Self-sampling to Optimize Anal Lesion Outcomes

Официальное название

Self-sampling to Optimize Anal Lesion Outcomes (SOLO)

Обзор

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.

Вмешательства

• Поведенческое 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.
• Другое 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.

Первичные конечные точки

• Effect of the self-sampling intervention at cytology [Срок оценки: 1 month]
• Effect of self-sampling intervention at high-resolution anoscopy [Срок оценки: 2 months]

Вторичные конечные точки (4)

• Effect of the self-sampling intervention at cytology on people with human immunodeficiency virus (HIV) [Срок оценки: 1 month]
• Effect of the self-sampling intervention at high-resolution anoscopy on people with HIV [Срок оценки: 2 months]
• Effect of the self-sampling intervention at cytology on people randomized to their preferred sampling method [Срок оценки: 1 month]
• Effect of the self-sampling intervention at high-resolution anoscopy on people randomized to their preferred sampling method [Срок оценки: 2 months]

Критерии участия

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.

Критерии включения

• 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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

США · 3 центра

• University of Chicago — Chicago
• The University of Texas M.D. Anderson Cancer Center — Houston
• Medical College of Wisconsin — Milwaukee

Идентификаторы

NCT: NCT07192055 · PRO00054186 · R01CA298844

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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