Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06360783
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-04-09
Brief Title:
COVID-19 Quick Start - Test and Treat in Africa
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Evaluation of a COVID-19 Quick Start Test and Treat Model in Africa
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 TT demonstration programs
Detailed Description:
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 TT 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 regimensduration 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 TT 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 TT 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 TT programs in low- and middle-income countries as the availability of therapeutics for COVID-19 scales up globally
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 TT 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 TT 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 TT programs in low- and middle-income countries as the availability of therapeutics for COVID-19 scales up globally
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None