HPV VaccineNCT04974619
Adaptation Of An HPV Education Resource To Promote HPV Vaccination
An observational study of HPV Vaccine and HPV, run by H. Lee Moffitt Cancer Center and Research Institute at 2 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HPV Vaccine, HPV
- What is being tested?
- Online survey, Focus groups or Individual Interviews and Interviews
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- How many people
- 155 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 23 Jul 2021to 30 Aug 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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)
Show all 13Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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)
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).
Read the 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.
- Conditions
- HPV Vaccine, HPV
- Being tested
- Online survey, Focus groups or Individual Interviews, Interviews
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online surveyBehavioural
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 InterviewsBehavioural
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.
InterviewsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) Receives: 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. Receives: Behavioral: Focus groups or Individual Interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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?"
Measured: Day 1
Part 2: Facilitators and Barriers to Intervention Implementation (Aim 2)
Number of participants who consented and participated in individual interviews.
Measured: 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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start23 Jul 2021
- Primary completion30 Aug 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HPV VaccineStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Shannon M Christy, PhD, Principal investigator, Moffitt Cancer CenterMelissa Marzan-Rodriguez, DrPH, Principal investigator, Ponce Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04974619
- Sponsor's protocol ID
- MCC-20819
- Other IDs
- U54CA163068, U54CA163071
- Status last verified
- Jun 2024
- First submitted
- 14 Jul 2021
- Last updated
- 4 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04974619
- Acronym / sponsor ID
- MCC-20819
- Conditions
- HPV Vaccine, HPV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 23 Jul 2021 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 23 Jul 2021 (actual)
- Results
- Posted 4 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aim 1 Only: Online Survey group | – | Behavioral: Online surveySpanish 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. |
| Aim 2 Only: Interview group | – | Behavioral: InterviewsIndividual interviews will be conducted with key healthcare stakeholders (i.e.,healthcare clinical leadership, providers and staff, community-based organization staff) |
| Aim 3 Only: Focus Groups or Interview Group | – | Behavioral: Focus groups or Individual InterviewsFocus 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online surveyAim 1 Participants will be asked to complete a Qualtrics survey to identify knowledge gaps, health beliefs, attitudes, and educational learning preferences. | Behavioural | Aim 1 Only: Online Survey group |
| Focus groups or Individual InterviewsFocus 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. | Behavioural | Aim 3 Only: Focus Groups or Interview Group |
| InterviewsIn-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. | Behavioural | Aim 2 Only: Interview group |
Primary outcome
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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?"
Part 2: Facilitators and Barriers to Intervention Implementation (Aim 2)
Time frame: Day 1
Number of participants who consented and participated in individual interviews.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shannon M Christy, PhD principal investigator
Moffitt Cancer Center
Melissa Marzan-Rodriguez, DrPH principal investigator
Ponce Health Sciences University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HPV Vaccine and HPV, run by H. Lee Moffitt Cancer Center and Research Institute at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: HPV Vaccine Knowledge (Aim 1) (time frame: Day 1). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.