- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT04325555
Pre-exposure Prophylaxis: A Miracle Drug or a Moral Hazard
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
Тип исследования
Регистрация (Действительный)
Контакты и местонахождение
Места учебы
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Abu Dhabi, Объединенные Арабские Эмираты, 00000
- New York University Abu Dhabi
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria:
- 18 years or above
- living in the London, New York, Toronto or Sydney metro area
- self-reported sex at birth is male
- reported ever having sex with a male
Exclusion Criteria:
- not meeting the inclusion criteria
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
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Respondents on PrEP
On PrEP status will be operationalized in multiple ways, and sensitivity analyses will be conducted using multiple definitions as a result of the self-reported nature of the study.
A comparison group will be constructed by matching on a variety of characteristics, when this method is applied. Most importantly, age, and STD testing frequency among others, which influence the likelihood of being on PrEP and via that avenue sexual practices, as well as the likelihood of detecting STDs (i.e., ascertainment bias). In other models adjustments will be made for these factors. |
The investigators measure self-reported PrEP status as exposure, i.e., PrEP status is not confirmed via matched medical records or any other type of information directly collected form subjects.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Syphilis diagnosis
Временное ограничение: All diagnosis data is collected in a time-stamped fashion between January 2015 and December 2019; diagnosis is reported within the year, but not in a specific month/day
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Self-reported diagnosis of syphilis
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All diagnosis data is collected in a time-stamped fashion between January 2015 and December 2019; diagnosis is reported within the year, but not in a specific month/day
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Chlamydia diagnosis
Временное ограничение: All diagnosis data is collected in a time-stamped fashion between January 2015 and December 2019; diagnosis is reported within the year, but not in a specific month/day
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Self-reported diagnosis of chlamydia
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All diagnosis data is collected in a time-stamped fashion between January 2015 and December 2019; diagnosis is reported within the year, but not in a specific month/day
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Gonorrhea diagnosis
Временное ограничение: All diagnosis data is collected in a time-stamped fashion between January 2015 and December 2019; diagnosis is reported within the year, but not in a specific month/day
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Self-reported diagnosis of gonorrhea
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All diagnosis data is collected in a time-stamped fashion between January 2015 and December 2019; diagnosis is reported within the year, but not in a specific month/day
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Sexually transmitted diseases
Временное ограничение: All diagnosis data is collected in a time-stamped fashion between January 2015 and December 2019; diagnosis is reported within the year, but not in a specific month/day
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Self-reported diagnosis of any STD
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All diagnosis data is collected in a time-stamped fashion between January 2015 and December 2019; diagnosis is reported within the year, but not in a specific month/day
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Percent of time that condoms were used in sexual intercourse
Временное ограничение: 12 months
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Self-reported condom adherence
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12 months
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Number of ongoing sexual relationships
Временное ограничение: Through study completion, approximately 2 months
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Self-reported number of concurrent sexual partners
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Through study completion, approximately 2 months
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Number of sexual partners over the past 12 months
Временное ограничение: 12 months
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Self-reported number of sexual partners over the past 12 months
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12 months
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Selecting a potential date with many recent partners
Временное ограничение: Through study completion, approximately 2 months
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The likelihood of selecting a potential date with 6 or more recent sexual partners in the conjoint experiment. Both AMCEs (average marginal component effects) and marginal means will be computed, see statistical analysis plan. As part of a conjoint experiment the investigators expose participants to a partner selection task. The attributes in the experiment and possible attribute values can be seen below: Race/ethnicity: White/Black/Asian Education: High school/Undergraduate degree/Graduate degree Number of sexual partners (past 3 months): 1/2-5 partners/6 or more Recreational drug use: Never/Sometimes/Often Seeking a...: Committed relationship/Casual relationship Use of condoms: Occasional/Frequent |
Through study completion, approximately 2 months
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Selecting a potential date with frequent recreational drug use
Временное ограничение: Through study completion, approximately 2 months
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The likelihood of selecting a potential date with frequent recreational drug use in the conjoint experiment. Both AMCEs (average marginal component effects) and marginal means will be computed, see statistical analysis plan. As part of a conjoint experiment the investigators expose participants to a partner selection task. The attributes in the experiment and possible attribute values can be seen below: Race/ethnicity: White/Black/Asian Education: High school/Undergraduate degree/Graduate degree Number of sexual partners (past 3 months): 1/2-5 partners/6 or more Recreational drug use: Never/Sometimes/Often Seeking a...: Committed relationship/Casual relationship Use of condoms: Occasional/Frequent |
Through study completion, approximately 2 months
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Selecting a potential date with occasional condom adherence
Временное ограничение: Through study completion, approximately 2 months
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The likelihood of selecting a potential date with occasional condom use in the conjoint experiment. Both AMCEs (average marginal component effects) and marginal means will be computed, see statistical analysis plan. As part of a conjoint experiment the investigators expose participants to a partner selection task. The attributes in the experiment and possible attribute values can be seen below: Race/ethnicity: White/Black/Asian Education: High school/Undergraduate degree/Graduate degree Number of sexual partners (past 3 months): 1/2-5 partners/6 or more Recreational drug use: Never/Sometimes/Often Seeking a...: Committed relationship/Casual relationship Use of condoms: Occasional/Frequent |
Through study completion, approximately 2 months
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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The likelihood at which a respondent would engage a partner in casual sex with without using condoms
Временное ограничение: Through study completion, approximately 2 months
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This is collected as a follow-up question for each profile in the conjoint experiment as detailed above
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Through study completion, approximately 2 months
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Kinga R Makovi, PhD, New York University Abu Dhabi
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
- Патологические процессы
- Инфекции
- Передающиеся заболевания
- Атрибуты болезни
- Грамотрицательные бактериальные инфекции
- Бактериальные инфекции
- Бактериальные инфекции и микозы
- Нейссериевые инфекции
- Заболевания, передающиеся половым путем, бактериальные
- Спирохетальные инфекции
- Трепонемные инфекции
- Гонорея
- Заболевания, передающиеся половым путем
- Сифилис
Другие идентификационные номера исследования
- 097-2018
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
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