Introduction
-
To determine the seroprevalence of SARS-CoV-2 and the viral load and antibody dynamics of COVID-19 in cohorts of people living with HIV (PLWHIV) and/or TBP.
-
To identify specific biomarkers of SARS-Cov-2 infection in PLWHIV and/or TBP.
-
To determine the risk factors for COVID-19 occurrence among PLWHIV and/or TBP;
-
To analyze the perceptions, psychological experiences and treatment trajectory of PLWHIV and/or TBP during the COVID-19 pandemic.
Methods
The design and setting of the study
Phase 1: Sero-epidemiological and clinical study
Circulation of SARS-CoV-2 in PLWH
The characteristics of participants
Inclusion criteria
-
All HIV-infected patients followed up at the SSUHC between March 2020 and March 2021.
-
Aged 18 years or older.
-
Having given their informed consent for the use of their medical records and plasma sample for research purposes.
Non‑inclusion criteria
-
Inappropriate or unavailable plasma samples.
Sample size calculation and sampling
Data collection and processing
Study endpoints
-
The proportion of HIV-infected persons with specific antibodies to SARS-CoV-2 in each socio-demographic group (age, sex).
-
The proportion of HIV-infected persons with specific antibodies to SARS-CoV-2 in each clinical/biological group (clinical stage, CD4 count, Viral Load).
Statistical analyses
-
Calculation of prevalence: the proportion of HIV-positive persons infected with SARS-CoV-2.
-
Description and comparison of sociodemographic, clinical and biological characteristics of all patients at the time of sampling according to their SARS-CoV-2 serological status.
Cohorts of PLWHIV and TBP
Characteristics of the participants
Inclusion criteria
-
Infected with HIV and/or tuberculosis.
-
Aged 18 years or older.
-
Being followed up in one of the HIV or TB care centers in Bobo-Dioulasso.
-
Having provided written informed consent.
Non-inclusion criteria
-
Patients unable to answer the survey questions.
-
Patients under legal guardianship or tutorship or other form of legal protection.
Sample size calculation and sampling
Specimen | Biological analysis | Day 0 | Month 6 | Month 12 |
---|---|---|---|---|
Nasopharyngeal swab | • Real-Time Quantitative Reverse Transcription Polymerase Chain Reaction | + | + | + |
Sputum | • Tuberculosis bacillus test | + | + | + |
Dried blood spot | • Luminex | + | + | + |
Venous blood (3 ml) on EDTA tube | • Enzyme-Linked Immuno Assay • CD4 count • HIV Viral Load | + | + | + |
Blood drop on blade | • Testing for Plasmodium | + |
Specimen | Bioanalysis | Day 7 | Day 14 | Month 6 | Month 12 |
---|---|---|---|---|---|
Nasopharyngeal swab ,urine, stool and saliva samples | • Real-Time Quantitative Reverse Transcription Polymerase Chain Reaction | + | + | + | + |
Sputum | • Tuberculosis bacillus test | + | + | + | + |
Dried blood spot | • Luminex analysis | + | + | + | + |
Venous blood (3 ml) on EDTA tube | • Enzyme-Linked Immuno Assay • CD4 count • HIV Viral Load | + | + | + | + |
Blood drop on blade | • Testing for Plasmodium | + | + |
Laboratory analysis
Real-time quantitative reverse transcription polymerase chain reaction (RT-qPCR)
SARS Cov 2 serological testing
Luminex analysis
Testing for tuberculous bacillus
CD4 count
HIV viral load
-
Amplification and detection with the m2000rt using the Abbott Real Time HIV-1® kit.
-
Automated extraction with m2000sp using the mSample Preparation Systems RNA kit.
Plasmodium testing by thick blood film
Research and development of innovative biomarkers for diagnosis and prognosis
Study endpoints
-
The proportion of susceptible individuals (HIV and TB) with specific antibodies against SARS-CoV-2.
-
The dynamics of viral load and antibodies against SARS-CoV-2.
-
The proportion of SARS-CoV-2 variants and novel biomarkers circulating in HIV and TB patients.
-
The average duration of clinical signs in COVID-19.
-
Infectivity and duration of SARS-CoV-2 in faeces.
Statistical analysis
-
Calculation of the cumulative incidence: the proportion of vulnerable persons (PLWHIV and TBP) who are seropositive for SARS-CoV-2 infection.
-
Description and comparison of socio-demographic, clinical and biological characteristics according to the serological status of the population.
-
Identification of SARS-COV-2 variants circulating in PLWHIV and TBP.
-
Identification of specific biological markers of SARS-Cov-2 infection in PLWHIV and TBP.
-
Characterization of viral load and anti-SARS-CoV-2 antibody dynamics.
-
Monitoring the duration and infectivity of viral shedding in urine, stool, saliva.
Phase 2: Socio-anthropological study
-
determine the level of knowledge of COVID 19 pandemic and the associated representations;
-
define the conditions for trust in intervention strategies for so-called vulnerable people;
-
identify the level of reference to conventional care after COVID 19;
-
identify the therapeutic response strategies and the reasons for these choices;
-
assess the level of compatibility of these response strategies on their health status;
-
identify community perceptions about people with HIV/TB and COVID co-infection.
Analysis design
Participant characteristics
Profile | Number |
---|---|
People living with HIV and former patient COVID 19 | 10 |
People living with HIV and current patient COVID 19 | 5 |
Tuberculosis and former patient COVID 19 | 10 |
Tuberculosis and current patient COVID 19 | 5 |
People living with HIV and tuberculosis and former patient COVID 19 | 10 |
People living with HIV and tuberculosis and current patient COVID 19 | 5 |
Relative of people living with HIV and tuberculosis and former patient COVID 19 | 5 |
Relative of people living with HIV and tuberculosis current patient COVID 19 | 5 |
General population | 10 |
Health workers | 10 |
Traditherapists | 6 |
Street drug sellers | 5 |
Resource persons | 10 |