Decision AidHPV DecideNCT06435338
Patient Decision Aid Tool for HPV Vaccination Among Adults Ages 27-45 Years Old
A study testing Patient decision aid in people with Decision Aid and Hpv, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 27 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Decision Aid, Hpv
- What is being tested?
- Patient decision aid
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 632 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2023to 18 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 27 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Unvaccinated for HPV
- 27-45 years
- Resides in the United States
- Reads English
- Consents to participate
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
UT School of Public Health San Antonio
San Antonio, Texas, 78229
About this study
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
- Being tested
- Patient decision aid, Control
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient decision aidBehavioural
The patient decision aid for HPV vaccination among mid-adults, named HPV Decide. It is delivered online on a website.
ControlBehavioural
Vaccine information sheet on HPV vaccination. Attention control condition.
| Study group | Role | What they receive |
|---|---|---|
| Patient decision aid | Experimental | Patient decision aid on HPV vaccination on webpage. Receives: Behavioral: Patient decision aid |
| Control | Active comparator | Vaccine information sheet on HPV vaccination view on webpage. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 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].
Measured: Immediate post-test
Secondary outcomes (6)
Knowledge
16-item knowledge item related to human papillomavirus and human papillomavirus vaccination. Scale from 0 [low knowledge] to 16 [high knowledge].
Measured: Immediate post-test
Intentions
Intentions for information seeking, talking to a healthcare provider, and getting vaccinated
Measured: Immediate post-test
Decision
Vaccine decision, including decide to get vaccinated, unsure, and decided not to get vaccinated
Measured: Immediate post-test
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.
Measured: Immediate post-test
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?
Measured: Immediate post-test
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].
Measured: Immediate post-test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start13 Dec 2023
- Primary completion18 Jan 2024
- Study completion18 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Decision AidStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 632 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Texas Health Science Center, University of South Florida, Temple University, Indiana University, Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Erika L. Thompson, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06435338
- Sponsor's protocol ID
- 100257
- Acronym
- HPV Decide
- Status last verified
- May 2024
- First submitted
- 20 May 2024
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Upon reasonable request to the PI, study materials will be shared.
Publications
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
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.
PubMed 20705870O'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
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.
PubMed 35608097Thompson 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.
PubMed 39717960
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Decision Aid Tool for HPV Vaccination Among Adults Ages 27-45 Years Old
- ClinicalTrials.gov ID
- NCT06435338
- Acronym / sponsor ID
- HPV Decide / 100257
- Conditions
- Decision Aid, Hpv
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 632 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- University of North Texas Health Science Center, University of South Florida, Temple University, Indiana University, Merck Sharp & Dohme LLC
- Study start
- 13 Dec 2023 (actual)
- Primary completion
- 18 Jan 2024 (actual)
- Study completion
- 18 Jan 2024 (actual)
- First posted
- 30 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient decision aid | Experimental | Behavioral: Patient decision aidPatient decision aid on HPV vaccination on webpage. |
| Control | Active comparator | Behavioral: ControlVaccine information sheet on HPV vaccination view on webpage. |
Who may qualify
- Ages
- 27 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Unvaccinated for HPV
- 27-45 years
- Resides in the United States
- Reads English
- Consents to participate
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient decision aidThe patient decision aid for HPV vaccination among mid-adults, named HPV Decide. It is delivered online on a website. | Behavioural | Patient decision aid |
| ControlVaccine information sheet on HPV vaccination. Attention control condition. | Behavioural | Control |
Primary outcome
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."
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].
6 secondary outcomes
Knowledge
Time frame: Immediate post-test
Intentions
Time frame: Immediate post-test
Decision
Time frame: Immediate post-test
Perceived expectation
Time frame: Immediate post-test
Perceived risk
Time frame: Immediate post-test
Decision self-efficacy
Time frame: Immediate post-test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- BackgroundO'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: PubMed 20705870Legare 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.
- BackgroundO'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: PubMed 35608097Garg 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.
- Derived from this study: PubMed 39717960Thompson 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.
- Individual participant dataSharing planned: No. Upon reasonable request to the PI, study materials will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient decision aid in people with Decision Aid and Hpv, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decisional conflict - 16 item scale (time frame: Immediate post-test). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06435338, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024.