Clinical trial NCT02384005: The Feasibility of Self or Partner-assisted Digital Anal Exam Screening
Official title: The Feasibility of Self or Partner-assisted Digital Anal Exam Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anus Neoplasms
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Baylor College of Medicine
First posted: 2015-03-10
Enrollment: 201
Sex: MALE
Minimum age (years): 27
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Kappa agreement will be calculated between lay person and nurse practitioner on the anal exam results.
timeFrame: This cross-sectional design measures agreement on Day 1.
Secondary outcomes:
measure: Odds ratios will be calculated for the association between partnership status and concordance between participant and clinician.
timeFrame: This cross-sectional design collects data for the odds ratios on Day 1
measure: Odds ratios will be calculated for the association between age and concordance between participant and clinician.
timeFrame: This cross-sectional design collects data for the odds ratios on Day 1
measure: Odds ratios will be calculated for the association between waist circumference and concordance between participant and clinician.
timeFrame: This cross-sectional design collects data for the odds ratios on Day 1
measure: Odds ratios will be calculated for the association between race and concordance between participant and clinician.
timeFrame: This cross-sectional design collects data for the odds ratios on Day 1
measure: Odds ratios will be calculated for the association between ethnicity and concordance between participant and clinician.
timeFrame: This cross-sectional design collects data for the odds ratios on Day 1
measure: Number of persons who state that a self-DAE is an acceptable procedure.
timeFrame: This cross-sectional design collects these data on Day 1
measure: Number of persons with adverse events after conducting a self-DAE.
timeFrame: This cross-sectional design collects these data on Day 1
measure: Number of persons who state they have the ability to conduct a self-DAE.
timeFrame: This cross-sectional design collects these data on Day 1
measure: Number of persons who state they intend to seek subsequent care in the event of an abnormal result to a self-DAE.
timeFrame: This cross-sectional design collects these data on Day 1
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas School of Public Health
state: Texas
Study officials:
affiliation: University of Texas School of Public Health at Houston
name: Alan G. Nyitray, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nyitray AG, Hicks JT, Hwang LY, Baraniuk S, White M, Millas S, Onwuka N, Zhang X, Brown EL, Ross MW, Chiao EY. A phase II clinical study to assess the feasibility of self and partner anal examinations to detect anal canal abnormalities including anal cancer. Sex Transm Infect. 2018 Mar;94(2):124-130. doi: 10.1136/sextrans-2017-053283. Epub 2017 Aug 23.