The Feasibility of Self or Partner-assisted Digital Anal Exam Screening

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.

Inclusion Criteria:

- Men who are aged 27-80 years

- Acknowledge sex with men in their lifetime

- Reside in Harris County, Texas

- Understand and speak English.

Exclusion Criteria:

- Current doctor's diagnosis of anal condyloma, hemorrhoids, fissures, or anal cancer