Human Papilloma Virus
Conditions
Keywords
HPV, adolescents, HPV Vaccine, social determinants
Brief summary
The purpose of this research study is to find out which factors influence parents' ability to complete the human papillomavirus (HPV) vaccine series for their child. The information learned from this study may help the investigators develop programs to improve HPV vaccine completion rates among adolescents and reduce barriers to receiving the second shot of the vaccine series.
Interventions
None listed
Sponsors
Duke University
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Inclusion criteria
* For adolescents, participants need to be between the ages 11 to 14 years. * Received 1 dose of the HPV vaccine series between January 2017 and December 2017. * For parents, there is no age limit required. * Parents as defined as the adolescent's biological mother or father, step-parents, or legal guardian. * Parents or legal guardians who self-identified as the primary caregiver of the adolescent child and most likely to make medical decisions for the adolescent.
Exclusion criteria
* Parents with cognitive impairment. * Adolescents with cognitive impairment. * Adolescents emancipated from their parents or legal guardian * Pregnant adolescent girls.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall HPV Vaccine Completion Rates | up to 14 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HPV Vaccine Completion Within 14-Months | within 14 months | 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. |
Countries
United States
Participant flow
Recruitment details
32 participants were recruited for the qualitative portion of the study to participate in interviews (n = 16 parents, n = 16 adolescents)
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 did not receive two vaccine doses). Qualitative sample. | 16 |
| 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. | 16 |
| 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. | 3,044 |
| Total | 3,076 |
Baseline characteristics
| Characteristic | Adolescents Ages 11 to 14 Years | Parent of Adolescents | Cohort of Adolescents From Electronic Health Record (EHR) | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 16 Participants | 0 Participants | 3044 Participants | 3060 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 16 Participants | 0 Participants | 16 Participants |
| Age, Continuous | 12 years | 43 years | 12.1 years | NA years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 5 Participants | 215 Participants | 225 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants | 11 Participants | 2653 Participants | 2675 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 176 Participants | 176 Participants |
| HPV vaccine completion status Completers | 8 Participants | 8 Participants | 1961 Participants | 1977 Participants |
| HPV vaccine completion status Non-Completers | 8 Participants | 8 Participants | 1083 Participants | 1099 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 12 Participants | 12 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 118 Participants | 118 Participants |
| Race/Ethnicity, Customized Hispanic Other | 4 Participants | 4 Participants | 131 Participants | 139 Participants |
| Race/Ethnicity, Customized Hispanic White | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized More than one race | 2 Participants | 1 Participants | 82 Participants | 85 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Non Hispanic Black or African American | 6 Participants | 5 Participants | 965 Participants | 976 Participants |
| Race/Ethnicity, Customized Non-Hispanic Other | 0 Participants | 0 Participants | 33 Participants | 33 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 3 Participants | 5 Participants | 1441 Participants | 1449 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 0 Participants | 0 Participants | 176 Participants | 176 Participants |
| Region of Enrollment United States | 16 Participants | 16 Participants | 3044 Participants | 3076 Participants |
| Sex: Female, Male Female | 9 Participants | 16 Participants | 1492 Participants | 1517 Participants |
| Sex: Female, Male Male | 7 Participants | 0 Participants | 1552 Participants | 1559 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 16 |
| other Total, other adverse events | 0 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 |
Outcome results
Primary
Overall HPV Vaccine Completion Rates
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.
Time frame: up to 14 months
Population: Vaccine completion rates were only analyzed for the quantitative sample of adolescents using the EHR data (N=3044).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort of Adolescents From Electronic Health Record (EHR) | Overall HPV Vaccine Completion Rates | Completers | 1961 Participants |
| Cohort of Adolescents From Electronic Health Record (EHR) | Overall HPV Vaccine Completion Rates | Non-Completers | 1083 Participants |
Secondary
HPV Vaccine Completion Within 14-Months
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.
Time frame: within 14 months
Population: Vaccine completion rates were only analyzed for the quantitative sample of adolescents using the EHR data (N=3044).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort of Adolescents From Electronic Health Record (EHR) | HPV Vaccine Completion Within 14-Months | 1637 Participants |