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Набор скоро начнётся NCT07103525

Initiative for Chinese Sex Workers to Promote Wellbeing and Improve HIV Prevention by Reducing intersEctional Stigma

Без фазы С лечением HIV Prevention Wellbeing

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: INSPIRE Initiative, Standard of Care.
Кому может быть актуально
Состояния в реестре: HIV Prevention, Wellbeing. Базовые параметры: от 18 лет · Женщины.
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 →
Официальное название

INSPIRE: Initiative for Chinese Sex Workers to Promote Wellbeing and Improve HIV Prevention by Reducing intersEctional Stigma

Обзор

During the development phase (Aim 1), investigators will use a community-driven process to further refine a preliminary intervention design that was developed based on previous research. For the intervention phase (Aim 2), investigators will conduct a pilot randomized controlled trial of the multi-level intervention. For the individual-level component of the intervention, investigators will recruit 70 Chinese immigrant FSWs who work in MPs in Queens, NYC (n=35 intervention participants and n=35 control participants). To assess the feasibility and acceptability of intervention implementation (Aim 3), investigators will conduct in-depth qualitative interviews with 12 FSW study participants and the 2 peer advocates and focus groups with 4-5 staff from each of the 3 organizations (3 focus groups total and 12-15 focus group participants in total).

Вмешательства

  • Поведенческое INSPIRE Initiative
    Culturally relevant, multi-level intervention designed to increase HIV testing through reducing intersectional stigma. Intervention includes series of four one-on-one conversations (45 minutes each over a six-week period) via mobile phone between the Hunter peer advocates and FSWs, which are reinforced through weekly text messages from the peer advocates and through role-model stories shared online.
  • Поведенческое Standard of Care
    Standard HIV prevention information with no tailored components via one mobile phone verbal conversation with peer advocates.

Первичные конечные точки

  • Percentage of Participants who Completed HIV Testing [Срок оценки: Follow-Up Visit 1 (Approximately Week 6)]
Вторичные конечные точки (1)
  • Percentage of Participants with PrEP Uptake [Срок оценки: Follow-Up Visit 1 (Approximately Week 6)]

Критерии участия

Критерии включения

  • Female Sex Workers: A person who identifies as a woman, Chinese, a massage parlor (MP) worker in Queens, who is at least 18 years old, and has provided sexual services in the past 12 months, will be eligible.
  • Community advisory board (CAB) members: self identifies as a community member providing services to immigrant Chinese women and is at least 18 years old.
  • Peer Advocates: self identifies as current or previous sex worker, is a Chinese adult woman, and speaks both Mandarin and English.
  • Medical Providers: self identifies as a current medical provider who works with Chinese immigrant adults and speaks English.

Критерии исключения

  • Female Sex Workers: Because completion of HIV testing is our primary study outcome, women who received an HIV test in the previous 3 months or who know they are HIV-positive will be excluded from the study.
  • Community advisory board (CAB) members: Does not speak English or is under the age of 18.
  • Peer Advocates: Does not speak English/Mandarin or is under the age of 18.
  • Medical Providers: Does not speak English or does not provide care to Chinese immigrant adults (e.g., pediatricians).

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
Открытое
Основная цель
Профилактика

Центры проведения

США · 3 центра
  • NYU Langone Health — New York
  • Columbia University Irving Medical Center — New York
  • CUNY-Hunter College — New York

Идентификаторы

NCT: NCT07103525 · 24-01572 · R34MH136914-01A1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗