The Feasibility of Self or Partner-assisted Digital Anal Exam Screening
2 other identifiers
interventional
201
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 3, 2015
CompletedFirst Posted
Study publicly available on registry
March 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedMay 12, 2016
May 1, 2016
1.2 years
March 3, 2015
May 10, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Kappa agreement will be calculated between lay person and nurse practitioner on the anal exam results.
This cross-sectional design measures agreement on Day 1.
Secondary Outcomes (9)
Odds ratios will be calculated for the association between partnership status and concordance between participant and clinician.
This cross-sectional design collects data for the odds ratios on Day 1
Odds ratios will be calculated for the association between age and concordance between participant and clinician.
This cross-sectional design collects data for the odds ratios on Day 1
Odds ratios will be calculated for the association between waist circumference and concordance between participant and clinician.
This cross-sectional design collects data for the odds ratios on Day 1
Odds ratios will be calculated for the association between race and concordance between participant and clinician.
This cross-sectional design collects data for the odds ratios on Day 1
Odds ratios will be calculated for the association between ethnicity and concordance between participant and clinician.
This cross-sectional design collects data for the odds ratios on Day 1
- +4 more secondary outcomes
Study Arms (1)
Self-anal exam arm
OTHERStudy only has one arm.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Men who are aged 27-80 years
- Acknowledge sex with men in their lifetime
- Reside in Harris County, Texas
- Understand and speak English.
You may not qualify if:
- Current doctor's diagnosis of anal condyloma, hemorrhoids, fissures, or anal cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The University of Texas Health Science Center, Houstonlead
- National Cancer Institute (NCI)collaborator
- Baylor College of Medicinecollaborator
Study Sites (1)
University of Texas School of Public Health
Houston, Texas, 77030, United States
Related Publications (1)
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.
PMID: 28835533DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alan G. Nyitray, PhD
University of Texas School of Public Health at Houston
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 3, 2015
First Posted
March 10, 2015
Study Start
February 1, 2015
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
May 12, 2016
Record last verified: 2016-05