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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | ||
| 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. | ||
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 14 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | within 14 months |
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Inclusion Criteria:
Exclusion Criteria:
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Adolescents ages 11 to 14 years and their parent from Duke University Primary Care Pediatrics at Roxboro Road.
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| Name | Affiliation | Role |
|---|---|---|
| Rosa Gonzalez-Guarda, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Primary Care Pediatrics at Roxboro Road | Durham | North Carolina | 27704 | United States |
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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.
32 participants were recruited for the qualitative portion of the study to participate in interviews (n = 16 parents, n = 16 adolescents)
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
There is no quantitative results beyond demographics for the Adolescents ages 11 to 14 years and parent of adolescents groups as this was not part of the aim of the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Vaccine completion rates were only analyzed for the quantitative sample of adolescents using the EHR data (N=3044). | Posted | Count of Participants | Participants | up to 14 months |
|
1 year
Participants in the Cohort of Adolescents From EHR group were not monitored/assessed for adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lisa Mansfield | Duke University | 919-681-9198 | lisa.mansfield@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 25, 2018 | Jun 4, 2020 | Prot_SAP_000.pdf |
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| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | 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. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| HPV vaccine completion status | Completer defined as receiving 2 or 3 vaccine doses within 14-month period determined by the CDC's vaccine administration schedule. Non-completer defined as receiving only 1 vaccine dose within 14-month period. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| 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. | Vaccine completion rates were only analyzed for the quantitative sample of adolescents using the EHR data (N=3044). | Posted | Count of Participants | Participants | within 14 months |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | 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. | 0 | 16 | 0 | 16 | 0 | 16 |
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