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

NCT ID: NCT06435338

Last Updated: 2024-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

632 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-13

Study Completion Date

2024-01-18

Brief Summary

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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.

Detailed Description

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Conditions

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Decision Aid Hpv

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Patient decision aid

Patient decision aid on HPV vaccination on webpage.

Group Type EXPERIMENTAL

Patient decision aid

Intervention Type BEHAVIORAL

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 view on webpage.

Group Type ACTIVE_COMPARATOR

Control

Intervention Type BEHAVIORAL

Vaccine information sheet on HPV vaccination. Attention control condition.

Interventions

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Patient decision aid

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

Intervention Type BEHAVIORAL

Control

Vaccine information sheet on HPV vaccination. Attention control condition.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Unvaccinated for HPV
* 27-45 years
* Resides in the United States
* Reads English
* Consents to participate

Exclusion Criteria

* none
Minimum Eligible Age

27 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of North Texas Health Science Center

OTHER

Sponsor Role collaborator

University of South Florida

OTHER

Sponsor Role collaborator

Temple University

OTHER

Sponsor Role collaborator

Indiana University School of Medicine

OTHER

Sponsor Role collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role lead

Responsible Party

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Erika L. Thompson

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UT School of Public Health San Antonio

San Antonio, Texas, United States

Site Status

Countries

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United States

References

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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

Reference Type 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.

Reference Type BACKGROUND
PMID: 20705870 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 35608097 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39717960 (View on PubMed)

Other Identifiers

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100257

Identifier Type: -

Identifier Source: org_study_id

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