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
2 other identifiers
interventional
253
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2018
CompletedFirst Posted
Study publicly available on registry
April 5, 2018
CompletedStudy Start
First participant enrolled
January 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2023
CompletedResults Posted
Study results publicly available
November 12, 2024
CompletedNovember 12, 2024
October 1, 2024
3.6 years
March 29, 2018
August 15, 2024
October 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (5)
Compliance With Annual Screening Based on HIV Status
12 months 12 months
Compliance With Annual Screening Based on Race/Ethnicity
12 months
Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity
12 months
Number of Participants Attending High-resolution Anoscopy Based on HIV Status
12 months
Attendance at High-resolution Anoscopy
12 months
Other Outcomes (2)
Human Papillomavirus (HPV) DNA Persistence and Its Association With High-grade Squamous Intraepithelial Lesions (HSIL).
12 months
Host/Viral Methylation and Its Association With High-grade Squamous Intraepithelial Lesions.
12 months
Study Arms (2)
Home-based human papillomavirus (HPV) DNA screening
EXPERIMENTALPersons 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
ACTIVE COMPARATORPersons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months.
Interventions
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 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months.
Eligibility Criteria
You may qualify if:
- 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-
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medical College of Wisconsinlead
- National Cancer Institute (NCI)collaborator
- The University of Texas Health Science Center, Houstoncollaborator
- M.D. Anderson Cancer Centercollaborator
Study Sites (1)
Medical College of Wisconsin
Milwaukee, Wisconsin, 53202, United States
Related Publications (2)
Nitkowski J, Giuliano AR, Ridolfi T, Chiao E, Fernandez ME, Schick V, Swartz MD, Smith JS, Nyitray AG. Acceptability of Anal Human Papillomavirus Home Self-Sampling and Clinician Sampling Among Sexual and Gender Minority Individuals in Milwaukee, Wisconsin: The Prevent Anal Cancer Self-Swab Study. LGBT Health. 2024 Jan;11(1):47-56. doi: 10.1089/lgbt.2023.0012. Epub 2023 Oct 24.
PMID: 37870947DERIVEDNyitray 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.
PMID: 34187833DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Alan Nyitray, PhD
- Organization
- Medical College of Wisconsin
Study Officials
- PRINCIPAL INVESTIGATOR
Alan G Nyitray, PhD
Medical College of Wisconsin
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 29, 2018
First Posted
April 5, 2018
Study Start
January 9, 2020
Primary Completion
August 31, 2023
Study Completion
August 31, 2023
Last Updated
November 12, 2024
Results First Posted
November 12, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Data will become available three years after study completion and be available for five years.
- 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.
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.