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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
253
Persons randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months.
Persons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months.
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Compliance With Annual Anal HPV DNA Screening
Compliance is assessed by the number of participants who provide specimens for annual anal HPV DNA screening
Time frame: Baseline
Compliance With Annual Anal HPV DNA Screening
Compliance is assessed by the number of participants who provide specimens for annual anal HPV DNA screening
Time frame: 12 months
Compliance With Annual Screening Based on HIV Status
The number of participants complying with annual screening with positive or negative HIV status. Compliance is defined as screening at baseline and one year.
Time frame: 12 months 12 months
Compliance With Annual Screening Based on Race/Ethnicity
The number of participants complying with annual screening based on race/ethnicity. Racial and ethnic categories are defined by the NIH as follows: American Indian or Alaska Native, Asian, Black or African American, Hispanic or Latino, Native Hawaiian or Other Pacific Islander, and White. Compliance is defined as screening at baseline and one year.
Time frame: 12 months
Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity
The number of participants attending high-resolution anoscopy based on race/ethnicity. Racial and ethnic categories are defined by the NIH as follows: American Indian or Alaska Native, Asian, Black or African American, Hispanic or Latino, Native Hawaiian or Other Pacific Islander, and White.
Time frame: 12 months
Number of Participants Attending High-resolution Anoscopy Based on HIV Status
The number of participants attending high-resolution anoscopy based on positive or negative HIV status.
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Time frame: 12 months
Attendance at High-resolution Anoscopy
Number of participants who attend high-resolution anoscopy (HRA)
Time frame: 12 months