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| Name | Class |
|---|---|
| University of North Texas Health Science Center | OTHER |
| University of South Florida | OTHER |
| Temple University | OTHER |
| Indiana University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient decision aid | Experimental | Patient decision aid on HPV vaccination on webpage. |
|
| Control | Active Comparator | Vaccine information sheet on HPV vaccination view on webpage. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient decision aid | Behavioral | The patient decision aid for HPV vaccination among mid-adults, named HPV Decide. It is delivered online on a website. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Intentions |
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Inclusion Criteria:
Exclusion Criteria:
Cis-gender male or female only due to randomization stratification
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT School of Public Health San Antonio | San Antonio | Texas | 78229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| 20705870 | 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. | |
| Background | 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 | ||
| 35608097 |
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Upon reasonable request to the PI, study materials will be shared.
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| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| OTHER |
| Merck Sharp & Dohme LLC | INDUSTRY |
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| Control | Behavioral | Vaccine information sheet on HPV vaccination. Attention control condition. |
|
Intentions for information seeking, talking to a healthcare provider, and getting vaccinated
| Immediate post-test |
| Decision | Vaccine decision, including decide to get vaccinated, unsure, and decided not to get vaccinated | 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. | 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? | 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]. | Immediate post-test |
| 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. |
| 39717960 | Derived | 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. |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |