COVID-19 Quick Start - Test and Treat in Africa

NCT ID: NCT06360783

Last Updated: 2025-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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COVID-19

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Ghana

Aggregated testing and treatment data from centers in Ghana.

No interventions assigned to this group

Malawi

Aggregated testing and treatment data from centers in Malawi.

No interventions assigned to this group

Rwanda

Aggregated testing and treatment data from centers in Rwanda.

No interventions assigned to this group

Zambia

Aggregated testing and treatment data from centers in Zambia.

No interventions assigned to this group

Zimbabwe

Aggregated testing and treatment data from centers in Zimbabwe.

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke Clinical Research Institute

OTHER

Sponsor Role collaborator

Clinton Health Access Initiative, Nigeria

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Krishna Udayakumar, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke Global Health Institute

Durham, North Carolina, United States

Site Status

Countries

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United States

References

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Narayanasamy S, Gambanga F, Boeke CE, Udayakumar K, Brothers L, Wolfe CR, Agwuocha C, Asamoa-Amoakohene MN, Detleuxay K, Griffith BC, Hamza N, Joseph J, Kimani P, Kirungi R, Lufesi N, Mbewe N, McCarthy E, Mulenga M, Mukiibi M, Mwenifumbo T, Ofori-Boadu L, Okoli IU, Phongphila S, Regan S, Rwagasore E, Staple A, Tebor J, Tomno W, Umuraza S, Bosworth HB; COVID Treatment QuickStart Consortium Members; COVID-19 QuickStart Consortium Members. Mixed methods implementation research of oral antiviral treatment for COVID-19 in low- and middle-income countries: a study protocol. BMJ Open. 2025 Sep 18;15(9):e088465. doi: 10.1136/bmjopen-2024-088465.

Reference Type DERIVED
PMID: 40973372 (View on PubMed)

Other Identifiers

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Pro00111388

Identifier Type: -

Identifier Source: org_study_id

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