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Background: Isoniazid preventive therapy (IPT) has been shown to reduce the risk of tuberculosis (TB) among people living with HIV (PLHIV). In 2017, India began a nationwide roll-out of IPT, but there is a lack of evidence on the implementation and the challenges. Objectives: Among PLHIV newly initiated on antiretroviral therapy (ART) from January 2017 to June 2018, to: (i) assess the proportion who started and completed IPT and (ii) explore reasons for non-initiation and non-completion from health-care providers' and patients' perspectives. Methods: An explanatory mixed-methods study was conducted in two selected districts of Karnataka, South India. A quantitative phase (cohort analysis of routinely collected program data) was followed by a qualitative phase involving thematic analysis of in-depth interviews with providers (n = 22) and patients (n = 8). Results: Of the 4020 included PLHIV, 3780 (94%) were eligible for IPT, of whom, 1496 (40%, 95% CI: 38%-41%) were initiated on IPT. Among those initiated, 423 (28.3%) were still on IPT at the time of analysis. Among 1073 patients with declared IPT outcomes 870 (81%, 95% CI: 79%-83%) had completed the six-month course of IPT. The main reason for IPT non-initiation and non-completion was frequent drug stock-outs. This required health-care providers to restrict IPT initiation in selected patient subgroups and earmark six-monthly courses for each patient to ensure that, once started, treatment was not interrupted. The other reasons for non-completion were adverse drug effects and loss to follow-up. Conclusion: The combined picture of 'low IPT initiation and high completion' seen in our study mirrors findings from other countries. Drug stock-out was the key challenge, which obliged health-care providers to prioritize 'IPT completion' over 'IPT initiation'. There is an urgent need to improve the procurement and supply chain management of isoniazid. [ABSTRACT FROM AUTHOR]

Background: In March 2018, the Government of India launched a direct benefit transfer (DBT) scheme to provide nutritional support for all tuberculosis (TB) patients in line with END TB strategy. Here, the money (@INR 500 [~8 USD] per month) is deposited electronically into the bank accounts of beneficiaries. To avail the benefit, patients are to be notified in NIKSHAY (web-based notification portal of India's national TB programme) and provide bank account details. Once these details are entered into NIKSHAY, checked and approved by the TB programme officials, it is sent to the public financial management system (PFMS) portal for further processing and payment. Objectives: To assess the coverage and implementation barriers of DBT among TB patients notified during April–June 2018 and residing in Dakshina Kannada, a district in South India. Methods: This was a convergent mixed-methods study involving cohort analysis of patient data from NIKSHAY and thematic analysis of in-depth interviews of providers and patients. Results: Of 417 patients, 208 (49.9%) received approvals for payment by PFMS and 119 (28.7%) got paid by 1 December 2018 (censor date). Reasons for not receiving DBT included (i) not having a bank account especially among migrant labourers in urban areas, (ii) refusal to avail DBT by rich patients and those with confidentiality concerns, (iii) lack of knowledge and (iv) perception that money was too little to meet the needs. The median (IQR) delay from diagnosis to payment was 101 (67–173) days. Delays were related to the complexity of processes requiring multiple layers of approval and paper-based documentation which overburdened the staff, bulk processing once-a-month and technological challenges (poor connectivity and issues related to NIKSHAY and PFMS portals). Conclusion: DBT coverage was low and there were substantial delays. Implementation barriers need to be addressed urgently to improve uptake and efficiency. The TB programme has begun to take action. [ABSTRACT FROM AUTHOR]

Background: In India, a new care package consisting of (i) daily regimen with fixed-dose combination drugs, collected once-a-month and self-administered by the patient, (ii) 'one stop service' at antiretroviral treatment (ART) centre for both HIV and tuberculosis (TB) treatment and (iii) technology-enabled adherence support (99DOTS, which required patients to give a missed phone call after consuming drugs) was piloted for treatment of TB among HIV-infected TB patients. Conventional care included intermittent regimen (drugs consumed thrice-weekly) delivered under direct observation of treatment supporter and the patients needing to visit TB and HIV care facilities, separately for treatment. Objective: To assess the effect of new care package on TB treatment outcomes among HIV-TB patients registered during January–December 2016, as compared to conventional care and explore the implementation challenges. Methods: A mixed-methods study was conducted in four districts of Karnataka, India where new care package was piloted in few ART centres while the rest provided conventional care. Quantitative component involved a secondary cohort analysis of routine programme data. Adjusted relative risk(aRR) was calculated using Poisson regression to measure association between new care package and unsuccessful treatment outcome. We conducted in-depth interviews with healthcare providers and patients to understand the challenges. Results: Unsuccessful TB treatment outcomes (death, loss to follow-up and failure) were higher in new care package (n = 871) compared to conventional care (n = 961) (30.5% vs 23.4%; P value<0.001) and aRR was 1.3(95% CI: 1.1–1.7). Key challenges included patients' inability to give missed call, increased work load for ART staff, reduced patient–provider interaction, deficiencies in training and lack of role clarity among providers and reduced involvement of TB program staff. Conclusion: With new care package, TB treatment outcomes did not improve as expected and conversely declined compared to conventional care. TB and HIV programs need to address the operational challenges to improve the outcomes. [ABSTRACT FROM AUTHOR]

Background: The national tuberculosis (TB) programme in India recommends screening all pregnant women for TB, but this is rarely implemented. We carried out systematic TB screening among women attending the antenatal clinic of a tertiary care hospital in Puducherry, South India, during February to April 2018. Objective: To assess the number screened and number (proportion) with presumptive and active TB, and understand potential implementation from the healthcare providers' perspective. Methods: We conducted a mixed-methods study. The quantitative phase was a cross-sectional study including 4203 pregnant women. Data were captured using a structured proforma. Any of the following symptoms constituted 'presumptive TB': any cough, haemoptysis, fever, weight loss, night sweats, neck swellings, joint pains, neck stiffness and disorientation. Those screening positive were referred for investigations and evaluation by a chest physician. The qualitative phase involved seven one-to-one interviews with healthcare providers. Manual thematic analysis was performed to generate themes. Results: Among 4203 women (two HIV-positive) screened, 77 (1.8%) had presumptive TB. Cough was the predominant symptom (n = 75). Only 12 women could produce a sputum sample, of whom one (0.02%) was diagnosed with active TB by the Xpert MTB/RIF assay. Challenges cited by healthcare providers were lack of awareness among clients and providers, high case load, lack of dedicated staff, perception that TB screening is a low-yield, low-priority activity and losses in the referral process. Suggested solutions were providing dedicated staff and space for screening, educating women to self-report using posters and videos, and creating a one-stop care provision. Conclusions: The TB yield among pregnant women was very low, calling into question the value of systematic screening in a low-HIV setting. However, the findings may not be generalizable. Evidence is urgently needed from primary and secondary care facilities. The challenges and solutions identified may help in optimizing the screening process. [ABSTRACT FROM AUTHOR]

Background: In 2016, the National AIDS Control Programme (NACP) in Gujarat, India implemented an innovative intervention called 'M-TRACK' (mobile phone reminders once every week for four weeks after diagnosis and electronic patient tracking tool) to reduce pre-treatment loss to follow-up (LFU) among people living with HIV (PLHIV) in Vadodara district while other districts received standard of care. Objectives: To assess the effectiveness of M-TRACK in reducing pre-treatment LFU (proportion of diagnosed PLHIV not registering for HIV care by four weeks after diagnosis) and to explore the implementation enablers and challenges from health care providers' and PLHIV perspective. Methods: An explanatory mixed-methods study design was used wherein the quantitative phase (cohort study with two groups: Vadodara district exposed to M-TRACK and Rajkot district as unexposed) was followed by a qualitative phase (descriptive study involving group interview with 16 health care providers, personal interviews with two programme managers and telephonic interviews with 16 PLHIV). Data were collected during October 2016 to February 2017. Results: During the pre-M-TRACK period (July-September 2016), the LFU proportion was similar [13% (25/191) in Vadodara; 15% (21/141) in Rajkot (p = 0.8)]. During the M-TRACK period (October-December 2016), LFU decreased to 4% (9/209) in Vadodara (exposed), whereas it remained similar at 16% (18/113) in Rajkot (unexposed) district (p = 0.02). PLHIV exposed to M-TRACK had an 80% lower risk of LFU (aRR 0.2; 95% CI: 0.1-0.5) compared with standard care, after adjusting for socio-demographics, time and clustering at district level. During interviews, M-TRACK was welcomed by both PLHIV and the counsellors. The latter felt it saved time by obviating the need for home visits and helped in documentation. Inconvenience of using landline phone available at the health facility, lack of budgets for reimbursement of mobile call expenses and internet connectivity problems were the key implementation challenges. Conclusion: M-TRACK was highly effective in reducing the gap between diagnosis and treatment. It may be considered for scale-up after addressing the challenges noted. [ABSTRACT FROM AUTHOR]

Background: The Global Fund encourages operational research (OR) in all its grants; however very few reports describe this aspect. In India, Project Axshya was supported by a Global Fund grant to improve the reach and visibility of the government Tuberculosis (TB) services among marginalised and vulnerable communities. OR was incorporated to build research capacity of professionals working with the national TB programme and to generate evidence to inform policies and practices. Objectives: To describe how Project Axshya facilitated building OR capacity within the country, helped in addressing several TB control priority research questions, documented project activities and their outcomes, and influenced policy and practice. Methods: From September 2010 to September 2016, three key OR-related activities were implemented. First, practical output-oriented modular training courses were conducted (n = 3) to build research capacity of personnel involved in the TB programme, co-facilitated by The Union, in collaboration with the national TB programme, WHO country office and CDC, Atlanta. Second, two large-scale Knowledge, Attitude and Practice (KAP) surveys were conducted at baseline and mid-project to assess the changes pertaining to TB knowledge, attitudes and practices among the general population, TB patients and health care providers over the project period. Third, studies were conducted to describe the project's core activities and outcomes. Results: In the training courses, 44 participant teams were supported to develop research protocols on topics of national priority, resulting in 28 peer-reviewed scientific publications. The KAP surveys and description of project activities resulted in 14 peer-reviewed publications. Of the published papers at least 12 have influenced change in policy or practice. Conclusions: OR within a Global Fund supported TB project has resulted in building OR capacity, facilitating research in areas of national priority and influencing policy and practice. We believe this experience will provide guidance for undertaking OR in Global Fund projects. [ABSTRACT FROM AUTHOR]

Background: A large state-wide tobacco survey was conducted using modified version of pretested, globally validated Global Adult Tobacco Survey (GATS) questionnaire in 2015–22016 in Tamil Nadu, India. Due to resource constrains, data collection was carrid out using paper-based questionnaires (unlike the GATS-India, 2009–2010, which used hand-held computer devices) while data entry was done using open access tools. The objective of this paper is to describe the process of data entry and assess its quality assurance and efficiency. Methods: In EpiData language, a variable is referred to as ‘field’ and a questionnaire (set of fields) as ‘record’. EpiData software was used for double data entry with adequate checks followed by validation. Teamviewer was used for remote training and trouble shooting. The EpiData databases (one each for each district and each zone in Chennai city) were housed in shared Dropbox folders, which enabled secure sharing of files and automatic back-up. Each database for a district/zone had separate file for data entry of household level and individual level questionnaire. Results: Of 32,945 households, there were 111,363 individuals aged ≥15 years. The average proportion of records with data entry errors for a district/zone in household level and individual level file was 4% and 24%, respectively. These are the errors that would have gone unnoticed if single entry was used.The median (inter-quartile range) time taken for double data entry for a single household level and individual level questionnaire was 30 (24, 40) s and 86 (64, 126) s, respectively. Conclusion: Efficient and quality-assured near-real-time data entry in a large sub-national tobacco survey was performed using innovative, resource-efficient use of open access tools. [ABSTRACT FROM PUBLISHER]

Background : Community-based active case finding (ACF) for tuberculosis (TB) implemented among marginalised and vulnerable populations in 285 districts of India resulted in reduction of diagnosis delay and prevalence of catastrophic costs due to TB diagnosis. We were interested to know whether this translated into improved treatment outcomes. Globally, there is limited published literature from marginalised and vulnerable populations on the independent effect of community-based ACF on treatment outcomes when compared to passive case finding (PCF). Objectives : To determine the relative differences in unfavourable treatment outcomes (death, loss-to-follow-up, failure, not evaluated) of ACF and PCF-diagnosed people. Methods : Cohort study involving record reviews and interviews in 18 randomly selected districts. We enrolled all ACF-diagnosed people with new smear-positive pulmonary TB, registered under the national TB programme between March 2016 and February 2017, and an equal number of randomly selected PCF-diagnosed people in the same settings. We used log binomial models to adjust for confounders. Results : Of 572 enrolled, 275 belonged to the ACF and 297 to the PCF group. The proportion of unfavourable outcomes were 10.2% (95% CI: 7.1%, 14.3%) in the ACF and 12.5% (95% CI: 9.2%, 16.7%) in the PCF group (p = 0.468). The association between ACF and unfavourable outcomes remained non-significant after adjusting for confounders available from records [aRR: 0.83 (95% CI: 0.56, 1.21)]. Due to patient non-availability at their residence, interviews were conducted for 465 (81.3%). In the 465 cohort too, there was no association after adjusting for confounders from records and interviews [aRR: 1.05 (95% CI: 0.62, 1.77)]. Conclusion : We did not find significant differences in the treatment outcomes. Due to the wide CIs, studies with larger sample sizes are urgently required. Studies are required to understand how to translate the benefits of ACF to improved treatment outcomes.

Background: There is limited evidence on whether active case finding (ACF) among marginalised and vulnerable populations mitigates the financial burden during tuberculosis (TB) diagnosis., Objectives: To determine the effect of ACF among marginalised and vulnerable populations on prevalence and inequity of catastrophic costs due to TB diagnosis among TB-affected households when compared with passive case finding (PCF)., Methods: In 18 randomly sampled ACF districts in India, during March 2016 to February 2017, we enrolled all new sputum-smear-positive TB patients detected through ACF and an equal number of randomly selected patients detected through PCF. Direct (medical and non-medical) and indirect costs due to TB diagnosis were collected through patient interviews at their residence. We defined costs due to TB diagnosis as 'catastrophic' if the total costs (direct and indirect) due to TB diagnosis exceeded 20% of annual pre-TB household income. We used concentration curves and indices to assess the extent of inequity., Results: When compared with patients detected through PCF (n = 231), ACF patients (n = 234) incurred lower median total costs (US$ 4.6 and 20.4, p < 0.001). The prevalence of catastrophic costs in ACF and PCF was 10.3 and 11.5% respectively. Adjusted analysis showed that patients detected through ACF had a 32% lower prevalence of catastrophic costs relative to PCF [adjusted prevalence ratio (95% CI): 0.68 (0.69, 0.97)]. The concentration indices (95% CI) for total costs in both ACF [-0.15 (-0.32, 0.11)] and PCF [-0.06 (-0.20, 0.08)] were not significantly different from the line of equality and each other. The concentration indices (95% CI) for catastrophic costs in both ACF [-0.60 (-0.81, -0.39)] and PCF [-0.58 (-0.78, -0.38)] were not significantly different from each other: however, both the curves had a significant distribution among the poorest quintiles., Conclusion: ACF among marginalised and vulnerable populations reduced total costs and prevalence of catastrophic costs due to TB diagnosis, but could not address inequity.

Background: Management of multidrug-resistant TB (MDR-TB) patients co-infected with human immunodeficiency virus (HIV) is highly challenging. Such patients are subject to long and potentially toxic treatments and may develop a number of different psychiatric illnesses such as anxiety and depressive disorders. A mental health assessment before MDR-TB treatment initiation may assist in early diagnosis and better management of psychiatric illnesses in patients already having two stigmatising and debilitating diseases., Objective: To address limited evidence on the baseline psychiatric conditions of HIV-infected MDR-TB patients, we aimed to document the levels of depressive symptoms at baseline, and any alteration following individualized clinical and psychological support during MDR-TB therapy, using the Patient Health Questionnaire-9 (PHQ-9) tool, among HIV-infected patients., Design: This was a retrospective review of the medical records of an adult (aged >15 years) HIV/MDR-TB cohort registered for care during the period of August 2012 through to March 2014., Results: A total of 45 HIV/MDR-TB patients underwent baseline assessment using the PHQ-9 tool, and seven (16%) were found to have depressive symptoms. Of these, four patients had moderate to severe depressive symptoms. Individualized psychological and clinical support was administered to these patients. Reassessments were carried out for all patients after 3 months of follow-up, except one, who died during the period. Among these 44 patients, three with baseline depressive symptoms still had depressive symptoms. However, improvements were observed in all but one after 3 months of follow-up., Conclusion: Psychiatric illnesses, including depressive symptoms, during MDR-TB treatment demand attention. Routine administration of baseline mental health assessments by trained staff has the potential to assist in determining appropriate measures for the management of depressive symptoms during MDR-TB treatment, and help in improving overall treatment outcomes. We recommend regular monitoring of mental health status by trained counsellors or clinical staff, using simple, validated and cost-effective tools.