NCT06360783

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 11, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

1.3 years

First QC Date

April 9, 2024

Last Update Submit

April 21, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    up to 3 years

Study Arms (5)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients in participating countries who receive COVID testing and treatment at a participating facility.

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Global Health Institute

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Krishna Udayakumar, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2024

First Posted

April 11, 2024

Study Start

February 1, 2023

Primary Completion

May 31, 2024

Study Completion

May 31, 2024

Last Updated

April 22, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations