Collision of three global pandemics: the effect of tuberculosis and HIV on the epidemiological, clinical, virological, and immunological trajectory of COVID-19 in Botswana and Namibia (Core-NB) - a protocol for a prospective case-ascertained and surveillance study.

内容摘要

In December 2019, the emergence of Coronavirus disease (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) led to a global pandemic, impacting over 620 million people, including approximately nine million in Africa. The COVID-19 pandemic introduced uncertainties, especially regarding co-infections, such as tuberculosis (TB) and human immunodeficiency virus (HIV). TB and HIV, both global pandemics, disproportionately affect low and middle-income countries. Namibia and Botswana reported high mortality rates due to TB and HIV which highlights ongoing challenges. This paper outlines the protocol for a comprehensive research study addressing the gaps, focusing on Botswana and Namibia, to enhance disease management for COVID-19 and TB/HIV especially when co-infections occur. The central hypothesis was that TB and HIV co-infection increase risk of adverse clinical, immunological, and virological COVID-19 outcomes. Core-NB was a prospective clinical cohort of COVID-19 patients with case identification through facility-based surveillance. The objectives were (i) to characterize the early COVID-19 epidemic in conjunction with TB and HIV, in terms of clinical, epidemiological, virological and immunological data, by conducting a household transmission study, and (ii) to conduct targeted COVID-19 screening and testing in conjunction with TB and HIV case finding, by conducting a primary healthcare facility (PHC) surveillance study. For (i) participants were identified based on laboratory RT-PCR confirmation of their COVID-19 infection at Ministry of Health designated laboratories in each country, and for (ii), attendees of primary healthcare facilities independent of the reason for attending were enrolled. Primary health care participants and their household contacts who agreed to participate in the study had home visits, including an initial enrollment visit at Day 1 (the day of COVID-19 diagnosis for the index case) and three follow-up visits occurring within 28 days of enrollment. Additionally, there were telephonic follow-ups three months after enrollment. Information on age, sex, race, occupation, income, and educational attainment was collected using a standardized questionnaire for all participants. Three respiratory specimens were obtained from each participant for: (i) SARS-CoV-2 RNA extraction and PCR (nasopharyngeal swab), (ii) GeneXpert Ultra for active TB (sputum sample) and (iii) extra sputum sample in case of a negative nasopharyngeal swab, mishandling or contamination. Enrollment was completed in February 2024 and analyses are ongoing. Preliminary results were presented at international conferences. This study will strengthen COVID-19, TB and HIV diagnosis, surveillance and control by: (i) high resolution surveillance and transmission data to guide guidelines and policies, (ii) data to develop further interventions, (iii) implementation of new technologies to improve care provision and boost the cooperation of stakeholders, (iv) supporting the development of skills and expertise in-country and (v) adding to evidence to build a regional network of expertise in the COVID-19, TB and HIV co-epidemics. Clinicaltrials.gov number NCT05268380. DERR1-10.2196/79438.