The Prevent Anal Cancer Self-Swab Study

Not Applicable

Completed

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

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Home-based human papillomavirus (HPV) DNA screening	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.
Clinic-based human papillomavirus (HPV) DNA screening	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.

Primary Outcome Measures

Name	Time	Method
Compliance With Annual Anal HPV DNA Screening	12 months	Compliance is assessed by the number of participants who provide specimens for annual anal HPV DNA screening

Secondary Outcome Measures

Name	Time	Method
Compliance With Annual Screening Based on HIV Status	12 months 12 months	The number of participants complying with annual screening with positive or negative HIV status. Compliance is defined as screening at baseline and one year.
Compliance With Annual Screening Based on Race/Ethnicity	12 months	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.
Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity	12 months	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.
Number of Participants Attending High-resolution Anoscopy Based on HIV Status	12 months	The number of participants attending high-resolution anoscopy based on positive or negative HIV status.
Attendance at High-resolution Anoscopy	12 months	Number of participants who attend high-resolution anoscopy (HRA)