HPV Vaccine Hesitancy Among Indiana Youth With Cancer and Blood Diseases

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 Overview

• Status: Completed
• Conditions: Human Papilloma Virus Vaccine Hesitancy
• Intervention / Treatment: Behavioral: Interviews

• Study Type: Observational
• Enrollment (Actual): 176

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Riley Hospital for Children - Indiana University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• n/a

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient Focused Interviews	Behavioral: Interviews; We will conduct a phone or virtual interview with patients with sickle cell disease or cancer, caregivers and their healthcare providers.
Caregiver Focused Interviews	Behavioral: Interviews; We will conduct a phone or virtual interview with patients with sickle cell disease or cancer, caregivers and their healthcare providers.
Healthcare Provider Focused Interviews	Behavioral: Interviews; We will conduct a phone or virtual interview with patients with sickle cell disease or cancer, caregivers and their healthcare providers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2021
• Primary Completion (Actual): July 14, 2021
• Study Completion (Actual): July 5, 2022

Study Registration Dates

• First Submitted: December 8, 2020
• First Submitted That Met QC Criteria: December 8, 2020
• First Posted (Actual): December 16, 2020

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Hematologic Diseases; Papilloma
• Other Study ID Numbers: 2010192007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No