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Идёт набор NCT07087145

Feasibility of HPV Testing With Mail-delivered Sample Collection Kits

— Наблюдательное HPV Infection HIV Infections HPV-Related Malignancy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Mail-based Saliva Sample Kit, Study-related Surveys.
Кому может быть актуально
Состояния в реестре: HPV Infection, HIV Infections, HPV-Related Malignancy. Базовые параметры: от 35 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Persistent Oral HPV Among Diverse PLWH: A Pilot Study to Evaluate the Feasibility and Acceptability of Testing for Oral HPV DNA Infection With Mail-delivered Sample Collection Kits

Обзор

People living with human immunodeficiency virus (PLWH) have an estimated 1.6-6.0 times increased risk of developing oropharyngeal cancer (OPC) compared with individuals in the general population. 70% of OPCs are caused by human papillomavirus (HPV), and PLWH also have an increased prevalence of oral HPV infection. Disparities by race/ethnicity also include a later stage of diagnosis and less frequent cancer-directed treatment for members of ethnic minority groups. There is little known regarding the racial/ethnic differences in oral HPV infection, persistence of oral HPV infection, or progression of oral HPV infection to OPC among PLWH. This is an observational, prospective cohort study to investigate the feasibility of alternative sample collection methods for HPV testing among PLWH.

Подробное описание

STUDY AIMS:

1. To determine if oral HPV deoxyribonucleic acid (HPV DNA) results obtained from self-collected oral rinse and gargle samples (ORG) sent by mail agree with results obtained from ORG samples collected in a clinic setting, among race/ethnically diverse sexual minority men (SMM) living with HIV (LWH). 2. To determine if oral HPV DNA results obtained from self-collected saliva samples applied to a Flinders Technology Associates (FTA) card sent by mail agree with results obtained from (1) ORG samples collected in a clinic setting, and (2) Home ORG, among race/ethnically diverse SMM-LWH. 3. To determine the feasibility, acceptability, and comfort of receiving HPV DNA sample collection kits by mail, self-collecting samples, and returning samples by FedEx, among racially/ethnically diverse SMM-LWH.

OUTLINE:

Participants will provide two saliva samples (at the same time), complete surveys, and complete a single clinic visit. Follow-up will be between 7 and 10 days post initial sample collection.

Вмешательства

  • Диагностический тест Mail-based Saliva Sample Kit
    Sent via United States Postal Service and returned via FedEx
  • Другое Study-related Surveys
    Online surveys will be administered

Первичные конечные точки

  • Percentage of participants with positive oral human papillomavirus infection [Срок оценки: Up to 10 days]
  • Agreement in the detection of oral HPV DNA between the oral rinse and gargle (ORG) and the clinic sample [Срок оценки: Up to 10 days]
  • Agreement in the detection of oral HPV DNA between Flinders Technology Associates (FTA) sample collection card and both the ORG samples (Home and Clinic). [Срок оценки: Up to 10 days]

Критерии участия

Критерии включения

  • Over 35 years of age
  • Member of a sexual or gender group considered sexual minority men (men who have sex with men, trans-women)
  • Person living with HIV
  • Willing and able to receive a package through United States (US) postal service
  • Willing and able to return a package through FedEx
  • Able to attend a clinic visit at University of California, San Francisco (UCSF) Mt. Zion campus

Критерии исключения

  • Does not meet the above criteria

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • University of California, San Francisco — San Francisco

Идентификаторы

NCT: NCT07087145 · 240514 · R03DE033930

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗