Human Papilloma VirusNCT03709602
SDH of HPV Vaccine Completion
An observational study of Human Papilloma Virus, run by Duke University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Human Papilloma Virus
- Type of treatment
- Vaccines
- How many people
- 3,076 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2019to 17 Dec 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Adolescents ages 11 to 14 years and their parent from Duke University Primary Care Pediatrics at Roxboro Road.
Who may be able to join
- 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.
Who cannot join
- Parents with cognitive impairment.
- Adolescents with cognitive impairment.
- Adolescents emancipated from their parents or legal guardian
- Pregnant adolescent girls.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Primary Care Pediatrics at Roxboro Road
Durham, North Carolina, 27704
About this study
Official title: Social Determinants of HPV Vaccine Completion Among Adolescents
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.
- Conditions
- Human Papilloma Virus
- Keywords
- HPV, adolescents, HPV Vaccine, social determinants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 14 months
Secondary outcomes (1)
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.
Measured: within 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start7 Jan 2019
- Primary completion17 Dec 2019
- Study completion17 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Human Papilloma VirusStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 3,076 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rosa Gonzalez-Guarda, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03709602
- Sponsor's protocol ID
- Pro00100733
- Status last verified
- Aug 2020
- First submitted
- 15 Oct 2018
- Last updated
- 1 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Determinants of HPV Vaccine Completion Among Adolescents
- ClinicalTrials.gov ID
- NCT03709602
- Acronym / sponsor ID
- Pro00100733
- Conditions
- Human Papilloma Virus
- Keywords
- HPV, adolescents, HPV Vaccine, social determinants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,076 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 17 Dec 2019 (actual)
- Study completion
- 17 Dec 2019 (actual)
- First posted
- 17 Oct 2018 (actual)
- Results
- Posted 1 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Adolescents ages 11 to 14 years and their parent from Duke University Primary Care Pediatrics at Roxboro Road.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Parents with cognitive impairment.
- Adolescents with cognitive impairment.
- Adolescents emancipated from their parents or legal guardian
- Pregnant adolescent girls.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall HPV Vaccine Completion Rates
Time frame: 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.
1 secondary outcome
HPV Vaccine Completion Within 14-Months
Time frame: within 14 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosa Gonzalez-Guarda, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Papilloma Virus, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall HPV Vaccine Completion Rates (time frame: up to 14 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2020; AzTrials last refreshed its copy on 30 Oct 2026.