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Идёт набор NCT07500415

Doxi-Rio: Study on the Use of Doxycycline to Prevent Sexually Transmitted Infections in Rio de Janeiro

Без фазы С лечением Sexually Transmitted Diseases Syphilis Gonorrhea Chlamydia Infections

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: Doxycycline.
Кому может быть актуально
Состояния в реестре: Sexually Transmitted Diseases, Syphilis, Gonorrhea, Chlamydia Infections. 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
Бразилия
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

Doxi-Rio: Pilot Implementation of Post-exposure Prophylaxis for Sexually Transmitted Infections With Doxycycline in Rio de Janeiro, Brazil

Обзор

The goal of this clinical trial is to learn if doxycycline post-exposure prophylaxis (doxy-PEP) can help prevent bacterial sexually transmitted infections (STIs) among sexual and gender minorities in Rio de Janeiro, Brazil, including men who have sex with men, transgender women, and travestis who are living with HIV or using HIV pre-exposure prophylaxis (PrEP). Bacterial STIs such as syphilis, gonorrhea, and chlamydia remain common in these populations, even with existing prevention strategies. This study aims to answer the following questions: whether doxy-PEP can reduce the number of new STIs, whether it is safe and well tolerated, whether participants use it as recommended, and whether its use may contribute to antibiotic resistance or changes in the body's natural bacteria. Doxy-PEP involves taking a dose of doxycycline, an antibiotic, shortly after sexual activity to reduce the risk of acquiring STIs. Participants will first receive information and counseling about doxy-PEP, including its possible benefits and risks, and will then choose whether or not to use this prevention strategy. Those who choose to use doxy-PEP will take doxycycline after sex as instructed and will be followed for up to 48 weeks, with clinic visits approximately every three months. During these visits, participants will be tested for STIs, monitored for side effects, and asked about medication use, sexual health, and overall well-being. Researchers will collect information on new STI diagnoses, safety, and how consistently participants use doxy-PEP. The study will also explore participants' experiences and perceptions of this strategy. The results of this study will help determine whether doxy-PEP is a practical and acceptable approach for STI prevention in Brazil and may inform future public health strategies.

Вмешательства

  • Препарат Doxycycline
    Doxycycline 200 mg taken orally within 72 hours after sexual activity, not exceeding one dose per 24 hours and a maximum of three doses per week.

Первичные конечные точки

  • Incidence of bacterial sexually transmitted infections (STIs) [Срок оценки: Up to 48 weeks]
Вторичные конечные точки (8)
  • Incidence of symptomatic and asymptomatic bacterial STIs [Срок оценки: Up to 48 weeks.]
  • Incidence of specific STIs (chlamydia, gonorrhea, and syphilis) [Срок оценки: Up to 48 weeks]
  • Antimicrobial resistance in Neisseria gonorrhoeae [Срок оценки: Baseline and up to 48 weeks]
  • Colonization with antimicrobial-resistant bacteria [Срок оценки: Baseline and week 48]
  • Adverse events [Срок оценки: From enrollment to 48 weeks]
  • Adherence to doxy-PEP [Срок оценки: Up to 48 weeks]
  • Uptake of doxy-PEP [Срок оценки: At enrollment]
  • Acceptability of doxy-PEP [Срок оценки: Up to 48 weeks]

Критерии участия

Критерии включения

  • Individuals assigned male at birth (cisgender or transgender men), transgender women, or travestis who have sex with men
  • Age ≥18 years
  • Living with HIV or currently using HIV pre-exposure prophylaxis (PrEP) for at least 6 months
  • History of at least one bacterial sexually transmitted infection (chlamydia, gonorrhea, or syphilis) in the past 12 months (laboratory-confirmed or self-reported)
  • Willing and able to provide informed consent

Критерии исключения

  • Known allergy or hypersensitivity to doxycycline or other tetracycline-class antibiotics
  • Current use of medications that may significantly interact with doxycycline or are contraindicated, including systemic retinoids, barbiturates, carbamazepine, or phenytoin

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Бразилия · 1 центр
  • Instituto Nacional de Infectologia Evandro Chagas — Rio de Janeiro

Идентификаторы

NCT: NCT07500415 · 87288525.2.0000.5262

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗