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Идёт набор NCT06472206

Community Health Workers And MHealth to ImProve Viral Suppression Plus (CHAMPS+)

Без фазы С лечением HIV/AIDS

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: CHW Sessions, CleverCap.
Кому может быть актуально
Состояния в реестре: HIV/AIDS. 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 →

Обзор

Although global efforts have been made to end the HIV epidemic, there are still some gaps in HIV testing, antiretroviral therapy (ART) adherence, and viral suppression (VS) among people with HIV (PWH). These gaps are particularly prominent in the Deep South of the United States (US), where PWH face challenges in accessing healthcare services. In response, a team of experienced researchers has developed and tested the Community Health Workers And MHealth to ImProve Viral Suppression (CHAMPS) intervention. This intervention uses mobile health (mHealth) technology and a team of community health workers (CHW) to design an intervention to improve ART adherence and VS. The CHAMPS+ intervention adds a CHW delivered supportive risk reduction counseling during periods of non-suppression to prevent HIV transmission. The study will engage the participants by developing culturally relevant materials and retention strategies, evaluating the clinical effectiveness and sustainability of the intervention in Deep South settings, and assessing regionalized implementation factors. Ultimately, the study will test the effectiveness of CHAMPS+ on ART adherence and viral load suppression for PWH in Alabama, Louisiana, and Mississippi.

Подробное описание

Despite efforts to achieve UNAIDS 95-95-95 targets, marked deficits remain in HIV testing, antiretroviral therapy (ART) adherence, and viral suppression (VS) among a growing number of persons with HIV (PWH). Gaps in HIV treatment success are particularly pronounced in the United States (US) Deep South. These suboptimal HIV health outcomes occur at a time when clinicians have limited time and the US healthcare system remains fragmented, further exacerbating the challenges inherent in the lives of underserved, marginalized groups, such as PWH. In this way, the development and evaluation of interventions using a resource-savvy cadre of community health workers (CHW) holds promise for addressing these challenges. Yet, gaps exist in the CHW literature, and research is needed to bring CHW interventions to scale to ameliorate the large gaps in the US HIV Care Continuum, particularly in Ending the HIV Epidemic (EHE) priority locations.

In response, the study team has developed and tested the Community Health Workers And MHealth to ImProve Viral Suppression (CHAMPS) intervention which leverages mobile health (mHealth) technology to create a multi-component intervention that targets multiple levels (individual, social and sexual networks, and community) to improve ART adherence and VS. The study team will build on the strong preliminary data of extant intervention work in PWH by leveraging the CHAMPS intervention which will be delivered by personnel from four HIV care settings in the Deep South. The CHAMPS+ intervention is delivered via an mHealth platform to support PWH to self-manage their ART regimens and adds to the extant CHAMPS intervention by adding a CHW-delivered supportive risk reduction counseling (sexual behavior and substance use) during periods of non-suppression to prevent HIV transmission. This study also builds upon mChoice (U01PS005229) and WiseApp (R01HS025071) studies to improve ART adherence and VS in the Deep South. This study design has a three-fold purpose of: 1) engaging the target population in the development of culturally relevant recruitment materials and retention strategies for the study, 2) assessing the clinical effectiveness and sustainability of the intervention in Deep South settings, and 3) evaluating regionalized implementation factors guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. Ultimately, this study will test CHAMPS+ to promote ART adherence and suppressed viral load for PWH in in Alabama, Louisiana (Orleans Parish), and Mississippi, US EHE prioritized jurisdictions. Importantly, the multi-component intervention targets multiple levels to address HIV risk behaviors during periods of non-suppression--an innovative and impactful component likely to be of great public health import.

Вмешательства

  • Поведенческое CHW Sessions
    Sessions with a Community Health Worker (CHW)
  • Устройство CleverCap
    The CleverCap pill bottle is an innovative technology that dispenses only the prescribed amount of medication, keeps track of medications dispensed, and communicates wirelessly with the WiseApp to deliver medication adherence reminders.

Первичные конечные точки

  • Change in Viral Load [Срок оценки: Baseline, 6 month follow up, 12 month follow up.]
Вторичные конечные точки (2)
  • Change in ART adherence - CleverCap. [Срок оценки: Up to 12 months.]
  • Change in Score on the Self-Rating Scale Item (SRSI). [Срок оценки: Baseline, 6 month follow up, 12 month follow up.]

Критерии участия

Критерии включения

  • Be able to speak, read, and write in English;
  • Be above 18 years of age;
  • Be willing to participate in any assigned arm of the intervention;
  • Have an HIV-1 RNA level >200 copies/mL;
  • Own a smartphone;
  • Be able and willing to provide informed consent for study participation and consent for access to medical records.
  • Live, work and or receive care in AL, LA, or MS

Критерии исключения

  • Reside in a nursing home, prison, and/or receiving in-patient psychiatric care at time of enrollment;
  • Terminal illness with life expectancy <6 months; and
  • Planning to move out of the area in the next 12 months.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

США · 5 центров
  • Health Services Center, Inc. — Hobson City
  • Unity Wellness Center — Opelika
  • Louisiana State University Health Sciences Center in New Orleans — New Orleans
  • Tulane University — New Orleans
  • University of Mississippi Medical Center — Jackson

Идентификаторы

NCT: NCT06472206 · AAAU8885 · R01MD019184

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗