People Living With HIV, Oral and Oropharyngeal Cancer, and Health Equity

HIV Infections Clinical Trial

Official title:

People Living With HIV (PLWH), Oral and Oropharyngeal Cancer, and Health Equity: A Qualitative Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06055868
• Other study ID #: 23363
• Secondary ID: R03DE032972
• Status: Not yet recruiting
• Start date: November 30, 2024
• Est. completion date: November 30, 2029

Study information

• Verified date: September 2023
• Source: University of California, San Francisco
• Contact: Arezou Sadighi Akha
• Phone: (415) 353-9042
• Email: arezou.sadighiakha[@]ucsf.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is an exploratory qualitative study among People Living With HIV (PLWH) of diverse racial/ethnic and sexual and gender minority (SGM) identities to explore individual, interpersonal, and structural oral health equity factors that serve as barriers or facilitators of accessing oral health care, knowledge and perceptions of human papillomavirus (HPV) vaccination and Oral squamous cell carcinoma (OSCC) /Oropharyngeal squamous cell carcinoma (OPSCC), and to collect recommendations on how to increase access to oral health care and engage PLWH in OSCC/OPSCC prevention.

Description:

OBJECTIVES:

1. To identify individual, interpersonal, and structural oral health equity factors (e.g., internalized stigma; enacted stigma; transportation/hours) that serve as barriers or facilitators to accessing regular and appropriate oral health care, among PLWH of intersecting racial/ethnic and SGM groups.

2. To explore knowledge and perceptions about causes, risk factors, prevention, and screening for OSCC/OPSCC and HPV vaccination and if identity group membership influences knowledge and perceptions of these issues.

3. To elicit recommendations for improving access to regular and appropriate oral health care, and suggestions on how to engage PLWH from diverse identity groups in prevention interventions.

OUTLINE:

There will be one screening and enrollment phone call and only one study visit for the Focus Group Discussions (FDGs). A short quantitative survey will be administered.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 144
• Est. completion date: November 30, 2029
• Est. primary completion date: November 30, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants must be 18-years old or older.

• Participants must be individuals living with HIV

• Ability to speak and understand English

• Identify as one or more racial/ethnic minority groups or sexual and gender minority groups

• All genders and members of all races and ethnic groups are eligible for this study.

Exclusion Criteria:

• Younger than 18-years old.

• Not living with HIV.

• Not able to speak and understand English.

• Not classified as one or more racial/ethnic minority groups or sexual and gender minority groups.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• HIV Infections
• Oral Squamous Cell Carcinoma
• Oropharyngeal Neoplasms
• Oropharyngeal Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

Other:
• Group Meeting (Focus Group)
Focus Group Discussions (FDGs) will be recorded, transcribed, and coded.
• Questionnaires
Given electronically or via phone by study team staff

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assess participant perceptions about OSCC/OPSCC and HPV vaccination	FGDs will be transcribed, coded, and the focus group guide will be updated following the Grounded Theory qualitative research methodology. The "data" from the FGD are the audio recordings and the transcripts. The digital transcript of each focus group will be uploaded to the software MAXQDA to aid with coding and analysis in assessing information on participant's perception of causes, risk factors, prevention, and screening for OSCC/OPSCC and HPV vaccination.	During focus group, 1 day
Other	Assess participant knowledge about OSCC/OPSCC and HPV vaccination	FGDs will be transcribed, coded, and the focus group guide will be updated following the Grounded Theory qualitative research methodology. The "data" from the FGD are the audio recordings and the transcripts. The digital transcript of each focus group will be uploaded to the software MAXQDA to aid with coding and analysis in assessing information on participant's knowledge of causes, risk factors, prevention, and screening for OSCC/OPSCC and HPV vaccination	During focus group, 1 day
Primary	Identification of potential oral health equity factors	Participants will complete a baseline questionnaire which will aid in the formation of the focus group with other individuals of shared identity. The Focus Group Discussions (FGDs) will be transcribed, coded, and the focus group guide will be updated following the Grounded Theory qualitative research methodology. The "data" from the FGD are the audio recordings and the transcripts. The digital transcript of each focus group will be uploaded to the software MAXQDA to aid with coding and analysis in identifying individual, interpersonal, and structural factors, if any, that may impact accessing oral health care.	Up to 3 days