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| ID | Type | Description | Link |
|---|---|---|---|
| U54CA163068 | U.S. NIH Grant/Contract | View source | |
| U54CA163071 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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) |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria for Aim 1 & 3:
Additional criteria for Aim 3:
Inclusion Criteria for Aim 2:
Exclusion Criteria for Aim 1 & 3:
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Shannon M Christy, PhD | Moffitt Cancer Center | Principal Investigator |
| Melissa Marzan-Rodriguez, DrPH | Ponce Health Sciences University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States | ||
| Ponce Health Sciences University |
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| ID | Title | Description |
|---|---|---|
| FG000 | Aim 1 Only: Online Survey Group | Spanish speaking young Latino men who have sex with men (YLMSM), ages 18-26 (in Florida and Puerto Rico) will be asked to complete a Qualtrics survey. Online survey: Aim 1 Participants will be asked to complete a Qualtrics survey to identify knowledge gaps, health beliefs, attitudes, and educational learning preferences. |
| FG001 | 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: In-depth interviews will be conducted with key stakeholders eliciting feedback to inform intervention content and delivery methods and identify potential facilitators and barriers to intervention implementation. |
| FG002 | Aim 3 Only: Focus Groups or Interview Group | Each site will conduct focus groups or individual interviews with English or Spanish speaking young Latino men who have sex with men (YLMSM). 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aim 1 Only: Online Survey Group | Spanish speaking young Latino men who have sex with men (YLMSM), ages 18-26 (in Florida and Puerto Rico) will be asked to complete a Qualtrics survey. Online survey: Aim 1 Participants will be asked to complete a Qualtrics survey to identify knowledge gaps, health beliefs, attitudes, and educational learning preferences. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Unvaccinated participants only | Posted | Mean | Standard Deviation | score on a scale | Day 1 |
|
Adverse Events were not collected
Adverse Events were not collected
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aim 1 Only: Online Survey Group | Spanish speaking young Latino men who have sex with men (YLMSM), ages 18-26 (in Florida and Puerto Rico) will be asked to complete a Qualtrics survey. Online survey: Aim 1 Participants will be asked to complete a Qualtrics survey to identify knowledge gaps, health beliefs, attitudes, and educational learning preferences. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shannon Christy | Moffitt Cancer Center | 813-745-8840 | Shannon.Christy@moffitt.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 17, 2022 | Aug 28, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 4, 2022 | Aug 28, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D017144 | Focus Groups |
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| 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. |
|
| 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 |
| Ponce |
| 00716 |
| Puerto Rico |
| Protocol Violation |
|
| BG001 |
| 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: In-depth interviews will be conducted with key stakeholders eliciting feedback to inform intervention content and delivery methods and identify potential facilitators and barriers to intervention implementation. |
| BG002 | Aim 3 Only: Focus Groups or Interview Group | Each site will conduct focus groups or individual interviews with English or Spanish speaking young Latino men who have sex with men (YLMSM). 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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 | Posted | Count of Participants | Participants | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Participants in analysis are unvaccinated. | Posted | Count of Participants | Participants | 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. | Participants in analysis are unvaccinated. | Posted | Count of Participants | Participants | 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. | Missing data from 79 participants because orginal survey did not include this item, due to eligibility criteria at the time. | Posted | Count of Participants | Participants | 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. | Analysis is of vaccinated participants | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 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?" | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| Primary | Part 2: Facilitators and Barriers to Intervention Implementation (Aim 2) | Number of participants who consented and participated in individual interviews. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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: In-depth interviews will be conducted with key stakeholders eliciting feedback to inform intervention content and delivery methods and identify potential facilitators and barriers to intervention implementation. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Aim 3 Only: Focus Groups/Individual Interviews | Each site will conduct focus groups or individual interviews with English or Spanish speaking young Latino men who have sex with men (YLMSM). 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. | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
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| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| Yes |
|
|
| What percentage of gay/bisexual males do you think have received HPV vaccine? Possible Range 1-100 |
|
| What percentage of female peers have received the HPV vaccine? Possible Scale Range 0-100 |
|
| What percentage of gay/bisexual females received the HPV vaccine? Possible Scale Range 0-100 |
|
| Perceived Norms. 8 items. Possible Score range 8-40 |
|
| Perceived Barriers. 3 items. Possible score range 3-15. |
|
| SELFEFF1 - SELFEFF9. 9 items. Possible Score range 9-45. |
|
| Above average |
|
| Much above average |
|
| I don't know |
|
| Neither Unikely nor Likely |
|
| A Little Likely |
|
| Somewhat Likely |
|
| Very Likely |
|
| Intention to obtain more than 1 shot in the next 12 months, |
|
| Intention to get more than one dose in the future |
|
| At Least 1 Shot, But I Don't Know How Many |
|
| At Least 2 Shots, But I Don't Know How Many |
|
| I Don't Know |
|
| Title | Measurements |
|---|---|
|
| Male Peer |
|
| Parent of Teen |
|
| Parent of Young Adult |
|
| HPV Cancer Survivor |
|
| Other |
|
| 4 |
|
| 5 |
|
| 6 |
|
| 7 |
|
| 8 |
|
| Website |
|
| Smart Phone App |
|
| Online Webinar |
|
| Text Message |
|
| Printed Booklet |
|
| Social Media Platform |
|
| Healthcare System Portal |
|
| Check |
|
| Ages 15-17 |
|
| Ages 18-22 |
|
| Ages 23-30 |
|
| Ages 30-45 |
|
| I Do Not Think So |
|