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Идёт набор NCT05384145

Implementation Trial to Evaluate a Population Health Combination Intervention to Meet HIV Testing, Linkage, and Viral Suppression Goals in Alabama

Без фазы С лечением HIV HIV Linkage to Care HIV Testing HIV Treatment

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: COAST-AL.
Кому может быть актуально
Состояния в реестре: HIV, HIV Linkage to Care, HIV Testing, HIV Treatment. Базовые параметры: от 13 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

A Type 2 Hybrid Effectiveness-implementation Trial to Evaluate a Population Health Combination Intervention to Meet HIV Testing, Linkage, and Viral Suppression Goals in Coastal Alabama

Обзор

The purpose of this study is to adapt and evaluate a combination intervention that includes: (1) a data-driven approach to directed community-based HIV testing to areas with high need, (2) Project Connect to expedite linkage to care at time of diagnosis, (3) and a Rapid ART (antiretroviral therapy)Start program, all in Mobile County Health Department (MCHD) jurisdictions in Alabama.

Подробное описание

Aim 1. Adapt and integrate COAST-AL using a pre-implementation formative assessment guided by the CFIR. In-depth interviews and clinic observations with community clinic providers, clinic administrators, and MCHD and Alabama Department of Public Health (ADPH) officials will inform targeted Community-based testing, linkage through Project Connect, and Rapid Start into existing work flows (inner setting, process), identify opportunities to use publicly available data to inform testing outreach (outer setting), and explore provider attitudes towards Rapid Start (individuals).

Aim 2. Assess the clinical and implementation effectiveness of COAST-AL in six AL counties served by MCHD. Using RE-AIM, the investigators will evaluate the effects of COAST-AL on clinical and implementation outcomes on progress towards EHE goals. The primary clinical effectiveness outcome is days to viral suppression (VS) for new HIV diagnoses. The primary implementation outcome is the proportion of Zip Code Tabulation Areas with at least 15% of adult population tested for HIV (Reach).

Aim 3. Utilize a community-academic partnership to identify implementation strategies to support maintenance and future dissemination of COAST-AL. Using interviews, concept mapping, and nominal group techniques to inform implementation mapping, the investigators will work collaboratively with local and state health department stakeholders to identify and prioritize implementation strategies to sustain and implement COAST-AL in other health departments across AL and rural EHE(Ending the Epidemic)-focus states.

Вмешательства

  • Другое COAST-AL
    This combination intervention includes three CDC evidence based interventions: (1) a data-driven approach to direct Community-based HIV testing to areas with high need, (2) Project Connect to expedite linkage to care at time of diagnosis, (3) and a Rapid ART Start program, all in MCHD jurisdictions in Alabama

Первичные конечные точки

  • Time to viral suppression [Срок оценки: From HIV diagnosis to 1 year]
  • Proportion of zctas with >15% population HIV tested [Срок оценки: 3 year intervention period]
Вторичные конечные точки (2)
  • Proportion linked to care within 30 days [Срок оценки: 3 year intervention period]
  • Days from diagnosis to initiation of ART [Срок оценки: 3 year intervention period]

Критерии участия

Критерии включения

  • AIM 1 \& 3:
  • Fit into one of the following categories:

1\) MCHD leadership, 2) ADPH leadership, 3) clinic administrators, 4) outreach testing specialists, 5) linkage coordinators and community health workers, 6) physicians, 7) nurses, 8) counselors all working at HIV care facilities in the six MCHD jurisdiction counties.

  • Over the age of 18 years old.

AIM 2: (IDIs)

  • Over the age of 13 years old
  • Tested for HIV in MCHD jurisdiction from time of COASTAL implementation to 36 months post-implementation start date.

Критерии исключения

  • Exclusion criteria include unwillingness or inability to provide informed consent.

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
Организация здравоохранения

Центры проведения

США · 1 центр
  • University of Alabama at Birmingham — Birmingham

Публикации

  • Hearld LR, Pratt MC, Smith D, Parman M, Murphree R, Michaels KP, Woods-Crawford S, Rana AI, Matthews LT. Integrating existing and novel methods to understand organizational context: A case study of an academic-public health department partnership. Ann Epidemiol. 2024 Dec;100:34-41. doi: 10.1016/j.annepidem.2024.10.005. Epub 2024 Oct 29. PMID 39481580

Идентификаторы

NCT: NCT05384145 · IRB-300009300 · 5R01AI169671-03

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗