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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06435338
Acronym
HPV Decide
Enrollment
632
Registered
2024-05-30
Start date
2023-12-13
Completion date
2024-01-18
Last updated
2024-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Decision Aid, Hpv

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.

Interventions

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

BEHAVIORALControl

Vaccine information sheet on HPV vaccination. Attention control condition.

Sponsors

University of North Texas Health Science Center
CollaboratorOTHER
University of South Florida
CollaboratorOTHER
Temple University
CollaboratorOTHER
Indiana University School of Medicine
CollaboratorOTHER
Merck Sharp & Dohme LLC
CollaboratorINDUSTRY
The University of Texas Health Science Center at San Antonio
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
27 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
Decisional conflict - 16 item scaleImmediate post-testThis 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.
Decisional conflict - 4 item scaleImmediate post-testDecision 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

MeasureTime frameDescription
IntentionsImmediate post-testIntentions for information seeking, talking to a healthcare provider, and getting vaccinated
DecisionImmediate post-testVaccine decision, including decide to get vaccinated, unsure, and decided not to get vaccinated
Decision self-efficacyImmediate post-testThe 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 \[extremely high self efficacy\].
Perceived riskImmediate post-testPerceived 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?
Perceived expectationImmediate post-testPerceived 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.
KnowledgeImmediate post-test16-item knowledge item related to human papillomavirus and human papillomavirus vaccination. Scale from 0 \[low knowledge\] to 16 \[high knowledge\].

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026