Clinical trial · Observational
Feasibility of HPV Testing With Mail-delivered Sample Collection Kits
Persistent Oral HPV Among Diverse PLWH: A Pilot Study to Evaluate the Feasibility and Acceptability of Testing for Oral HPV DNA Infection With Mail-delivered Sample Collection Kits
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
People living with human immunodeficiency virus (PLWH) have an estimated 1.6-6.0 times increased risk of developing oropharyngeal cancer (OPC) compared with individuals in the general population. 70% of OPCs are caused by human papillomavirus (HPV), and PLWH also have an increased prevalence of oral HPV infection. Disparities by race/ethnicity also include a later stage of diagnosis and less frequent cancer-directed treatment for members of ethnic minority groups. There is little known regarding the racial/ethnic differences in oral HPV infection, persistence of oral HPV infection, or progression of oral HPV infection to OPC among PLWH. This is an observational, prospective cohort study to investigate the feasibility of alternative sample collection methods for HPV testing among PLWH.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HIV Infections | — | UNRESOLVED | — |
| HPV Infection | — | UNRESOLVED | — |
| HPV-Related Malignancy | Human Papillomavirus-Related Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mail-based Saliva Sample Kit | Diagnostic Test | — | UNRESOLVED |
| Study-related Surveys | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Samples from Persons Living With HIV (PLWH)
- description
- Participants will complete an online survey and receive a sample collection kit in the United States (US) mail. Two saliva samples will be obtained at home (one sample collected with two foam swabs and applied to a single FTA indicating card) and one oral rinse and gargle sample. Participants will complete a follow-up survey, and 7-10 days after the date of home sample collection, participants will visit the UCSF Anal Neoplasia Clinic, Research and Education (ANCRE) Clinic at Mt. Zion for a 15-minute clinic visit. During this clinic visit, participants will additionally complete one oral rinse and gargle sample.
- interventionNames
- Diagnostic Test: Mail-based Saliva Sample Kit
- Other: Study-related Surveys
Primary outcomes (3)
- measure
- Percentage of participants with positive oral human papillomavirus infection
- timeFrame
- Up to 10 days
- description
- The prevalence of oral high-risk human papillomavirus (hrHPV) infection will be determined by the percentage of participants with a positive result for human papillomavirus deoxyribonucleic acid (HPV DNA) after testing
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 35 Years
Show eligibility criteria text
Inclusion Criteria: 1. Over 35 years of age 2. Member of a sexual or gender group considered sexual minority men (men who have sex with men, trans-women) 3. Person living with HIV 4. Willing and able to receive a package through United States (US) postal service 5. Willing and able to return a package through FedEx 6. Able to attend a clinic visit at University of California, San Francisco (UCSF) Mt. Zion campus Exclusion Criteria: * Does not meet the above criteria
References
Publications (0)
Data not yet available