Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
1000 participants
OBSERVATIONAL
2023-02-01
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of the Integration of Ag-RDTs for COVID-19 in MNCH, HIV and TB Services in Cameroon and Kenya
NCT05498727
Community-based Evaluation of a Pilot PMTCT Project in Kafue District
NCT00753428
Optimizing Clinical Outcomes in HIV-Infected Adults & Children
NCT02043080
INTEGrating Ag-RDTs for COVID-19 in MNCH,HIV and TB Services in Cameroon and Kenya
NCT05382130
Antigen Rapid Diagnostic Tests for Community Identification of Severe Acute Respiratory Syndrome Coronavirus 2
NCT05458557
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Duke Clinical Research Institute
OTHER
Clinton Health Access Initiative, Nigeria
OTHER
Duke University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Krishna Udayakumar, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Duke Global Health Institute
Durham, North Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Pro00111388
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.