Adaptation Of An HPV Education Resource To Promote HPV Vaccination

HPV Clinical Trial

Official title:

Adaptation of an HPV Education Resource to Promote HPV Vaccination Among Latino Young Men Who Have Sex With Men in Puerto Rico and Florida -- Proyecto Hombres Previniendo el VPH (Proyecto HPV)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04974619
• Other study ID #: MCC-20819
• Secondary ID: CA163068CA163071
• Status: Active, not recruiting
• Start date: July 23, 2021
• Est. completion date: August 2023

Study information

• Verified date: April 2023
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of the study is to assess Human Papillomavirus (HPV) and HPV vaccination knowledge, awareness, attitudes, health beliefs, and behaviors as well as educational preferences for learning more about HPV and HPV vaccination and to receive feedback on and adapt HPV educational materials for Young Latino Men who have Sex with Men (YLMSM).

Description:

To characterize HPV and HPV vaccination knowledge, vaccine awareness, attitudes, health literacy, health beliefs (e.g., perceived risk, perceived barriers, perceived norms), behaviors and intentions to receive the vaccine as well as educational preferences among 260 Spanish-language speaking YLMSM ages 18-26 in Florida and Puerto Rico via an online survey. To conduct 20 in-depth interviews with key stakeholders (i.e., healthcare clinic leadership, providers and staff, community-based organization staff; 10 in PR and 10 in FL) to inform intervention content and delivery methods and identify potential facilitators and barriers to intervention implementation. To culturally adapt an existing Cancer 101 educational resource in English and Spanish-language for YLMSM ages 18-26 and to conduct focus groups or individual interviews with 24 YLMSM in PR (n=12) and FL (n=12) to gain feedback on the acceptability, accessibility, content, delivery preferences, and aesthetics of the theoretically informed, HPV educational intervention targeted for English and/or Spanish-Speaking YLMSM.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 155
• Est. completion date: August 2023
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria for Aim 1 & 3:

• Men who have had sex with a man and/or are attracted to men
• Hispanic/Latino ethnicity
• Able to read, write and understand Spanish (for Aim 1) and Spanish or English (for Aim 3)
• aged 18-26 years
• Primary residence in either Puerto Rico or Florida
• Has access to the internet

Additional criteria for Aim 3:

• Has regular access to a working telephone or be able to attend an in-person focus group (modifications related to COVID-19 situation will allow virtual modality to complete the focus groups or individual interviews).
• Able to read, write and understand Spanish or English

Inclusion Criteria for Aim 2:

• Individuals with a current or prior role (within last twelve months) in a community-based organization, private or public healthcare clinic, health department, college/university organization, or interest group that provides services to sexual minorities in FL or PR as a healthcare provider, staff member, group member, or in a leadership role
• Age 21 or older
• Male and Female
• Able to understand, read and speak either Spanish or English
• Access to a working telephone or computer

Exclusion Criteria for Aim 1 & 3:

• Self identifies as either transman or transwoman
• aged <18 years or >27 years
• Individuals who contact the research team about interest in participating on Aims 1 or 3 (when recruitment cap has been completed for that aim) can be directed to Aims 1 or 3 for possible recruitment. Individuals can participate in more than 1 aim, but not more than one time in a single aim.

Related Conditions & MeSH terms

• HPV
• HPV Vaccine

Intervention

Behavioral:
• Online survey
Aim 1 Participants will be asked to complete a Qualtrics survey to identify knowledge gaps, health beliefs, attitudes, and educational learning preferences.
• Focus groups
Focus groups will be conducted in-person or remotely to evaluate the newly created educational materials about HPV vaccination. Individual interviews and/or focus groups (n=24) with young Latino men who have sex with men (YLMSM) (12 in Puerto Rico and 12 in Florida) will be conducted to gain feedback on the education intervention. The purpose will be to gain feedback on the acceptability, accessibility, content, delivery preference and aesthetics of the theoretically informed, HPV education target for Spanish-speaking YLMSM.
• Interviews
In-depth interviews (n=20) will be conducted with key stakeholders (10 in PR and 10 in FL) eliciting feedback to inform intervention content and delivery methods and identify potential facilitators and barriers to intervention implementation.

Locations

Country	Name	City	State
Puerto Rico	Ponce Health Sciences University	Ponce
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1: HPV Vaccine Knowledge (Aim 1)	A survey consisting of 19 items assessing general HPV knowledge and 9 items assessing HPV vaccination-specific knowledge (modified from scales by Perez et al 2016 and Waller et al 2013, respectively), using a response scale consisting of True, False, and I don't know; higher scores mean higher knowledge.	Day 1
Primary	Part 1: HPV Vaccine Awareness (Aim 1)	A survey consisting of 2 items from the Health Information National Trends Survey (HINTS) 2018, with response options Yes or No; Positive responses mean higher awareness	Day 1
Primary	Part 1: HPV Vaccine Attitudes (Aim 1)	A survey consisting of 8 items modified from the Carolina HPV Immunization Attitudes and Beliefs Scale (CHIAS); with a 5-point response scale ranging from strongly disagree to strongly agree; higher scores mean stronger attitudes	Day 1
Primary	Part 1: HPV Vaccine Health Beliefs (Aim 1)	Participants will complete surveys; a. Perceived Risk a 7-point scale from no chance to Certain I will get; higher scores mean higher perceived risk; b. Comparable risk assessing perceived likelihood of getting HPV in their lifetime, 6 options ranging from Much below average to I don't know; c. Descriptive norms scale from 0% to 100%, higher score mean greater descriptive norms; d. Perceived norms 5 point scale ranging from strongly disagree to strongly agree, not applicable, higher scores mean stronger perceived norms; e. Perceived Barriers 4-point scale ranging from Not concerned at all to Very concerned, higher scores mean higher perceived barriers; f. Self-efficacy scale ranging from Strongly agree to Strongly Disagree; lower scores mean higher self-efficacy, and g. Intention to get HPV vaccine among those unvaccinated 7-point scale ranging from Very unlikely to Very likely, higher scores mean stronger intentions.	Day 1
Primary	Part 1: HPV Vaccine Behaviors (Aim 1)	A survey consisting of two items (modified from Brewer et al., 2009 and Brewer et al., 2017) assessing past receipt of the HPV vaccine and number of shots received. Responses for the first item were: Yes, No, I don't know.	Day 1
Primary	Part 1: HPV Vaccine Educational Preferences (Aim 1)	A survey consisting of 3 items developed by Christy (unpublished) assessing HPV vaccine education preferences.	Day 1
Primary	Part 2: Facilitators and Barriers to Intervention Implementation (Aim 2)	20 in-depth individual interviews with key stakeholders (10 in PR and 10 in FL) eliciting feedback to inform intervention content and delivery methods and identify potential facilitators and barriers to intervention implementation, using a semi-structured interview guide. Thematic content analyses will be conducted to analyze qualitative data from these interviews.	Day 1
Primary	Part 3: Feedback from Focus Groups or Individual Interviews (Aim 3)	Acceptability, accessibility, content, delivery preferences, and aesthetics of the theoretically informed HPV educational intervention culturally adapted and targeted for English and /or Spanish-speaking YLMSM, will be examined via qualitative surveys (opened ended questions). A semi-structured interview guide will be used to guide individual interviews. Thematic content analyses will be conducted to analyze qualitative data from these interviews or focus groups.	Day 1

External Links

•   Moffitt Cancer Center Clinical Trials website