Adaptation Of An HPV Education Resource To Promote HPV Vaccination

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)

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).

Study Overview

• Status: Active, not recruiting
• Conditions: HPV Vaccine; HPV
• Intervention / Treatment: Behavioral: Online survey; Behavioral: Interviews; Behavioral: Focus groups

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 155

Contacts and Locations

Study Locations

• Puerto Rico
  • Ponce, Puerto Rico, 00716
    • Ponce Health Sciences University
• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Young Latino men who have sex with men in Puerto Rico and Florida and key stakeholders (i.e., healthcare clinic leadership, providers and staff, community-based organization staff, and individuals who serve and/or have provided services to YLMSM within the past 12 months).

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Aim 1 Only: Online Survey group; Spanish speaking young Latino men who have sex with men (YLMSM), ages 18-26 (approximately 260 in Florida and Puerto Rico) will be asked to complete a Qualtrics survey.	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.
Aim 2 Only: Interview group; Individual interviews will be conducted with key healthcare stakeholders (i.e.,healthcare clinical leadership, providers and staff, community-based organization staff)	Behavioral: 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.
Aim 3 Only: Focus Groups; Each site will conduct focus groups or individual interviews with English or Spanish speaking young Latino men who have sex with men (YLMSM). The total participants will be 24 with 12 participants per site.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Investigators: Principal Investigator: Shannon M Christy, PhD, Moffitt Cancer Center; Principal Investigator: Melissa Marzan-Rodriguez, DrPH, Ponce Health Sciences University

Publications and helpful links

Helpful Links

• Moffitt Cancer Center Clinical Trials website

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2021
• Primary Completion (Actual): August 30, 2022
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: July 14, 2021
• First Submitted That Met QC Criteria: July 22, 2021
• First Posted (Actual): July 23, 2021

Study Record Updates

• Last Update Posted (Actual): April 14, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: MCC-20819; CA163068 (Other Identifier: NCI); CA163071 (Other Identifier: NCI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No