Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
572 participants
INTERVENTIONAL
2025-11-30
2029-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Self-sampling
Participants will self-sample the anal canal with a swab. They will do this at home and at a clinic.
Nylon-flocked Swab
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.
Clinician sampling
A clinician will collect a sample from the anal canal of the participant with a swab. They will do this at the clinic.
Self-sampling
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
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.
Nylon-flocked swab
This is a swab with nylon-flocked material at the tip.
Self-sampling
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.
Dacron swab
This is a swab with a Dacron tip.
Self-sampling
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
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.
Interventions
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Self-sampling
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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
35 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
University of Chicago
OTHER
Froedtert Hospital
OTHER
The University of Texas MD Anderson Cancer Center
UNKNOWN
Medical College of Wisconsin
OTHER
Responsible Party
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Alan Nyitray, PhD
Associate Professor
Principal Investigators
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Alan Nyitray, PhD
Role: PRINCIPAL_INVESTIGATOR
Medical College of Wisconsin
Locations
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University of Chicago
Chicago, Illinois, United States
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Aniruddha Hazra, MD
Role: primary
Craig Messick, MD
Role: primary
Role: backup
Alan Nyitray
Role: primary
Other Identifiers
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PRO00054186
Identifier Type: -
Identifier Source: org_study_id