been created by the Centers for Disease Control and Prevention.	Usual Care Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey. Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed.
Overall Study No match to vaccination records	60	52	41

Baseline Characteristics

Row population differs from overall, because young adult and adolescent groups were analyzed separately.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tailored Intervention n=430 Participants Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey. Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented.	Untailored Intervention n=425 Participants Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers. Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV "Vaccine Information Sheet" that has been created by the Centers for Disease Control and Prevention.	Usual Care n=439 Participants Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey. Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed.	Total n=1294 Participants Total of all reporting groups
Age, Continuous Young Adults	22 Years n=143 Participants • Row population differs from overall, because young adult and adolescent groups were analyzed separately.	23 Years n=151 Participants • Row population differs from overall, because young adult and adolescent groups were analyzed separately.	23 Years n=152 Participants • Row population differs from overall, because young adult and adolescent groups were analyzed separately.	22 Years n=446 Participants • Row population differs from overall, because young adult and adolescent groups were analyzed separately.
Age, Continuous Adolescents	12 Years n=287 Participants • Row population differs from overall, because young adult and adolescent groups were analyzed separately.	12 Years n=274 Participants • Row population differs from overall, because young adult and adolescent groups were analyzed separately.	12 Years n=287 Participants • Row population differs from overall, because young adult and adolescent groups were analyzed separately.	12 Years n=848 Participants • Row population differs from overall, because young adult and adolescent groups were analyzed separately.
Sex/Gender, Customized Female Young Adults	143 participants n=143 Participants • Row population differs from overall because young adults and adolescents were analyzed separately.	151 participants n=151 Participants • Row population differs from overall because young adults and adolescents were analyzed separately.	152 participants n=152 Participants • Row population differs from overall because young adults and adolescents were analyzed separately.	446 participants n=446 Participants • Row population differs from overall because young adults and adolescents were analyzed separately.
Sex/Gender, Customized Male Young Adults	0 participants n=430 Participants • Row population differs from overall because young adults and adolescents were analyzed separately.	0 participants n=425 Participants • Row population differs from overall because young adults and adolescents were analyzed separately.	0 participants n=439 Participants • Row population differs from overall because young adults and adolescents were analyzed separately.	0 participants n=1294 Participants • Row population differs from overall because young adults and adolescents were analyzed separately.
Sex/Gender, Customized Female Adolescents	143 participants n=287 Participants • Row population differs from overall because young adults and adolescents were analyzed separately.	133 participants n=274 Participants • Row population differs from overall because young adults and adolescents were analyzed separately.	139 participants n=287 Participants • Row population differs from overall because young adults and adolescents were analyzed separately.	415 participants n=848 Participants • Row population differs from overall because young adults and adolescents were analyzed separately.
Sex/Gender, Customized Male Adolescents	144 participants n=287 Participants • Row population differs from overall because young adults and adolescents were analyzed separately.	141 participants n=274 Participants • Row population differs from overall because young adults and adolescents were analyzed separately.	148 participants n=287 Participants • Row population differs from overall because young adults and adolescents were analyzed separately.	433 participants n=848 Participants • Row population differs from overall because young adults and adolescents were analyzed separately.
Race/Ethnicity, Customized Self-Identify Hispanic Young Adults	123 Participants n=143 Participants • Row population differs from overall because young adults and adolescents were analyzed separately.	127 Participants n=151 Participants • Row population differs from overall because young adults and adolescents were analyzed separately.	130 Participants n=152 Participants • Row population differs from overall because young adults and adolescents were analyzed separately.	380 Participants n=446 Participants • Row population differs from overall because young adults and adolescents were analyzed separately.
Race/Ethnicity, Customized Self-Identify Hispanic Adolescents	266 Participants n=287 Participants • Row population differs from overall because young adults and adolescents were analyzed separately.	254 Participants n=274 Participants • Row population differs from overall because young adults and adolescents were analyzed separately.	269 Participants n=287 Participants • Row population differs from overall because young adults and adolescents were analyzed separately.	789 Participants n=848 Participants • Row population differs from overall because young adults and adolescents were analyzed separately.
Race/Ethnicity, Customized White Non-Hispanic Young Adults	17 Participants n=143 Participants • Row population differs from overall because young adults and adolescents were analyzed separately.	20 Participants n=151 Participants • Row population differs from overall because young adults and adolescents were analyzed separately.	19 Participants n=152 Participants • Row population differs from overall because young adults and adolescents were analyzed separately.	56 Participants n=446 Participants • Row population differs from overall because young adults and adolescents were analyzed separately.
Race/Ethnicity, Customized Other Race Young Adults	3 Participants n=143 Participants • Row population differs from overall because young adults and adolescents were analyzed separately.	4 Participants n=151 Participants • Row population differs from overall because young adults and adolescents were analyzed separately.	3 Participants n=152 Participants • Row population differs from overall because young adults and adolescents were analyzed separately.	10 Participants n=446 Participants • Row population differs from overall because young adults and adolescents were analyzed separately.
Race/Ethnicity, Customized White Non-Hispanic Adolescents	18 Participants n=287 Participants • Row population differs from overall because young adults and adolescents were analyzed separately.	19 Participants n=274 Participants • Row population differs from overall because young adults and adolescents were analyzed separately.	17 Participants n=287 Participants • Row population differs from overall because young adults and adolescents were analyzed separately.	54 Participants n=848 Participants • Row population differs from overall because young adults and adolescents were analyzed separately.
Race/Ethnicity, Customized Other Race Adolescents	3 Participants n=287 Participants • Row population differs from overall because young adults and adolescents were analyzed separately.	1 Participants n=274 Participants • Row population differs from overall because young adults and adolescents were analyzed separately.	1 Participants n=287 Participants • Row population differs from overall because young adults and adolescents were analyzed separately.	5 Participants n=848 Participants • Row population differs from overall because young adults and adolescents were analyzed separately.
Region of Enrollment United States	430 participants n=430 Participants	425 participants n=425 Participants	439 participants n=439 Participants	1294 participants n=1294 Participants

PRIMARY outcome

Timeframe: 16 months

Population: Includes young adults in the sample who could be matched to vaccination data and had not received all 3 doses of the HPV vaccine prior to baseline.

This outcome describes the number of young adult participants between the ages of 18-26 who received any dose of the HPV vaccine during the study period.

Outcome measures

Outcome measures
Measure	Tailored Intervention n=143 Participants Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey. Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented.	Untailored Intervention n=151 Participants Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers. Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV "Vaccine Information Sheet" that has been created by the Centers for Disease Control and Prevention.	Usual Care n=152 Participants Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey. Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed.
Number of Young Adults Who Received Any Dose of the HPV Vaccine During the Study Period	8 participants	9 participants	3 participants

PRIMARY outcome

Timeframe: 16 months

Population: Includes young adults in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0 doses of the HPV vaccine prior to baseline.

This outcome describes the number of young adult participants between the ages of 18-26 who had 0 doses of the HPV vaccine at study enrollment and received at least one dose during the study period.

Outcome measures

Outcome measures
Measure	Tailored Intervention n=87 Participants Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey. Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented.	Untailored Intervention n=110 Participants Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers. Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV "Vaccine Information Sheet" that has been created by the Centers for Disease Control and Prevention.	Usual Care n=106 Participants Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey. Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed.
Number of Young Adults Who Initiated the HPV Vaccine Series During the Study Period	7 participants	4 participants	3 participants

PRIMARY outcome

Timeframe: 16 months

Population: Includes young adults in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0 doses of the HPV vaccine prior to baseline and did not complete the vaccine series during the study period.

This outcome describes the number of young adult participants between the ages of 18-26 who had 0 doses of the HPV vaccine at study enrollment and did not complete the vaccine series during the study period.

Outcome measures

Outcome measures
Measure	Tailored Intervention n=11 Participants Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey. Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented.	Untailored Intervention n=12 Participants Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers. Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV "Vaccine Information Sheet" that has been created by the Centers for Disease Control and Prevention.	Usual Care n=11 Participants Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey. Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed.
Number of Young Adults Who Initiated But Did Not Complete the HPV Vaccine Series During the Study Period	9 participants	12 participants	6 participants

PRIMARY outcome

Timeframe: 16 months

Population: Includes young adults in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0, 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.

This outcome describes the number of young adult participants between the ages of 18-26 who had 0, 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.

Outcome measures

Outcome measures
Measure	Tailored Intervention n=100 Participants Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey. Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented.	Untailored Intervention n=120 Participants Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers. Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV "Vaccine Information Sheet" that has been created by the Centers for Disease Control and Prevention.	Usual Care n=117 Participants Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey. Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed.
Number of Young Adults, Among All Eligible, Who Completed the HPV Vaccine Series During the Study Period	1 participants	4 participants	2 participants

PRIMARY outcome

Timeframe: 16 months

Population: Includes young adults in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.

This outcome describes the number of young adult participants between the ages of 18-26 who had 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.

Outcome measures

Outcome measures
Measure	Tailored Intervention n=31 Participants Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey. Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented.	Untailored Intervention n=36 Participants Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers. Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV "Vaccine Information Sheet" that has been created by the Centers for Disease Control and Prevention.	Usual Care n=42 Participants Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey. Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed.
Number of Young Adults Who Completed the HPV Vaccine Series During the Study Period, Among Those Who Initiated the Series at Study Start	0 participants	4 participants	0 participants

PRIMARY outcome

Timeframe: 16 months

Population: Includes young adults in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.

This outcome describes the number of young adult participants between the ages of 18-26 who had 0 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.

Outcome measures

Outcome measures
Measure	Tailored Intervention n=11 Participants Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey. Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented.	Untailored Intervention n=12 Participants Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers. Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV "Vaccine Information Sheet" that has been created by the Centers for Disease Control and Prevention.	Usual Care n=11 Participants Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey. Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed.
Number of Young Adults Who Completed the HPV Vaccine Series Among Those Who Initiated the Series During the Study Period	2 participants	0 participants	5 participants

PRIMARY outcome

Timeframe: 16 months

Population: Includes adolescents in the sample who could be matched to vaccination data and had not received all 3 doses of the HPV vaccine prior to baseline.

This outcome describes the number of adolescent participants between the ages of 9-17 who received any dose of the HPV vaccine during the study period.

Outcome measures

Outcome measures
Measure	Tailored Intervention n=287 Participants Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey. Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented.	Untailored Intervention n=274 Participants Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers. Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV "Vaccine Information Sheet" that has been created by the Centers for Disease Control and Prevention.	Usual Care n=287 Participants Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey. Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed.
Number of Adolescents Who Received Any Dose of the HPV Vaccine During the Study Period	124 participants	122 participants	121 participants

PRIMARY outcome

Timeframe: 16 months

Population: Includes adolescents in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0 doses of the HPV vaccine prior to baseline.

This outcome describes the number of adolescent participants between the ages of 9-17 who had 0 doses of the HPV vaccine at study enrollment and received at least one dose during the study period.

Outcome measures

Outcome measures
Measure	Tailored Intervention n=187 Participants Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey. Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented.	Untailored Intervention n=174 Participants Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers. Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV "Vaccine Information Sheet" that has been created by the Centers for Disease Control and Prevention.	Usual Care n=197 Participants Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey. Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed.
Number of Adolescents Who Initiated the HPV Vaccine Series During the Study Period	74 participants	73 participants	75 participants

PRIMARY outcome

Timeframe: 16 months

Population: Includes adolescents in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0 doses of the HPV vaccine prior to baseline and did not complete the vaccine series during the study period.

This outcome describes the number of adolescent participants between the ages of 9-17 who had 0 doses of the HPV vaccine at study enrollment and did not complete the vaccine series during the study period.

Outcome measures

Outcome measures
Measure	Tailored Intervention n=103 Participants Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey. Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented.	Untailored Intervention n=106 Participants Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers. Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV "Vaccine Information Sheet" that has been created by the Centers for Disease Control and Prevention.	Usual Care n=125 Participants Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey. Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed.
Number of Adolescents Who Initiated But Did Not Complete the HPV Vaccine Series During the Study Period	79 participants	93 participants	89 participants

PRIMARY outcome

Timeframe: 16 months

Population: Includes adolescents in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0, 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.

This outcome describes the number of adolescent participants between the ages of 9-17 who had 0, 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.

Outcome measures

Outcome measures
Measure	Tailored Intervention n=233 Participants Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey. Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented.	Untailored Intervention n=229 Participants Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers. Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV "Vaccine Information Sheet" that has been created by the Centers for Disease Control and Prevention.	Usual Care n=241 Participants Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey. Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed.
Number of Adolescents, Among All Eligible, Who Completed the HPV Vaccine Series During the Study Period	54 participants	39 participants	48 participants

PRIMARY outcome

Timeframe: 16 months

Population: Includes adolescents in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.

This outcome describes the number of adolescent participants between the ages of 9-17 who had 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.

Outcome measures

Outcome measures
Measure	Tailored Intervention n=140 Participants Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey. Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented.	Untailored Intervention n=145 Participants Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers. Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV "Vaccine Information Sheet" that has been created by the Centers for Disease Control and Prevention.	Usual Care n=165 Participants Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey. Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed.
Number of Adolescents Who Completed the HPV Vaccine Series During the Study Period, Among Those Who Initiated the Series at Study Start	59 participants	41 participants	55 participants

PRIMARY outcome

Timeframe: 16 months

Population: Includes adolescents in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.

This outcome describes the number of adolescent participants between the ages of 9-17 who had 0 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.

Outcome measures

Outcome measures
Measure	Tailored Intervention n=103 Participants Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey. Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented.	Untailored Intervention n=106 Participants Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers. Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV "Vaccine Information Sheet" that has been created by the Centers for Disease Control and Prevention.	Usual Care n=125 Participants Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey. Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed.
Number of Adolescents Who Completed the HPV Vaccine Series Among Those Who Initiated the Series During the Study Period	24 participants	13 participants	36 participants

Adverse Events

Tailored Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Untailored Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

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

Julie A. Maertens

University of Colorado Denver

Phone: 303-724-7319

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place