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BMC Infect Dis ; 21(1): 896, 2021 Sep 03.
Article in English | MEDLINE | ID: covidwho-1455931


BACKGROUND: The world has high hopes of vaccination against COVID-19 to protect the population, boost economies and return to normal life. Vaccination programmes are being rolled out in high income countries, but the pandemic continues to progress in many low-and middle-income countries (LMICs) despite implementation of strict hygiene measures. We aim to present a comprehensive research protocol that will generate epidemiological, sociological and anthropological data about the COVID-19 epidemic in Burkina Faso, a landlocked country in West Africa with scarce resources. METHODS: We will perform a multidisciplinary research using mixed methods in the two main cities in Burkina Faso (Ouagadougou and Bobo-Dioulasso). Data will be collected in the general population and in COVID-19 patients, caregivers and health care professionals in reference care centers: (i) to determine cumulative incidence of SARS-CoV-2 infection in the Burkinabe population using blood samples collected from randomly selected households according to the WHO-recommended protocol; (ii) develop a score to predict severe complications of COVID-19 in persons infected with SARS-CoV-2 using retrospective and prospective data; (iii) perform semi-structured interviews and direct observation on site, to describe and analyze the healthcare pathways and experiences of patients with COVID-19 attending reference care centers, and to identify the perceptions, acceptability and application of preventive strategies among the population. DISCUSSION: This study will generate comprehensive data that will contribute to improving COVID-19 response strategies in Burkina Faso. The lessons learned from the management of this epidemic may serve as examples to the country authorities to better design preventive strategies in the case of future epidemics or pandemics. The protocol was approved by the Ministry for Health (N° 2020-00952/MS/CAB/INSP/CM) and the Health Research Ethics Committee in Burkina Faso (N° 2020-8-140).

COVID-19 , Burkina Faso/epidemiology , Humans , Prospective Studies , Retrospective Studies , SARS-CoV-2
Contemp Clin Trials ; 105: 106402, 2021 06.
Article in English | MEDLINE | ID: covidwho-1188374


Post-natal HIV infection through breastfeeding remains a challenge in many low and middle-income countries, particularly due to non-availability of alternative infant feeding options and the suboptimal Prevention of Mother to Child Transmission of HIV-1 (PMTCT) cascade implementation and monitoring. The PROMISE-EPI study aims to address the latter by identifying HIV infected mothers during an almost never-missed visit for their infant, the second extended program on immunization visit at 6-8 weeks of age (EPI-2). The study is divided into 3 components inclusive of an open-label randomized controlled trial aiming to assess the efficacy of a responsive preventive intervention compared to routine intervention based on the national PMTCT guidelines for HIV-1 uninfected exposed breastfeeding infants. The preventive intervention includes: a) Point of care testing for early infant HIV diagnosis and maternal viral load; b) infant, single-drug Pre-Exposure Prophylaxis (PrEP) (lamivudine) if mothers are virally unsuppressed. The primary outcome is HIV-transmission rate from EPI-2 to 12 months. The study targets to screen 37,000 mother/infant pairs in Zambia and Burkina Faso to identify 2000 mother/infant pairs for the clinical trial. The study design and challenges faced during study implementation are described, including the COVID-19 pandemic and the amended HIV guidelines in Zambia in 2020 (triple-drug PrEP in HIV exposed infants guided by quarterly maternal viral load). The changes in the Zambian guidelines raised several questions including the equipoise of PrEP options, the standard of care-triple-drug (control arm in Zambia) versus the study-single-drug (intervention arm). Trial registration number ( NCT03869944. Submission category: Study Design, Statistical Design, Study Protocols.

Anti-HIV Agents/therapeutic use , Breast Feeding , HIV Infections/drug therapy , HIV Infections/transmission , Infectious Disease Transmission, Vertical/prevention & control , Lamivudine/therapeutic use , Adolescent , Adult , Anti-HIV Agents/administration & dosage , Anti-HIV Agents/adverse effects , Burkina Faso , COVID-19/epidemiology , Cross-Sectional Studies , Female , HIV Infections/diagnosis , Humans , Infant , Lamivudine/administration & dosage , Lamivudine/adverse effects , Pandemics , Pre-Exposure Prophylaxis/methods , Research Design , SARS-CoV-2 , Viral Load , Young Adult , Zambia