NCT06055868

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P50-P75 for all trials

Timeline
43mo left

Started Feb 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
Feb 2025Nov 2029

First Submitted

Initial submission to the registry

September 20, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
1.4 years until next milestone

Study Start

First participant enrolled

February 13, 2025

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2029

Last Updated

May 28, 2025

Status Verified

March 1, 2025

Enrollment Period

4.8 years

First QC Date

September 20, 2023

Last Update Submit

May 23, 2025

Conditions

Keywords

Health EquityFocus GroupSexual and Gender MinorityPeople living with HIVHPV, human papillomavirus

Outcome Measures

Primary Outcomes (1)

  • 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

Other Outcomes (2)

  • Assess participant perceptions about OSCC/OPSCC and HPV vaccination

    During focus group, 1 day

  • Assess participant knowledge about OSCC/OPSCC and HPV vaccination

    During focus group, 1 day

Study Arms (1)

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)Other: Questionnaires

Interventions

Focus Group Discussions (FDGs) will be recorded, transcribed, and coded.

Qualitative Focus Group

Given electronically or via phone by study team staff

Qualitative Focus Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

Related Publications (1)

  • Hernandez AL, Lingas EO, Juarez W, Villa A, Palefsky J. Using an anti-racist research framework to design studies of oral human papillomavirus and oropharyngeal cancer in San Francisco: rationale and protocol for the Health Equity and Oral Health in People living with HIV (HEOHP) qualitative study. BMJ Open. 2024 Sep 24;14(9):e091474. doi: 10.1136/bmjopen-2024-091474.

MeSH Terms

Conditions

HIV InfectionsSquamous Cell Carcinoma of Head and NeckCoitusPapillomavirus Infections

Interventions

Focus GroupsSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by SiteSexual BehaviorBehaviorDNA Virus InfectionsTumor Virus InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Alexandra Hernandez Levenston, PhD, MPH

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2023

First Posted

September 28, 2023

Study Start

February 13, 2025

Primary Completion (Estimated)

November 30, 2029

Study Completion (Estimated)

November 30, 2029

Last Updated

May 28, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations