Self-sampling to Optimize Anal Lesion Outcomes (SOLO)

Medical College of Wisconsin

Status: Enrolling

Conditions: Anal Cancer

Treatments: Other: Nylon-flocked Swab; Behavioral: Self-sampling

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07192055

R01CA298844 (U.S. NIH Grant/Contract)

PRO00054186

Details and patient eligibility

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.

Enrollment: 572 estimated patients

Sex: All

Ages: 35+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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572 participants in 4 patient groups

Self-sampling

Experimental group

Description:

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

Treatment:

Other: Nylon-flocked Swab

Clinician sampling

Active Comparator group

Description:

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

Treatment:

Behavioral: Self-sampling

Other: Nylon-flocked Swab

Nylon-flocked swab

Experimental group

Description:

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

Treatment:

Behavioral: Self-sampling

Dacron swab

Active Comparator group

Description:

This is a swab with a Dacron tip.

Treatment:

Behavioral: Self-sampling

Other: Nylon-flocked Swab