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Набор скоро начнётся NCT07399873

Outcomes From Point-of-Care Sexually Transmitted Infection (STI) Testing in an Urban Sexual Health Clinic: A Randomized Trial

Без фазы С лечением Neisseria Gonorrhoeae Infection Chlamydia Trachomatis Infection

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: Point-of-care assay for chlamydia and gonorrhea, Laboratory-based chlamydia and gonorrhea NAAT, CRISPR-based assay.
Кому может быть актуально
Состояния в реестре: Neisseria Gonorrhoeae Infection, Chlamydia Trachomatis Infection. Базовые параметры: от 18 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Outcomes From Point-of-Care STI Testing in an Urban Sexual Health Clinic: A Randomized Trial

Обзор

The goal of this clinical trial is to learn about the impact of a point-of-care test for gonorrhea and chlamydia in people without symptoms who are seeking sexually transmitted infection testing. The main questions it aims to answer are: Does the point of care test reduce the time to antibiotic treatment? Does the point of care test increase the number of people who have completed treatment by day 7? Researchers will compare the point-of-care test to a standard laboratory-based test for gonorrhea and chlamydia. Participants will be asked to provide a urine sample or vaginal swab for testing. They will also complete surveys about their experiences with the testing.

Подробное описание

Investigators will prospectively enroll asymptomatic individuals presenting for STI screening. Individuals will be randomized in a 1:1 manner to receive either standard-of-care screening or standard-of-care plus point-of-care testing for Chlamydia trachomatis and Neisseria gonorrhoeae. Among individuals enrolled and randomized to the intervention arm, investigators will collect an additional vaginal swab among women or urine sample among men for point-of-care testing using the Cobas® Liat CT/NG Assay (Roche, United States). Individuals who test positive for either pathogen (in either arm) will receive treatment according to Centers for Disease Control and Prevention (CDC) guidelines. The time to treatment and the proportion of patients who are on or have completed treatment at day 7 day after the initial visit will be evaluated.

Primary Objective: To compare the time to antimicrobial therapy initiation for C. trachomatis and/or N. gonorrhoeae among patients treated according to a point-of-care test plus standard of care versus patients treated according to standard of care alone.

Secondary Objective: To evaluate the proportion of patients who have completed or have started therapy by day 7 after a positive C. trachomatis and/or N. gonorrhoeae test result among patients treated according to a point-of-care test plus standard of care versus patients treated according to standard of care alone.

As a second aim, investigators will seek to compare performance of a novel clustered regularly interspaced short palindromic repeats (CRISPR)-based point-of-care STI and antimicrobial resistance assay to reference testing on additional samples collected from symptomatic participants in this study.

Вмешательства

  • Диагностический тест Point-of-care assay for chlamydia and gonorrhea
    This intervention consists of use of Cobas® Liat CT/NG Assay (Roche, United States).
  • Диагностический тест Laboratory-based chlamydia and gonorrhea NAAT
    This intervention consists of routine, laboratory-based diagnostic testing for chlamydia and gonorrhea via nucleic acid amplification.
  • Диагностический тест CRISPR-based assay
    This is a novel assay using CRISPR technology to assess for STIs and antimicrobial resistance.

Первичные конечные точки

  • Days to antibiotic initiation [Срок оценки: Time in days (0-365)]
Вторичные конечные точки (1)
  • Antimicrobial therapy initiation within 7 days [Срок оценки: 7 days from baseline]

Критерии участия

Критерии включения

  • At least 18 years of age
  • Willing and able to provide informed consent
  • Asymptomatic at the urogenital site
  • Being screened for urogenital C. trachomatis and/or N. gonorrhoeae as part of routine clinical care

Критерии исключения

  • Indication for antimicrobial therapy for C. trachomatis or N. gonorrhoeae at the time of the visit, regardless of test results

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
Двойное слепое
Основная цель
Диагностика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07399873 · 2025P002645

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗