Clinical trial NCT06360783: COVID-19 Quick Start - Test and Treat in Africa
Official title: Evaluation of a COVID-19 Quick Start "Test and Treat" Model in Africa
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: COVID-19
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Duke Clinical Research Institute
name: Clinton Health Access Initiative, Nigeria
First posted: 2024-04-11
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in participating countries who receive COVID testing and treatment at a participating facility.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Stakeholder Perspectives
timeFrame: up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Global Health Institute
state: North Carolina
Study officials:
affiliation: Duke University
name: Krishna Udayakumar, MD
role: PRINCIPAL_INVESTIGATOR
References: