{
  "abstract": "Introduction There 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.",
  "authors": [
    {
      "affiliations": [
        "Duke University, Durham, North Carolina, USA",
        "Department of Infectious Diseases and Immunology, Austin Health, Melbourne, Victoria, Australia"
      ],
      "name": "Shanti Narayanasamy"
    },
    {
      "affiliations": [
        "Clinton Health Access Initiative, Boston, Massachusetts, USA"
      ],
      "name": "Fiona Gambanga"
    },
    {
      "affiliations": [
        "Clinton Health Access Initiative, Boston, Massachusetts, USA"
      ],
      "name": "Caroline E Boeke"
    },
    {
      "affiliations": [
        "Duke Global Health Innovation Center, Duke University, Durham, North Carolina, USA"
      ],
      "name": "Krishna Udayakumar"
    },
    {
      "affiliations": [
        "Duke Clinical Research Institute, Duke University, Durham, North Carolina, USA"
      ],
      "name": "Leo Brothers"
    },
    {
      "affiliations": [
        "Division of Infectious Disease, Duke University, Durham, North Carolina, USA"
      ],
      "name": "Cameron R Wolfe"
    },
    {
      "affiliations": [
        "Clinton Health Access Initiative, Abuja, Nigeria"
      ],
      "name": "Chukwuemeka Agwuocha"
    },
    {
      "affiliations": [
        "Clinton Health Access Initiative, Accra, Ghana"
      ],
      "name": "Maame Nkansaa Asamoa-Amoakohene"
    },
    {
      "affiliations": [
        "Department of Healthcare and Rehabilitation, Lao Ministry of Health, Vientiane, Lao People’s Democratic Republic"
      ],
      "name": "Khamsay Detleuxay"
    },
    {
      "affiliations": [
        "Clinton Health Access Initiative, Boston, Massachusetts, USA"
      ],
      "name": "Bridget C Griffith"
    },
    {
      "affiliations": [
        "Clinton Health Access Initiative, Boston, Massachusetts, USA"
      ],
      "name": "Nervine Hamza"
    },
    {
      "affiliations": [
        "Clinton Health Access Initiative, Boston, Massachusetts, USA"
      ],
      "name": "Jessica Joseph"
    },
    {
      "affiliations": [
        "Clinton Health Access Initiative, Nairobi, Kenya"
      ],
      "name": "Philip Kimani"
    },
    {
      "affiliations": [
        "Clinton Health Access Initiative, Kampala, Uganda"
      ],
      "name": "Robert Kirungi"
    },
    {
      "affiliations": [
        "Acute Respiratory Infection Unit, Ministry of Health, Lilongwe, Malawi"
      ],
      "name": "Norman Lufesi"
    },
    {
      "affiliations": [
        "University of Zambia/University Teaching Hospital, Lusaka, Zambia"
      ],
      "name": "Nyuma Mbewe"
    },
    {
      "affiliations": [
        "Clinton Health Access Initiative, Boston, Massachusetts, USA"
      ],
      "name": "Elizabeth McCarthy"
    },
    {
      "affiliations": [
        "Clinton Health Access Initiative, Lusaka, Zambia"
      ],
      "name": "Mwaba Mulenga"
    },
    {
      "affiliations": [
        "Republic of Uganda Ministry of Health, Kampala, Uganda"
      ],
      "name": "Moses Mukiibi"
    },
    {
      "affiliations": [
        "Clinton Health Access Initiative, Lilongwe, Malawi"
      ],
      "name": "Tamara Mwenifumbo"
    },
    {
      "affiliations": [
        "Institutional Care Division, Ghana Health Service, Accra, Ghana",
        "Ga East Municipal Hospital, Ghana Health Service, Accra, Ghana"
      ],
      "name": "Lawrence Ofori-Boadu"
    },
    {
      "affiliations": [
        "Nigeria Federal Ministry of Health, Abuja, Federal Capital Territory, Nigeria"
      ],
      "name": "Ijeoma Uzondu Okoli"
    },
    {
      "affiliations": [
        "Clinton Health Access Initiative, Vientiane, Lao People’s Democratic Republic"
      ],
      "name": "Sompasong Phongphila"
    },
    {
      "affiliations": [
        "Clinton Health Access Initiative, Boston, Massachusetts, USA"
      ],
      "name": "Sean Regan"
    },
    {
      "affiliations": [
        "Rwanda Biomedical Center, Rwanda Ministry of Health, Kigali, Rwanda"
      ],
      "name": "Edison Rwagasore"
    },
    {
      "affiliations": [
        "Clinton Health Access Initiative, Boston, Massachusetts, USA"
      ],
      "name": "Alan Staple"
    },
    {
      "affiliations": [
        "Clinton Health Access Initiative, Boston, Massachusetts, USA"
      ],
      "name": "Jessica Tebor"
    },
    {
      "affiliations": [
        "TB Division, Kenya Ministry of Health, Nairobi, Kenya"
      ],
      "name": "Wesley Tomno"
    },
    {
      "affiliations": [
        "Clinton Health Access Initiative, Kigali, Rwanda"
      ],
      "name": "Sabine Umuraza"
    },
    {
      "affiliations": [
        "Duke University, Durham, North Carolina, USA"
      ],
      "name": "Hayden B Bosworth"
    },
    {
      "affiliations": [],
      "name": "COVID Treatment QuickStart Consortium Members"
    }
  ],
  "title": "Mixed methods implementation research of oral antiviral treatment for COVID-19 in low- and middle-income countries: a study protocol",
  "uid": "83f28f4f-8aa5-5108-ad5a-34a76d2f5a0b"
}