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OpenTrials
Completed

NCT Number: NCT06435338

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

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.

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Key information

Age range

27 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UT School of Public Health San Antonio

San Antonio, Texas, 78229, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

Patient Decision Aid

Behavioral

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

Control

Behavioral

Vaccine information sheet on HPV vaccination. Attention control condition.

Primary outcomes

  1. Decisional conflict - 16 item scale

    Time frame: Immediate post-test

    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."

  2. Decisional conflict - 4 item scale

    Time frame: Immediate post-test

    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].

Secondary outcomes

  1. Knowledge

    Time frame: Immediate post-test

    16-item knowledge item related to human papillomavirus and human papillomavirus vaccination. Scale from 0 [low knowledge] to 16 [high knowledge].

  2. Intentions

    Time frame: Immediate post-test

    Intentions for information seeking, talking to a healthcare provider, and getting vaccinated

  3. Decision

    Time frame: Immediate post-test

    Vaccine decision, including decide to get vaccinated, unsure, and decided not to get vaccinated

  4. Perceived expectation

    Time frame: Immediate post-test

    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.

  5. Perceived risk

    Time frame: Immediate post-test

    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?

  6. Decision self-efficacy

    Time frame: Immediate post-test

    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].

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Collaborators

  • Indiana University
  • Merck Sharp & Dohme LLC
  • Temple University
  • University of North Texas Health Science Center
  • University of South Florida

Registry information

Acronym: HPV Decide

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 30, 2024
Registry last updated
May 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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