Actively Recruiting

Phase Not Applicable
Age: 35Years +
All Genders
Healthy Volunteers
NCT07192055

Self-sampling to Optimize Anal Lesion Outcomes

Led by Medical College of Wisconsin · Updated on 2026-05-12

572

Participants Needed

3

Research Sites

175 weeks

Total Duration

On this page

Sponsors

M

Medical College of Wisconsin

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Self-sampling to Optimize Anal Lesion Outcomes

Who Can Participate

Age: 35Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 35 years or older if HIV-positive, or 45 years or older if HIV-negative
  • Identify as a cisgender or transgender sexual minority man, or a transgender woman who has sex with men
  • Reside in the Chicago, Houston, or Milwaukee metropolitan area
  • Willing to attend a study clinic
  • Speak and understand English or Spanish
  • Able to understand and willing to sign a written informed consent document
Not Eligible

You will not qualify if you...

  • Previously participated in the PAC Self-Swab Study in Milwaukee
  • Currently taking anticoagulants, except for aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen
  • Diagnosed with hemophilia, cirrhosis with bleeding varices, or thrombocytopenia
  • Have any severe disease or condition that contraindicates participation, such as anal stenosis
  • Planning to move within 12 months after enrollment

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Trial Site Locations

Total: 3 locations

1

University of Chicago

Chicago, Illinois, United States, 60637

Actively Recruiting

2

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

3

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

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Research Team

A

Alan G Nyitray, PhD

CONTACT

J

Jenna Nitkowski, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

4

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