Self-sampling to Optimize Anal Lesion Outcomes (SOLO)

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this research study is to find ways to increase anal cancer screening among people at increased risk for anal cancer. This study will try to find out if persons will do an intervention (self-sampling of the anal canal) and if it affects cytology and high-resolution anoscopy (HRA) appointment attendance. Secondarily, the study will assess if a person who gets their choice of either self-sampling or healthcare provider sampling affects clinic attendance.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 35
Healthy Volunteers: t
View:

• Age ≥ 35 years for those who are HIV-positive or ≥ 45 years for those who are HIV-negative.

• Must be either:

‣ A cisgender or transgender sexual minority man, or

⁃ A transgender woman who has sex with men.

• Resides in Chicago, Houston, or Milwaukee metropolitan area.

• Is willing to attend a study clinic.

• Speak and understand either English or Spanish

• Ability to understand a written informed consent document, and the willingness to sign it.

Locations
United States
Illinois
University of Chicago
NOT_YET_RECRUITING
Chicago
Texas
The University of Texas M.D. Anderson Cancer Center
NOT_YET_RECRUITING
Houston
Wisconsin
Medical College of Wisconsin
RECRUITING
Milwaukee
Contact Information
Primary
Alan G Nyitray, PhD
anyitray@mcw.edu
4149557701
Backup
Jenna Nitkowski, PhD
jnitkowski@mcw.edu
414-955-2126
Time Frame
Start Date: 2025-11
Estimated Completion Date: 2029-03-31
Participants
Target number of participants: 572
Treatments
Experimental: Self-sampling
Participants will self-sample the anal canal with a swab. They will do this at home and at a clinic.
Active_comparator: Clinician sampling
A clinician will collect a sample from the anal canal of the participant with a swab. They will do this at the clinic.
Experimental: Nylon-flocked swab
This is a swab with nylon-flocked material at the tip.
Active_comparator: Dacron swab
This is a swab with a Dacron tip.
Related Therapeutic Areas
Sponsors
Leads: Medical College of Wisconsin
Collaborators: The University of Texas MD Anderson Cancer Center, National Cancer Institute (NCI), Froedtert Hospital, University of Chicago

This content was sourced from clinicaltrials.gov

Similar Clinical Trials