Tuberculosis (TB) Aftermath: study protocol for a hybrid type I effectiveness-implementation non-inferiority randomized trial in India comparing two active case finding (ACF) strategies among individuals treated for TB and their household contacts.

BACKGROUND: Approximately 7% of all reported tuberculosis (TB) cases each year are recurrent, occurring among people who have had TB in the recent or distant past. TB recurrence is particularly common in India, which has the largest TB burden worldwide. Although patients recently treated for TB are at high risk of developing TB again, evidence around effective active case finding (ACF) strategies in this population is scarce. We will conduct a hybrid type I effectiveness-implementation non-inferiority randomized trial to compare the effectiveness, cost-effectiveness, and feasibility of two ACF strategies among individuals who have completed TB treatment and their household contacts (HHCs). METHODS: We will enroll 1076 adults (≥ 18 years) who have completed TB treatment at a public TB unit (TU) in Pune, India, along with their HHCs (averaging two per patient, n = 2152). Participants will undergo symptom-based ACF by existing healthcare workers (HCWs) at 6-month intervals and will be randomized to either home-based ACF (HACF) or telephonic ACF (TACF). Symptomatic participants will undergo microbiologic testing through the program. Asymptomatic HHCs will be referred for TB preventive treatment (TPT) per national guidelines. The primary outcome is rate per 100 person-years of people diagnosed with new or recurrent TB by study arm, within 12 months following treatment completion. The secondary outcome is proportion of HHCs < 6 years, by study arm, initiated on TPT after ruling out TB disease. Study staff will collect socio-demographic and clinical data to identify risk factors for TB recurrence and will measure post-TB lung impairment. In both arms, an 18-month "mop-up" visit will be conducted to ascertain outcomes. We will use the RE-AIM framework to characterize implementation processes and explore acceptability through in-depth interviews with index patients, HHCs and HCWs (n = 100). Cost-effectiveness will be assessed by calculating the incremental cost per TB case detected within 12 months and projected for disability-adjusted life years averted based on modeled estimates of morbidity, mortality, and time with infectious TB. DISCUSSION: This novel trial will guide India's scale-up of post-treatment ACF and provide an evidence base for designing strategies to detect recurrent and new TB in other high burden settings. TRIAL REGISTRATION: NCT04333485 , registered April 3, 2020. CTRI/2020/05/025059 [Clinical Trials Registry of India], registered May 6 2020.

The burden of anxiety among people living with HIV during the COVID-19 pandemic in Pune, India.

INTRODUCTION: Globally, India has the third largest population of people living with HIV (PLHIV) and the second highest number of COVID-19 cases. Anxiety is associated with antiretroviral therapy (ART) nonadherence. It is crucial to understand the burden of anxiety and its sources among Asian Indian PLHIV during the COVID pandemic, but data are limited. METHODS: During the first month of government mandated lockdown, we administered an anxiety assessment via telephone among PLHIV registered for care at a publicly funded antiretroviral therapy (ART) center in Pune, India. Generalized anxiety was defined as GAD-7 score ≥ 10. Sociodemographic and clinical variables were compared by anxiety status (GAD-7 score ≥ 10 vs GAD-7 score < 10). Qualitative responses to an open-ended question about causes of concern were evaluated using thematic analysis. RESULTS: Among 167 PLHIV, median age was 44 years (IQR 40-50); the majority were cisgender women (60%) and had a monthly family income < 200 USD (81%). Prior history of tuberculosis and other comorbidities were observed in 38 and 27%, respectively. Overall, prevalence of generalized anxiety was 25% (n = 41). PLHIV with GAD-7 score ≥ 10 had fewer remaining doses of ART than those with lower GAD-7 scores (p = 0.05). Thematic analysis indicated that concerns were both health related and unrelated, and stated temporally. Present concerns were often also projected as future concerns. CONCLUSIONS: The burden of anxiety was high during COVID lockdown in our population of socioeconomically disadvantaged PLHIV in Pune and appeared to be influenced by concerns about ART availability. The burden of anxiety among PLHIV will likely increase with the worsening pandemic in India, as sources of anxiety are expected to persist. We recommend the regular use of short screening tools for anxiety to monitor and triage patients as an extension of current HIV services.

Mental health and quality of life among healthcare professionals during the COVID-19 pandemic in India.

BACKGROUND: The COVID-19 pandemic has placed healthcare professionals (HCP) in stressful circumstances with increased patient loads and a high risk of exposure. We sought to assess the mental health and quality of life (QoL) of Indian HCPs, the fourth highest-burden country for COVID-19. METHOD: Using snowball sampling, we conducted an online survey in May 2020 among HCPs. Data were collected on demographics, depression, and anxiety using validated tools, quality of life, and perceived stressors. Multivariable logistic regression and principal component analysis were performed to assess risk factors associated with mental health symptoms. FINDINGS: Of 197 HCPs assessed, 157 (80%) were from Maharashtra, 130 (66%) from public hospitals, 47 (24%) nurses, 66 (34%) physicians, 101 (52%) females, and 81 (41%) ≤30 years. Eighty-seven percent provided direct COVID-19 care with 43% caring for >10 patients/day. A large proportion reported symptoms of depression (92, 47%), anxiety (98, 50%), and low QoL (89, 45%). Odds of combined depression and anxiety were 2.37 times higher among single HCPs compared to married (95% CI: 1.03-4.96). Work environment stressors were associated with 46% increased risk of combined depression and anxiety (95% CI: 1.15-1.85). Moderate to severe depression and anxiety were independently associated with increased risk of low QoL [OR: 3.19 (95% CI: 1.30-7.84), OR: 2.84 (95% CI: 1.29-6.29)]. CONCLUSION: Our study demonstrated a high prevalence of symptoms of depression and anxiety and low QoL among Indian HCPs during the COVID-19 pandemic. There is an urgent need to prevent and treat mental health symptoms among frontline HCPs.

The Burden of Anxiety During the COVID-19 Pandemic Among People Living with HIV (PLHIV) in Pune, India.

Introduction : There is a dearth of data on anxiety related to the COVID-19 pandemic from people living with HIV (PLHIV). This is a cause of concern as anxiety is associated with antiretroviral therapy (ART) nonadherence. Globally, India has the third largest population of PLHIV and third highest number of COVID-19 cases which are rapidly increasing. Therefore, it is crucial to understand the burden of anxiety and its sources among Asian Indian PLHIV during this pandemic. Methods: We used data from a telephonically delivered assessment among PLHIV engaged in care at a tertiary healthcare associated antiretroviral therapy (ART) center in Pune, India. Assessments were conducted between April 21 and May 28, 2020, one month into the government mandated lockdown. GAD-7 was used to assess for anxiety over two-preceding weeks. Significant sociodemographic and clinical differences between groups (GAD-7<10 and GAD-7≥10) were assessed using Fisher's exact and Wilcoxson rank sum tests, for categorical and continuous variables, respectively. Thematic analysis was employed to analyze an open-ended question that asked about the most pressing cause(s) of concern. Results : Of 167 PLHIV contacted, median age was 44 years (IQR:40 - 50), 60% (n=100) were cisgender women and 81% (n=135) had a monthly family income<200 USD. Thirty-eight percent (n=64) had prior history of tuberculosis and 27% (n=45) were living with another comorbidity. A fourth (25%, n=41) had GAD-7 scores indicative of generalized anxiety. PLHIV who had fewer remaining doses of ART had significantly higher GAD-7 scores compared to those that had more doses (p=0.05). Thematic analysis indicated that concerns were both health related and unrelated, and stated temporally. Present concerns were often also projected as future concerns. Conclusions : In a group of socioeconomically disadvantaged PLHIV, a fourth were found to have anxiety, that appeared to be influenced by concerns about ART availability. Furthermore, the persistence of sources of anxiety and therefore an increase in anxiety for these PLHIV is anticipated as the pandemic worsens in India. We recommend the regular utilization of short screening tools for anxiety to monitor and triage PLHIV as an extension of current HIV-services.