Feasibility of HPV Testing With Mail-delivered Sample Collection Kits

University of California San Francisco (UCSF)

Status: Enrolling

Conditions: HPV Infection; HPV-Related Malignancy; HIV Infections

Treatments: Other: Study-related Surveys; Diagnostic Test: Mail-based Saliva Sample Kit

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT07087145

R03DE033930 (U.S. NIH Grant/Contract)

240514

Details and patient eligibility

About

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.

Full description

STUDY AIMS:

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.

Enrollment: 135 estimated patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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

Trial design

135 participants in 1 patient group

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.

Treatment:

Diagnostic Test: Mail-based Saliva Sample Kit

Other: Study-related Surveys