Recruiting

Anal Cancer Screening

Sponsor:

Medical College of Wisconsin

Code:

NCT07192055

Conditions

Anal Cancer

Eligibility Criteria

Sex: All

Age: 35+

Healthy Volunteers: Accepted

Interventions

Self-sampling

Nylon-flocked Swab

Study Details

Brief summary:

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.

Conditions

Anal Cancer

Study ID

NCT07192055

Start date

Nov 18, 2025

Status verified date

Jan, 2026

Completion date

Mar 31, 2029

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 35+

Healthy Volunteers: Accepted

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.

Inclusion Criteria:

1. Age ≥ 35 years for those who are HIV-positive or ≥ 45 years for those who are HIV-negative.
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:

A potential study subject who meets any of the following exclusion criteria is ineligible to participate in the study.

1. Was a participant in the PAC Self-Swab Study in Milwaukee.
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.

Study Design

Enrollment

572 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

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.

Primary outcome measure

  • Effect of the self-sampling intervention at cytology [ Time Frame: 1 month ]
  • Effect of self-sampling intervention at high-resolution anoscopy [ Time Frame: 2 months ]

Central Contacts and Locations

Central contacts

Alan G Nyitray, PhD

4149557701anyitray@mcw.edu

Locations

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

The University of Texas M.D. Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

More Information

Sponsor

Medical College of Wisconsin

Last update posted

May 12, 2026

Last verified

Jan, 2026

Keywords

  • anal cancer
  • human papillomavirus

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Medical College of Wisconsin on 2026-05-12.