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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Self-sampling
BehavioralSelf-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
Other interventionAt 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.
Treatment groups
572 Participants
are divided into 4 treatment groupsGroup A: Self-samplingExperimental treatment 1 intervention
Group B: Clinician samplingActive comparator 2 interventions
Group C: Nylon-flocked swabExperimental treatment 1 intervention
Group D: Dacron swabActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Effect of the self-sampling intervention at cytology
Determine the number of individuals who attend the cytology appointment after exposure to the self-sampling intervention.
Time frame
1 month2
Effect of self-sampling intervention at high-resolution anoscopy
Determine the number of individuals who attend the high-resolution anoscopy appointment after exposure to the self-sampling intervention.
Time frame
2 monthsSecondary outcomes
1
Effect of the self-sampling intervention at cytology on people with human immunodeficiency virus (HIV)
Determine the number of individuals with HIV who attend the cytology appointment after exposure to the self-sampling intervention.
Time frame
1 month2
Effect of the self-sampling intervention at high-resolution anoscopy on people with HIV
Determine the number of individuals with HIV who attend the high-resolution anoscopy appointment after exposure to the self-sampling intervention.
Time frame
2 months3
Effect of the self-sampling intervention at cytology on people randomized to their preferred sampling method
Assess the number of participants who attend their cytology appointment in the group randomized to their preferred sampling method.
Time frame
1 month4
Effect of the self-sampling intervention at high-resolution anoscopy on people randomized to their preferred sampling method
Assess the number of participants who attend their high-resolution anoscopy appointment in the group randomized to their preferred sampling method.
Time frame
2 monthsOther outcomes
1
Effect of the self-sampling intervention among Black individuals at cytology
Determine the number of Black individuals who attend the cytology appointment after exposure to the self-sampling intervention.
Time frame
1 month2
Effect of the self-sampling intervention among Black individuals at high-resolution anoscopy
Determine the number of Black individuals who attend high-resolution anoscopy appointments after exposure to the self-sampling intervention.
Time frame
2 months3
Assess the adequacy of nylon-flocked swabs
Determine the number of nylon-flocked swabs that are cytologically adequate (defined as 2000-3000 nucleated squamous cells/mm3).
Time frame
1 month4
Assess the adequacy of Dacron swabs
Determine the number of Dacron swabs that are cytologically adequate (defined as 2000-3000 nucleated squamous cells/mm3).
Time frame
1 monthSponsors and contacts
Click on the lead sponsor to view all of their trials.
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