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

NACompletedINTERVENTIONAL
Enrollment

201

Participants

Timeline

Start Date

February 28, 2015

Primary Completion Date

April 30, 2016

Study Completion Date

April 30, 2016

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.

Trial Locations (1)

77030

University of Texas School of Public Health, Houston

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

Baylor College of Medicine

OTHER

lead

The University of Texas Health Science Center, Houston

OTHER

NCT02384005 - The Feasibility of Self or Partner-assisted Digital Anal Exam Screening | Biotech Hunter | Biotech Hunter