RecruitingNot ApplicableNCT07192055

Self-sampling to Optimize Anal Lesion Outcomes

Self-sampling to Optimize Anal Lesion Outcomes (SOLO)

Sponsor

Medical College of Wisconsin

Enrollment

572 participants

Start Date

Nov 18, 2025

Study Type

INTERVENTIONAL

Conditions

Anal Cancer

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

Min Age: 35 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether self-collected anal swabs can accurately detect precancerous anal lesions caused by HPV (human papillomavirus) — a common virus linked to anal cancer — in gay, bisexual, and other men who have sex with men, as well as transgender women. **You may be eligible if...** - You are HIV-positive and age 35 or older, OR HIV-negative and age 45 or older - You are a cisgender or transgender man or transgender woman who has sex with men - You live in the Chicago, Houston, or Milwaukee area - You are willing to attend a study clinic - You speak English or Spanish **You may NOT be eligible if...** - You participated in the PAC Self-Swab Study in Milwaukee previously - You are on blood thinners (except aspirin or NSAIDs like ibuprofen) - You have hemophilia, liver cirrhosis with bleeding, or very low platelet counts - You have anal stenosis (narrowing) or another condition preventing the swab - You plan to move away within 12 months of enrolling Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALSelf-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.

OTHERNylon-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.