NCT07192055

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
572

participants targeted

Target at P75+ for not_applicable

Timeline
36mo left

Started Nov 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Nov 2025Mar 2029

First Submitted

Initial submission to the registry

September 10, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 25, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

November 18, 2025

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2029

Last Updated

April 16, 2026

Status Verified

January 1, 2026

Enrollment Period

2.4 years

First QC Date

September 10, 2025

Last Update Submit

April 15, 2026

Conditions

Anal Cancer

Keywords

anal cancerhuman papillomavirus

Outcome Measures

Primary Outcomes (2)

  • 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.

    1 month

  • 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.

    2 months

Secondary Outcomes (4)

  • Effect of the self-sampling intervention at cytology on people with human immunodeficiency virus (HIV)

    1 month

  • Effect of the self-sampling intervention at high-resolution anoscopy on people with HIV

    2 months

  • Effect of the self-sampling intervention at cytology on people randomized to their preferred sampling method

    1 month

  • Effect of the self-sampling intervention at high-resolution anoscopy on people randomized to their preferred sampling method

    2 months

Other Outcomes (8)

  • Effect of the self-sampling intervention among Black individuals at cytology

    1 month

  • Effect of the self-sampling intervention among Black individuals at high-resolution anoscopy

    2 months

  • Assess the adequacy of nylon-flocked swabs

    1 month

  • +5 more other outcomes

Study Arms (4)

Self-sampling

EXPERIMENTAL

Participants will self-sample the anal canal with a swab. They will do this at home and at a clinic.

Other: Nylon-flocked Swab

Clinician sampling

ACTIVE COMPARATOR

A clinician will collect a sample from the anal canal of the participant with a swab. They will do this at the clinic.

Behavioral: Self-samplingOther: Nylon-flocked Swab

Nylon-flocked swab

EXPERIMENTAL

This is a swab with nylon-flocked material at the tip.

Behavioral: Self-sampling

Dacron swab

ACTIVE COMPARATOR

This is a swab with a Dacron tip.

Behavioral: Self-samplingOther: Nylon-flocked Swab

Interventions

Self-samplingBEHAVIORAL

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.

Also known as: self-collection
Clinician samplingDacron swabNylon-flocked swab
Nylon-flocked SwabOTHER

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 samplingDacron swabSelf-sampling

Eligibility Criteria

Age35 Years+
Sexall(Gender-based eligibility)
Gender Eligibility Detailscisgender males and transgender persons who have sex with men
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 35 years for those who are HIV-positive or ≥ 45 years for those who are HIV-negative.
  • Must be either:
  • A cisgender or transgender sexual minority man, or
  • A transgender woman who has sex with men.
  • Resides in Chicago, Houston, or Milwaukee metropolitan area.
  • Is willing to attend a study clinic.
  • Speak and understand either English or Spanish
  • Ability to understand a written informed consent document, and the willingness to sign it.

You may not qualify if:

  • 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.
  • Plans to move within 12 months after enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

NOT YET RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

MeSH Terms

Conditions

Anus Neoplasms

Condition Hierarchy (Ancestors)

Rectal NeoplasmsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesAnus DiseasesRectal Diseases

Study Officials

  • Alan Nyitray, PhD

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alan G Nyitray, PhD

CONTACT

4149557701anyitray@mcw.edu

Jenna Nitkowski, PhD

CONTACT

414-955-2126jnitkowski@mcw.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
When care providers are scheduling cytology appointments, they will not know the participant arm assignment. When specimens are sent to laboratories, the lab will not know the participant arm assignment.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 10, 2025

First Posted

September 25, 2025

Study Start

November 18, 2025

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2029

Last Updated

April 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Fully de-identified datasets will be shared with properly trained investigators after assessment of institutional policies, Medical College of Wisconsin Human Protections Committee rules, as well as local, state, and Federal laws and regulations.

Time Frame
Data will become available one year after study completion.
Access Criteria
Fully de-identified datasets will be shared with properly trained investigators after assessment of institutional policies, Medical College of Wisconsin Human Protections Committee rules, as well as local, state, and Federal laws and regulations.

Locations

US(3)