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COVID-19 Quick Start - Test and Treat in Africa

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06360783
Enrollment
148
Registered
2024-04-11
Start date
2023-02-01
Completion date
2024-05-31
Last updated
2026-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

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.

Interventions

None listed

Sponsors

Duke University
Lead SponsorOTHER
Duke Clinical Research Institute
CollaboratorOTHER
Clinton Health Access Initiative, Nigeria
CollaboratorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Stakeholder Perspectivesup to 3 yearsAssess 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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORKrishna Udayakumar, MD

Duke University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 23, 2026