HIV InfectionsNCT06055868
People Living With HIV, Oral and Oropharyngeal Cancer, and Health Equity
An observational study of HIV Infections and Oral Squamous Cell Carcinoma, run by University of California, San Francisco at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Oral Squamous Cell Carcinoma, Oropharyngeal Squamous Cell Carcinoma
- What is being tested?
- Group Meeting (Focus Group) and Questionnaires
- How many people
- 133 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2025to 30 Nov 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People living with HIV who identify with one or more racial/ethnic/ sexual or gender minority groups
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: 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.
Read the detailed description
OBJECTIVES:
- 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.
- 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.
- 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.
- Being tested
- Group Meeting (Focus Group), Questionnaires
- Keywords
- Health Equity, Focus Group, Sexual and Gender Minority, People living with HIV, HPV, human papillomavirus
- Medical subject headings
- HIV Infections, Squamous Cell Carcinoma of Head and Neck, Coitus, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Meeting (Focus Group)Other
Focus Group Discussions (FDGs) will be recorded, transcribed, and coded.
QuestionnairesOther
Given electronically or via phone by study team staff
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Group Meeting (Focus Group); Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start13 Feb 2025
- Primary completion30 Nov 2029 (estimated)
- Study completion30 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor
- Investigators
- Alexandra Hernandez Levenston, PhD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055868
- Sponsor's protocol ID
- 23363
- Other IDs
- R03DE032972
- Status last verified
- Sep 2026
- First submitted
- 20 Sep 2023
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39317508
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- People Living With HIV (PLWH), Oral and Oropharyngeal Cancer, and Health Equity: A Qualitative Study
- ClinicalTrials.gov ID
- NCT06055868
- Acronym / sponsor ID
- 23363
- Keywords
- Health Equity, Focus Group, Sexual and Gender Minority, People living with HIV, HPV, human papillomavirus
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 133 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 13 Feb 2025 (actual)
- Primary completion
- 30 Nov 2029 (estimated)
- Study completion
- 30 Nov 2029 (estimated)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
- 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.
- 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.
- 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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Qualitative Focus Group | – | Other: Group Meeting (Focus Group), Other: QuestionnairesParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People living with HIV who identify with one or more racial/ethnic/ sexual or gender minority groups
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group Meeting (Focus Group)Focus Group Discussions (FDGs) will be recorded, transcribed, and coded. | Other | Qualitative Focus Group |
| QuestionnairesGiven electronically or via phone by study team staff | Other | Qualitative Focus Group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Derived from this study: PubMed 39317508Hernandez 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra Hernandez Levenston, PhD, MPH principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Oral Squamous Cell Carcinoma, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of potential oral health equity factors (time frame: Up to 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06055868, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.