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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
253

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical College of Wisconsin

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
The University of Texas Health Science Center, Houston

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 9, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 5, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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