COVID-19 Quick Start - Test and Treat in Africa

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19

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 Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke Global Health Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients in participating countries who receive COVID testing and treatment at a participating facility.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stakeholder Perspectives	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	up to 3 years

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Duke Clinical Research Institute; Clinton Health Access Initiative, Nigeria
• Investigators: Principal Investigator: Krishna Udayakumar, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: April 9, 2024
• First Submitted That Met QC Criteria: April 9, 2024
• First Posted (Actual): April 11, 2024

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: Pro00111388

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes