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Completed

NCT Number: NCT04974619

Adaptation Of An HPV Education Resource To Promote HPV Vaccination

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).

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Key information

Conditions

HPV Vaccine HPV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ponce Health Sciences University, Ponce, Puerto Rico

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Part 1: HPV Vaccine Knowledge (Aim 1)

    Time frame: Day 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.

  2. Part 1: HPV Vaccine Awareness (Aim 1)

    Time frame: Day 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

  3. Part 1: HPV Vaccine Attitude (Aim 1)

    Time frame: Day 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.

  4. Part 1: HPV Vaccine Health Beliefs 1 (Aim 1)

    Time frame: Day 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.

  5. Part 1: HPV Vaccine Health Beliefs 2 (Aim 1)

    Time frame: Day 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.

  6. Part 1: HPV Vaccine Health Beliefs 3 (Aim 1)

    Time frame: Day 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.

  7. Part 1: HPV Vaccine Behaviors 1 (Aim 1)

    Time frame: Day 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.

  8. Part 1: HPV Vaccine Behaviors 2 (Aim 1)

    Time frame: Day 1

    Count of participants that self reported number of shots received among vaccinated individuals. Items range from 1 shot to I don't know.

  9. Part 1: HPV Vaccine Educational Preferences 1 (Aim 1)

    Time frame: Day 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.

  10. Part 1: HPV Vaccine Educational Preferences 2 (Aim 1)

    Time frame: Day 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.

  11. Part 1: HPV Vaccine Educational Preferences 3 (Aim 1)

    Time frame: Day 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?"

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

    Time frame: Day 1

    Number of participants who consented and participated in individual interviews.

  13. Part 3: Feedback From Focus Groups or Individual Interviews (Aim 3)

    Time frame: Day 1

    Number of Participants who completed either an individual interview or participated in a focus group.

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study 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)

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 23, 2021
Registry last updated
Jun 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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