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临床试验/NCT05384145
NCT05384145招募中不适用

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

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年3月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
1
主要终点
Time to viral suppression

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
13 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

研究组 & 干预措施

COAST-AL

Other

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

干预措施: COAST-AL (Other)

结局指标

主要结局

Time to viral suppression

时间窗: From HIV diagnosis to 1 year

Effectiveness outcome: Using ADPH EHARS data of all newly diagnosed individuals in MCHD jurisdiction during the study period

Proportion of zctas with >15% population HIV tested

时间窗: 3 year intervention period

Implementation outcome: Using commercial lab data sets (Quest/LabCorp) and ADPH data

次要结局

  • Proportion linked to care within 30 days(3 year intervention period)
  • Days from diagnosis to initiation of ART(3 year intervention period)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aadia Rana

Professor

University of Alabama at Birmingham

研究点 (1)

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