Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts 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

Study Design

Phase
Study Type
Observational
Observational Model
Case-Only
Time Perspective
Retrospective

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

More Details

NCT ID
NCT06360783
Status
Active, not recruiting
Sponsor
Duke University

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.