NCT07192055Recruiting
Self-sampling to Optimize Anal Lesion Outcomes
Self-sampling to Optimize Anal Lesion Outcomes (SOLO)
Source: ClinicalTrials.gov · Last updated 12 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 572 (estimated)
- First submitted
- 10 Sept 2025
- Start date
- 18 Nov 2025
- Primary completion date
- 31 Mar 2028
- Lead sponsor
- Medical College of Wisconsin
- NCT number
- NCT07192055
What you commit to
- Study type: Interventional
- Planned participants: 572
- From 18 Nov 2025 to the primary completion date, 31 Mar 2028
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently on anticoagulants, with the exception of aspirin or non-steroidal anti-inflammatory drugs (NSAIDs), e.g., ibuprofen, naproxen.
Other illness
- Diagnosed with hemophilia, cirrhosis with bleeding varices, or thrombocytopenia.
- Presence of any contraindicating severe disease or condition, e.g., anal stenosis.
Other
- 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.
- Plans to move within 12 months after enrollment.
Who the study is looking for
- 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.
Criteria the registry did not label
- 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.
Age in the registry: 35 years to - · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| The University of Texas M. D. Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.