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Clinical Trials/NCT04974619
NCT04974619
Completed
N/A

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)

H. Lee Moffitt Cancer Center and Research Institute2 sites in 2 countries155 target enrollmentJuly 23, 2021
ConditionsHPV VaccineHPV

Overview

Phase
N/A
Intervention
Not specified
Conditions
HPV Vaccine
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Enrollment
155
Locations
2
Primary Endpoint
Part 1: HPV Vaccine Health Beliefs 1 (Aim 1)
Status
Completed
Last Updated
last year

Overview

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).

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.

Registry
clinicaltrials.gov
Start Date
July 23, 2021
End Date
August 30, 2022
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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 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 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 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 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 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.

Study Sites (2)

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