Self-sampling to Optimize Anal Lesion Outcomes

Recruiting now · Not applicable

Conditions studied: Anal Cancer

In brief

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.

Key facts

Study ID

NCT07192055

Run by

Medical College of Wisconsin

People needed

572

Starts

2025-11-18

Expected to finish

2029-03-31

Last updated by the study team

2026-05-12

Who can join

Age: 35 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• A potential study subject who meets any of the following exclusion criteria is ineligible to participate in the study.
• Was a participant in the PAC Self-Swab Study in Milwaukee.
• Currently on anticoagulants, with the exception of aspirin or non-steroidal anti-inflammatory drugs (NSAIDs), e.g., ibuprofen, naproxen.
• Diagnosed with hemophilia, cirrhosis with bleeding varices, or thrombocytopenia.
• Presence of any contraindicating severe disease or condition, e.g., anal stenosis.
• Plans to move within 12 months after enrollment.

Where it is running

• University of Chicago — Chicago, Illinois, United States (enrolling)
• The University of Texas M.D. Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States (enrolling)

Full record on ClinicalTrials.gov

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