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

National Cancer Institute (NCI), The University of Texas Health Science Center, Houston, M.D. Anderson Cancer Center

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 and transpersons 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 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 transpersons; 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.

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.

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.

Compliance as assessed by the number of participants who provide specimens for annual anal HPV DNA screening

Compliance as assessed by the number of participants who provide specimens for annual anal HPV DNA screening

Compliance as assessed by the number of participants who provide specimens for annual anal HPV DNA screening

Compliance as assessed by the number of participants who provide specimens for annual anal HPV DNA screening

Factors associated with annual screening compliance as assessed by the Computer-Assisted Self-Interview (CASI) questionnaire (pre-test)

Factors associated with annual screening compliance as assessed by the Computer-Assisted Self-Interview (CASI) questionnaire (pre-test)

Factors associated with annual screening compliance as assessed by the Computer-Assisted Self-Interview (CASI) questionnaire

Factors associated with annual screening compliance as assessed by the Computer-Assisted Self-Interview (CASI) questionnaire

Factors associated with annual screening compliance as assessed by the Computer-Assisted Self-Interview (CASI) questionnaire

Factors associated with annual screening compliance as assessed by the Computer-Assisted Self-Interview (CASI) questionnaire

Factors associated with annual screening compliance as assessed by the Computer-Assisted Self-Interview (CASI) questionnaire

Human papillomavirus (HPV) DNA persistence and its association with high-grade squamous intraepithelial lesions.

Human papillomavirus (HPV) DNA persistence and its association with high-grade squamous intraepithelial lesions: The presence of high-risk HPV (human papillomavirus) DNA will be assessed at baseline and at 12 months. High-risk HPV types that are present at both time points determines the presence of persistence of high-risk HPV DNA. HPV DNA persistence will be assessed for its association with high-grade squamous intraepithelial lesions.

Host/viral methylation and its association with high-grade squamous intraepithelial lesions: The presence of host/viral methylation patterns will be assessed at baseline and at 12 months. Methylation patterns that are present at either time point will be assessed for its association with high-grade squamous intraepithelial lesions.

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

Fully de-identified datasets will be shared with properly trained investigators after assessment of institutional policies, Medical College of Wisconsin Human Protections Committee rules, as well as local, state, and Federal laws and regulations.

Fully de-identified datasets will be shared with properly trained investigators after assessment of institutional policies, Medical College of Wisconsin Human Protections Committee rules, as well as local, state, and Federal laws and regulations.

Nyitray AG, Schick V, Swartz MD, Giuliano AR, Fernandez ME, Deshmukh AA, Ridolfi TJ, Ajala C, Brzezinski B, Sandoval M, Nedjai B, Smith JS, Chiao EY. Rationale and design of the Prevent Anal Cancer Self-Swab Study: a protocol for a randomised clinical trial of home-based self-collection of cells for anal cancer screening. BMJ Open. 2021 Jun 29;11(6):e051118. doi: 10.1136/bmjopen-2021-051118.