## Protocol Section
### Identification Module
**NCT ID:** NCT06435338

**Acronym:** HPV Decide

**Brief Title:** Patient Decision Aid Tool for HPV Vaccination Among Adults Ages 27-45 Years Old

**Official Title:** Patient Decision Aid Tool for HPV Vaccination Among Adults Ages 27-45 Years Old

#### Organization Study ID Info
**ID:** 100257
#### Organization
**Class:** OTHER
**Full Name:** The University of Texas Health Science Center at San Antonio
### Status Module
#### Completion Date
**Date:** 2024-01-18

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-01-18

**Type:** ACTUAL

#### Start Date
**Date:** 2023-12-13

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** University of North Texas Health Science Center

**Class:** OTHER

**Name:** University of South Florida

**Class:** OTHER

**Name:** Temple University

**Class:** OTHER

**Name:** Indiana University School of Medicine

**Class:** INDUSTRY

**Name:** Merck Sharp & Dohme LLC

#### Lead Sponsor

**Class:** OTHER

**Name:** The University of Texas Health Science Center at San Antonio

#### Responsible Party

**Investigator Affiliation:** The University of Texas Health Science Center at San Antonio

**Investigator Full Name:** Erika L. Thompson

**Investigator Title:** Associate Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Decision Aid

- Hpv

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** HEALTH_SERVICES_RESEARCH

#### Enrollment Info

**Count:** 632

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patient decision aid on HPV vaccination on webpage.

**Intervention Names:**

- Behavioral: Patient decision aid

**Label:** Patient decision aid

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Vaccine information sheet on HPV vaccination view on webpage.

**Intervention Names:**

- Behavioral: Control

**Label:** Control

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Patient decision aid

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

**Name:** Patient decision aid

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Control

**Description:** Vaccine information sheet on HPV vaccination. Attention control condition.

**Name:** Control

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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."

**Measure:** Decisional conflict - 16 item scale

**Time Frame:** Immediate post-test

**Description:** 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 \[no decisional conflict\].

**Measure:** Decisional conflict - 4 item scale

**Time Frame:** Immediate post-test

#### Secondary Outcomes

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

**Measure:** Knowledge

**Time Frame:** Immediate post-test

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

**Measure:** Intentions

**Time Frame:** Immediate post-test

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

**Measure:** Decision

**Time Frame:** Immediate post-test

**Description:** 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.

**Measure:** Perceived expectation

**Time Frame:** Immediate post-test

**Description:** 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?

**Measure:** Perceived risk

**Time Frame:** Immediate post-test

**Description:** 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 \[extremely high self efficacy\].

**Measure:** Decision self-efficacy

**Time Frame:** Immediate post-test

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

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

Exclusion Criteria:

* none

**Gender Based:** True

**Gender Description:** Cis-gender male or female only due to randomization stratification

**Healthy Volunteers:** True

**Maximum Age:** 45 Years

**Minimum Age:** 27 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** San Antonio

**Country:** United States

**Facility:** UT School of Public Health San Antonio

**State:** Texas

**Zip:** 78229

### IPD Sharing Statement Module

**Description:** Upon reasonable request to the PI, study materials will be shared.

**IPD Sharing:** NO

### References Module

#### References

**Citation:** 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

**Citation:** 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.

**PMID:** 20705870

**Citation:** 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

**Citation:** 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.

**PMID:** 35608097

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M17360

- Name: Vaccines

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
