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Идёт набор NCT05753683

Gathering Online for Dialogue and Discussion to Enhance Social Support

Без фазы С лечением Alcohol Misuse HIV Sexually Transmitted Infections Pre-exposure Prophylaxis

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: mHealth-Women's CoOp, Virtual Group.
Кому может быть актуально
Состояния в реестре: Alcohol Misuse, HIV, Sexually Transmitted Infections, Pre-exposure Prophylaxis. Базовые параметры: 18 лет — 30 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
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Официальное название

GODDESS (Gathering Online for Dialogue and Discussion to Enhance Social Support): Engaging Young African American Women in a Virtual Group App to Address Alcohol Misuse, Sexual Risk, and Pre-exposure Prophylaxis (PrEP) in North Carolina (NC)

Обзор

The goal of this trial is to test a modified mobile health intervention (with a group component) relative to a mobile health intervention in a two-arm randomized trial with up to 500 young women who are human immunodeficiency virus (HIV)-negative and who misuse alcohol. The expected outcomes are to: (1) determine the efficacy of the virtual group component in reducing alcohol use and sexual risk and increasing pre-exposure prophylaxis (PrEP) utilization; and (2) understand selected outcomes for implementation. Participants will be randomized to receive either the mHealth app or the mHealth app plus the group component, and followed up at 3- and 6-months post-enrollment.

Подробное описание

Up to 500 participants who are human immunodeficiency virus (HIV)-negative who engage in heavy alcohol use will be enrolled and referred to their local health departments for pre-exposure prophylaxis (PrEP). Primary biobehavioral outcomes assessed will include reduced alcohol use (self-reported and biological, including phosphatidylethanol \[PEth\]), increased PrEP uptake (self-reported and biological), and reduced sexual risk (self-reported condomless sex and impaired sex and biological testing for HIV) at 3- and 6-month follow-up.

Вмешательства

  • Поведенческое mHealth-Women's CoOp
    The mHealth-Women's CoOp, was developed and tested in a previous randomized trial, is a human immunodeficiency virus (HIV) risk-reduction intervention that addresses the intersection of substance use, sexual risk and violence through education, skills-building, and role-play and rehearsal via a mobile app. The mHealth-Women's CoOp app is also used to help participants monitor progress toward their goals throughout the study period. Specifically, the app is programmed to prompt the user, to visit
  • Поведенческое Virtual Group
    The enhanced online group component will be available to be accessed using the mHealth-Women's CoOp platform for participants in the enhanced arm. The purpose of this component is to allow for young women who use alcohol to interact with young women like them and also discuss issues related to substance use and sexual risk-taking via a guided conversation to allow for motivational and informational support. The virtual group component will include online live discussions moderated and monitored

Первичные конечные точки

  • Alcohol (Biological) [Срок оценки: Baseline]
  • Alcohol (Biological) [Срок оценки: 3-month]
  • Alcohol (Biological) [Срок оценки: 6-month]
  • Alcohol (Biological) [Срок оценки: Baseline]
  • Alcohol (Biological) [Срок оценки: 3-month]
  • Alcohol (Biological) [Срок оценки: 6-month]
  • Alcohol (Self-Reported) [Срок оценки: Baseline]
  • Alcohol (Self-Reported) [Срок оценки: 3-month]
  • Alcohol (Self-Reported) [Срок оценки: 6-month]
  • Alcohol (Self-Reported) [Срок оценки: Baseline]
Вторичные конечные точки (12)
  • Drug Use (Biological) [Срок оценки: Baseline]
  • Drug Use (Biological) [Срок оценки: 3-month]
  • Drug Use (Biological) [Срок оценки: 6-month]
  • Drug Use (Self-Reported) [Срок оценки: Baseline]
  • Drug Use (Self-Reported) [Срок оценки: 3-month]
  • Drug Use (Self-Reported) [Срок оценки: 6-month]
  • Perceived social support [Срок оценки: Baseline]
  • Perceived social support [Срок оценки: 3-month]
  • Perceived social support [Срок оценки: 6-month]
  • Violence [Срок оценки: Baseline]
  • Violence [Срок оценки: 3-month]
  • Violence [Срок оценки: 6-month]

Критерии участия

Selected Inclusion Criteria:

  • identify as Black/African American
  • identify as female
  • be between 18 and 30 years old
  • recent substance use
  • HIV negative and not currently on PrEP
  • have an Android or iOS-based smartphone

Selected Exclusion Criteria:

  • test positive for HIV
  • participated in the previous study activities of the current study or previous related studies

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 · 1 центр
  • RTI International — Durham

Публикации

  • van der Drift IM, Browne FA, Nyamaizi AM, Wechsberg WM. "A lot of the answers come from within you as well": benefits and limitations to utilizing and adapting a virtual platform to enhance social interaction and group learning. BMC Digit Health. 2025;3(1):64. doi: 10.1186/s44247-025-00204-1. Epub 2025 Sep 22. PMID 40989241

Идентификаторы

NCT: NCT05753683 · 0218271 · R01AA030452

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗