COVID-19NCT06360783
COVID-19 Quick Start - Test and Treat in Africa
An observational study of COVID-19, run by Duke University at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 31 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in participating countries who receive COVID testing and treatment at a participating facility.
Who may be able to join
- 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)
Who cannot join
- None if other inclusion criteria are met
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Global Health Institute
Durham, North Carolina, 27705
About this study
Official title: Evaluation of a COVID-19 Quick Start "Test and Treat" Model in Africa
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
Read the 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:
- 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.
- 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.
- 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
- COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start1 Feb 2023
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Duke Clinical Research Institute, Clinton Health Access Initiative, Nigeria
- Responsible party
- Sponsor
- Investigators
- Krishna Udayakumar, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06360783
- Sponsor's protocol ID
- Pro00111388
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2024
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Narayanasamy S, Griffith BC, Gonzales S, Boeke C, Gumulira Y, Hamza N, Joseph JTT, Lewinski AA, Lufesi N, Martin-Odoom A, Mbewe N, McCarthy EA, Mhina C, Miller J, Mweeba MS, Mintah FO, Ofori-Boadu L, Ndayishimiye R, Regan S, Rwagasore E, Udayakumar K, Wolfe CR, Oakes MM, Bosworth HB; COVID-19 QuickStart Consortium. Recommendations for enhancing COVID-19 test and treat programmes in four African countries: insights and strategies from a qualitative study. BMJ Public Health. 2026 Oct 29;4(4):e004175. doi: 10.1136/bmjph-2025-004175. eCollection 2026.
PubMed 42968914Narayanasamy 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.
PubMed 40973372
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a COVID-19 Quick Start "Test and Treat" Model in Africa
- ClinicalTrials.gov ID
- NCT06360783
- Acronym / sponsor ID
- Pro00111388
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Duke Clinical Research Institute, Clinton Health Access Initiative, Nigeria
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 11 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in participating countries who receive COVID testing and treatment at a participating facility.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- None if other inclusion criteria are met
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Stakeholder Perspectives
Time frame: up to 3 years
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Derived from this study: PubMed 42968914Narayanasamy S, Griffith BC, Gonzales S, Boeke C, Gumulira Y, Hamza N, Joseph JTT, Lewinski AA, Lufesi N, Martin-Odoom A, Mbewe N, McCarthy EA, Mhina C, Miller J, Mweeba MS, Mintah FO, Ofori-Boadu L, Ndayishimiye R, Regan S, Rwagasore E, Udayakumar K, Wolfe CR, Oakes MM, Bosworth HB; COVID-19 QuickStart Consortium. Recommendations for enhancing COVID-19 test and treat programmes in four African countries: insights and strategies from a qualitative study. BMJ Public Health. 2026 Oct 29;4(4):e004175. doi: 10.1136/bmjph-2025-004175. eCollection 2026.
- Derived from this study: PubMed 40973372Narayanasamy 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Krishna Udayakumar, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stakeholder Perspectives (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06360783, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.