Study population and procedure
This prospective cohort study was conducted in Guangzhou, China, from June 2016 to May 2018. Face-to-face interviews were conducted at baseline (the first day of ART admission), and at Month 6 and Month 12 after ART admission. The inclusion criteria were that the subjects were 1) aged 18 years or above, 2) HIV seropositive, 3) initiating ART for the first time, and 4) willing to attend surveys at baseline, Month 6, and Month 12. Those who had major psychiatric illnesses (schizophrenia or bipolar disorder) or could not communicate with the interviewers were excluded.
The participants were recruited from the ART clinic of Guangzhou Eighth People’s Hospital in Guangzhou. The Guangzhou Eighth People’s Hospital was the first ART centre in Guangdong province and has provided ART to over 10,000 PLWH since 2004 [33]. During the recruitment period (June 2016 to May 2017), trained nurses screened the new ART users for eligibility and referred those who met the criteria to the research team. The trained interviewers then reconfirmed the participants’ eligibility, explained the details of the study, and assured them that refusal would not affect their right to use any related services and that they could quit the study at any time without being questioned. After providing written informed consent, the participants completed a self-administered questionnaire which took about 15 minutes. They were invited to visit the hospital again to complete two other self-administered questionnaires after six and twelve months. On completion of each of the three surveys, the participants received a souvenir (worth 15 RMB or 2 USD) in appreciation of their time. Ethical approval for the study was obtained from the Institutional Review Board (IRB) of the School of Public Health, Sun Yat-sen University, Guangzhou, China (No: 2016-003).
Of the 480 prospective participants approached, 425 passed the eligibility screening. Of these, 400 provided written informed consent and completed the baseline survey (response rate: 94.1%, 400/425), among whom 353 (88.3%, 353/400) completed the Month 6 follow-up survey, and 300 (75.0%, 300/400) also completed the Month 12 survey. Of the participants who did not complete both follow-up surveys (n=100), 12 were lost to clinic follow-up (didn't come back since the last visit), 11 were transferred to other ART clinics, 2 were died, 4 refused to participate in the follow-up surveys, and 71 didn't show up during the appointed follow-up period but remained in the treatment.
Measurements
Mental health problems measured at baseline and Month 12
Depressive symptoms were measured by the validated Chinese version of the Patient Health Questionnaire (PHQ-9) [34, 35]. The PHQ-9 has been widely used to screen for depression in different Chinese populations [34, 35], including PLWH [36], and has acceptable reliability and validity. The scale contains nine items regarding the frequency of certain negative feelings over the past two weeks (response categories: 0 = never, 1 = sometimes, 2 = often, 3 = almost every day). The total scores ranged from 0 to 27, and a higher score indicated more severe depression. A score of ≥10 was used to define probable depression [22, 26].
Generalized anxiety disorder was measured by the validated Chinese version of the Generalized Anxiety Disorder Scale (GAD-7), which has shown acceptable reliability and validity in prior research [37]. The scale contains 7 items, with a score range of 0–21, a higher score representing greater anxiety. In this study, a score of ≥10 was used to define moderate/severe anxiety [38].
Experiences related to ART measured at Month 6
A panel of HIV epidemiologists, behavioural health researchers, nurses, and physicians from the ART clinic was formed to develop the questions regarding patients’ experiences related to ART. The questions were then pilot tested among 15 PLWH who were currently on ART. Based on their feedback, the experience questions were revised to form the experiences measurement, which included four positive and four negative experiences.
Four items measured positive experiences related to ART. The participants were asked to report whether they had had the following experiences during the past six months: 1) a rise in CD4 cell count, 2) improvement in physical health, 3) improvement in relationships with sexual partners, and 4) regained self-confidence (response categories: 1 = yes, 0 = no). Negative experiences related to ART in the past six months were also measured by four items: 1) side effects of ART, 2) AIDS-related symptoms, 3) inconvenience of ART use in daily life, and 4) exposure of HIV-positive status due to ART use (response categories: 1 = yes, 0 = no).
Baseline characteristics
The participants were asked about their background characteristics, including age, sex, education, current marital status, monthly personal income, employment status, and city of permanent residence. HIV/AIDS-related characteristics were also recorded, including AIDS-related symptoms, CD4 cell count at the most recent test, route of HIV transmission (sexual behaviour with same-sex partner, sexual behaviour with opposite-sex partner, intravenous drug use, mother-to-child transmission, blood transfusion, occupational exposure, or not sure), and ART regime.
Psychosocial status including social support and social stigma was also measured at baseline. Social support was measured by the validated Chinese version of the Multidimensional Scale of Perceived Social Support (MSPSS) [39, 40]. The MSPSS contains 12 items and 3 dimensions including family, friends, and significant others. The score range for each dimension is 1–7, with a higher score indicating better support. We used the social stigma module of the Chinese Courtesy Stigma Scales (CSSSs) to measure the social stigma patients experienced [41]. The scale contains 13 items, with a score range of 13–52, a higher score representing greater stigma.
Statistical Analysis
The baseline characteristics of those who completed all follow-up surveys and those who did not were compared using a chi-square test (for categorical variables), independent samples t-test (for continuous variables with normal distribution), or non-parametric test (for ranked variables and continuous with non-normal/skewed distribution). Further analysis was performed among those who completed all three surveys: baseline, Month 6, and Month 12 (n = 300).
The depression and anxiety status were presented using both scores of assessments (continuous variables) and clinically defined thresholds (categorical variables). The difference in mental health problems between baseline and Month 12 was tested by the Wilcoxon signed rank test (for scores) and the paired-sample Chi-square test (for categorical mental health statuses). Associations between baseline characteristics and probable depression and moderate/severe anxiety measured at Month 12 were described by the odds ratio (OR) obtained from univariate logistic regression models. Multivariate stepwise logistic regression models were used to identify baseline factors that independently affected mental health status at Month 12. To test whether ART-related experiences measured at Month 6 were associated with future mental health problems (probable depression and moderate/severe anxiety measured at Month 12), both univariate and adjusted logistic regression models were applied, adjusted for baseline variables with P < 0.1, plus baseline mental health status. R software version 4.0.2 was used for the data analysis, and P < 0.05 was considered statistically significant.