Multicenter observational survey on psychosocial and behavioral … – Nature.com

Study design and study participants

From June 2021 to January 2022, we conducted SARS-CoV-2 antibody testing and administered a self-report questionnaire survey on the psychosocial and behavioral impacts of COVID-19 among PLHIV (aged18years) at 11 ART facilities in Northern Vietnam. These facilities were involved in an HIV research project entitled, Establishment of the bench-to-bedside feedback system for sustainable ART and the prevention of new HIV transmission in Vietnam, which started in 2019 under a Japanese government program, the Science and Technology Research Partnership for Sustainable Development (SATREPS). These 11 ART facilities were selected in consultation with the Vietnamese Ministry of Health from multiple perspectives, including region, facility level, HIV prevalence, and support from other overseas donors. Additionally, owing to SATREPS being implemented within the framework of the Japanese governments official development assistance, some facilities were selected with an intention to provide technical assistance to facilities with insufficient access to HIV services, such as viral load testing. The study sites include one national-level hospital (NHTD), seven provincial/city-level hospitals, and three district-level hospitals. Four of the 11 hospitals were located in Hanoi (Table 1).

The content validity of the revised questionnaire was determined by an expert panel comprising HIV/AIDS experts, including HIV clinicians and social epidemiologists. The panel reviewed each item to ensure that the questionnaire was comprehensive and that no items were inappropriate in the Vietnamese cultural context.

All outpatient PLHIV who visited the study sites during the survey period were invited to complete the survey and to have a blood sample collected for antibody testing during their regular consultations. Individuals who provided written informed consent participated in the survey on the same day as their consultation. Because data collection was carried out during the largest COVID-19 outbreak in Vietnam, those who could not visit the study sites during the study period because of movement restrictions and those who received ART via post or in other facilities could not participate in the survey.

Information on sex, age, and occupation before the COVID-19 pandemic were collected. Age was divided into four categories using interquartile values. Occupation before the pandemic fell into the following categories: salaried worker, self-employed, household worker, unemployed or student or retired, or other.

The incidence of SARS-CoV-2 infection was investigated using the questionnaire survey and laboratory-based immunoassay to detect anti-SARS-CoV-2 N IgG antibodies with an automated immunoassay system (ARCHITECT i2000, Abbott Laboratories Inc., Abbott Park, IL, USA) and a 6R86 SARS-CoV-2 IgG Reagent Kit (Abbott Laboratories Inc.). In the questionnaire, the self-reported incidence was assessed by asking whether the respondent had been diagnosed with SARS-CoV-2 infection in a polymerase chain reaction (PCR) test or quarantined as a close contact of another person with such a diagnosis. The methods used for IgG antibody testing were the same as those in a previous study conducted in 2020 at the NHTD and are described elsewhere15.

The SARS-CoV-2 IgG assay is designed to detect IgG antibodies to the nucleocapsid (N) protein of SARS-CoV-2 whereas the main target of SARS-CoV-2 vaccines available in Vietnam is the spike (S) protein at the time of the survey. No study participant had received an inactivated whole-cell vaccine containing the N protein. Therefore, our antibody test results were not affected by vaccine history.

The questionnaire included the total vaccine doses received so far, behaviors to prevent COVID-19 infection (i.e., wearing a mask, hand washing, gargling, social distancing, and others), changes in social contacts compared with those pre-COVID-19 (i.e., no change, reduced, or increased), and willingness to have a diagnostic test when having symptoms of COVID-19 (i.e., willing to be tested, not willing to be tested, or unsure). Participants who said they were not willing to be tested were asked the reasons. The response options included fear of HIV status being disclosed, fear of laboratory confirmation of COVID-19 infection, and fear of discrimination against people with COVID-19 infection, and participants could select all applicable options.

The questionnaire assessed participants experience of continuing ART during the outbreak (i.e., continued to receive ART without interruption or discontinuation owing to the pandemic) and their experience of receiving ART at another clinic that was not their regular hospital during the outbreak. Question responses were dichotomous. Additionally, participants were asked whether they had received any form of social support to continue ART and HIV care during the COVID-19 pandemic. Participants used free text to describe the type of social support that could be effective in ensuring continuity of ART during the pandemic. For the NHTD, all patients had scheduled visits to measure HIV viral load during JuneJuly each year. We obtained visit status and reasons for missing a scheduled visit, as well as data on HIV viral load in JuneJuly 2020 and 2021.

Alcohol intake, drug use, and sexual behaviors were assessed. Regarding alcohol intake, participants were asked whether they had any episodes of binge drinking, defined as >5 drinks on one occasion18, in the past month and any change in alcohol consumption before and after the COVID-19 pandemic. As for drug use, participants were asked whether they had used illegal drugs in the past 3months and whether there was a change in the amount of drug use before and after the pandemic. Finally, we queried changes in the number of sex partners and frequency of using a condom during sex, before and after the outbreak. For questions asking about these changes, possible responses were no change, decreased, and increased. For the items on alcohol intake and drug use, non-drinker and non-drug user were added to the response categories.

Changes in employment status were assessed using five categories (i.e., no change, lost job, reduced working hours, increased working hours, and other). Participants pre- and post-COVID-19 household income and their current financial status were also assessed. Financial status was rated according to categories (i.e., no problems, a little challenging, very challenging, and other). We also asked whether participants had ever received financial assistance from any public authority. Finally, participants reported any forms of emergency assistance that could be helpful to support their lives using six options (i.e., no need, cash benefit, food benefit, tax exemption, rent subsidy, and other); participants could select all applicable options.

In the first survey conducted at the NHTD during 2020, the Vietnamese version of the Depression, Anxiety and Stress Scale-21 (DASS-21-V) with a cutoff score of 34 was used to measure the general distress experienced by study participants15. However, one limitation of our previous study was that there was no comparable prevalence of general distress using that cutoff score in the Vietnamese PLHIV population before and after the COVID-19 pandemic.

Prior to the COVID-19 pandemic, the National Center for Global Health and Medicine began a collaboration with NHTD, a study site in the present research, to monitor clinical outcomes of PLHIV. Under this collaboration, we conducted a study to assess depression using the Center for Epidemiological Studies-Depression (CES-D) scale in an HIV patient cohort at the NHTD in 201619. To address limitations of the first survey and compare the prevalence of depression before and after the COVID-19 pandemic, we assessed depression using the CES-D, as well as general distress using the DASS-21-V, among participants in the second survey at the NHTD. The CES-D is a widely used self-reporting scale and there is strong evidence for both its reliability and validity in Vietnams HIV population, with a Cronbachs alpha of 0.81 and sensitivity and specificity of 79.8% and 83.0%, respectively, with a cutoff score of 1620. The CES-D comprises 20 items answered on a four-point scale ranging from 0 (rarely or none of the time) to 3 (most or almost all the time), except for four items that are positively worded and scored in reverse. Regardless of whether questions were scored in reverse, if a respondent provided the same answer to all 20 items, the CES-D score was considered invalid and was excluded from the analysis. We used the Vietnamese version of the CES-D, which was previously available20. We defined a CES-D score of 16 as experiencing depression because this cutoff has been proven optimal for assessing depression in Vietnams HIV population20. The DASS-21-V comprises 21 items answered on a four-point scale ranging from 0 (does not apply to me at all) to 3 (applies to me very much or most of the time). According to the scoring instructions21, the total score is calculated by multiplying the sum of the responses by two. In line with the first survey, a cutoff score of 34 was used to measure general distress. This cutoff score was suggested by Tran et al. to detect general distress, including depression and anxiety, with a sensitivity of 79.1% and specificity of 77.0% in Vietnamese women22.

First, we descriptively evaluated the incidence of SARS-CoV-2 infection, prevention against COVID-19 infection, impact of COVID-19 on ART continuity, economic security, and risky health behaviors among all study participants. Next, to assess changes in the impacts of COVID-19 during different pandemic phases, we compared differences in responses between the two surveys conducted at the NHTD in 2020 and 2021 using the McNemar test. Additionally, a study on depression among PLHIV patients was previously conducted at the NHTD in 2016, prior to the COVID-19 pandemic. Using that available data, the prevalence of and factors associated with depression were compared between the 2016 survey (pre-COVID-19) and the present 2021 survey (post-COVID-19). Comparisons between the 2020 and 2021 surveys and the 2016 and 2021 surveys were conducted for the same questions or using the same scales among those who participated in both surveys (i.e., the same population). Univariate logistic regression models were used to investigate factors associated with depression, and crude odds ratios (ORs) were calculated. As supplementary analysis, we performed logistic regression models using all data, including from participants who gave the same response to all items on the CES-D.

All analyses were performed using SAS 9.4 software (SAS Institute Inc., Cary, NC, USA). All tests were two-sided, with the significance level set at 5%. Missing data were excluded from the analyses.

The study was approved by the Human Research Ethics Committee of the National Center for Global Health and Medicine (reference: NCGM-G-003560-02) and the Bio-medical Research Ethics Committees of the National Hospital for Tropical Diseases (reference: 12/HDDD-NDTU). We performed this study in accordance with Japans Ethical Guidelines for Medical and Health Research Involving Human Subjects, issued by the Japanese Ministry of Health, Labour and Welfare.

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