Clinical trial · Interventional
Self-sampling to Optimize Anal Lesion Outcomes
Self-sampling to Optimize Anal Lesion Outcomes (SOLO)
NCT07192055CI-TRIAL-00111238SOLOrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Cancer | Malignant Anal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nylon-flocked Swab | Other | — | UNRESOLVED |
| Self-sampling | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Self-sampling
- description
- Participants will self-sample the anal canal with a swab. They will do this at home and at a clinic.
- interventionNames
- Other: Nylon-flocked Swab
- type
- ACTIVE_COMPARATOR
- label
- Clinician sampling
- description
- A clinician will collect a sample from the anal canal of the participant with a swab. They will do this at the clinic.
- interventionNames
- Behavioral: Self-sampling
- Other: Nylon-flocked Swab
- type
- EXPERIMENTAL
- label
- Nylon-flocked swab
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 35 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.