HPV Vaccine Hesitancy Among Indiana Youth With Cancer and Blood Diseases

NCT04667702 | Completed

• 1 other identifier: 2010192007
• Study Type: observational
• Target: 176
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  1 Day

• Hesitancy or Confidence of counseling or giving the HPV vaccine of health care providers

  Interview Results - no scale available. Themes and descriptive.

  1 Day

Study Arms (3)

Patient Focused Interviews

Behavioral: Interviews

Caregiver Focused Interviews

Behavioral: Interviews

Healthcare Provider Focused Interviews

Behavioral: Interviews

Interventions

Interviews BEHAVIORAL

We will conduct a phone or virtual interview with patients with sickle cell disease or cancer, caregivers and their healthcare providers.

Caregiver Focused Interviews; Healthcare Provider Focused Interviews; Patient Focused Interviews

Eligibility Criteria

• Age: 9 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• n/a

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Riley Hospital for Children - Indiana University

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Interventions

Interviews as Topic

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 16, 2020
• Study Start: January 4, 2021
• Primary Completion: July 14, 2021
• Study Completion: July 5, 2022
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)