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Набор скоро начнётся NCT06068283

An mHealth Intervention to Improve HIV Prevention Service Engagement Among People Who Use Drugs

Без фазы С лечением HIV 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: LOTUS mHealth Intervention Group.
Кому может быть актуально
Состояния в реестре: HIV Infections. 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 →

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Официальное название

LOTUS: An mHealth Intervention to Improve HIV Prevention Service Engagement Among People Who Use Drugs

Обзор

The goal of this single arm pre-post study is to assess the feasibility, acceptability, and preliminary impact of the LOTUS intervention to improve HIV prevention service engagement among people who use drugs. LOTUS is a technology-delivered intervention that provides HIV prevention informational content and tips, peer social support and social networking features, a resource locator, HIV prevention monitoring and reminders (e.g., reminders for HIV/STI testing and PrEP doses), and a virtual space to have questions answered by health care professionals.

Подробное описание

The LOTUS intervention is a technology-delivered intervention to improve HIV prevention service engagement for people who use drugs. LOTUS provides HIV prevention informational content and tips, peer social support and social networking features, a resource locator, HIV prevention monitoring and reminders (e.g., reminders for HIV/STI testing and PrEP doses), and a virtual space to have questions answered by health care professionals. Given the disproportionate HIV-related harms people who use drugs face, and critical need for HIV prevention mHealth interventions tailored to the unique needs of this population, the current study seeks to accomplish the following aim. The primary aim is to assess the feasibility, acceptability, and preliminary impact of the LOTUS intervention in a single arm pre-post study. People who use drugs residing in Southern California (n = 40) will receive the LOTUS intervention for 6-months. The proportion of participants retained, intervention use data, and validated self-reported usability and HIV prevention service (e.g., HIV/STI testing, PrEP) knowledge, motivation, and use measures will be collected at baseline, 3-, and 6-months to assess LOTUS feasibility, acceptability, and preliminary impact. The investigators hypothesize that participants in the LOTUS intervention will find the intervention to be feasible and usable, and that they will demonstrate significant improvements in HIV prevention service use at each follow-up time point when compared to baseline. The investigators will also conduct exit interviews with LOTUS participants (n = 20) to gain feedback on the intervention characteristics, as defined by the Consolidated Framework for Implementation Research, and to elicit suggestions for improvement in anticipation of a future large-scale randomized controlled trial.

Вмешательства

  • Поведенческое LOTUS mHealth Intervention Group
    A mobile, WebApp-based intervention comprised of tips for HIV prevention, a community wall for peer interaction and support, HIV prevention monitoring and reminders, a virtual space to have questions answered by a healthcare professional, a resource database, and a personalized profile. Intervention components are designed to promote HIV prevention service use and improve social support, coping strategies, and positive affect.

Первичные конечные точки

  • LOTUS Feasibility [Срок оценки: 6 months]
  • LOTUS Acceptability [Срок оценки: 6 months]
  • HIV Prevention Service Engagement [Срок оценки: 6 months]
Вторичные конечные точки (1)
  • Attitudes and Perceptions [Срок оценки: 6 months]

Критерии участия

Критерии включения

  • 18 years of age or older
  • Report weekly or daily use of opioids and/or stimulants in the past 6 months
  • Meet current CDC eligibility criteria for PrEP
  • Report low levels of HIV prevention service engagement in the past 6 months
  • Not currently, or planning on becoming, pregnant during the study
  • Owns a smartphone with internet web-browsing capabilities

Критерии исключения

  • 17 years of age or younger
  • Does not report weekly or daily use of opioids and/or stimulants in the past 6 months
  • Does not meet current CDC eligibility criteria for PrEP
  • Report high levels of HIV prevention service engagement in the past 6 months
  • Currently, or planning on becoming, pregnant during the study
  • Does not own a smartphone with internet web-browsing capabilities

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
  • University of California San Diego — La Jolla

Идентификаторы

NCT: NCT06068283 · 310548-00001 · K01DA055983

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗