Clinical trial · Interventional
The Feasibility of Self or Partner-assisted Digital Anal Exam Screening
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anus Neoplasms | Anal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Self-anal exam arm | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Self-anal exam arm
- description
- Study only has one arm.
- interventionNames
- Other: Self-anal exam arm
Primary outcomes (1)
- 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 (9)
- 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
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 27 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDNyitray 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 28835533