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: Completed

Administrative data

• NCT number: NCT04974619
• Other study ID #: MCC-20819
• Secondary ID: U54CA163068U54CA
• Status: Completed
• Start date: July 23, 2021
• Est. completion date: August 30, 2022

Study information

• Verified date: June 2024
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: August 30, 2022
• 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 (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.

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 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.
• 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 (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	National Cancer Institute (NCI)

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 scale consisting of 19 items (Score range 0-18) assessing general HPV knowledge and 9 items (Score range 0-9) 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 scale 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 Attitude (Aim 1)	A scale 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. The possible scale score range = 8-40.	Day 1
Primary	Part 1: HPV Vaccine Health Beliefs 1 (Aim 1)	Participants will complete scales; a. Perceived Risk 5 point scale from no chance to Certain I will get; higher scores mean higher perceived risk; b. Descriptive norms scale from 0% to 100%, higher score mean greater descriptive norms; c. Perceived norms 8 point scale ranging from strongly disagree to strongly agree, not applicable, higher scores mean stronger perceived norms; d. Perceived Barriers 3-point scale ranging from Not concerned at all to Very concerned, higher scores mean higher perceived barriers; e. Self-efficacy scale ranging from Strongly agree to Strongly Disagree; lower scores mean higher self-efficacy.	Day 1
Primary	Part 1: HPV Vaccine Health Beliefs 2 (Aim 1)	Count of participants who responded what they thought their perceived risk is contracting HPV. Questions range from Much below average, below average, average risk, above average risk, much above average risk, and I don't know.	Day 1
Primary	Part 1: HPV Vaccine Health Beliefs 3 (Aim 1)	Count of participants who responded within each category asking intention to get HPV vaccine among those unvaccinated, using a 7-point scale ranging from Very unlikely to Very likely, higher scores mean stronger intentions.	Day 1
Primary	Part 1: HPV Vaccine Behaviors 1 (Aim 1)	Count of participants who responded within each category that assesses past receipt of the HPV vaccine (modified from Brewer et al., 2009 and Brewer et al., 2017). Responses were: Yes, No, I don't know.	Day 1
Primary	Part 1: HPV Vaccine Behaviors 2 (Aim 1)	Count of participants that self reported number of shots received among vaccinated individuals. Items range from 1 shot to I don't know.	Day 1
Primary	Part 1: HPV Vaccine Educational Preferences 1 (Aim 1)	A scale developed by Christy (unpublished) assessing HPV vaccine education preferences. The survey question, "Who would you like to receive information from?". Options were Physician, Other healthcare provider (Nurse, Medical Assistant), Female peer, Male peer, Parent of teen, Parent of young adult, Someone who has survived an HPV-related Cancer Other. Participants marked all that applied.	Day 1
Primary	Part 1: HPV Vaccine Educational Preferences 2 (Aim 1)	Items developed by Christy (unpublished) assessing HPV vaccine education preferences. The survey question, "Best method for delivering education?". 1 being the best method and 8 being the worst method.	Day 1
Primary	Part 1: HPV Vaccine Educational Preferences 3 (Aim 1)	An item developed by Christy (unpublished) assessing HPV vaccine education preferences. The survey question, "What age would it be most helpful to for a person to receive educational information?"	Day 1
Primary	Part 2: Facilitators and Barriers to Intervention Implementation (Aim 2)	Number of participants who consented and participated in individual interviews.	Day 1
Primary	Part 3: Feedback From Focus Groups or Individual Interviews (Aim 3)	Number of Participants who completed either an individual interview or participated in a focus group.	Day 1

External Links

•   Moffitt Cancer Center Clinical Trials website