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

Hpv Clinical Trial

— HPV Decide  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06435338
• Other study ID #: 100257
• Status: Completed
• Phase: N/A
• Start date: December 13, 2023
• Est. completion date: January 18, 2024

Study information

• Verified date: May 2024
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 632
• Est. completion date: January 18, 2024
• Est. primary completion date: January 18, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 27 Years to 45 Years

Eligibility

Inclusion Criteria:

• Unvaccinated for HPV

• 27-45 years

• Resides in the United States

• Reads English

• Consents to participate

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Decision Aid
• Hpv

Intervention

Behavioral:
• Patient decision aid
The patient decision aid for HPV vaccination among mid-adults, named HPV Decide. It is delivered online on a website.
• Control
Vaccine information sheet on HPV vaccination. Attention control condition.

Locations

Country	Name	City	State
United States	UT School of Public Health San Antonio	San Antonio	Texas

Sponsors (6)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	Indiana University School of Medicine, Merck Sharp & Dohme LLC, Temple University, University of North Texas Health Science Center, University of South Florida

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Knowledge	16-item knowledge item related to human papillomavirus and human papillomavirus vaccination. Scale from 0 [low knowledge] to 16 [high knowledge].	Immediate post-test
Secondary	Intentions	Intentions for information seeking, talking to a healthcare provider, and getting vaccinated	Immediate post-test
Secondary	Decision	Vaccine decision, including decide to get vaccinated, unsure, and decided not to get vaccinated	Immediate post-test
Secondary	Perceived expectation	Perceived expectation was assessed by asking participant agreement on a 5-point Likert scale to the following statement, "The effectiveness of the HPV vaccine will vary from person to person." Higher score indicates higher perceived effectiveness.	Immediate post-test
Secondary	Perceived risk	Perceived risks of HPV infection were also assessed, including participants' perceptions of getting an HPV-associated infection genital/anal warts, or cancer in their lifetime. Response options ranged from very unlikely (lower score) to very likely (higher score).; How likely are you to get an HPV related cancer, like cervical, oral, or anal cancer, in your lifetime? How likely are you to get an HPV infection in your lifetime? How likely are you to get anal or genital warts in your lifetime?	Immediate post-test
Secondary	Decision self-efficacy	The Decision Self-Efficacy Scale evaluates an individual's self-confidence to make decisions on their own or with support from other sources. Scores range from 0 [extremely low self-efficacy] to 100 [extremely high self efficacy].	Immediate post-test