The Prevent Anal Cancer Self-Swab Study

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Brief Title

The Prevent Anal Cancer Self-Swab Study

Official Title

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

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.
    

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 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.
    


Study Type

Interventional


Primary Outcome

Compliance as assessed by the number of participants who provide specimens for annual anal HPV DNA screening

Secondary Outcome

 Factors associated with annual screening compliance as assessed by the Computer-Assisted Self-Interview (CASI) questionnaire (pre-test)

Condition

Anal Cancer

Intervention

Home-based human papillomavirus (HPV) DNA screening

Study Arms / Comparison Groups

 Home-based human papillomavirus (HPV) DNA screening
Description:  Persons randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

400

Start Date

January 9, 2020

Completion Date

August 31, 2023

Primary Completion Date

August 31, 2023

Eligibility Criteria

        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
      

Gender

All

Ages

25 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Alan G Nyitray, PhD, 4149557701, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03489707

Organization ID

HSC-MS-17-0635

Secondary IDs

R01CA215403

Responsible Party

Principal Investigator

Study Sponsor

Medical College of Wisconsin

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Alan G Nyitray, PhD, Principal Investigator, Medical College of Wisconsin


Verification Date

October 2021