Stick2PrEP Cisgender Women and Trans Individuals
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: Individualized Feedback.
- Кому может быть актуально
- Состояния в реестре: HIV Prevention, Pre-exposure Prophylaxis. 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
- США
- 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
Stick2PrEP Women/Trans Individuals: Increasing Pre-Exposure Prophylaxis (PrEP) Uptake, Adherence, and Retention in Care, and Understanding PrEP Preferences Among Predominantly Black and Latinx Cisgender Women and Transgender Individuals
Обзор
Taking a daily anti-HIV pill can protect people from HIV infection. This is called preexposure prophylaxis \[PrEP\]. Many cisgender women and trans individuals do not know this medication is available; others struggle to take the pill every day. It is important to understand attitudes and preferences about HIV prevention options, especially as new options become available. This study plans to evaluate preferences over time among cisgender women and trans individuals who are taking medication to prevent HIV, and among cisgender women and trans individuals who are not taking medication but are at risk of HIV. The investigators enroll up to 175 participants who visit the HIV prevention clinic, and the investigators will ask participants to complete questionnaires at regular follow up visits and between visits. This study may help the investigators understand how best to prevent HIV among people at risk.
Подробное описание
Participants will receive online questionnaires about demographic characteristics, social determinants of health, and preferences regarding PrEP modalities. Qualitative, in-depth surveys will be conducted with 12 CWTI who decide not to start PrEP and 12 CWTI who decide to discontinue PrEP to explore the drivers behind those decisions. Participants who are taking PrEP will be offered the option of providing dried blood spot samples at clinic visits to measure PrEP levels and will receive an online questionnaire addressing their preferences regarding different modalities of measuring PrEP levels. The purpose of the HemaSpot™ kit is to understand the subjects' perceptions of using this kit for self-testing PrEP levels; this will inform future strategies regarding PrEP monitoring. Participants taking PrEP will also receive questionnaires regarding self-reported weekly PrEP adherence; they will then receive individualized text-message or email feedback based on their self-reported adherence in addition to standard-of-care retention/adherence counseling. Participants on PrEP can also elect to receive or emails messages to remind them to take PrEP and attend follow up appointments.
Вмешательства
- Поведенческое Individualized Feedback
Participants taking PrEP will receive questionnaires regarding self-reported weekly PrEP adherence; they will then receive individualized text-message or email feedback based on their self-reported adherence.
Первичные конечные точки
- Correlation Between PrEP modality preference and PrEP initiation/persistence in care [Срок оценки: 12 months]
- PrEP Measurement Preferences Scale Score [Срок оценки: 12 months]
- Percentage of participants on PrEP who remain engaged in sexual health care [Срок оценки: 12 months]
Вторичные конечные точки (2)
- Correlation of risk factors for low PrEP adherence and retention [Срок оценки: 12 months]
- Web-Based App User Satisfaction Score [Срок оценки: 12 months]
Критерии участия
Критерии включения
- Cisgender women and trans individuals who have an indication for PrEP and have 1) decided to take PrEP, 2) decided not to take PrEP, or 3) decided to discontinue PrEP
Критерии исключения
- Cannot provide informed consent
- Living with HIV
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
- Профилактика
Центры проведения
США · 1 центр
- Columbia University Medical Center — New York
Идентификаторы
NCT: NCT05165745 · AAAS6460