Feasibility of HPV Testing With Mail-delivered Sample Collection Kits
NCT ID: NCT07087145
Last Updated: 2025-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
135 participants
OBSERVATIONAL
2024-11-17
2026-12-31
Brief Summary
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Detailed Description
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1. To determine if oral HPV deoxyribonucleic acid (HPV DNA) results obtained from self-collected oral rinse and gargle samples (ORG) sent by mail agree with results obtained from ORG samples collected in a clinic setting, among race/ethnically diverse sexual minority men (SMM) living with HIV (LWH).
2. To determine if oral HPV DNA results obtained from self-collected saliva samples applied to a Flinders Technology Associates (FTA) card sent by mail agree with results obtained from (1) ORG samples collected in a clinic setting, and (2) Home ORG, among race/ethnically diverse SMM-LWH.
3. To determine the feasibility, acceptability, and comfort of receiving HPV DNA sample collection kits by mail, self-collecting samples, and returning samples by FedEx, among racially/ethnically diverse SMM-LWH.
OUTLINE:
Participants will provide two saliva samples (at the same time), complete surveys, and complete a single clinic visit. Follow-up will be between 7 and 10 days post initial sample collection.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Samples from Persons Living With HIV (PLWH)
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.
Mail-based Saliva Sample Kit
Sent via United States Postal Service and returned via FedEx
Study-related Surveys
Online surveys will be administered
Interventions
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Mail-based Saliva Sample Kit
Sent via United States Postal Service and returned via FedEx
Study-related Surveys
Online surveys will be administered
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
35 Years
ALL
No
Sponsors
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National Institute of Dental and Craniofacial Research (NIDCR)
NIH
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Alexandra Hernandez Levenston, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, San Francisco
San Francisco, California, United States
Countries
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Central Contacts
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Facility Contacts
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Role: backup
Other Identifiers
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240514
Identifier Type: -
Identifier Source: org_study_id
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