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

NCT02384005 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2016-05-12

No results posted yet for this study

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.

Conditions

  • Anus Neoplasms

Interventions

OTHER

Self-anal exam arm

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Baylor College of Medicine

    collaborator OTHER

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Alan G. Nyitray, PhD · University of Texas School of Public Health at Houston

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
27 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02384005 on ClinicalTrials.gov