Self-sampling to Optimize Anal Lesion Outcomes

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Medical College of Wisconsin
Study ID
NCT07192055
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
35 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Self-sampling — 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 — 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

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.

Key Dates

Start date
Nov 18, 2025
Status verified
Jan 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2029

Study Design

Enrollment
572 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Self-sampling
    Participants will self-sample the anal canal with a swab. They will do this at home and at a clinic.
  • Active Comparator: 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.
  • Experimental: Nylon-flocked swab
    This is a swab with nylon-flocked material at the tip.
  • Active Comparator: Dacron swab
    This is a swab with a Dacron tip.

Primary Outcome Measure

Effect of the self-sampling intervention at cytology [ Time Frame: 1 month ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of ChicagoChicagoIllinois60637
Aniruddha Hazra, MD
[email protected]
773-795-2016
The University of Texas M.D. Anderson Cancer CenterHoustonTexas77030
Craig Messick, MD
713-745-1544
[email protected]
Medical College of WisconsinMilwaukeeWisconsin53226
Alan Nyitray
[email protected]
4149557701

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