COVID-19 Quick Start - Test and Treat in Africa

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06360783
• Other study ID #: Pro00111388
• Status: Active, not recruiting
• Start date: February 1, 2023
• Est. completion date: June 2024

Study information

• Verified date: April 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Locations

Country	Name	City	State
United States	Duke Global Health Institute	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	Clinton Health Access Initiative, Nigeria, Duke Clinical Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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