Self-sampling to improve anal lesion outcomes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will offer a nylon-flocked self-swab of the anal canal to at-risk sexual minority men and transgender women at clinics in Chicago, Houston, and Milwaukee and measure who completes the self-sampling. The study tracks whether self-sampling affects completion of cytology testing and attendance at high-resolution anoscopy (HRA) visits, and secondarily whether allowing participants to choose self-sampling versus provider sampling changes clinic attendance. Enrollment requires meeting age and gender/sexual behavior criteria, residency in one of the three metropolitan areas, and the ability to consent in English or Spanish. Primary outcomes include self-sampling uptake, cytology results, and HRA appointment attendance.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Alan Nyitray, PhD — Medical College of Wisconsin
• Study coordinator: Alan G Nyitray, PhD
• Email: anyitray@mcw.edu
• Phone: 4149557701

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.