Adaptation Of An HPV Education Resource To Promote HPV Vaccination

NCT04974619 | Completed Results

• 3 other identifiers: MCC-20819U54CA163068U54CA163071
• Study Type: observational
• Target: 155
• Locations: 2 countries
• Sites: 2

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).

Conditions

HPV Vaccine; HPV

Outcome Measures

Primary Outcomes (13)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• Part 2: Facilitators and Barriers to Intervention Implementation (Aim 2)

  Number of participants who consented and participated in individual interviews.

  Day 1

• 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

Study Arms (3)

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 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

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.

Behavioral: Focus groups or Individual Interviews

Interventions

Online survey BEHAVIORAL

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

Aim 1 Only: Online Survey group

Focus groups or Individual Interviews 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.

Aim 3 Only: Focus Groups or Interview Group

Interviews 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 2 Only: Interview group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Ponce Health Sciences University

Ponce, 00716, Puerto Rico

Location

Related Links

• Moffitt Cancer Center Clinical Trials website

MeSH Terms

Interventions

Focus Groups; Interviews as Topic

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Dr. Shannon Christy
• Organization: Moffitt Cancer Center

Shannon.Christy@moffitt.org

813-745-8840

Study Officials

• Shannon M Christy, PhD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

• Melissa Marzan-Rodriguez, DrPH

  Ponce Health Sciences University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: July 23, 2021
• Study Start: July 23, 2021
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: June 4, 2024
• Results First Posted: June 4, 2024

Record last verified: 2024-06

Locations

US (1); PR (1)