COVID-19 Quick Start - Test and Treat in Africa

Active, not recruiting

• Conditions: COVID-19

• Registration Number: NCT06360783
• Lead Sponsor: Duke University

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 (T\&T) 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 (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.

Study Timeline

• Study Start: 2023-02-01
• Study First Submitted: 2024-04-09
• Study First Submitted QC: 2024-04-09
• Study First Posted: 2024-04-11
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-27
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• 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)

Exclusion Criteria

None if other inclusion criteria are met

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stakeholder Perspectives	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

Trial Locations

Locations (1)

Duke Global Health Institute; 🇺🇸 Durham, North Carolina, United States