Human Papilloma Virus Vaccine HesitancyNCT04667702
HPV Vaccine Hesitancy Among Indiana Youth With Cancer and Blood Diseases
An observational study of Human Papilloma Virus Vaccine Hesitancy, run by Indiana University at 1 site in United States.
Trial summary
For the identified groups of patients (survivors of childhood cancer and youth with sickle cell disease) the investigators want to better understand the barriers to, and facilitators of, HPV vaccination. Read more about this study
- Who is it for?
- Ages 9 to 75 years
- Conditions the study is for
- Human Papilloma Virus Vaccine Hesitancy
- What is being tested?
- Interviews
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 176 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2021to 5 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 9 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with sickle cell disease or cancer. Caregivers of patients with sickle cell disease or cancer. Healthcare providers of patients with sickle cell disease or cancer.
Who may be able to join
- Age 9-21 years of age for patients with sickle cell disease or cancer.
- Caregiver of patient with sickle cell disease or cancer.
- Healthcare provider of patient with sickle cell disease or cancer.
Who cannot join
- n/a
Trial locations and contacts
1 site in 1 country.
United States1 site
Riley Hospital for Children - Indiana University
Indianapolis, Indiana, 46202
About this study
For the identified groups of patients (survivors of childhood cancer and youth with sickle cell disease) the investigators want to better understand the barriers to, and facilitators of, HPV vaccination. Through HCP interviews the investigators will also assess both attitudinal and logistical obstacles to HPV vaccination. Some subspecialty HCPs may believe, for instance, that it is the primary care provider's responsibility to vaccinate or they may be unfamiliar with the requirement to enter vaccination data into CHIRP. Also, in some cases HPV vaccine may not be readily available in subspecialty clinic locations and/or subspecialty HCPs may not be Vaccines for Children (VFC) providers. Participants: the investigators will focus on two patient groups: survivors of childhood cancer, which includes children aged 9-21 years who have completed active therapy for cancer and are eligible for vaccination, and sickle cell disease, which includes children aged 9-21 years with a diagnosis of sickle cell disease. The investigators will recruit parents of children aged 9-21 years and older adolescents aged 18-21 years. For pediatric patients, the investigators selected a lower age of 9 years because HPV vaccine is licensed down to 9 years of age, and an upper limit of 21 years, as that is considered the upper bound of adolescence by the American Academy of Pediatrics. For patients 9-17 years of age, only parents will be interviewed by video or phone because parents are the vaccine decision-makers. For patients 18-21 years of age, the investigators will interview both young adults and their parents, because, while the young adult has legal decision-making capacity, in reality, the decision is frequently made jointly by the young adult and parent, and older adolescents are frequently unwilling to go against their parents' wishes. All research procedures will be conducted in English. Participants will be excluded if they have an intellectual disability or severe medical illness such that they are unable to consent or to understand the questions.
- Conditions
- Human Papilloma Virus Vaccine Hesitancy
- Being tested
- Interviews
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewsBehavioural
We will conduct a phone or virtual interview with patients with sickle cell disease or cancer, caregivers and their healthcare providers.
| Study group | Role | What they receive |
|---|---|---|
| Patient Focused Interviews | Not described Receives: Behavioral: Interviews | |
| Caregiver Focused Interviews | Not described Receives: Behavioral: Interviews | |
| Healthcare Provider Focused Interviews | Not described Receives: Behavioral: Interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccine Hesitancy 5 point Likert scale
Patients will be scored using scale: 1=strongly disagree; 2=disagree; 3=neither agree nor disagree; 4=agree; and 5=strongly agree; lower scores mean less confidence/more hesitancy; higher scores mean more confidence/less hesitancy.
Measured: 1 Day
Vaccine Hesitancy 5 point Likert scale
Caregivers will be scored using scale: 1=strongly disagree; 2=disagree; 3=neither agree nor disagree; 4=agree; and 5=strongly agree; lower scores mean less confidence/more hesitancy; higher scores mean more confidence/less hesitancy.
Measured: 1 Day
Hesitancy or Confidence of counseling or giving the HPV vaccine of health care providers
Interview Results - no scale available. Themes and descriptive.
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start4 Jan 2021
- Primary completion14 Jul 2021
- Study completion5 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papilloma Virus Vaccine HesitancyStudies of the same condition, open and under way.
- More trials run by Indiana 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott L Coven, DO, MPH, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04667702
- Sponsor's protocol ID
- 2010192007
- Status last verified
- May 2024
- First submitted
- 8 Dec 2020
- Last updated
- 8 May 2024
- Results posted
- 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 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HPV Vaccine Hesitancy Among Indiana Youth With Cancer and Blood Diseases
- ClinicalTrials.gov ID
- NCT04667702
- Acronym / sponsor ID
- 2010192007
- Conditions
- Human Papilloma Virus Vaccine Hesitancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 14 Jul 2021 (actual)
- Study completion
- 5 Jul 2022 (actual)
- First posted
- 16 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
For the identified groups of patients (survivors of childhood cancer and youth with sickle cell disease) the investigators want to better understand the barriers to, and facilitators of, HPV vaccination. Through HCP interviews the investigators will also assess both attitudinal and logistical obstacles to HPV vaccination. Some subspecialty HCPs may believe, for instance, that it is the primary care provider's responsibility to vaccinate or they may be unfamiliar with the requirement to enter vaccination data into CHIRP. Also, in some cases HPV vaccine may not be readily available in subspecialty clinic locations and/or subspecialty HCPs may not be Vaccines for Children (VFC) providers. Participants: the investigators will focus on two patient groups: survivors of childhood cancer, which includes children aged 9-21 years who have completed active therapy for cancer and are eligible for vaccination, and sickle cell disease, which includes children aged 9-21 years with a diagnosis of sickle cell disease. The investigators will recruit parents of children aged 9-21 years and older adolescents aged 18-21 years. For pediatric patients, the investigators selected a lower age of 9 years because HPV vaccine is licensed down to 9 years of age, and an upper limit of 21 years, as that is considered the upper bound of adolescence by the American Academy of Pediatrics. For patients 9-17 years of age, only parents will be interviewed by video or phone because parents are the vaccine decision-makers. For patients 18-21 years of age, the investigators will interview both young adults and their parents, because, while the young adult has legal decision-making capacity, in reality, the decision is frequently made jointly by the young adult and parent, and older adolescents are frequently unwilling to go against their parents' wishes. All research procedures will be conducted in English. Participants will be excluded if they have an intellectual disability or severe medical illness such that they are unable to consent or to understand the questions.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patient Focused Interviews | – | Behavioral: Interviews |
| Caregiver Focused Interviews | – | Behavioral: Interviews |
| Healthcare Provider Focused Interviews | – | Behavioral: Interviews |
Who may qualify
- Ages
- 9 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with sickle cell disease or cancer. Caregivers of patients with sickle cell disease or cancer. Healthcare providers of patients with sickle cell disease or cancer.
Key inclusion criteria (3 listed)
- Age 9-21 years of age for patients with sickle cell disease or cancer.
- Caregiver of patient with sickle cell disease or cancer.
- Healthcare provider of patient with sickle cell disease or cancer.
Key exclusion criteria (1 listed)
- n/a
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewsWe will conduct a phone or virtual interview with patients with sickle cell disease or cancer, caregivers and their healthcare providers. | Behavioural | Caregiver Focused Interviews, Healthcare Provider Focused Interviews, Patient Focused Interviews |
Primary outcome
Vaccine Hesitancy 5 point Likert scale
Time frame: 1 Day
Patients will be scored using scale: 1=strongly disagree; 2=disagree; 3=neither agree nor disagree; 4=agree; and 5=strongly agree; lower scores mean less confidence/more hesitancy; higher scores mean more confidence/less hesitancy.
Vaccine Hesitancy 5 point Likert scale
Time frame: 1 Day
Caregivers will be scored using scale: 1=strongly disagree; 2=disagree; 3=neither agree nor disagree; 4=agree; and 5=strongly agree; lower scores mean less confidence/more hesitancy; higher scores mean more confidence/less hesitancy.
Hesitancy or Confidence of counseling or giving the HPV vaccine of health care providers
Time frame: 1 Day
Interview Results - no scale available. Themes and descriptive.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No
Related trials for Human Papilloma Virus Vaccine Hesitancy
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Active Health Education to Increase HPV Vaccine Coverage in Youth: A Stepped-wedge, Cluster, and Randomized Trial
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Vaccine Hesitancy, run by Indiana 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 3 inclusion and 1 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 8 May 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Vaccine Hesitancy 5 point Likert scale (time frame: 1 Day). The study lists 3 primary outcomes in all. 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 8 May 2024.