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Completed

NCT Number: NCT03489707

The Prevent Anal Cancer Self-Swab Study

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.

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Key information

Conditions

Anal Cancer Anus Diseases Anus Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home-based human papillomavirus (HPV) DNA screening

Behavioral

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

Behavioral

Persons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months.

Primary outcomes

  1. Compliance With Annual Anal HPV DNA Screening

    Time frame: Baseline

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

  2. Compliance With Annual Anal HPV DNA Screening

    Time frame: 12 months

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

Secondary outcomes

  1. Compliance With Annual Screening Based on HIV Status

    Time frame: 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.

  2. Compliance With Annual Screening Based on Race/Ethnicity

    Time frame: 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.

  3. Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity

    Time frame: 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.

  4. Number of Participants Attending High-resolution Anoscopy Based on HIV Status

    Time frame: 12 months

    The number of participants attending high-resolution anoscopy based on positive or negative HIV status.

  5. Attendance at High-resolution Anoscopy

    Time frame: 12 months

    Number of participants who attend high-resolution anoscopy (HRA)

Other outcomes

  1. Human Papillomavirus (HPV) DNA Persistence and Its Association With High-grade Squamous Intraepithelial Lesions (HSIL).

    Time frame: 12 months

    The number of participants that have DNA persistence at 12 months with and without high-grade squamous intraepithelial lesions (HSIL).

  2. Host/Viral Methylation and Its Association With High-grade Squamous Intraepithelial Lesions.

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

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

Registry information

Official study title

Annual Anal Sampling Using DNA Screening to Identify Men Who Have Sex With Men at Increased Risk for Anal Cancer

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Apr 5, 2018
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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