What this study is
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.
What's being tested
- Self-sampling
Intervention · BEHAVIORAL
Self-sampling instructions will be provided to participants who will insert the swab into the anus to collect cells. Then the participant will put the swab in a vial of transport fluid for assessment at a laboratory.
- Nylon-flocked Swab
Intervention · OTHER
At the cytology appointment, participants may receive self-sampling or clinician sampling with 1 of 2 kinds of swabs. The nylon-flocked swab is the intervention and will be assessed on patient acceptability and patient and clinician ability to collect an adequate sample.
Study details
- Official title
- Self-sampling to Optimize Anal Lesion Outcomes (SOLO)
- Sponsor
- Medical College of Wisconsin
- Conditions
- Anal Cancer
- Enrolling
- 572 people
- Starts
- 2025-11-18
- Est. completion
- 2029-03-31
- Design
- Triple-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 35 Years and overSex ALLHealthy volunteers AcceptedYou may qualify if
- 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 ≥ 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.
You can't join if
- 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.
- Currently on anticoagulants, with the exception of aspirin or non-steroidal anti-inflammatory drugs (NSAIDs), e.g., ibuprofen, naproxen.
- Diagnosed with hemophilia, cirrhosis with bleeding varices, or thrombocytopenia.
- Presence of any contraindicating severe disease or condition, e.g., anal stenosis.
- Plans to move within 12 months after enrollment.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (3)
3 openUniversity of Chicago
Chicago, Illinois, United States
- Aniruddha Hazra, MD · Contact773-795-2016ahazra2@bsd.uchicago.edu
RecruitingThe University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
- Craig Messick, MD · Contact713-745-1544
- Contactcmessick@mdanderson.org
RecruitingMedical College of Wisconsin
Milwaukee, Wisconsin, United States
- Alan Nyitray · Contact4149557701anyitray@mcw.edu
Recruiting
Study team
Sponsor
Medical College of Wisconsin
Study ID PRO00054186
Principal investigator
Alan Nyitray, PhD
Medical College of Wisconsin
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.