The Self-Sampling Pilot Study
SOLOPilot
Self-Sampling to Optimize Anal Lesion Outcomes (SOLO) Pilot
1 other identifier
interventional
50
1 country
1
Brief Summary
The investigators will test the cytological performance of a nylon-flocked swab at two insertion depths in the anus, 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 10, 2025
CompletedFirst Posted
Study publicly available on registry
July 25, 2025
CompletedStudy Start
First participant enrolled
July 31, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 12, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 12, 2025
CompletedResults Posted
Study results publicly available
November 18, 2025
CompletedJanuary 27, 2026
December 1, 2025
1 month
July 10, 2025
November 4, 2025
January 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Presence of Squamocolumnar Cells
The presence of cells from the squamocolumnar junction will be assessed in each specimen (Yes/No). Proportions of specimens with squamocolumnar cells will be compared for the 5 cm and 3 cm swabs.
Day 1
Secondary Outcomes (4)
Cytologic Adequacy
Day 1
User Acceptability of New NF Swab Compared to Swab From Prior Research
Day 1
User Pain of New NF Swab Compared to Swab From Prior Research
Day 1
User Pain by Swab Length
Day 1
Study Arms (2)
Intervention arm
EXPERIMENTALIndividuals in the intervention arm will self-sample with a swab and insert the swab 5 cm into the anus.
Control arm
ACTIVE COMPARATORIndividuals in the control arm will self-sample with a swab and insert the swab 3 cm into the anus.
Interventions
The swab will be inserted into the anus by the lay individual. The individual will insert the swab to a depth of 5 cm to collect anal exfoliated cells.
The swab will be inserted into the anus by the lay individual. The individual will insert the swab to a depth of 3 cm to collect anal exfoliated cells.
Eligibility Criteria
You may qualify if:
- Aged ≥ 35 years.
- Must be either:
- A sexual minority man, or
- A woman who has a different identity than the sex she was born with.
- Resides in the Milwaukee metropolitan area.
- Speak and understand English.
- Ability to understand a written informed consent document, and the willingness to sign it.
You may not qualify if:
- \. Presence of any contraindicating severe anal disease or condition, e.g., anal stenosis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Curative Building
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Alan Nyitray, PhD
- Organization
- Medical College of Wisconsin
Study Officials
- PRINCIPAL INVESTIGATOR
Alan Nyitray, PhD
Medical College of Wisconsin
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 10, 2025
First Posted
July 25, 2025
Study Start
July 31, 2025
Primary Completion
September 12, 2025
Study Completion
September 12, 2025
Last Updated
January 27, 2026
Results First Posted
November 18, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- All scientific data generated from this project will be made available as soon as possible, and no later than the time of publication. The duration of preservation and sharing of the data will be a minimum of 10 years.
- Access Criteria
- The openICPSR provides metadata, persistent identifiers using ICPSR ID numbers and DOI, and long-term access. The repository is supported by the Inter-university Consortium for Political and Social Research (ICPSR) and datasets are available under a Creative Commons Attribution 4.0 International (CC BY 4.0) License. The dataset will be discoverable online by anyone through a standard web search of the study-level metadata as well as the persistent pointer from the ICPSR ID and DOI to the dataset.
This Self-sampling to Optimize anal Lesion Outcomes (SOLO) pilot study will produce quantitative data generated from surveys with 60 participants. We will also collect data on intervention performance, biospecimen collection, and laboratory assays. Data from the 60 persons will be collected at 1 time point, the cytology appointment. To protect research participant identities, only de-identified individual quantitative data will be made available for sharing. The final datasets will include quantitative data as delineated in 1.A. We will share de-identified individual participant-level data. We will use typical strategies such as "safe harbor" methods that remove all protected health information (e.g., name, address, and contact information) per MCW policy AD.HP.090. Informed consent forms will reflect those plans. In circumstances where small sample sizes may allow identification of research participants, only summarized data will be made available for sharing.