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Self-sampling to Optimize Anal Lesion Outcomes

Self-sampling to Optimize Anal Lesion Outcomes

Recruiting
35 years and older
All
Phase N/A

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Overview

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

A potential study subject who meets all of the following inclusion criteria is eligible to participate in the study. Note that these criteria apply regardless of HPV vaccination status or disability status.

Inclusion Criteria:

  1. Age ≥ 35 years for those who are HIV-positive or ≥ 45 years for those who are HIV-negative.
  2. Must be either:
    1. A cisgender or transgender sexual minority man, or
    2. A transgender woman who has sex with men.
  3. Resides in Chicago, Houston, or Milwaukee metropolitan area.
  4. Is willing to attend a study clinic.
  5. Speak and understand either English or Spanish
  6. Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

A potential study subject who meets any of the following exclusion criteria is ineligible to participate in the study.

  1. Was a participant in the PAC Self-Swab Study in Milwaukee.
  2. Currently on anticoagulants, with the exception of aspirin or non-steroidal anti-inflammatory drugs (NSAIDs), e.g., ibuprofen, naproxen.
  3. Diagnosed with hemophilia, cirrhosis with bleeding varices, or thrombocytopenia.
  4. Presence of any contraindicating severe disease or condition, e.g., anal stenosis.
  5. Plans to move within 12 months after enrollment.

Study details
    Anal Cancer

NCT07192055

Medical College of Wisconsin

1 February 2026

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FAQs

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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