Patient Decision Aid Tool for HPV Vaccination Among Adults Ages 27-45 Years Old

NCT06435338 | Completed

• 1 other identifier: 100257
• Study Type: interventional
• Target: 632
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to learn if a patient decision tool for HPV vaccination works for decision-making among adults ages 27-45. Researchers will compare a web-based patient decision tool to an information sheet to see if the tool works for decision-making. Participants will take a baseline survey, view the intervention or control condition, and then take a follow-up survey.

Conditions

Decision Aid; Hpv

Outcome Measures

Primary Outcomes (2)

• Decisional conflict - 16 item scale

  This scale has 16 items and 5 response categories. The decisional conflict scale (DCS) measures personal perceptions of: uncertainty in choosing options; modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making; and effective decision making (in full version) such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice. The scores ranged from 0 "no conflict" to 100 "extreme decisional conflict."

  Immediate post-test

• Decisional conflict - 4 item scale

  Decision conflict scale recommended for every day clinical practice. It has 4 items and two response categories. Scores range from 0 \[extremely high decisional conflict\] to 4 \[no decisional conflict\].

  Immediate post-test

Secondary Outcomes (6)

• Knowledge

  Immediate post-test

• Intentions

  Immediate post-test

• Decision

  Immediate post-test

• Perceived expectation

  Immediate post-test

• Perceived risk

  Immediate post-test

Study Arms (2)

Patient decision aid

EXPERIMENTAL

Patient decision aid on HPV vaccination on webpage.

Behavioral: Patient decision aid

Control

ACTIVE COMPARATOR

Vaccine information sheet on HPV vaccination view on webpage.

Behavioral: Control

Interventions

Patient decision aid BEHAVIORAL

The patient decision aid for HPV vaccination among mid-adults, named HPV Decide. It is delivered online on a website.

Patient decision aid

Control BEHAVIORAL

Vaccine information sheet on HPV vaccination. Attention control condition.

Control

Eligibility Criteria

• Age: 27 Years - 45 Years
• Gender Eligibility Details: Cis-gender male or female only due to randomization stratification
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Unvaccinated for HPV
• years
• Resides in the United States
• Reads English
• Consents to participate

You may not qualify if:

• none

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• University of North Texas Health Science Center: collaborator
• University of South Florida: collaborator
• Temple University: collaborator
• Indiana University School of Medicine: collaborator
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

UT School of Public Health San Antonio

San Antonio, Texas, 78229, United States

Location

Related Publications (5)

• O'Connor AM. User Manual - Decisional Conflict Scale (16 item question format). Ottawa: Ottawa Hospital Research Institute. 1993. http://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_Decisional_Conflict.pdf

  BACKGROUND

• Legare F, Kearing S, Clay K, Gagnon S, D'Amours D, Rousseau M, O'Connor A. Are you SURE?: Assessing patient decisional conflict with a 4-item screening test. Can Fam Physician. 2010 Aug;56(8):e308-14.

  PMID: 20705870 BACKGROUND

• O'Connor AM. User Manual - Decision Self-Efficacy Scale. Ottawa: Ottawa Hospital Research Institute. 1993. http://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_Decision_SelfEfficacy.pdf

  BACKGROUND

• Garg A, Wheldon CW, Galvin AM, Moore JD, Griner SB, Thompson EL. The Development and Psychometric Evaluation of the Mid-adult Human Papillomavirus Vaccine Knowledge Scale in the United States. Sex Transm Dis. 2022 Jun 1;49(6):423-428. doi: 10.1097/OLQ.0000000000001615. Epub 2022 Feb 8.

  PMID: 35608097 BACKGROUND

• Thompson EL, Luningham J, Alkhatib SA, Grace J, Akpan IN, Daley EM, Zimet GD, Wheldon CW. Testing an HPV Vaccine Decision Aid for 27- to 45-Year-Old Adults in the United States: A Randomized Trial. Med Decis Making. 2025 Feb;45(2):192-204. doi: 10.1177/0272989X241305142. Epub 2024 Dec 24.

  PMID: 39717960 DERIVED

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: May 30, 2024
• Study Start: December 13, 2023
• Primary Completion: January 18, 2024
• Study Completion: January 18, 2024
• Last Updated: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)