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NCT Number: NCT07192055

Self-sampling to Optimize Anal Lesion Outcomes

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.

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Key information

Conditions

Anal Cancer Anus Diseases Anus Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago, Chicago, Illinois, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Exclusion criteria

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

  • 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.

Treatment and study plan

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.

Other names: self-collection

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.

Primary outcomes

  1. Effect of the self-sampling intervention at cytology

    Time frame: 1 month

    Determine the number of individuals who attend the cytology appointment after exposure to the self-sampling intervention.

  2. Effect of self-sampling intervention at high-resolution anoscopy

    Time frame: 2 months

    Determine the number of individuals who attend the high-resolution anoscopy appointment after exposure to the self-sampling intervention.

Secondary outcomes

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

    Time frame: 1 month

    Determine the number of individuals with HIV who attend the cytology appointment after exposure to the self-sampling intervention.

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

    Time frame: 2 months

    Determine the number of individuals with HIV who attend the high-resolution anoscopy appointment after exposure to the self-sampling intervention.

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

    Time frame: 1 month

    Assess the number of participants who attend their cytology appointment in the group randomized to their preferred sampling method.

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

    Time frame: 2 months

    Assess the number of participants who attend their high-resolution anoscopy appointment in the group randomized to their preferred sampling method.

Other outcomes

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

    Time frame: 1 month

    Determine the number of Black individuals who attend the cytology appointment after exposure to the self-sampling intervention.

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

    Time frame: 2 months

    Determine the number of Black individuals who attend high-resolution anoscopy appointments after exposure to the self-sampling intervention.

  3. Assess the adequacy of nylon-flocked swabs

    Time frame: 1 month

    Determine the number of nylon-flocked swabs that are cytologically adequate (defined as 2000-3000 nucleated squamous cells/mm3).

  4. Assess the adequacy of Dacron swabs

    Time frame: 1 month

    Determine the number of Dacron swabs that are cytologically adequate (defined as 2000-3000 nucleated squamous cells/mm3).

  5. Assess participant pain after using the nylon-flocked swab

    Time frame: 1 month

    The Wong-Baker FACES® Pain Rating Scale measures the severity of pain, if any. Possible scores range from 0 to 10 with higher scores indicating increased severity of pain.

  6. Assess participant pain after using the Dacron swab

    Time frame: 1 month

    The Wong-Baker FACES® Pain Rating Scale measures the severity of pain, if any. Possible scores range from 0 to 10 with higher scores indicating increased severity of pain.

  7. Assess participant comfort after using the nylon-flocked swab

    Time frame: 1 month

    The variable comfort measures the individual's reported comfort on a 4-point Likert scale from Strongly Agree to Strongly Disagree. Possible scores range from 1 to 4 with higher scores indicating decreased comfort after using the nylon-flocked swab.

  8. Assess participant comfort after using the Dacron swab

    Time frame: 1 month

    The variable comfort measures the individual's reported comfort on a 4-point Likert scale from Strongly Agree to Strongly Disagree. Possible scores range from 1 to 4 with higher scores indicating decreased comfort after using the Dacron swab

Study contacts

Contact information is provided by the study sponsor or research team.

Alan G Nyitray, PhD

CONTACT

[email protected]

4149557701

Jenna Nitkowski, PhD

CONTACT

[email protected]

414-955-2126

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • Froedtert Hospital
  • M.D. Anderson Cancer Center
  • National Cancer Institute (NCI)
  • University of Chicago

Registry information

Official study title

Self-sampling to Optimize Anal Lesion Outcomes (SOLO)

Acronym: SOLO

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Sep 25, 2025
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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