Adaptation Of An HPV Education Resource To Promote HPV Vaccination

NCT ID: NCT04974619

Last Updated: 2024-06-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

155 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-23

Study Completion Date

2022-08-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HPV Vaccine HPV

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Online survey

Intervention Type BEHAVIORAL

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)

Interviews

Intervention Type BEHAVIORAL

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 or Interview Group

Focus groups and/or individual interviews will be conducted in-person and/or remotely to receive feedback on the HPV vaccine education materials. Focus groups and/or individual interviews will be conducted with 24 young adult Latino men who have sex with men (YLMSM) in either English or Spanish (approximately 12 in Puerto Rico and approximately 12 in Florida). The purpose will be to gain feedback on the acceptability, accessibility, content, delivery preference, and aesthetics of the theoretically informed HPV education materials culturally targeted for Spanish- and/or English-speaking YLMSM.

Focus groups or Individual Interviews

Intervention Type BEHAVIORAL

Focus groups and/or individual interviews will be conducted in-person and/or remotely to receive feedback on the HPV vaccine education materials. Focus groups and/or individual interviews will be conducted with 24 young adult Latino men who have sex with men (YLMSM) in either English or Spanish (approximately 12 in Puerto Rico and approximately 12 in Florida). The purpose will be to gain feedback on the acceptability, accessibility, content, delivery preference, and aesthetics of the theoretically informed HPV education materials culturally targeted for Spanish- and/or English-speaking YLMSM.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Online survey

Aim 1 Participants will be asked to complete a Qualtrics survey to identify knowledge gaps, health beliefs, attitudes, and educational learning preferences.

Intervention Type BEHAVIORAL

Focus groups or Individual Interviews

Focus groups and/or individual interviews will be conducted in-person and/or remotely to receive feedback on the HPV vaccine education materials. Focus groups and/or individual interviews will be conducted with 24 young adult Latino men who have sex with men (YLMSM) in either English or Spanish (approximately 12 in Puerto Rico and approximately 12 in Florida). The purpose will be to gain feedback on the acceptability, accessibility, content, delivery preference, and aesthetics of the theoretically informed HPV education materials culturally targeted for Spanish- and/or English-speaking YLMSM.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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


* 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

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Shannon M Christy, PhD

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Melissa Marzan-Rodriguez, DrPH

Role: PRINCIPAL_INVESTIGATOR

Ponce Health Sciences University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Moffitt Cancer Center

Tampa, Florida, United States

Site Status

Ponce Health Sciences University

Ponce, , Puerto Rico

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Puerto Rico

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

U54CA163068

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U54CA163071

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MCC-20819

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.