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

May 23, 2025 updated by: University of California, San Francisco

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

144

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California, San Francisco
        • Sub-Investigator:
          • Joel Palefsky, MD
        • Contact:
        • Principal Investigator:
          • Alexandra Hernandez Levenston, PhD, MPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

People living with HIV who identify with one or more racial/ethnic/ sexual or gender minority groups

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Qualitative Focus Group
Participants will be asked to a series of questions to help place them in a focus group with other individuals of shared identity and will also complete a short quantitative survey either emailed to the participant or the outreach worker/study coordinator will administer the survey by phone. Participants will then participate in one 1.5-2 hour, facilitated, focus group discussions (FGD).
Other: Group Meeting (Focus Group)
Focus Group Discussions (FDGs) will be recorded, transcribed, and coded.
Other: Questionnaires
Given electronically or via phone by study team staff

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of potential oral health equity factors
Time Frame: Up to 3 days
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess participant perceptions about OSCC/OPSCC and HPV vaccination
Time Frame: During focus group, 1 day
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
Assess participant knowledge about OSCC/OPSCC and HPV vaccination
Time Frame: During focus group, 1 day
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

National Institute of Dental and Craniofacial Research (NIDCR)

Investigators

  • Principal Investigator: Alexandra Hernandez Levenston, PhD, MPH, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2025

Primary Completion (Estimated)

November 30, 2029

Study Completion (Estimated)

November 30, 2029

Study Registration Dates

First Submitted

September 20, 2023

First Submitted That Met QC Criteria

September 20, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

May 28, 2025

Last Update Submitted That Met QC Criteria

May 23, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23363
  • R03DE032972 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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