Self-sampling to Optimize Anal Lesion Outcomes

Sponsored by Medical College of Wisconsin

About this trial

Last updated 3 months ago

Study ID

PRO00054186

Status

Recruiting

Type

Interventional

Phase

N/A

Placebo

Accepting

35+ Years

All Sexes

Trial Timing

Started 5 months ago

What is this trial about?

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.

What are the participation requirements?

Inclusion Criteria

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. 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.