The Prevent Anal Cancer Self-Swab Study
October 17, 2024 updated by: Alan Nyitray, PhD, Medical College of Wisconsin
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
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wisconsin
-
Milwaukee, Wisconsin, United States, 53202
- Medical College of Wisconsin
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
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.
|
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.
|
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
Time Frame: Baseline
|
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
Time Frame: 12 months
|
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
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.
|
12 months 12 months
|
|
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. |
12 months
|
|
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.
|
12 months
|
|
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.
|
12 months
|
|
Attendance at High-resolution Anoscopy
Time Frame: 12 months
|
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).
Time Frame: 12 months
|
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.
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.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Alan G Nyitray, PhD, Medical College of Wisconsin
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
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
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