Clinical trial NCT04974619: Adaptation Of An HPV Education Resource To Promote HPV Vaccination
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HPV Vaccine
HPV
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-07-23
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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).

Brief 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).

Detailed description: To assess HPV and HPV vaccination knowledge, awareness, attitudes, health beliefs, and behaviors as well as educational preferences among 260 Spanish-speaking YLMSM ages 18-26 in Florida and Puerto Rico. To conduct 20 in-depth 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. To culturally adapt an existing Cancer 101 educational resource in English and Spanish 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.

Eligibility criteria: 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 (Aim 1 only)

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
* 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.

Primary outcomes:
measure: Part 1: HPV Vaccine Knowledge (Aim 1)
timeFrame: Day 1
measure: Part 1: HPV Vaccine Awareness (Aim 1)
timeFrame: Day 1
measure: Part 1: HPV Vaccine Attitude (Aim 1)
timeFrame: Day 1
measure: Part 1: HPV Vaccine Health Beliefs 1 (Aim 1)
timeFrame: Day 1
measure: Part 1: HPV Vaccine Health Beliefs 2 (Aim 1)
timeFrame: Day 1
measure: Part 1: HPV Vaccine Health Beliefs 3 (Aim 1)
timeFrame: Day 1
measure: Part 1: HPV Vaccine Behaviors 1 (Aim 1)
timeFrame: Day 1
measure: Part 1: HPV Vaccine Behaviors 2 (Aim 1)
timeFrame: Day 1
measure: Part 1: HPV Vaccine Educational Preferences 1 (Aim 1)
timeFrame: Day 1
measure: Part 1: HPV Vaccine Educational Preferences 2 (Aim 1)
timeFrame: Day 1
measure: Part 1: HPV Vaccine Educational Preferences 3 (Aim 1)
timeFrame: Day 1
measure: Part 2: Facilitators and Barriers to Intervention Implementation (Aim 2)
timeFrame: Day 1
measure: Part 3: Feedback From Focus Groups or Individual Interviews (Aim 3)
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Ponce
country: Puerto Rico
facility: Ponce Health Sciences University
Study officials:
affiliation: Moffitt Cancer Center
name: Shannon M Christy, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ponce Health Sciences University
name: Melissa Marzan-Rodriguez, DrPH
role: PRINCIPAL_INVESTIGATOR
References: