NCT07192055

Self-sampling to Optimize Anal Lesion Outcomes

Self-sampling to Optimize Anal Lesion Outcomes (SOLO)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 572 (estimated)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• Anal Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Self-sampling	Self-sampling instructions will be provided to participants who will insert the swab into the anus to collect cells. Then the participant will put the swab in a vial of transport fluid for assessment at a laboratory.
OTHER	Nylon-flocked Swab	At the cytology appointment, participants may receive self-sampling or clinician sampling with 1 of 2 kinds of swabs. The nylon-flocked swab is the intervention and will be assessed on patient acceptability and patient and clinician ability to collect an adequate sample.

Timeline

• Start date: 2025-11-18
• Primary completion: 2028-03-31
• Completion: 2029-03-31
• First posted: 2025-09-25
• Last updated: 2026-04-16

Locations

3 sites across 1 country: United States