NCT03489707

The Prevent Anal Cancer Self-Swab Study

Annual Anal Sampling Using DNA Screening to Identify Men Who Have Sex With Men at Increased Risk for Anal Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 253 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 25 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Anal Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Home-based human papillomavirus (HPV) DNA screening	Persons randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months.
BEHAVIORAL	Clinic-based human papillomavirus (HPV) DNA screening	Persons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months.

Timeline

• Start date: 2020-01-09
• Primary completion: 2023-08-31
• Completion: 2023-08-31
• First posted: 2018-04-05
• Last updated: 2024-11-12
• Results posted: 2024-11-12

Locations

1 site across 1 country: United States