Self-sampling to improve anal lesion outcomes

Self-sampling to Optimize Anal Lesion Outcomes (SOLO)

This study will test whether people at higher risk for anal cancer will use a self-collected anal swab and whether that increases follow-up cytology and high-resolution anoscopy (HRA) appointment attendance.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 572 (estimated)
• Ages: 35 Years and up
• Sex: All
• Sponsor: Medical College of Wisconsin (Academic / other)
• Locations: 3 sites (Chicago, Illinois and 2 other locations)
• Trial ID: NCT07192055 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are cisgender or transgender sexual minority men and transgender women who have sex with men, aged ≥35 if HIV-positive or ≥45 if HIV-negative, who live in the Chicago, Houston, or Milwaukee metro areas and can attend study clinics and consent in English or Spanish.

Not a fit: People who are below the age thresholds, live outside the three metro areas, are currently on anticoagulants other than aspirin or NSAIDs, previously participated in the PAC Self-Swab study in Milwaukee, or cannot attend clinic visits may not receive benefit from participating.

Why it matters

Potential benefit: If successful, offering self-sampling could make screening easier to access, increase follow-up for abnormal findings, and help detect anal precancers earlier.

How similar studies have performed: Prior studies of self-collected anal and genital swabs for HPV testing have shown good uptake and often comparable detection to clinician samples, but using self-sampling specifically to boost follow-up HRA attendance is less well established.

Eligibility criteria

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 this trial is running

Chicago, Illinois and 2 other locations

• 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

Conditions Anal Cancer; anal cancer; human papillomavirus