Epidémiolgie - Santé Publique (Epidemiology - Public Health) - Prévalence de l'infection à COVID-19 chez des patients VIH séropositifs à l'étude pour la tuberculose dans le contexte de l'étude FujiLAM Prevalence of COVID-19 infection in HIV-positive patients being investigated for tuberculosis in the context of the Fujilam study

Background The outbreak of a novel coronavirus (SARS-CoV-2), characterized as a pandemic by the WHO on 11 March 2020, has disrupted the health systems worldwide. Most of the cases of coronavirus disease (COVID-19) have been reported in the North hemisphere of the globe, but the epidemic has taken hold in the South including African countries. People with underlying comorbidities and suppressed immune systems are particularly vulnerable to coronavirus disease. There is a lack of information on prevalence and severity of this emerging disease among HIV patients with TB. This study proposes to incorporate COVID-19 testing and follow-up into an existing multi-country study of novel tuberculosis diagnostics among HIV-positive patients at high risk. The objectives of this study are to assess the prevalence and severity of COVID-19 among HIV positive patients. Methods Prospective observational study nested in the FujiLAM study. Covid-19 testing will be done in 2 of the 4 FujiLAM study sites, in Mbarara, Uganda and in Homa Bay, Kenya. The parent study includes two groups of ambulatory adult HIV-positive patients at high risk of TB: Ambulatory HIV-positive patients with symptoms of TB (Group 1) and ambulatory HIV-positive patients with advanced HIV disease and no symptoms of TB (Group 2). Patients included in the study will be seen by a clinician, who will conduct a clinical exam and will request COVID-19 and TB investigations. Patients will be followed for 6 months. Patients diagnosed with Covid-19 will be managed as per the national recommendations. The main study endpoints will be the proportion of HIV-positive patients diagnosed with COVID-19 among those with symptoms of TB and the proportion of HIV-positive patients with past contact with SARS-CoV-2 measured through the presence of antibodies among those with symptoms of TB and among those with advanced HIV disease and no symptoms of TB. A total of 500 HIV-positive patients with symptoms of TB and 780 patients with advanced HIV disease and no symptoms of TB are expected to be included in Kenya and Uganda. Timelines The study is expected to start in August 2020. Patients recruitment is expected to take 6 months and patients will be followed for 6 months.