Clinical trial NCT03489707: The Prevent Anal Cancer Self-Swab Study
Official title: Annual Anal Sampling Using DNA Screening to Identify Men Who Have Sex With Men at Increased Risk for Anal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anal Cancer
Keywords: anal cancer
human papillomavirus
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: The University of Texas Health Science Center, Houston
name: M.D. Anderson Cancer Center
First posted: 2018-04-05
Enrollment: 253
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Compliance With Annual Anal HPV DNA Screening
timeFrame: Baseline
measure: Compliance With Annual Anal HPV DNA Screening
timeFrame: 12 months
Secondary outcomes:
measure: Compliance With Annual Screening Based on HIV Status
timeFrame: 12 months 12 months
measure: Compliance With Annual Screening Based on Race/Ethnicity
timeFrame: 12 months
measure: Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity
timeFrame: 12 months
measure: Number of Participants Attending High-resolution Anoscopy Based on HIV Status
timeFrame: 12 months
measure: Attendance at High-resolution Anoscopy
timeFrame: 12 months
Other outcomes:
measure: Human Papillomavirus (HPV) DNA Persistence and Its Association With High-grade Squamous Intraepithelial Lesions (HSIL).
timeFrame: 12 months
measure: Host/Viral Methylation and Its Association With High-grade Squamous Intraepithelial Lesions.
timeFrame: 12 months
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Alan G Nyitray, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.