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临床试验/NCT06360783
NCT06360783已完成不适用

Evaluation of a COVID-19 Quick Start "Test and Treat" Model in Africa

Duke University1 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2023年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
148
试验地点
1
主要终点
Stakeholder Perspectives

研究概览

简要总结

Duke University and the Clinton Health Access Initiative (CHAI), in partnership with the Ministries of Health (MoH) of Ghana, Malawi, Rwanda, Zambia, and Zimbabwe, aim to assess the implementation and impact of COVID-19 test -and -treat (T&T) demonstration programs

详细描述

Duke University and the Clinton Health Access Initiative (CHAI), in partnership with the Ministries of Health (MoH) of Ghana, Malawi, Rwanda, Zambia, and Zimbabwe, aim to assess the implementation and impact of COVID-19 test -and -treat (T&T) demonstration programs, titled "COVID-19 Quick Start Program". The MoHs in collaboration with CHAI will implement SARS-CoV-2 antigen testing programs linked to patient triage and initiation of eligible patients on a complete course of oral antivirals for COVID-19. The eligibility criteria and treatment regimens/duration may vary by country and over time depending on changes to guidelines.

This mixed method study will leverage data from three independent data collection activities to guide implementation:

  1. Programmatic monitoring: A formative evaluation of the implementation of test and treat (T&T) programs to identify implementation gaps and help implementers make evidence-based decisions and course-correct as needed.
  2. Collection of retrospective, patient-level data from treatment facility registers to understand impact of T&T implementation on testing and treatment initiation rates, as well as costs of treatment initiation for cost modeling.
  3. Qualitative Semi-structured interviews with key stakeholders including MoH and public sector personnel, healthcare workers, and patients to understand the feasibility and acceptability of the program.

Data from this operational research study will help to ensure optimized delivery of T&T programs in low- and middle-income countries as the availability of therapeutics for COVID-19 scales up globally.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

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

入选标准

  • •18 years and older
  • •Able to provide informed consent
  • •Patients who have received COVID-19 testing and/or treatment at the facility
  • •Have a positive COVID-19 test and were prescribed oral antiviral medication (and may or may not have initiated on treatment (Only for subset of patients who will be followed to assess treatment completion and outcomes)

排除标准

  • •None if other inclusion criteria are met

研究组 & 干预措施

Ghana

Aggregated testing and treatment data from centers in Ghana.

Malawi

Aggregated testing and treatment data from centers in Malawi.

Rwanda

Aggregated testing and treatment data from centers in Rwanda.

Zambia

Aggregated testing and treatment data from centers in Zambia.

Zimbabwe

Aggregated testing and treatment data from centers in Zimbabwe.

结局指标

主要结局

Stakeholder Perspectives

时间窗: up to 3 years

Assess perspectives from key stakeholders including MoH and public sector personnel, healthcare workers, and patients on feasibility and acceptability of COVID-19 T\&T programs as implemented

次要结局

未报告次要终点

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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