The Prevent Anal Cancer Self-Swab Study

Anal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03489707
• Other study ID #: HSC-MS-17-0635
• Secondary ID: R01CA215403
• Status: Completed
• Phase: N/A
• Start date: January 9, 2020
• Est. completion date: August 31, 2023

Study information

• Verified date: June 2024
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 and transpersons 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 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 transpersons; 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 253
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anal Cancer
• Anus Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (4)

Lead Sponsor	Collaborator
Medical College of Wisconsin	M.D. Anderson Cancer Center, National Cancer Institute (NCI), The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Human papillomavirus (HPV) DNA persistence and its association with high-grade squamous intraepithelial lesions.	The number of participants that have DNA persistence at 12 months with and without high-grade squamous intraepithelial lesions.	12 months
Other	Host/viral methylation and its association with high-grade squamous intraepithelial lesions.	Mean of host/viral methylation score among those with and without high-grade squamous intraepithelial lesions.	12 months
Primary	Compliance as assessed by the number of participants who provide specimens for annual anal HPV DNA screening	Compliance as assessed by the number of participants who provide specimens for annual anal HPV DNA screening	baseline
Primary	Compliance as assessed by the number of participants who provide specimens for annual anal HPV DNA screening	Compliance as assessed by the number of participants who provide specimens for annual anal HPV DNA screening	12 months
Secondary	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.	One year
Secondary	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.	One year
Secondary	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.	About 1 hour after the high-resolution anoscopy (high-resolution anoscopy occurs about 2 weeks after the 12-month DNA screening)
Secondary	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.	About 1 hour after the high-resolution anoscopy (high-resolution anoscopy occurs about 2 weeks after the 12-month DNA screening)
Secondary	Number of participants who attend high resolution anoscopy	Number of participants who attend high resolution anoscopy	2 weeks after the 12-month DNA screening