Averting catastrophic tuberculosis costs in an Indian state: integration of Ayushman Bharat Arogya Karnataka with National Tuberculosis Elimination Program.

The WHO's "End TB" initiative aims to reduce catastrophic expenses, incidence, and mortality by 90%, 80%, and 0%, respectively by 2030 and Government of India has committed to reaching these goals by 2025. Despite tremendous progress, tuberculosis (TB) remains one of the main public health issues. To limit TB transmission and expedite reduction in incidence, further measures are needed. These milestones and objectives remain aspirational until we achieve "Universal access" to high-quality TB diagnosis and treatment. The goals of the study include outlining the process of 'Ayushman Bharat-Pradhan Mantri Jan Arogya Yojana-Arogya Karnataka' (AB-PMJAY-ArK) integration with the National TB Elimination Program (NTEP) in Karnataka, the types of TB patients who used AB-PMJAY-ArK services, and calculating the cost per TB patient at primary, secondary, and tertiary healthcare facilities, both public and private, stratified by type of service. Increased coverage, elimination of treatment delays, early and free treatment, and prevention of missing patients are benefits of integrating NTEP with Ayushman Bharat-PMJAY.

Tuberculosis screening for pediatric household contacts in India: Time to adapt newer strategies under the National TB Elimination Programme!

INTRODUCTION: The study aimed to evaluate the effectiveness of screening pediatric household contacts (under the age of 15 years) for tuberculosis (TB) in India through verbal screening, tuberculin skin testing, and chest radiography at intervals of 0, 3, 6, 9, and 12 months. The study also aimed to determine the proportion of contacts who tested positive for TB and to describe the challenges in implementing regular follow-up. Current National TB Elimination Programme (NTEP) guidelines only require verbal screening for contacts under 6 years old at TB treatment initiation. The study aimed to fill this knowledge gap and provide valuable insights for improving TB screening in pediatric household contacts in India. METHODS: The study was conducted in two districts of Karnataka, India from 2021 to 2022, and utilized a cohort study design to enroll contacts of index tuberculosis (TB) cases diagnosed under the National TB Elimination Programme (NTEP). Participants were followed up at regular intervals for one year to evaluate the effectiveness of TB screening in pediatric household contacts. RESULTS: In this study, 686 pediatric household contacts were enrolled and screened for tuberculosis (TB) using verbal symptom screening, tuberculin skin testing (TST), and chest radiography. Projected figures estimated that 0.8%, 42%, and 4% of contacts would test positive for symptomatic screening, TST, and chest radiography, respectively. TB cases were detected in 2.91% (1.84-4.38) of contacts, with females above 6 years of age having a 22% higher risk of contracting the infection than males above 6 to < 15 years. However, not all cases were subjected to TST and chest radiography. The primary reason for not investigating child contact for TB was their reported healthy or asymptomatic status. CONCLUSION: The implementation of regular screening intervals for tuberculin skin test (TST) and chest radiography, along with verbal screening, among pediatric household contacts under the age of 15 years seems to be beneficial for the National TB Elimination Programme (NTEP), despite the challenges faced during implementation. Innovative strategies should be explored by NTEP to ensure effective implementation.

Screening for Severe Illness at Diagnosis Has the Potential to Prevent Early TB Deaths: Programmatic Experience From Karnataka, India.

Due to the coronavirus disease (COVID-19) pandemic and its associated response, TB deaths increased for the first time in a decade. In any potentially fatal illness, an assessment of severity is essential. This is not systematically done for adults with TB, mostly due to a lack of policy and/or limited availability of diagnostic and clinical capacity. We developed a screening tool using simple and easily measurable indicators that can be used by paramedical TB program staff to quickly identify people with severe illness. During October-November 2020 in Karnataka, India, the paramedical program staff from 16 districts screened people with TB (aged ≥15 years) notified by public facilities for "high risk of severe illness," which was defined as the presence of any of the following indicators: (1) body mass index (BMI) ≤14.0 kg/m2; (2) BMI ≤16.0 kg/m2 with bilateral leg swelling; (3) respiratory rate >24/minute; (4) oxygen saturation <94%; (5) inability to stand without support. In this cohort study, we determined the incidence of program-recorded early deaths (within 2 months) and its association with high risk of severe illness. Of 3,010 people with TB, 1,529 (50.8%) were screened at diagnosis/notification, of whom 537 (35.1%) had a high risk of severe illness. There were 195 (6.5%, 95% CI=5.7, 7.4) early deaths: 59 (30.2%) within a week and 100 (51.3%) within 2 weeks of treatment initiation. The incidence of early deaths was significantly higher among those with high risk of severe illness (8.9%) at diagnosis compared to those without (3.8%) [adjusted relative risk: 2.36 (95% confidence interval=1.57, 3.55)]. To conclude, early deaths were especially high during the first 2 weeks and strongly associated with a high risk of severe illness at diagnosis/notification. Screening for severe illness should be explored as a potential strategy to end TB deaths.

Challenges Perceived by Health Care Providers for Implementation of Contact Screening and Isoniazid Chemoprophylaxis in Karnataka, India.

Background: In India, challenges in pediatric TB contact screening and chemoprophylaxis initiation are still underexplored. Elucidating these challenges will help in better implementation of the programme at the grass-roots level thereby helping in early detection of pediatric cases and timely initiation of preventive therapy. This study aimed at exploring the challenges faced by the health care provider in contact screening and chemoprophylaxis initiation implementation of the pediatric household contacts. Methods: A qualitative study was conducted in the districts of Bengaluru and Udupi and in-depth interviews of key participants were adopted to explore the challenges. Qualitative data analysis was done after developing transcripts by generating themes and codes. Results: The key challenges were identified as stigma towards the disease, migrant patients with changing address, difficulty in sample collection, anxiety among parents due to long duration of the prophylactic treatment and adherence to IPT is not well documented, inadequate transportation from rural areas, and the ongoing COVID-19 pandemic. Conclusions: It is important for the National TB programme to address these challenges efficiently and effectively. Innovative solutions, feasible engagements, and massive efforts are to be taken by the programme to improve contact screening and isoniazid chemoprophylaxis implementation.

Screening People with Tuberculosis for High Risk of Severe Illness at Notification: Programmatic Experience from Karnataka, India.

Due to limited availability of diagnostics and capacity, people with tuberculosis do not always undergo systematic assessment for severe illness (requiring inpatient care). In Karnataka (south India), para-medical programme staff used a screening tool to identify people at 'high risk of severe illness', defined using indicators of very severe undernutrition, abnormal vital signs and poor performance status (any one): (i) body mass index (BMI) ≤ 14.0 kg/m2 (ii) BMI ≤ 16.0 kg/m2 with bilateral leg swelling (iii) respiratory rate > 24/min (iv) oxygen saturation < 94% (v) inability to stand without support. Of 3020 adults notified from public facilities (15 October to 30 November 2020) in 16 districts, 1531 (51%) were screened (district-wise range: 13-90%) and of them, 538 (35%) were classified as 'high risk of severe illness'. Short median delays in screening from notification (five days), and all five indicators being collected for 88% of patients, suggests the feasibility of using this tool in programme settings. However, districts with poor screening coverage require further attention. To end tuberculosis deaths, screening should be followed by referral to higher facilities for comprehensive clinical evaluation, to assess the need for inpatient care. Future studies should assess the validity (especially sensitivity in picking severely ill patients) of this screening tool.

An exploration of the oral health beliefs and behaviors of people living with HIV in Mangalore, India: a qualitative study.

INTRODUCTION: People living with HIV (PLWHIV) have increased oral healthcare needs due to an increase in the prevalence of oral and dental diseases. Their oral health is influenced by psychosocial, behavioral and biologic factors. The aim of this study was to explore and obtain a deeper understanding of the oral health beliefs and behaviors of PLWHIV that could potentially affect their oral health. METHODS: We have used the Health Belief Model (HBM) and qualitative methods using in-depth interviews with 16 PLWHIV. Content analysis of the transcribed data was done. The data was grouped under the constructs of the HBM. FINDINGS: The perceived susceptibility to oral diseases and awareness on the importance of good oral health was low. Regular tooth brushing and traditional methods for oral hygiene maintenance were considered beneficial. Regular dental visits were not considered important. Psychosocial issues, time and financial constraints were the barriers. Participants believed that information on oral health should be provided by the health providers in hospitals and dental clinics.  CONCLUSION: The findings on the oral health beliefs and behaviors support the need for education on oral health and preventive healthcare practices among PLWHIV. Oral health promotion should include behavioral change as one of its components.

Does provision of cash incentive to HIV-infected tuberculosis patients improve the treatment success in programme settings? A cohort study from South India.

BACKGROUND: In April 2018, the Government of India launched 'Nikshay Poshan Yojana' (NPY), a cash assistance scheme (500 Indian rupees [~8 USD] per month) intended to provide nutritional support and improve treatment outcomes among tuberculosis (TB) patients. OBJECTIVE: To compare the treatment outcomes of HIV-infected TB patients initiated on first-line anti-TB treatment in five selected districts of Karnataka, India before (April-September 2017) and after (April-September 2018) implementation of NPY. METHODS: This was a cohort study using secondary data routinely collected by the national TB and HIV programmes. RESULTS: A total of 630 patients were initiated on ATT before NPY and 591 patients after NPY implementation. Of the latter, 464 (78.5%, 95% CI: 75.0%-81.8%) received at least one installment of cash incentive. Among those received, the median (inter-quartile range) duration between treatment initiation and receipt of first installment was 74 days (41-165) and only 16% received within the first month of treatment. In 117 (25.2%) patients, the first installment was received after declaration of their treatment outcome. Treatment success (cured and treatment completed) in 'before NPY' cohort was 69.2% (95% CI: 65.6%-72.8%), while it was 65.0% (95% CI: 61.2%-68.8%) in 'after NPY' cohort. On adjusted analysis using modified Poisson regression we did not find a statistically significant association between NPY and unsuccessful treatment outcomes (adjusted relative risk-1.1, 95% CI: 0.9-1.3). CONCLUSION: Contrary to our hypothesis and previous evidence from systematic reviews, we did not find an association between NPY and improved treatment outcomes.

Pretreatment Out-of-Pocket Expenses for Presumptive Multidrug-Resistant Tuberculosis Patients, India, 2016-2017.

In India, under the National Tuberculosis Elimination Programme, the government provides free treatment for multidrug-resistant tuberculosis; however, many patients seek care elsewhere, which is costly. To determine those out-of-pocket expenses, we interviewed 40 presumptive patients and found that they spent more than their median annual income before registering for the government program.

To start or to complete? - Challenges in implementing tuberculosis preventive therapy among people living with HIV: a mixed-methods study from Karnataka, India.

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.

'I am on treatment since 5 months but I have not received any money': coverage, delays and implementation challenges of 'Direct Benefit Transfer' for tuberculosis patients - a mixed-methods study from South India.

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.

Outcomes and implementation challenges of using daily treatment regimens with an innovative adherence support tool among HIV-infected tuberculosis patients in Karnataka, India: a mixed-methods study.

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.

Metabolic syndrome and cardiovascular disease risk assessment among human immunodeficiency virus-infected individuals on antiretroviral therapy.

BACKGROUND: The association of cardiovascular risk with first-line antiretroviral therapy (ART) in Indians has been a matter of concern with the background of a high risk in South Asians. AIMS: This study aimed to compare metabolic syndrome and its components, dyslipidemia, insulin resistance, and cardiovascular risk among patients on first-line ART (Group 1) with age-matched, ART-naïve human immunodeficiency virus (HIV)-infected patients (Group 2) and normal controls (Group 3). METHODS: Patients attending a tertiary care center in Mysore were enrolled in the study after obtaining informed consent and controls were chosen from relatives of patients. RESULTS: The total number of patients enrolled in the study was 217 (males 111; females 106), and the mean age of these patients was 34.1 ± 7.4 years. The number of patients in Group 1 (HIV+, ART experienced) was 76; in Group 2 (HIV+, ART naïve) was 71, and in Group 3 (HIV-) was 70. There was no statistically significant difference in the prevalence of metabolic syndrome between the three groups. On comparing the components of metabolic syndrome, serum triglycerides (mg/dl) were significantly higher in the ART group (Group 1: 149.5 [interquartile range (IQR): 84-187], Group 2: 108 [IQR: 74-152], and Group 3: 141.5 [IQR: 89-192]; P = 0.014) and serum high-density lipoprotein cholesterol was higher in HIV-uninfected individuals (Group 1: 37.5 ± 11.83, Group 2: 31.5 ± 12.23, and Group 3: 40.1 ± 12.09; P = 0.0002). There was no association between metabolic syndrome, duration of HIV, and type of first-line ART. Total and low-density lipoprotein (LDL) cholesterol were significantly higher in the ART group. Homeostatic model assessment and Framingham scores did not reveal any significant difference across the three groups. CONCLUSION: HIV-infected individuals on ART had higher levels of triglycerides, LDL, and total cholesterol, but no increased cardiovascular risk compared to other groups.

Adoption of the 2015 World Health Organization guidelines on antiretroviral therapy: Programmatic implications for India.

The therapeutic and preventive benefits of early initiation of antiretroviral therapy (ART) for HIV are now well established. Reflecting new research evidence, in 2015 the World Health Organization (WHO) recommended initiation of ART for all people living with HIV (PLHIV), irrespective of their clinical staging and CD4 cell count. The National AIDS Control Programme (NACP) in India is currently following the 2010 WHO ART guidelines for adults and the 2013 guidelines for pregnant women and children. This desk study assessed the number of people living with HIV who will additionally be eligible for ART on adoption of the 2015 WHO recommendations on ART. Data routinely recorded for all PLHIV registered under the NACP up to 31 December 2015 were analysed. Of the 250 865 individuals recorded in pre-ART care, an estimated 135 593 would be eligible under the WHO 2013 guidelines. A further 100 221 would be eligible under the WHO 2015 guidelines. Initiating treatment for all PLHIV in pre-ART care would raise the number on ART from 0.92 million to 1.17 million. In addition, nearly 0.07 million newly registered PLHIV will become eligible every year if the WHO 2015 guidelines are adopted, of which 0.028 million would be attributable to implementation of the WHO 2013 guidelines alone. In addition to drugs, there will be a need for additional CD4 tests and tests of viral load, as the numbers on ART will increase significantly. The outlay should be seen in the context of potential health-care savings due to early initiation of ART, in terms of the effect on disease progression, complications, deaths and new infections. While desirable, adoption of the new guidance will have significant programmatic and resource implications for India. The programme needs to plan and strengthen the service-delivery mechanism, with emphasis on newer and innovative approaches before implementation of these guidelines.

Delivery of antiretroviral treatment services in India: Estimated costs incurred under the National AIDS Control Programme.

Competing domestic health priorities and shrinking financial support from external agencies necessitates that India's National AIDS Control Programme (NACP) brings in cost efficiencies to sustain the programme. In addition, current plans to expand the criteria for eligibility for antiretroviral therapy (ART) in India will have significant financial implications in the near future. ART centres in India provide comprehensive services to people living with HIV (PLHIV): those fulfilling national eligibility criteria and receiving ART and those on pre-ART care, i.e. not on ART. ART centres are financially supported (i) directly by the NACP; and (ii) indirectly by general health systems. This study was conducted to determine (i) the cost incurred per patient per year of pre-ART and ART services at ART centres; and (ii) the proportion of this cost incurred by the NACP and by general health systems. The study used national data from April 2013 to March 2014, on ART costs and non-ART costs (human resources, laboratory tests, training, prophylaxis and management of opportunistic infections, hospitalization, operational, and programme management). Data were extracted from procurement records and reports, statements of expenditure at national and state level, records and reports from ART centres, databases of the National AIDS Control Organisation, and reports on use of antiretroviral drugs. The analysis estimates the cost for ART services as US$ 133.89 (?8032) per patient per year, of which 66% (US$ 88.66, ?5320) is for antiretroviral drugs and 34% (US$ 45.23, ?2712) is for non-ART recurrent expenditure, while the cost for pre-ART care is US$ 33.05 (?1983) per patient per year. The low costs incurred for patients in ART and pre-ART care services can be attributed mainly to the low costs of generic drugs. However, further integration with general health systems may facilitate additional cost saving, such as in human resources.

HIV-infected presumptive tuberculosis patients without tuberculosis: How many are eligible for antiretroviral therapy in Karnataka, India?

For certain subgroups within people living with the human immunodeficiency virus (HIV) [active tuberculosis (TB), pregnant women, children <5years old, and serodiscordant couples], the World Health Organization recommends antiretroviral therapy (ART) irrespective of CD4 count. Another subgroup which has received increased attention is "HIV-infected presumptive TB patients without TB". In this study, we assess the proportion of HIV-infected presumptive TB patients eligible for ART in Karnataka State (population 60million), India. This was a cross-sectional analysis of data of HIV-infected presumptive TB patients diagnosed in May 2015 abstracted from national TB and HIV program records. Of 42,585 presumptive TB patients, 28,964 (68%) were tested for HIV and 2262 (8%) were HIV positive. Of the latter, 377 (17%) had active TB. Of 1885 "presumptive TB patients without active TB", 1100 (58%) were already receiving ART. Of the remaining 785 who were not receiving ART, 617 (79%) were assessed for ART eligibility and of those, 548 (89%) were eligible for ART. About 90% of "HIV-infected presumptive TB patients without TB" were eligible for ART. This evidence supports a public health approach of starting all "HIV-infected presumptive TB patients without TB" on ART irrespective of CD4 count in line with global thinking about 'test and treat'.

HIV Testing among Patients with Presumptive Tuberculosis: How Do We Implement in a Routine Programmatic Setting? Results of a Large Operational Research from India.

BACKGROUND: In March 2012, World Health Organization recommended that HIV testing should be offered to all patients with presumptive TB (previously called TB suspects). How this is best implemented and monitored in routine health care settings in India was not known. An operational research was conducted in Karnataka State (South India, population 64 million, accounts for 10% of India's HIV burden), to test processes and learn results and challenges of screening presumptive TB patients for HIV within routine health care settings. METHODS: In this cross-sectional study conducted between January-March 2012, all presumptive TB patients attending public sector sputum microscopy centres state-wide were offered HIV testing by the laboratory technician, and referred to the nearest public sector HIV counselling and testing services, usually within the same facility. The HIV status of the patients was recorded in the routine TB laboratory form and TB laboratory register. The laboratory register was compiled to obtain the number of presumptive TB patients whose HIV status was ascertained, and the number found HIV positive. Aggregate data on reasons for non-testing were compiled at district level. RESULTS: Overall, 115,308 patients with presumptive TB were examined for sputum smear microscopy at 645 microscopy centres state-wide. Of these, HIV status was ascertained for 62,847(55%) among whom 7,559(12%) were HIV-positive, and of these, 3,034(40%) were newly diagnosed. Reasons for non-testing were reported for 37,700(72%) of the 52,461 patients without HIV testing; non-availability of testing services at site of sputum collection was cited by health staff in 54% of respondents. Only 4% of patients opted out of HIV testing. CONCLUSION: Offering HIV testing routinely to presumptive TB patients detected large numbers of previously-undetected instances of HIV infection. Several operational challenges were noted which provide useful lessons for improving uptake of HIV testing in this important group.

Longitudinal Analysis of Adherence to First-Line Antiretroviral Therapy: Evidence of Treatment Sustainability from an Indian HIV Cohort.

INTRODUCTION: Given the chronic nature of HIV infection and the need for life-long antiretroviral therapy (ART), maintaining long-term optimal adherence is an important strategy for maximizing treatment success. In order to understand better the dynamic nature of adherence behaviors in India where complex cultural and logistic features prevail, we assessed the patterns, trajectories and time-dependent predictors of adherence levels in relation to virological failure among individuals initiating first-line ART in India. METHODS: Between July 2010 and August 2013, eligible ART-naïve HIV-infected individuals newly initiating first-line ART within the national program at three sites in southern India were enrolled and monitored for two years. ART included zidovudine/stavudine/tenofovir plus lamivudine plus nevirapine/efavirenz. Patients were assessed using clinical, laboratory and adherence parameters. Every three months, medication adherence was measured using pill count, and a structured questionnaire on adherence barriers was administered. Optimal adherence was defined as mean adherence ≥95%. Statistical analysis was performed using a bivariate and a multivariate model of all identified covariates. Adherence trends and determinants were modeled as rate ratios using generalized estimating equation analysis in a Poisson distribution. RESULTS: A total of 599 eligible ART-naïve patients participated in the study, and contributed a total of 921 person-years of observation time. Women constituted 43% and mean CD4 count prior to initiating ART was 192 cells/mm3. Overall mean adherence among all patients was 95.4%. The proportion of patients optimally adherent was 75.6%. Predictors of optimal adherence included older age (≥40 years), high school-level education and beyond, lower drug toxicity-related ART interruption, full disclosure, sense of satisfaction with one's own health and patient's perception of having good access to health-care services. Adherence was inversely proportional to virological failure (IRR 0.55, 95%CI 0.44-0.69 p<0.001). Drug toxicity and stigma-related barriers were significantly associated with virological failure, while forgetfulness was not associated with virological failure. CONCLUSION: Our study highlights the overall high level of medication adherence among individuals initiating ART within the Indian national program. Primary factors contributing towards poor adherence and subsequent virological failure in the proportion of individuals with poor adherence included drug toxicity, perceived stigma and poor access to health care services. Strategies that may contribute towards improved adherence include minimizing drug interruptions for medical reasons, use of newer ART regimens with better safety profiles and increasing access with more link ART centers that decentralize ART dispensing systems to individuals.

Predictors and Timing of ATT Initiation among HIV-TB Patients at ART Centers of Karnataka, India: Two Year Follow-Up.

BACKGROUND: In India, TB and HIV co-infection remains as a serious public health problem. From 2006 onwards, the intensified TB-HIV collaborative activities are being jointly implemented by National AIDS Control Programme (NACP) and Revised National TB Control programme (RNTCP) at high HIV burden states. OBJECTIVES: To determine (a) the predictors of outcome among a cohort of HIV-TB co-infected patients after two years after initiation of ART treatment. (b) prognostic significance of time difference between the initiation of ATT and ART in HIV-TB co-infected patients. METHODS: Patients registered at sixteen ART centres in Karnataka, from October through December 2009 formed the study cohort and were followed till December 2011. RESULTS: A total of 604 HIV-TB patients were registered. Follow-up (a) at the end of one year had shown 63.6% (377)patients with unfavorable TB treatment outcomes (b) at the end of second year, 55.6% (336)patients were alive on ART treatment. The variables male, smear negative TB, CD4 count less than 50cells per cumm and unfavorable TB outcome were significantly associated with unfavorable ART treatment outcome. CONCLUSIONS: The programmes need to review the existing strategies and strengthen HIV-TB collaborative activities for timely treatment initiation with intensive monitoring of HIV-TB patients on treatment.

Virological efficacy with first-line antiretroviral treatment in India: predictors of viral failure and evidence of viral resuppression.

OBJECTIVE: Combination antiretroviral therapy (ART) has improved in efficacy, durability and tolerability. Virological efficacy studies in India are limited. We determined incidence and predictors of virological failure among patients initiating first-line ART and described virological resuppression after confirmed failure, with the goal of informing national policy. METHODS: Therapy-naïve patients initiated on first-line ART as per national guidelines were monitored every 3 months for adherence and virological response over 2 years. Genotyping on baseline samples was performed to assess primary drug resistance. Multivariate Cox regression analysis was used to assess predictors of virological failure. RESULTS: Virological failure rate among 599 eligible patients was 10.7 failures per 100 person-years. Cumulative failure incidence was 13.2% in the first year and 16.5% over 2 years. Patients initiated on tenofovir had a significantly lower rate of virological failure than those on stavudine or zidovudine (6.7 vs. 11.9 failures per 100 person-years, P = 0.013). Virological failure was independently associated with age <40 years, mean adherence <95%, non-tenofovir-containing regimens and presence of primary drug resistance. In a subset of 311 patients who were reassessed after treatment failure, 19% (11/58) patients resuppressed their viral load to <400 copies/ml after confirmed virological failure. CONCLUSIONS: Our results support the inclusion of tenofovir as first-line ART in resource-limited settings and a role for regular adherence counselling and virological monitoring for enhanced treatment success. Detection of early virological failure should provide an opportunity to augment adherence counselling and repeat viral load testing before therapy switch is considered.