The Prevent Anal Cancer Self-Swab Study

Medical College of Wisconsin

Status: Completed

Conditions: Anal Cancer

Treatments: Behavioral: Home-based human papillomavirus (HPV) DNA screening; Behavioral: Clinic-based human papillomavirus (HPV) DNA screening

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03489707

HSC-MS-17-0635

R01CA215403 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this research study is to find ways to screen for anal cancer among gay, bisexual, and other men who have sex with men (MSM) and transgender persons. This study will try to find out if persons will do annual anal cancer screening, what factors are associated with repeated screening, and how this affects a person's decision to have high-resolution anoscopy.

Full description

This is a prospective, randomized, two-arm clinical study to evaluate compliance with annual home-based vs clinic-based DNA screening of anal canal exfoliated cells among Milwaukee HIV+ and HIV- men who have sex with men (MSM) and transgender persons aged ≥25 years. At study entry, persons randomized to arm 1 will receive a home-based collection kit in the mail at 0 and 12 months and those in arm 2 will attend a clinic where a clinician will collect the exfoliated cell specimen at 0 and 12 months. Then, persons will receive high-resolution anoscopy (HRA)-directed biopsy to assess precancerous lesions by study arm. We hypothesize that a majority of persons will comply with annual screening with increased compliance among persons in the home-based arm vs clinic-based arm. The proposed research could indicate that annual HPV DNA screening and subsequent HRA are acceptable to MSM and transgender persons; thus, we will determine how high-risk persons are identified for HRA in light of limited HRA resources. The duration of each participant's activities is expected to be 12 months. The study is expected have participant activity from 2019 to 2023.

Enrollment: 253 patients

Sex: All

Ages: 25+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Be > 25 years of age
• Sex at birth is male or gender identity is a transgender person
• Acknowledge sex with men in the last 5 years, or identify as gay or bisexual
• Understand and be willing to give informed consent
• Be willing to be randomized and able to comply with the protocol
• Spanish and/or English speakers/readers, and
• HIV+ or HIV-

Exclusion criteria

• Not acknowledge sex with men in the past five years and not identify as gay or bisexual
• Use of anticoagulants other than Aspirin or NSAIDS
• Prior diagnosis of anal cancer
• Plans to move within 12 months
• Not Milwaukee metro residents
• Not willing to attend one of the designated study clinics at baseline, or
• Inability to give informed consent

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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253 participants in 2 patient groups

Home-based human papillomavirus (HPV) DNA screening

Experimental group

Description:

Persons randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months.

Treatment:

Behavioral: Home-based human papillomavirus (HPV) DNA screening

Clinic-based human papillomavirus (HPV) DNA screening

Active Comparator group

Description:

Persons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months.

Treatment:

Behavioral: Clinic-based human papillomavirus (HPV) DNA screening