Study design and participants recruitment
As an extension of our former work[6, 7], this cross-sectional study has consisted of two groups of the population that participated in the seroepidemiological survey of SARS-CoV-2 in Wuchang district, Wuhan. The investigation was proceeded from May 1, 2020, to May 31, 2020. All the participants (age ≥ 18 years old) were lived in the Wuchang district for at least 1 month from December 1, 2019, to April 8, 2020.
All PLWH who were managed by the Wuchang district center for disease control and prevention (CDC) were recruited. The participants who were tested positive for HIV have been reported to Wuchang CDC through the China National HIV/AIDS Comprehensive Response Information Management System (CRIMS).
For the general group, a two-stage cluster sampling method was used to recruit the study population. Selecting communities as primary sampling units (PSUs) at the first stage and families at the second stage. Overall, all communities were certainty PSUs and 11 communities were selected with probability proportional to the size sampling method. Within each community, 36 households were selected by systematic random sampling method and all members of the households were invited to participate in the study. If individuals of a certain age group were missing, we swallowed the sample randomly to ensure that the age structure of the sample was similar to the natural structure of the population.
For PLWH, demographic information includes age, gender, chronic comorbidities, the mode of HIV acquisition, antiretroviral (ARV) regimens, current opportunistic infections (OIs). ARV regimens were obtained from CRIMS. Basic information about HIV negative participants was collected through a questionnaire. All participants were inquired of COVID-19 history, and we double-checked the name and identification card number with that of recorded COVID-19 patients in the CDC information management systems. All SARS-CoV-2 infections are diagnosed according to the 8th edition of clinical practice guidelines for COVID-19 in China. The total SARS-CoV-2 infection rate including the rate of COVID-19, asymptomatic carrier, and unapparent infector.
Chronic comorbidities include hypertension, diabetes, chronic respiratory disease, cancer, and any other chronic disease that has been diagnosed. The definition of OIs was referring to the guideline formulated by the U.S. Department of Health and Human Services (DHHS). The Asymptomatic carrier is defined as a patient who does not have clinical manifestations of COVID-19 but the nucleic acid is positive. The unapparent infector is defined as a patient who does not have clinical manifestations and nucleic acid negative but serum antibody for SARS-CoV-2 was positive.
The CD4 + T lymphocyte count (CD4 count) and HIV viral load (HIV-VL) were detected for PLWH. All recruited general individuals received HIV antibody screening tests. Methods for laboratory confirmation of SARS-CoV-2 infection included: respiratory specimens SARS-CoV-2 real-time fluorescence Polymerase Chain Reaction (RT-PCR), serum SARS-CoV-2 IgM/IgG antibody colloidal gold test, and magnetic particle chemiluminescence (qualitative result). The detection kits were provided by Shengxiang Biotechnology Co., LTD, and Guangzhou Wanfu Biotech Co., LTD. The kits were approved by the China Food and Drug Administration (FDA). In this study, swab nucleic and serum antibodies (IgM/IgG) were detected for all subjects. All positive specimens (nucleic acid, IgM, or IgG positive) were sent to China CDC for confirmation.
Continuous variables were expressed as means (SD) or median (interquartile range) and categorical variables were expressed as frequency and percent. Comparisons of continuous variables were assessed using the independent sample T-test or Wilcoxon rank-sum test, while categorical variables were assessed using the χ2 test or the Fisher exact test. We calculated the crude rate and 95% confidence interval (95% CI) of SARS-CoV-2 infection to estimated using the exact binomial distribution. Then we used a logistic regression model to calculate the adjusted rate and 95% CI of SARS-CoV-2 infection after adjusting for age, gender, and chronic comorbidities to compare the difference in SARS-CoV-2 infection rate between PLWH and the HIV negative group in the Wuchang district. Univariate and multivariable modified Poisson regression methods were used to explore the risk factors associated with PLWH co-infected with SARS-CoV-2.
Statistical significance was defined as a two-sided p-value of less than 0.05. All analyses were conducted using STATA version 13.0 (STATA Corporation, College Station, Texas) and IBM SPSS Statistics (Version 26.0) software.