Self-sampling to Optimize Anal Lesion Outcomes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Self-sampling, Nylon-flocked Swab.
- Who it may be relevant to
- Registry conditions: Anal Cancer. Basic parameters: from 35 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Self-sampling to Optimize Anal Lesion Outcomes (SOLO)
Overview
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.
Interventions
- Behavioral Self-sampling
Self-sampling instructions will be provided to participants who will insert the swab into the anus to collect cells. Then the participant will put the swab in a vial of transport fluid for assessment at a laboratory. - Other Nylon-flocked Swab
At the cytology appointment, participants may receive self-sampling or clinician sampling with 1 of 2 kinds of swabs. The nylon-flocked swab is the intervention and will be assessed on patient acceptability and patient and clinician ability to collect an adequate sample.
Primary outcome measures
- Effect of the self-sampling intervention at cytology [Time frame: 1 month]
- Effect of self-sampling intervention at high-resolution anoscopy [Time frame: 2 months]
Secondary outcome measures (4)
- Effect of the self-sampling intervention at cytology on people with human immunodeficiency virus (HIV) [Time frame: 1 month]
- Effect of the self-sampling intervention at high-resolution anoscopy on people with HIV [Time frame: 2 months]
- Effect of the self-sampling intervention at cytology on people randomized to their preferred sampling method [Time frame: 1 month]
- Effect of the self-sampling intervention at high-resolution anoscopy on people randomized to their preferred sampling method [Time frame: 2 months]
Eligibility 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
- Age ≥ 35 years for those who are HIV-positive or ≥ 45 years for those who are HIV-negative.
- Must be either:
- A cisgender or transgender sexual minority man, or
- A transgender woman who has sex with men.
- Resides in Chicago, Houston, or Milwaukee metropolitan area.
- Is willing to attend a study clinic.
- Speak and understand either English or Spanish
- 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.
- Was a participant in the PAC Self-Swab Study in Milwaukee.
- Currently on anticoagulants, with the exception of aspirin or non-steroidal anti-inflammatory drugs (NSAIDs), e.g., ibuprofen, naproxen.
- Diagnosed with hemophilia, cirrhosis with bleeding varices, or thrombocytopenia.
- Presence of any contraindicating severe disease or condition, e.g., anal stenosis.
- Plans to move within 12 months after enrollment.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
United States · 3 centers
- University of Chicago — Chicago
- The University of Texas M.D. Anderson Cancer Center — Houston
- Medical College of Wisconsin — Milwaukee
Identifiers
NCT: NCT07192055 · PRO00054186 · R01CA298844