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Background: Rapid diagnostic tests (RPTs) for high-risk HPV genotypes can help triage people living with HIV (PLHIV), who are at greater risk for oral cancers especially in low-and-middle-income-countries (LMICs), that have a high burden of both HIV and oral cancers. We evaluated the utility of Xpert® HPV, a RPT for oral HPV among PLHIV. Methods: We used data from 429 PLHIV receiving care at a tertiary care hospital affiliated antiretroviral therapy center in Pune, India. Oral HPV was evaluated using oral rinse samples. Samples were classified as usable (if they were successfully processed on Xpert® HPV) or not usable (if they were not successfully processed on Xpert® HPV). Factors associated with non-usability were evaluated using logistic regression. We compared the sensitivity and specificity of the Xpert® HPV for oral samples with conventional polymerase chain reaction (PCR). Results: The Xpert® HPV deemed almost a third (29.8%) of the oral samples not usable for oral HPV detection. We were unable to identify factors associated with non-usability. Compared to conventional polymerase chain reaction (PCR), the sensitivity of Xpert® HPV was 6.2% and specificity 100%, for detection of oral HPV. Conclusions: Xpert® HPV cannot be used for the detection of oral HPV among PLHIV presently. More research to optimize Xpert® HPV for oral samples is required.

Background Despite antiretroviral therapy, chronic lung diseases remain an important source of morbidity and mortality in people with HIV (PWH). We sought to identify clinical and immunological markers of pulmonary impairment among PWH in India. Methods Two hundred ten adult PWH receiving antiretroviral therapy (ART) were prospectively evaluated for 3 years. Plasma concentrations of interleukin (IL)-6, IL-10, tumor necrosis factor alpha, D-dimer, C-reactive protein, soluble (s)CD14, and sCD163 were measured at enrollment. We used multivariable linear and logistic regression to measure the association of baseline and time-varying clinical and immunological variables with spirometry-defined chronic obstructive pulmonary disease (COPD), restrictive spirometry pattern (RSP), preserved ratio impaired spirometry (PRISm), forced expiratory volume in 1 second (FEV1), and forced vital capacity (FVC) during the third year of follow-up. Results After adjusting confounders, females were 7 times more likely to have RSP (95% CI, 2.81 to 17.62; P Conclusions Female sex, higher concentrations of IL-6 and D-dimer, and lower concentrations of IL-10 were associated with pulmonary impairment in adult PWH receiving ART in India.

Mosquitoborne diseases (e.g., malaria, dengue, and chikungunya) are endemic to India and pose diagnostic challenges during pregnancy. We evaluated an intensified short symptom screening program in India to diagnose dengue during pregnancy. During October 2017–January 2018, we screened pregnant women during antenatal surveillance for symptoms of mosquitoborne diseases (fever only, fever with conjunctivitis, fever with rash, or all 3 symptoms) within the previous 15 days. Of 5,843 pregnant women screened, 52 were enrolled and tested for dengue, chikungunya, and Zika viruses by using a Trioplex real-time reverse transcription PCR. Of 49 who had complete results, 7 (14%) were dengue positive. Of these ocular pain was seen in 4 (57%) and conjunctivitis in 7 (100%). Intensified symptom screening using conjunctivitis, in addition to rash, in pregnant women with fever might improve dengue case detection and can be included in routine symptom screening during pregnancy.

Background The number of people receiving second-line antiretroviral therapy (ART) has increased as global access to ART has expanded. Data on the burden and factors associated with second-line ART virologic failure (VF) from India remain limited. Methods We conducted cross-sectional viral load (VL) testing among adults (≥ 18 years) who were registered at a publicly funded ART center in western India between 2014 and 2015 and had received second-line ART for at least 6 months. Sociodemographic and clinical characteristics were abstracted from routinely collected programmatic data. Logistic regression evaluated factors associated with VF (defined as VL > 1000 copies/mL). Results Among 400 participants, median age was 40 years (IQR 34–44), 71% (285/400) were male, and 15% (59/400) had VF. Relative to participants without VF, those with VF had lower median CD4 counts (230 vs 406 cells/mm3, p Conclusions We found second-line VF in about a sixth of participants in our setting, which was associated with nearly fivefold increased odds in the context of opportunistic infection. Weight could be a useful clinical indicator for second-line VF.

Background: In India, smokeless tobacco (SLT) is a predominant form of tobacco used among people living with HIV (PLHIV). Despite SLT being a risk factor for oral potentially malignant disorders (OPMDs), no prior studies have quantified the association of OPMDs with SLT use among PLHIV. This limits the planning of preventive and control strategies for oral cancer among PLHIV, who are at higher risk for the disease. Methods: We enrolled 601 PLHIV and 633 HIV-uninfected individuals in an oral cancer screening study at BJ Government Medical College, Pune, India. Oral cavity images were collected using an m-Health application and reviewed by three clinicians. Participants with two clinician positive diagnoses were deemed to have suspected OPMDs. Prevalence ratios (PRs) were used to quantify the association between suspected OPMDs and SLT use among PLHIV. PRs for current SLT users, across HIV status and use duration were also estimated. Corrected PRs were obtained by modifying the maximum likelihood estimation. Models were adjusted for age, smoking, alcohol use and CD4 counts. Findings: Of those enrolled, 61% were men, median age was 36 years (IQR: 28-44), and 33% currently use SLT. Proportion of current SLT users was similar across PLHIV and HIV-uninfected groups but use duration for current SLT use was higher among PLHIV(p

Background Diabetes prevalence in HIV is not well characterized for India, despite the high burden of both individual diseases. Epidemiology of insulin resistance (IR): a precursor to diabetes, and its associated risk factors are also poorly understood in Asian Indian people living with HIV (PLHIV). We assessed the prevalence of diabetes and IR in Pune, India and the associated risk factors for IR. Methods Cross-sectional analysis of adult (≥18 years) PLHIV receiving care at Byramjee Jeejeebhoy Government Medical College and Sassoon General Hospitals, Pune, India (BJGMC- SGH). Proportions and medians of PLHIV characteristics by diabetes status and IR were described. Homeostatic Model Assessment (HOMA) index value ≥2 was used to define IR. Line of least squares assessed the relationship between IR and hyperinsulinemia. Association between sociodemographic, clinical factors with IR was determined using logistic regression. Results Of 485 enrollees, 47% were men, median age was 40 years (IQR: 35–46), median CD4 counts were 389 cells/mm3 (246–609). Thirty-five percent were centrally obese, 75% were adherent to WHO recommended physical activity guidelines. Prevalence of diabetes, prediabetes, IR were 9%, 16% and 38%, respectively. Twenty-nine percent non-diabetics had IR and it occurred much prior to the threshold for hyperinsulinemia. IR was associated with the use of ART drugs (OR: 6.6, 95% CI: 2.9–15.2 and 5.4, 95% CI: 2.2–13.6 for first- and second line ART respectively) and central obesity (OR:1.9, 95% CI: 1.1–3.4). Conclusions One fourth of the study population was diabetic or prediabetic and more than a third had IR. Better understanding of diabetes disease progression in relation to IR and the effect of physical activity on central obesity among Asian Indian PLHIV is mandated.

People living with HIV have greater diabetes (T2DM) than the general population despite lower prevalence of overweight/obesity. Both insulin resistance (IR), a T2DM precursor, and HIV are independently associated with chronic inflammation. Inflammation may be a pathophysiological link explaining IR in people living with HIV who are not overweight but is not well understood.To study the association between inflammation and IR in non-overweight and overweight people living with HIV.In a cohort of adult people living with HIV with undetectable viral load in Pune, India, we measured fasting insulin, glucose, and 9 inflammatory markers. IR was defined as HOMA-IR ≥2, and non-overweight as BMI ≤23 kg/mOf 288 participants, 66% (n = 189) were non-overweight. Among non-overweight, prevalence of IR was 34% (n = 65). Each doubling of MCP-1 and leptin was associated with IR on univariate analysis (prevalence ratio (PR) 1.29, 95%CI 1.07-1.53, p 0.01; PR 1.13 95%CI 1.01-1.26, p = 0.03). Leptin remained associated with IR after adjustment for age, MCP-1, gender, cholesterol, and waist circumference (adjusted PR 1.20 95%CI 1.06-1.36, p 0.01). Among overweight, prevalence of IR was 69% and no markers were associated with IR.One in 3 non-overweight people living with HIV in India with controlled viremia have IR. Leptin was associated with IR among non-overweight people living with HIV and may provide insight into the pathophysiology of metabolic disease in this population.

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., In this cross‐sectional survey of 204 Health Care Professionals (HCPs) from 13 states of India we found a high burden of depression and anxiety among young, unmarried HCPs serving COVID‐19 patients. Further, we found that mental health distress negatively impacted overall quality of life. In countries like India where COVID‐19 is rapidly spreading, there is an urgent need to safeguard the mental health of HCPs.

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-7Results: 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 incomeConclusions: 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.

Introduction Tuberculous meningitis (TBM) results in significant morbidity and mortality among children worldwide. Associated neurocognitive complications are common but not well characterized. The Mullen Scales of Early Learning (MSEL), a well-established measure for assessment of neurodevelopment, has not yet been adapted for use in India. This study’s goal was to adapt the MSEL for local language and culture to assess neurocognition among children in India, and apply the adapted measure for assessment of children with TBM. Methods Administration of MSEL domains was culturally adapted. Robust translation procedures for instructions took place for three local languages: Marathi, Hindi and Tamil. Multilingual staff compared instructions against the original version for accuracy. The MSEL stimuli and instructions were reviewed by psychologists and pediatricians in India to identify items concerning for cultural bias. Results MSEL stimuli unfamiliar to children in this setting were identified and modified within Visual Reception, Fine-Motor, Receptive Language and Expressive Language Scales. Item category was maintained for adaptations of items visually or linguistically different from those observed in daily life. Adjusted items were administered to six typically developing children to determine modification utility. Two children diagnosed with confirmed TBM (ages 11 and 29 months) were evaluated with the adapted MSEL before receiving study medications. Skills were below age-expectation across visual reception, fine motor and expressive language domains. Conclusions This is the first study to assess children with TBM using the MSEL adapted for use in India. Future studies in larger groups of Indian children are warranted to validate the adapted measure.

Test and treat is the current global standard, yet sex differences persist in access to HIV care. We assessed the differences in presentation and antiretroviral therapy (ART) uptake by sex and ART-eligibility period among ART-naive adults registered at a public ART center in India. Four ART eligibility periods were defined by programmatically determined CD4 criteria (periods I-IV: CD4

Delayed presentation to care of perinatally infected children in India is a hindrance to achieving the “end pediatric HIV by 2020” goal. We describe the prevalence, risk factors and temporal trends of delayed presentation to care among them. Programmatic data of perinatally infected antiretroviral therapy (ART) - naïve children of Byramjee Jeejeebhoy Government Medical College (BJGMC) and Sassoon General Hospitals’ (SGH) ART center, Pune, India from 2006 to 2016 was used. Children with WHO categories for moderate and severe immunodeficiency were classified as delayed presenters. Multivariable logistic regression was used to identify risk factors for delayed presentation. Of 269 children with available CD4 count registered for care, median age at presentation was 4 years (IQR: 3 – 6 years), 53% were male and 76% registered for care after 2009. Prevalence of delayed presentation was 52% (95% Confidence Interval 46% −58%). In multivariable models adjusted for age, sex and domicile distance, unit increase in age was inversely associated with delayed presentation (OR: 0.8, 95% CI: 0.7 – 0.9). Domicile distance ≥ 20km from the ART center was also associated with delayed presentation (OR: 2.2, 95% CI: 1.02 – 4.7). Median age at presentation increased over time (p

Background Programmatic data on the baseline risk of tuberculosis in people living with HIV (PLHIV) are needed to evaluate long-term effectiveness of the ongoing isoniazid preventive therapy (IPT) roll-out in India. Methods We estimated the incidence rate and risk factors of tuberculosis disease in adult PLHIV initiating first- and second-line anti-retroviral therapy (ART) prior to widespread IPT in a public ART center in Pune, India. Results 4067 participants contributing 5205.7 person-years of follow-up on first-line ART and 871 participants contributing 1031.7 person-years of follow-up on second-line ART were included in the analysis. The incidence rate of tuberculosis was 4.39 cases (95%CI 3.86–5.00) per 100 person-years on first-line ART and 1.64 cases (95%CI 1.01–2.63) per 100 person-years on second-line ART (p p = 0.03), urban residence (aSHR = 1.53, 95%CI 1.13–2.07, p = 0.006) and CD4+ counts 3 (aSHR = 3.06 vs CD4 > 350 cells/mm3, 95%CI 1.58–5.94, p Conclusion Risk of tuberculosis was lower in PLHIV receiving second-line ART compared to first-line ART. Prioritizing IPT in PLHIV with low CD4+ counts, urban residence and in males may further mitigate the risk of tuberculosis during ART.

OBJECTIVES India has the highest number of HIV-infected adolescents in Asia, but little is known about their treatment outcomes. We assessed rates and factors associated with loss to follow-up (LTFU) and mortality among Indian adolescents. METHODS The analysis included adolescents (10-19 years old) starting antiretroviral therapy (ART) between 2005 and 2014 at BJ Government Medical College, Pune, India. LTFU was defined as missing more than three consecutive monthly visits. The competing-risks method was used to calculate subdistribution hazard ratios (SHRs) of predictors for LTFU, with death as the competing risk. Cox proportional hazard models were used to identify predictors of mortality. RESULTS Of 717 adolescents starting ART, 402 with complete data were included in the analysis. Of these, 61% were male and 80% were perinatally infected, and the median baseline CD4 count was 174 cells/μL. LTFU and mortality rates were 4.4 and 4.9/100-person years, respectively. Cumulative LTFU incidence increased from 6% to 15% over 6 years. Age ≥ 15 years [adjusted SHR (aSHR) 2.44; 95% confidence interval (CI) 1.18-5.02] was a risk factor for LTFU. Cumulative mortality increased from 9.5% to 17.9% over 6 years. World Health Organization (WHO) stages III and IV [adjusted hazard ratio (aHR) 2.26; 95% CI: 1.14-4.48] and an increase in CD4 count by 100 cells/μL (aHR: 0.59; 95% CI: 0.43-0.83) were associated with mortality. CONCLUSIONS A third of adolescents had been lost to follow-up or died by follow-up year 6. Older age was a risk factor for LTFU and advanced clinical disease for death. Strategies to improve retention counselling for older adolescents and closer clinical monitoring of all adolescents must be considered.

We measured hair and plasma concentrations of isoniazid among sixteen children with tuberculosis who underwent personal or video-assisted directly observed therapy and thus had 100% adherence. This study therefore defined typical isoniazid exposure parameters after two months of treatment among fully-adherent patients in both hair and plasma (plasma area under the concentration-time curve, AUC, estimated using pharmacokinetic data collected 0, 2, 4, and 6 hours after drug administration). We found that INH levels in hair among highly-adherent individuals did not correlate well with plasma AUC or trough concentrations, suggesting that each measure may provide incremental and complementary information regarding drug exposure in the context of TB treatment.

Effective guidelines around disclosure of HIV status are lacking and limited data from India reveal low rates of HIV disclosure to perinatally infected children. This study, conducted in Pune, India, attempts to understand the experiences of caregivers of perinatally infected children around the HIV disclosure process. We interviewed 98 caregivers whose children were receiving care at the ART clinic of a large government hospital. Caregivers report that 23% of HIV+ children had been told of their HIV status. Older caregivers had higher odds of disclosure as well as those who were widowed, had limited formal education, and who worked as maids/servants. Older children (14 years+) had higher odds of being disclosed to. Major themes from qualitative data included uncertainty among caregivers about disclosure, concerns about the child's well-being after disclosure, and an overall lack of guidance around disclosure. Significant concerns related to perceived and experienced stigma and discrimination as well as the child's marital future contributed to caregivers' willingness to disclose. There is need for the development and testing of behavioural interventions in India to guide health care workers and caregivers in appropriate disclosure to HIV-infected children, with the ultimate goal of informing national guidelines for pediatric HIV disclosure in resource poor settings.

Background Diabetes mellitus (DM) increases tuberculosis (TB) risk, and there is increasing concern over the public health implications of the convergence of these two epidemics. Screening for TB among people with DM is now recommended in India. Methods People with DM seeking care at a large public sector tertiary care hospital clinic in Pune, India, were screened for TB from June 2015 to May 2016. All consenting people with DM were screened for TB at each clinic visit using a five-item, WHO-recommended questionnaire and those with TB symptoms and/or risk factors were tested for active TB using sputum smear microscopty, Xpert® MTB/RIF and TB culture. Categorical data and continuous variables were summarized using descriptive statistics. The x 2 test or Wilcoxon rank-sum test was used to ascertain significant associations between categorical and continuous variables, respectively. Results Among 630 adults approached for screening, median age was 60 (interquartile range (IQR), 57–64) years and 350 (56%) were females. Median hemoglobin A1c (HbA1c) was 8.7% (IQR, 6.7–9.9) and 444 (70.5%) were poorly controlled DM (HbA1c > 7). Forty-four (7%) had prior history of TB but the proportion with TB risk factors at screening was low (

Assessing treatment adherence and quantifying exposure to anti-tuberculosis drugs among children is challenging. We undertook a 'proof of concept' study to assess the drug concentrations of isoniazid (INH) in hair as a therapeutic drug monitoring tool. Children aged