Self-sampling to Optimize Anal Lesion Outcomes

Not Applicable

Not yet recruiting

• Conditions: Anal Cancer

• Registration Number: NCT07192055
• Lead Sponsor: Medical College of Wisconsin

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-10
• Study First Submitted QC: 2025-09-23
• Last Update Submitted: 2025-09-23
• Study First Posted: 2025-09-25
• Last Update Posted: 2025-09-25
• Study Start: 2025-10-15
• Primary Completion: 2028-03-31
• Study Completion: 2029-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 572

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Effect of self-sampling intervention at high-resolution anoscopy	2 months	Determine the number of individuals who attend the high-resolution anoscopy appointment after exposure to the self-sampling intervention.
Effect of the self-sampling intervention at cytology	1 month	Determine the number of individuals who attend the cytology appointment after exposure to the self-sampling intervention.

Secondary Outcome Measures

Name	Time	Method
Effect of the self-sampling intervention at high-resolution anoscopy on people with HIV	2 months	Determine the number of individuals with HIV who attend the high-resolution anoscopy appointment after exposure to the self-sampling intervention.
Effect of the self-sampling intervention at cytology on people with human immunodeficiency virus (HIV)	1 month	Determine the number of individuals with HIV who attend the cytology appointment after exposure to the self-sampling intervention.
Effect of the self-sampling intervention at cytology on people randomized to their preferred sampling method	1 month	Assess the number of participants who attend their cytology appointment in the group randomized to their preferred sampling method.
Effect of the self-sampling intervention at high-resolution anoscopy on people randomized to their preferred sampling method	2 months	Assess the number of participants who attend their high-resolution anoscopy appointment in the group randomized to their preferred sampling method.

Trial Locations

Locations (3)

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