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

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.

Study Overview

• Status: Completed
• Conditions: Anal Cancer
• Intervention / Treatment: Behavioral: Home-based human papillomavirus (HPV) DNA screening; Behavioral: Clinic-based human papillomavirus (HPV) DNA screening

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.

• Study Type: Interventional
• Enrollment (Actual): 253
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53202
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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: 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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	12 months
Attendance at High-resolution Anoscopy	Number of participants who attend high-resolution anoscopy (HRA)	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Human Papillomavirus (HPV) DNA Persistence and Its Association With High-grade Squamous Intraepithelial Lesions (HSIL).	The number of participants that have DNA persistence at 12 months with and without high-grade squamous intraepithelial lesions (HSIL).	12 months
Host/Viral Methylation and Its Association With High-grade Squamous Intraepithelial Lesions.	Mean of host/viral methylation score among participants stratified by high-grade squamous intraepithelial lesions. The Score 5 (S5) methylation score is an arithmetic continuous risk score with a minimum value of 0 and no maximum value. Higher methylation scores indicate higher risk for disease. While a theoretical maximum for a methylation score does not exist, one published maximum value for anal cancer is approximately 100. In this publication (Lorincz et al., Methylation of HPV and a tumor suppressor gene reveals anal cancer and precursor lesions, DOI: 10.18632/oncotarget.17984), a cut-off of 7.5 for methylation score identified all anal cancers and HSIL.	12 months

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Collaborators: M.D. Anderson Cancer Center; National Cancer Institute (NCI); The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Alan G Nyitray, PhD, Medical College of Wisconsin

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2020
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: March 29, 2018
• First Submitted That Met QC Criteria: March 29, 2018
• First Posted (Actual): April 5, 2018

Study Record Updates

• Last Update Posted (Estimated): November 12, 2024
• Last Update Submitted That Met QC Criteria: October 17, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: human papillomavirus; anal cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Anus Diseases; Rectal Neoplasms; Anus Neoplasms
• Other Study ID Numbers: HSC-MS-17-0635; R01CA215403 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will become available three years after study completion and be available for five years.
• IPD Sharing Access Criteria: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No