跳至主要内容
临床试验/NCT05894655
NCT05894655已完成不适用

CO-CREATE-Ex: Community-engaged Optimization of COVID-19 Rapid Evaluation And TEsting Experiences

University of California, San Diego1 个研究点 分布在 1 个国家目标入组 6,527 人开始时间: 2023年8月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
6,527
试验地点
1
主要终点
Identify solutions and evaluation methods to refine a multi-component implementation strategy bundle using a Community and Scientific Advisory Board.

研究概览

简要总结

Throughout the Coronavirus disease (COVID-19) pandemic, rates of COVID-19 have been persistently high in San Diego County's central and southern communities near the United States/Mexico border. These regions predominantly house Latino residents, the ethnic minority community most impacted by COVID-19 in San Diego. In the Phase I project, University of California, San Diego (UCSD) partnered with San Ysidro Health (SYH) and the Global Action Research Center, to co-create and demonstrate the impact of a COVID-19 testing program in San Ysidro, one of the most impacted areas from COVID-19 in San Diego County. To date, the project tested >10,000 community members (92% Latino) and received requests to scale-out the testing program to additional primary care clinic sites.

In this Phase III project, Community-engaged Optimization of COVID-19 Rapid Evaluation And TEsting Experiences (CO-CREATE-Ex) will extend work with the Phase I community and clinical partners to refine, specify, implement, and evaluate an implementation strategy bundle that optimizes COVID-19 testing, expanding beyond current polymerase chain reaction (PCR) testing to FDA-authorized COVID-19 rapid antigen testing.

详细描述

CO-CREATE-Ex will roll-out our implementation using 3 strategies:

  1. keeping the current, walk-up free testing protocol
  2. Offering Community Health Worker (CHW) to lead COVID-19 test counseling, preventive care reminders, and offer testing support
  3. Installing vending machines that will dispense FDA-authorized self-testing kits.

For each strategy, participants will consent into study, provide demographics and test history, and receive a free rapid antigen test (RAT) kit. After receiving the test kit, participants will be prompted to return their results and fill out a survey about their COVID-19 experiences. Study subjects will be contacted up to three times over a course of 4 weeks to return their results and complete the survey. Study coordinators will use participants' preferred method of contact.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Health Services Research
盲法
None

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •Speak English and/or Spanish
  • •Affiliated with San Ysidro Health as a patient at select clinics (San Ysidro, Chula Vista, Lincoln Park, and Logan Heights) OR
  • •A member of a community near a San Ysidro Health clinic (San Ysidro, Chula Vista, Lincoln Park, and Logan Heights).

排除标准

  • •Institutionalization for psychiatric disorder, developmental delay, or criminal activity.
  • •Unable to provide informed consent.

研究组 & 干预措施

San Ysidro Health Center - Logan Heights

Experimental

A vending machine and Community Health Worker (CHW) providing education will be available at Logan Heights

干预措施: Community Health Worker (CHW) leading testing navigation and general preventive care reminders (Behavioral)

San Ysidro Health Center - Main Clinic

Placebo Comparator

At the main clinic all 3 strategies will be available: walk-up testing, vending machine, and Community Health Worker (CHW) providing education.

干预措施: COVID-19 walk-up, on-site testing strategy (Behavioral)

San Ysidro Health Center - Main Clinic

Placebo Comparator

At the main clinic all 3 strategies will be available: walk-up testing, vending machine, and Community Health Worker (CHW) providing education.

干预措施: Community Health Worker (CHW) leading testing navigation and general preventive care reminders (Behavioral)

San Ysidro Health Center - Main Clinic

Placebo Comparator

At the main clinic all 3 strategies will be available: walk-up testing, vending machine, and Community Health Worker (CHW) providing education.

干预措施: No-cost self-testing kit vending machines (Behavioral)

San Ysidro Health Center - Logan Heights

Experimental

A vending machine and Community Health Worker (CHW) providing education will be available at Logan Heights

干预措施: No-cost self-testing kit vending machines (Behavioral)

San Ysidro Health Center - Lincoln Park

Experimental

A vending machine and Community Health Worker (CHW) providing education will be available at Lincoln Park

干预措施: Community Health Worker (CHW) leading testing navigation and general preventive care reminders (Behavioral)

San Ysidro Health Center - Lincoln Park

Experimental

A vending machine and Community Health Worker (CHW) providing education will be available at Lincoln Park

干预措施: No-cost self-testing kit vending machines (Behavioral)

San Ysidro Health Center - Chula Vista

Experimental

A vending machine and Community Health Worker (CHW) providing education will be available at Chula Vista

干预措施: Community Health Worker (CHW) leading testing navigation and general preventive care reminders (Behavioral)

San Ysidro Health Center - Chula Vista

Experimental

A vending machine and Community Health Worker (CHW) providing education will be available at Chula Vista

干预措施: No-cost self-testing kit vending machines (Behavioral)

结局指标

主要结局

Identify solutions and evaluation methods to refine a multi-component implementation strategy bundle using a Community and Scientific Advisory Board.

时间窗: 2 years

The primary objective is to refine and operationalize the multi-component implementation strategy bundle and measures of implementation and sustainment success for rapid FDA-authorized COVID-19 rapid testing using the partnership with the Global Arc and Community and Scientific Advisory Board. Each session will be recorded while Global Arc partners guide the board to identify potential failures in the implementation design. Measures of success will be collected by partner engagement surveys, which will be administered and analyzed after each meeting.

次要结局

  • Number of distributed rapid antigen tests within our target communities as measured by a proxy outcome.(18 months)

研究者

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

Louise Laurent, MD/PhD

Principal Investigator

University of California, San Diego

研究点 (1)

Loading locations...

相似试验