The Feasibility of Self or Partner-assisted Digital Anal Exam Screening
Condition: Anus Neoplasms
MeSH terms: Anus Neoplasms
Study type: Interventional

Summary: 
      There is no standard screening protocol for anal cancer even as disease incidence increases.
      This single-visit study will clarify if single persons can do a self-digital anal exam, or
      perhaps the exam requires a partner, or if, in fact, the exam requires a clinician for
      reasons of safety, accuracy, or acceptability.

      The investigators hypothesize that men having sex with men's digital anal exam (DAE) findings
      will have moderate or substantial agreement with a nurse practitioner DAE for detecting an
      anal abnormality (defined as condylomas, hemorrhoids, fissures, and malignant tumors). As a
      secondary hypothesis the investigator believe a partner-assisted DAE conducted within a
      couple will have better agreement with the nurse practitioner DAE than will a self-DAE
      conducted by a single person.
    

Detailed description: 
      There is no standard screening protocol for anal cancer even as disease incidence and
      mortality increases; however, a digital anorectal exam (also called a digital rectal exam)
      will play a role in any recommended protocol. Critically, fewer digital anorectal exams are
      being performed by physicians even though it is a simple and quick procedure. If men who have
      sex with men (MSM) can learn to examine the anal canal, then detection and treatment of early
      cancers among this population may increase. This single-visit Phase II feasibility study will
      investigate increasing digital anal exam (DAE) use to enhance screening for anal cancer among
      MSM aged 27-80 years. The investigators hypothesize that MSM's DAE findings will have
      moderate or substantial agreement with a nurse practitioner DAE for detecting an anal
      abnormality (defined as condylomas, hemorrhoids, fissures, and malignant tumors). As a
      secondary hypothesis the investigators believe a partner-assisted DAE conducted within a
      couple will have better agreement with the nurse practitioner DAE than will a self-DAE
      conducted by a single person. It is not proposed that lay persons recognize specific
      conditions but, rather, that any abnormality should trigger a doctor visit. The specific aims
      are:

        1. Estimate the agreement between the digital anal exams of 200 MSM and the gold standard
           of a highly experienced nurse practitioner during a single clinical visit.

           This aim will answer the question: under optimal circumstances, will MSM report accurate
           findings after performing their own DAE?

        2. Determine factors independently associated with concordance of MSM and nurse
           practitioner DAEs including age, single men vs. men in couples, race, ethnicity and
           waist circumference.

           This aim will provide insight into which MSM are more likely to perform accurate DAEs.

        3. Assess DAE acceptability, self-efficacy, safety, and intentions-to-seek subsequent care.

      This aim will answer the question: will lay-performed DAEs have sufficient acceptability and
      safety and trigger appropriate follow-up care?

      The goal is to advance knowledge of how to increase use of digital anal exams to reduce anal
      cancer morbidity and mortality. The study will clarify if single persons can do a
      self-digital anal exam, or perhaps the exam requires a partner, or if, in fact, the exam
      requires a clinician for reasons of safety, accuracy, or acceptability.
    

Intervention name(s): Self-anal exam arm
Intervention type(s): Other
Intervention description(s): After a short pre-test the clinician will use a model to show a normal and diseased anal canal and then use pictures to show a self-DAE. The clinician will describe how to do a self-DAE for single men and partners. Next, the clinician will ask the participant to lower his pants for collection of anal human papillomavirus (HPV) DNA and cytology. The clinician will conduct a DAE and then participants will do self-DAE done in private. Then the research assistant will demonstrate the computer-assisted self-interview. When participants return to the clinician to receive the DAE results, the clinician will conduct a safety-related interview. The clinician will treat external anal disease, triage internal anal disease, and ask to be notified if a participant has any anus-related concerns in the following week. A complete appointment will require 70 minutes for singles and 105 minutes for couples. The PI will later conduct 3 focus groups.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening