The Prevent Anal Cancer Self-Swab Study
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Anal Cancer
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Screening
Participation Requirements
- Age
- Between 25 years and 125 years
- Gender
- Both males and females
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 wi...
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.
Tracking Information
- NCT #
- NCT03489707
- Collaborators
- National Cancer Institute (NCI)
- The University of Texas Health Science Center, Houston
- M.D. Anderson Cancer Center
- Investigators
- Principal Investigator: Alan G Nyitray, PhD Medical College of Wisconsin