Trial Outcomes & Findings for SDH of HPV Vaccine Completion (NCT NCT03709602)
NCT ID: NCT03709602
Last Updated: 2020-09-01
Results Overview
Adolescents who completed the required HPV vaccine doses (e.g. two or three doses based on the CDC's vaccine administration guidelines for adolescents' ages 11 to 14 years) during the January 2017 to February 2019 observation period.
Recruitment status
COMPLETED
Target enrollment
3076 participants
Primary outcome timeframe
up to 14 months
Results posted on
2020-09-01
Participant Flow
32 participants were recruited for the qualitative portion of the study to participate in interviews (n = 16 parents, n = 16 adolescents)
Cohort of Adolescents from electronic health record group were reviewed retrospectively from January 1, 2017- February 28, 2019. Enrollment of parents and adolescents (n = 32) began on the start date of January 7, 2019.
Participant milestones
| Measure |
Adolescents Ages 11 to 14 Years
Adolescents ages 11 to 14 years who have received 1 dose of the HPV vaccine series between January 2017 and December 2017. Adolescents were stratified into two groups: Completer (defined as adolescents who received two vaccine doses within a 14-month period) and Non-Completer (defined as adolescents who received only one vaccine dose within 14-month period). Qualitative sample.
|
Parent of Adolescents
Parents as defined as the adolescent's biological mother or father, step-parents, or legal guardian, and who self-identified as the primary caregiver of the adolescent child and most likely to make medical decisions for the adolescent. Parents were stratified into two groups (Completer or Non-Completer as described in the adolescent group) based on the adolescent's vaccination status. Qualitative sample.
|
Cohort of Adolescents From Electronic Health Record (EHR)
A cohort of adolescents ages 11 to 14 who received 1 dose of the HPV vaccine from January 2017 to December 2017 within the university's health system network. The cohort was followed from January 2018 to February 2019 to assess vaccine completion within a 14-month period. Quantitative sample.
|
|---|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
3044
|
|
Overall Study
COMPLETED
|
16
|
16
|
3044
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The sample size of the cohort of adolescent group for the race variable differs from overall quantitative sample population (N=3044) because race information was not provided for some participants who reported Hispanic ethnicity.
Baseline characteristics by cohort
| Measure |
Adolescents Ages 11 to 14 Years
n=16 Participants
Adolescents ages 11 to 14 years who have received 1 dose of the HPV vaccine series between January 2017 and December 2017. Adolescents were stratified into two groups: Completer (defined as adolescents who received two vaccine doses within a 14-month period) and Non-Completer (defined as adolescents who did not receive two vaccine doses). Qualitative sample.
|
Parent of Adolescents
n=16 Participants
Parents as defined as the adolescent's biological mother or father, step-parents, or legal guardian, and who self-identified as the primary caregiver of the adolescent child and most likely to make medical decisions for the adolescent. Parents were stratified into two groups (Completer or Non-Completer as described in the adolescent group) based on the adolescent's vaccination status. Qualitative sample.
|
Cohort of Adolescents From Electronic Health Record (EHR)
n=3044 Participants
A cohort of adolescents ages 11 to 14 who received 1 dose of the HPV vaccine from January 2017 to December 2017 within the university's health system network. The cohort was followed from January 2018 to February 2019 to assess vaccine completion within a 14-month period. Quantitative sample.
|
Total
n=3076 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
16 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3044 Participants
n=27 Participants
|
3060 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
16 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Continuous
|
12 years
n=93 Participants
|
43 years
n=4 Participants
|
12.1 years
n=27 Participants
|
NA years
n=483 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
1492 Participants
n=27 Participants
|
1517 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1552 Participants
n=27 Participants
|
1559 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
215 Participants
n=27 Participants
|
225 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
2653 Participants
n=27 Participants
|
2675 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
176 Participants
n=27 Participants
|
176 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=93 Participants • The sample size of the cohort of adolescent group for the race variable differs from overall quantitative sample population (N=3044) because race information was not provided for some participants who reported Hispanic ethnicity.
|
0 Participants
n=4 Participants • The sample size of the cohort of adolescent group for the race variable differs from overall quantitative sample population (N=3044) because race information was not provided for some participants who reported Hispanic ethnicity.
|
12 Participants
n=27 Participants • The sample size of the cohort of adolescent group for the race variable differs from overall quantitative sample population (N=3044) because race information was not provided for some participants who reported Hispanic ethnicity.
|
12 Participants
n=483 Participants • The sample size of the cohort of adolescent group for the race variable differs from overall quantitative sample population (N=3044) because race information was not provided for some participants who reported Hispanic ethnicity.
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=93 Participants • The sample size of the cohort of adolescent group for the race variable differs from overall quantitative sample population (N=3044) because race information was not provided for some participants who reported Hispanic ethnicity.
|
0 Participants
n=4 Participants • The sample size of the cohort of adolescent group for the race variable differs from overall quantitative sample population (N=3044) because race information was not provided for some participants who reported Hispanic ethnicity.
|
118 Participants
n=27 Participants • The sample size of the cohort of adolescent group for the race variable differs from overall quantitative sample population (N=3044) because race information was not provided for some participants who reported Hispanic ethnicity.
|
118 Participants
n=483 Participants • The sample size of the cohort of adolescent group for the race variable differs from overall quantitative sample population (N=3044) because race information was not provided for some participants who reported Hispanic ethnicity.
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants • The sample size of the cohort of adolescent group for the race variable differs from overall quantitative sample population (N=3044) because race information was not provided for some participants who reported Hispanic ethnicity.
|
0 Participants
n=4 Participants • The sample size of the cohort of adolescent group for the race variable differs from overall quantitative sample population (N=3044) because race information was not provided for some participants who reported Hispanic ethnicity.
|
2 Participants
n=27 Participants • The sample size of the cohort of adolescent group for the race variable differs from overall quantitative sample population (N=3044) because race information was not provided for some participants who reported Hispanic ethnicity.
|
2 Participants
n=483 Participants • The sample size of the cohort of adolescent group for the race variable differs from overall quantitative sample population (N=3044) because race information was not provided for some participants who reported Hispanic ethnicity.
|
|
Race/Ethnicity, Customized
Non Hispanic Black or African American
|
6 Participants
n=93 Participants • The sample size of the cohort of adolescent group for the race variable differs from overall quantitative sample population (N=3044) because race information was not provided for some participants who reported Hispanic ethnicity.
|
5 Participants
n=4 Participants • The sample size of the cohort of adolescent group for the race variable differs from overall quantitative sample population (N=3044) because race information was not provided for some participants who reported Hispanic ethnicity.
|
965 Participants
n=27 Participants • The sample size of the cohort of adolescent group for the race variable differs from overall quantitative sample population (N=3044) because race information was not provided for some participants who reported Hispanic ethnicity.
|
976 Participants
n=483 Participants • The sample size of the cohort of adolescent group for the race variable differs from overall quantitative sample population (N=3044) because race information was not provided for some participants who reported Hispanic ethnicity.
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
3 Participants
n=93 Participants • The sample size of the cohort of adolescent group for the race variable differs from overall quantitative sample population (N=3044) because race information was not provided for some participants who reported Hispanic ethnicity.
|
5 Participants
n=4 Participants • The sample size of the cohort of adolescent group for the race variable differs from overall quantitative sample population (N=3044) because race information was not provided for some participants who reported Hispanic ethnicity.
|
1441 Participants
n=27 Participants • The sample size of the cohort of adolescent group for the race variable differs from overall quantitative sample population (N=3044) because race information was not provided for some participants who reported Hispanic ethnicity.
|
1449 Participants
n=483 Participants • The sample size of the cohort of adolescent group for the race variable differs from overall quantitative sample population (N=3044) because race information was not provided for some participants who reported Hispanic ethnicity.
|
|
Race/Ethnicity, Customized
More than one race
|
2 Participants
n=93 Participants • The sample size of the cohort of adolescent group for the race variable differs from overall quantitative sample population (N=3044) because race information was not provided for some participants who reported Hispanic ethnicity.
|
1 Participants
n=4 Participants • The sample size of the cohort of adolescent group for the race variable differs from overall quantitative sample population (N=3044) because race information was not provided for some participants who reported Hispanic ethnicity.
|
82 Participants
n=27 Participants • The sample size of the cohort of adolescent group for the race variable differs from overall quantitative sample population (N=3044) because race information was not provided for some participants who reported Hispanic ethnicity.
|
85 Participants
n=483 Participants • The sample size of the cohort of adolescent group for the race variable differs from overall quantitative sample population (N=3044) because race information was not provided for some participants who reported Hispanic ethnicity.
|
|
Race/Ethnicity, Customized
Hispanic Other
|
4 Participants
n=93 Participants • The sample size of the cohort of adolescent group for the race variable differs from overall quantitative sample population (N=3044) because race information was not provided for some participants who reported Hispanic ethnicity.
|
4 Participants
n=4 Participants • The sample size of the cohort of adolescent group for the race variable differs from overall quantitative sample population (N=3044) because race information was not provided for some participants who reported Hispanic ethnicity.
|
131 Participants
n=27 Participants • The sample size of the cohort of adolescent group for the race variable differs from overall quantitative sample population (N=3044) because race information was not provided for some participants who reported Hispanic ethnicity.
|
139 Participants
n=483 Participants • The sample size of the cohort of adolescent group for the race variable differs from overall quantitative sample population (N=3044) because race information was not provided for some participants who reported Hispanic ethnicity.
|
|
Race/Ethnicity, Customized
Hispanic White
|
1 Participants
n=93 Participants • The sample size of the cohort of adolescent group for the race variable differs from overall quantitative sample population (N=3044) because race information was not provided for some participants who reported Hispanic ethnicity.
|
1 Participants
n=4 Participants • The sample size of the cohort of adolescent group for the race variable differs from overall quantitative sample population (N=3044) because race information was not provided for some participants who reported Hispanic ethnicity.
|
0 Participants
n=27 Participants • The sample size of the cohort of adolescent group for the race variable differs from overall quantitative sample population (N=3044) because race information was not provided for some participants who reported Hispanic ethnicity.
|
2 Participants
n=483 Participants • The sample size of the cohort of adolescent group for the race variable differs from overall quantitative sample population (N=3044) because race information was not provided for some participants who reported Hispanic ethnicity.
|
|
Race/Ethnicity, Customized
Non-Hispanic Other
|
0 Participants
n=93 Participants • The sample size of the cohort of adolescent group for the race variable differs from overall quantitative sample population (N=3044) because race information was not provided for some participants who reported Hispanic ethnicity.
|
0 Participants
n=4 Participants • The sample size of the cohort of adolescent group for the race variable differs from overall quantitative sample population (N=3044) because race information was not provided for some participants who reported Hispanic ethnicity.
|
33 Participants
n=27 Participants • The sample size of the cohort of adolescent group for the race variable differs from overall quantitative sample population (N=3044) because race information was not provided for some participants who reported Hispanic ethnicity.
|
33 Participants
n=483 Participants • The sample size of the cohort of adolescent group for the race variable differs from overall quantitative sample population (N=3044) because race information was not provided for some participants who reported Hispanic ethnicity.
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 Participants
n=93 Participants • The sample size of the cohort of adolescent group for the race variable differs from overall quantitative sample population (N=3044) because race information was not provided for some participants who reported Hispanic ethnicity.
|
0 Participants
n=4 Participants • The sample size of the cohort of adolescent group for the race variable differs from overall quantitative sample population (N=3044) because race information was not provided for some participants who reported Hispanic ethnicity.
|
176 Participants
n=27 Participants • The sample size of the cohort of adolescent group for the race variable differs from overall quantitative sample population (N=3044) because race information was not provided for some participants who reported Hispanic ethnicity.
|
176 Participants
n=483 Participants • The sample size of the cohort of adolescent group for the race variable differs from overall quantitative sample population (N=3044) because race information was not provided for some participants who reported Hispanic ethnicity.
|
|
Region of Enrollment
United States
|
16 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
3044 Participants
n=27 Participants
|
3076 Participants
n=483 Participants
|
|
HPV vaccine completion status
Completers
|
8 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
1961 Participants
n=27 Participants
|
1977 Participants
n=483 Participants
|
|
HPV vaccine completion status
Non-Completers
|
8 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
1083 Participants
n=27 Participants
|
1099 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: up to 14 monthsPopulation: Vaccine completion rates were only analyzed for the quantitative sample of adolescents using the EHR data (N=3044).
Adolescents who completed the required HPV vaccine doses (e.g. two or three doses based on the CDC's vaccine administration guidelines for adolescents' ages 11 to 14 years) during the January 2017 to February 2019 observation period.
Outcome measures
| Measure |
Cohort of Adolescents From Electronic Health Record (EHR)
n=3044 Participants
A cohort of adolescents ages 11 to 14 who received 1 dose of the HPV vaccine from January 2017 to December 2017 within the university's health system network. The cohort was followed from January 2018 to February 2019 to assess vaccine completion within a 14-month period.
|
|---|---|
|
Overall HPV Vaccine Completion Rates
Completers
|
1961 Participants
|
|
Overall HPV Vaccine Completion Rates
Non-Completers
|
1083 Participants
|
SECONDARY outcome
Timeframe: within 14 monthsPopulation: Vaccine completion rates were only analyzed for the quantitative sample of adolescents using the EHR data (N=3044).
Adolescents who received the required number of doses for vaccine completion, defined as the receipt of two or three doses based on the CDC's guidelines for adolescents' ages 11 to 14 years, within 14-months from their first vaccine dose.
Outcome measures
| Measure |
Cohort of Adolescents From Electronic Health Record (EHR)
n=3044 Participants
A cohort of adolescents ages 11 to 14 who received 1 dose of the HPV vaccine from January 2017 to December 2017 within the university's health system network. The cohort was followed from January 2018 to February 2019 to assess vaccine completion within a 14-month period.
|
|---|---|
|
HPV Vaccine Completion Within 14-Months
|
1637 Participants
|
Adverse Events
Adolescents Ages 11 to 14 Years
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Parent of Adolescents
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place