HPV Clinical Trial
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)
Verified date | April 2023 |
Source | H. Lee Moffitt Cancer Center and Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Active, not recruiting |
Enrollment | 155 |
Est. completion date | August 2023 |
Est. primary completion date | August 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 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 - Male and Female - 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. |
Country | Name | City | State |
---|---|---|---|
Puerto Rico | Ponce Health Sciences University | Ponce | |
United States | Moffitt Cancer Center | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
H. Lee Moffitt Cancer Center and Research Institute |
United States, Puerto Rico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Part 1: HPV Vaccine Knowledge (Aim 1) | A survey consisting of 19 items assessing general HPV knowledge and 9 items 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 | |
Primary | Part 1: HPV Vaccine Awareness (Aim 1) | A survey 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 | |
Primary | Part 1: HPV Vaccine Attitudes (Aim 1) | A survey 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 | Day 1 | |
Primary | Part 1: HPV Vaccine Health Beliefs (Aim 1) | Participants will complete surveys; a. Perceived Risk a 7-point scale from no chance to Certain I will get; higher scores mean higher perceived risk; b. Comparable risk assessing perceived likelihood of getting HPV in their lifetime, 6 options ranging from Much below average to I don't know; c. Descriptive norms scale from 0% to 100%, higher score mean greater descriptive norms; d. Perceived norms 5 point scale ranging from strongly disagree to strongly agree, not applicable, higher scores mean stronger perceived norms; e. Perceived Barriers 4-point scale ranging from Not concerned at all to Very concerned, higher scores mean higher perceived barriers; f. Self-efficacy scale ranging from Strongly agree to Strongly Disagree; lower scores mean higher self-efficacy, and g. Intention to get HPV vaccine among those unvaccinated 7-point scale ranging from Very unlikely to Very likely, higher scores mean stronger intentions. | Day 1 | |
Primary | Part 1: HPV Vaccine Behaviors (Aim 1) | A survey consisting of two items (modified from Brewer et al., 2009 and Brewer et al., 2017) assessing past receipt of the HPV vaccine and number of shots received. Responses for the first item were: Yes, No, I don't know. | Day 1 | |
Primary | Part 1: HPV Vaccine Educational Preferences (Aim 1) | A survey consisting of 3 items developed by Christy (unpublished) assessing HPV vaccine education preferences. | Day 1 | |
Primary | Part 2: Facilitators and Barriers to Intervention Implementation (Aim 2) | 20 in-depth individual 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, using a semi-structured interview guide. Thematic content analyses will be conducted to analyze qualitative data from these interviews. | Day 1 | |
Primary | Part 3: Feedback from Focus Groups or Individual Interviews (Aim 3) | Acceptability, accessibility, content, delivery preferences, and aesthetics of the theoretically informed HPV educational intervention culturally adapted and targeted for English and /or Spanish-speaking YLMSM, will be examined via qualitative surveys (opened ended questions). A semi-structured interview guide will be used to guide individual interviews. Thematic content analyses will be conducted to analyze qualitative data from these interviews or focus groups. | Day 1 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05736588 -
Elimisha HPV (Human Papillomavirus)
|
N/A | |
Completed |
NCT01105000 -
Human Papilloma Virus (HPV) Knowledge and Attitudes and the Role of (SES) Socioeconomic Status and Ethnicity
|
||
Recruiting |
NCT06147388 -
Regression of Cervical Precancerous Lesions and Associated Risk Factors
|
||
Recruiting |
NCT04708470 -
A Phase I/II Study of Combination Immunotherapy for Advanced Cancers Including HPV-Associated Malignancies, Small Bowel, and Colon Cancers
|
Phase 1/Phase 2 | |
Recruiting |
NCT06109870 -
Prevención en Sus Manos: Feasibility of a Novel Community-Based Strategy to Improve Access to Cervical Cancer Screening
|
N/A | |
Completed |
NCT03082950 -
HPV Infections, Cancer of the Vulva and Therapeutical Success
|
||
Recruiting |
NCT01512784 -
Long Term Immunogenicity of Quadrivalent Human Papillomavirus Vaccine (Gardasil®)in HIV-infected Adolescents and Young Adults
|
Phase 3 | |
Recruiting |
NCT05363709 -
BALSTILIMAB on Viral Clearance in HPV+ Oropharyngeal Cancer Patients
|
Phase 2 | |
Completed |
NCT01231945 -
Low-Cost Molecular Cervical Cancer Screening Study
|
N/A | |
Recruiting |
NCT01011712 -
The Natural History of Severe Viral Infections and Characterization of Immune Defects in Patients Without Known Immunocompromise
|
||
Recruiting |
NCT05996016 -
Gut and Vaginal Microbiota Profile Study for HIV Women
|
||
Completed |
NCT05907187 -
Research in Ethno-Medicine and Education (REMED)
|
N/A | |
Completed |
NCT05616767 -
Prevention and Screening for Early Detection of HPV-related Cancers in Gay and Bisexual Men in Tanzania
|
N/A | |
Completed |
NCT02247999 -
Improving Cervical Cancer Screening Among HIV-Infected Women in India
|
||
Terminated |
NCT01468636 -
A RTC to Examine the Effectiveness of 400 mg of Oral Zinc Gluconate as Adjunctive Therapy for Ano-genital Warts
|
Phase 4 | |
Active, not recruiting |
NCT04965792 -
Post-treatment Surveillance in HPV+ Oropharyngeal SCC
|
||
Active, not recruiting |
NCT05006833 -
Text and Talk: A Multi-level Intervention to Increase Provider HPV Vaccine Recommendation Effectiveness
|
N/A | |
Enrolling by invitation |
NCT06120205 -
SELF-CERV Pivotal Study: SELF-Collection for CERVical Cancer Screening
|
N/A | |
Recruiting |
NCT05208710 -
PANHPVAX, Study of a New HPV Vaccine in Healthy Volunteers
|
Early Phase 1 | |
Completed |
NCT05462249 -
Impact of Catch-up HPV Vaccination
|