Self-sampling to Optimize Anal Lesion Outcomes
ConditionAnal Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35+
SponsorMedical College of Wisconsin
About this trial
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.
Eligibility criteria
Qualifiers
Age ≥ 35 years for those who are HIV-positive or ≥ 45 years for those who are HIV-negative.
A cisgender or transgender sexual minority man, or
A transgender woman who has sex with men.
Resides in Chicago, Houston, or Milwaukee metropolitan area.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Self-sampling
- Nylon-flocked Swab
Treatment groups
572 Participants
are divided into 4 treatment groupsLocations
3University of Chicago60637, ChicagoIllinois, United States
The University of Texas M.D. Anderson Cancer Center77030, HoustonTexas, United States
Medical College of Wisconsin53226, MilwaukeeWisconsin, United States
Sponsors and collaborators
Medical College of Wisconsin
Lead sponsor
National Cancer Institute (NCI)
Collaborator
University of Chicago
Collaborator
Froedtert Hospital
Collaborator
M.D. Anderson Cancer Center
Collaborator
Source ClinicalTrials.gov