Self-Sampling to Optimize Anal Lesion Outcomes (SOLO) Pilot

An important component of our parent SOLO study is the testing of two different kinds of swabs, nylon-flocked and Dacron, for cytological adequacy and end user acceptability within a self-sampling and clinician-sampling context. The investigators chose a nylon-flocked (NF) swab given its high adequacy in our prior study; however, this NF swab is unlikely to be available for clinical use in the future due to recent changes in the manufacturer's priorities. Since the parent study results need to be widely generalizable and relevant to anal cancer screening, The investigators need to use a different NF swab model and assess its cytological performance characteristics in a pilot study before beginning the parent study.

Given our prior success with a NF swab developed by Copan Italia s.p.a. (Brescia, Italy) the investigators will test the feasibility of a new Copan swab developed for anal cancer screening. The investigators will test the cytological performance of the swab at two insertion depths, 3 cm and 5 cm, to determine which insertion depth is better at collecting cells from the squamocolumnar junction (SCJ), an anatomic site that is particularly vulnerable to carcinogenic transformation. The investigators hypothesize that the 5 cm insertion will result in a higher quality specimen with cells from the SCJ. However, the deeper swab insertion may affect end user acceptability without increasing adequacy or quality.

The investigators will test the new swab with 60 individuals who were participants in a prior study and who agreed to be contacted for follow-up studies. Individuals will be randomized to use the new NF swab with either a 3 cm or 5 cm insertion depth. After consenting, individuals will receive written instructions and then conduct the self-sampling in private. Staff will take the swab in PreservCyt® to the Medical College of Wisconsin Tissue Bank where it will be aliquoted for assessment of cytology and reflex human papillomavirus (HPV) testing at Wisconsin Diagnostic Labs.

The investigators have one objective: To ensure the use of a swab in SOLO that is comparable to the originally proposed swab for SOLO, determine the preliminary performance characteristics of the new NF swab. • H1: A higher proportion of the new NF swabs with 5 cm insertion will have SCJ cells compared to the NF swab for 3 cm insertion.• H2: A higher proportion of the new NF swabs with 5 cm insertion will be adequate for cytopathology interpretation compared to the NF swab for 3 cm insertion.• H3: The new NF swab will have acceptability/pain performance commensurate with the originally proposed NF swab and the 5 cm insertion depth will have similar acceptability/pain performance as the 3 cm insertion depth. Our expected outcomes are cytological preliminary performance characteristics of the new NF swab in addition to user acceptability. These outcomes will help ensure the use of a viable swab in the parent study that is relevant in future anal cancer screening programs.

Recruitment Potential participants will be recruited first from the group of individuals who consented into the prior Prevent Anal Cancer (PAC) Self-Swab Study (PRO00032999) and then indicated an interest in a follow-up study (n=126). The investigators will enroll those aged ≥ 35 years. If the initial recruitment results in fewer than 60 people, the investigators will recruit by placing print materials in local gay-friendly businesses. The material will mention the study is recruiting for an anal cancer screening study. Recruitment material will be approved by a Medical College of Wisconsin (MCW) Institutional Review Board (IRB). The SOLO Study Coordinator in Milwaukee will oversee recruitment activity. The investigators will record recruitment activities.