Evidence map›Paper›PMID 40973372›Full record

ArticleBMJ open2025

Mixed methods implementation research of oral antiviral treatment for COVID-19 in low- and middle-income countries: a study protocol.

Shanti Narayanasamy, Fiona Gambanga, Caroline E Boeke, Krishna Udayakumar, Leo Brothers, Cameron R Wolfe, Chukwuemeka Agwuocha, Maame Nkansaa Asamoa-Amoakohene, Khamsay Detleuxay, Bridget C Griffith and 22 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06360783 (Evaluation of a COVID-19 Quick Start "Test and Treat" Model in Africa), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06360783 completednot on this map

Evaluation of a COVID-19 Quick Start "Test and Treat" Model in Africa

TypeobservationalSponsorDuke UniversityRan2023 to 2024Enrolled148ConditionsCOVID-19
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

32 authors.

Shanti NarayanasamyDuke University, Durham, North Carolina, USA shanti.narayanasamy@duke.edu.ORCID http://orcid.org/0000-0002-6667-2868
Fiona GambangaClinton Health Access Initiative, Boston, Massachusetts, USA.
Caroline E BoekeClinton Health Access Initiative, Boston, Massachusetts, USA.
Krishna UdayakumarDuke Global Health Innovation Center, Duke University, Durham, North Carolina, USA.
Leo BrothersDuke Clinical Research Institute, Duke University, Durham, North Carolina, USA.
Cameron R WolfeDivision of Infectious Disease, Duke University, Durham, North Carolina, USA.
Chukwuemeka AgwuochaClinton Health Access Initiative, Abuja, Nigeria.
Maame Nkansaa Asamoa-AmoakoheneClinton Health Access Initiative, Accra, Ghana.
Khamsay DetleuxayDepartment of Healthcare and Rehabilitation, Lao Ministry of Health, Vientiane, Lao People's Democratic Republic.
Bridget C GriffithClinton Health Access Initiative, Boston, Massachusetts, USA.
Nervine HamzaClinton Health Access Initiative, Boston, Massachusetts, USA.
Jessica JosephClinton Health Access Initiative, Boston, Massachusetts, USA.ORCID http://orcid.org/0000-0002-3860-4673
Philip KimaniClinton Health Access Initiative, Nairobi, Kenya.
Robert KirungiClinton Health Access Initiative, Kampala, Uganda.
Norman LufesiAcute Respiratory Infection Unit, Ministry of Health, Lilongwe, Malawi.
Nyuma MbeweUniversity of Zambia/University Teaching Hospital, Lusaka, Zambia.ORCID http://orcid.org/0000-0002-3309-0538
Elizabeth McCarthyClinton Health Access Initiative, Boston, Massachusetts, USA.
Mwaba MulengaClinton Health Access Initiative, Lusaka, Zambia.
Moses MukiibiRepublic of Uganda Ministry of Health, Kampala, Uganda.
Tamara MwenifumboClinton Health Access Initiative, Lilongwe, Malawi.
Lawrence Ofori-BoaduInstitutional Care Division, Ghana Health Service, Accra, Ghana.
Ijeoma Uzondu OkoliNigeria Federal Ministry of Health, Abuja, Federal Capital Territory, Nigeria.
Sompasong PhongphilaClinton Health Access Initiative, Vientiane, Lao People's Democratic Republic.
Sean ReganClinton Health Access Initiative, Boston, Massachusetts, USA.
Edison RwagasoreRwanda Biomedical Center, Rwanda Ministry of Health, Kigali, Rwanda.
Alan StapleClinton Health Access Initiative, Boston, Massachusetts, USA.
Jessica TeborClinton Health Access Initiative, Boston, Massachusetts, USA.
Wesley TomnoTB Division, Kenya Ministry of Health, Nairobi, Kenya.
Sabine UmurazaClinton Health Access Initiative, Kigali, Rwanda.
Hayden B BosworthDuke University, Durham, North Carolina, USA.
COVID Treatment QuickStart Consortium Members
COVID-19 QuickStart Consortium Members

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThere is an absence of real-world evidence, especially from low- and middle-income countries (LMICs), on the implementation successes and challenges of COVID-19 Test and Treat (T&T) programmes. In 2022, nirmatrelvir/ritonavir was provided as standard of care for mild to moderate COVID-19 treatment in eight LMICs (Ghana, Kenya, Laos, Malawi, Nigeria, Rwanda, Uganda and Zambia). This manuscript describes a research protocol to study novel drug introduction during the COVID-19 health emergency, with implications and learnings for future pandemic preparedness. The goal of the study is to provide simultaneous programme learnings and improvements with programme rollout, to fill a gap in real-world implementation data on T&T programmes of oral antiviral treatment for COVID-19 and inform programme implementation and scale-up in other LMICs. METHODS AND ANALYSIS: This multiple methods implementation research study is divided into three components to address key operational research objectives: (1) programme learnings, monitoring and evaluation; (2) patient-level programme impact; and (3) key stakeholder perspectives. Data collection will occur for a minimum of 6 months in each country up to the end of grant. Quantitative data will be analysed using descriptive statistics for each country and then aggregated across the programme countries. Stakeholder perspectives will be examined using the Consolidated Framework for Implementation Research implementation science framework and semistructured interviews. ETHICS AND DISSEMINATION: This study was approved by the Duke University Institutional Review Board (Pro00111388). The study was also approved by the local institutional review boards in each country participating in individual-level data collection (objectives 2 and 3): Ghana, Malawi, Rwanda, Nigeria and Zambia. The study's findings will be published in peer-reviewed journals and disseminated through dialogue events, national and international conferences and through social media. TRIAL REGISTRATION NUMBER: NCT06360783.

Indexed as

Antiviral AgentsCOVID-19 Drug TreatmentRitonavirAdministration, OralCOVID-19Developing CountriesHumansObservational Studies as TopicResearch DesignAntiviral AgentsRitonavirCOVID-19Health EquityImplementation Science

Identifiers

PMID40973372
PMCPMC12458809

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.