Strengthened capacity of India´s bedaquiline Conditional Access Programme for introducing new drugs and regimens.

BACKGROUND: Addressing TB in India is critical to meeting global targets. With the scale-up of diagnostic networks and the availability of new TB drugs, India had the opportunity to improve the detection and treatment outcomes in drug-resistant TB (DR-TB).OBJECTIVE: To document how the introduction of new drugs and regimens is helping India improve the care of DR-TB patients.DESIGN: In 2016, India´s National TB Programme (NTP) introduced bedaquiline (BDQ) under a Conditional Access Programme (BDQ-CAP) at six sites after providing extensive training and strengthening laboratory testing, pre-treatment evaluation, active drug safety monitoring and management (aDSM) and follow-up systems.RESULTS: An interim analysis reflected earlier and better culture conversion rates: 83% of the 620 patients converted within a median time of 60 days. However, 248 serious adverse events were reported, including 73 deaths (12%) and 100 cardiotoxicity events (16.3%). Encouraged by the evidence of safety and efficacy of BDQ, the NTP took steps to systematically expand its access to cover the entire population by 2018.CONCLUSION: The cautious yet focused approach used to introduce BDQ under BDQ-CAP paved the way for the rapid introduction of delamanid, as well as the shorter treatment regimen and the all-oral regimen for DR-TB.

Challenges and opportunities to prevent tuberculosis in people living with HIV in low-income countries.

People living with the human immunodeficiency virus (HIV) (PLHIV) are at high risk for tuberculosis (TB), and TB is a major cause of death in PLHIV. Preventing TB in PLHIV is therefore a key priority. Early initiation of antiretroviral therapy (ART) in asymptomatic PLHIV has a potent TB preventive effect, with even more benefits in those with advanced immunodeficiency. Applying the most recent World Health Organization recommendations that all PLHIV initiate ART regardless of clinical stage or CD4 cell count could provide a considerable TB preventive benefit at the population level in high HIV prevalence settings. Preventive therapy can treat tuberculous infection and prevent new infections during the course of treatment. It is now established that isoniazid preventive therapy (IPT) combined with ART among PLHIV significantly reduces the risk of TB and mortality compared with ART alone, and therefore has huge potential benefits for millions of sufferers. However, despite the evidence, this intervention is not implemented in most low-income countries with high burdens of HIV-associated TB. HIV and TB programme commitment, integration of services, appropriate screening procedures for excluding active TB, reliable drug supplies, patient-centred support to ensure adherence and well-organised follow-up and monitoring that includes drug safety are needed for successful implementation of IPT, and these features would also be needed for future shorter preventive regimens. A holistic approach to TB prevention in PLHIV should also include other important preventive measures, such as the detection and treatment of active TB, particularly among contacts of PLHIV, and control measures for tuberculous infection in health facilities, the homes of index patients and congregate settings.

Cost of hospitalisation for non-communicable diseases in India: are we pro-poor?

OBJECTIVES: To estimate out-of-pocket (OOP) expenditure due to hospitalisation from NCDs and its impact on households in India. METHODS: The study analysed nationwide representative data collected by the National Sample Survey Organisation in 2014 that reported health service utilisation and healthcare-related OOP expenditure by income quintiles and by type of health facility (public or private). The recall period for inpatient hospitalisation expenditure was 365 days. Consumption expenditure was collected for a recall period of 1 month. OOP expenditure amounting to >10% of annual consumption expenditure was termed as catastrophic. Weighted analysis was performed. RESULTS: The median expenditure per episode of hospitalisation due to NCDs was USD 149 - this was ~3 times higher among the richest quintile compared to poorest quintile. There was a significantly higher prevalence of catastrophic expenditure among the poorest quintile, more so for cancers (85%), psychiatric and neurological disorders (63%) and injuries (63%). Mean private-sector OOP hospitalisation expenditure was nearly five times higher than that in the public sector. Medicines accounted for 40% and 27% of public- and private-sector OOP hospitalisation expenditure, respectively. CONCLUSION: Strengthening of public health facilities is required at community level for the prevention, control and management of NCDs. Promotion of generic medicines, better availability of essential drugs and possible subsidisation for the poorest quintile will be measures to consider to reduce OOP expenditure in public-sector facilities.

Experience of active tuberculosis case finding in nearly 5 million households in India.

In India, to increase tuberculosis (TB) case detection under the National Tuberculosis Programme, active case finding (ACF) was implemented by the Global Fund-supported Project Axshya, among high-risk groups in 300 districts. Between April 2013 and December 2014, 4.9 million households covering ~20 million people were visited. Of 350 047 presumptive pulmonary TB cases (cough of ⩾2 weeks) identified, 187 586 (54%) underwent sputum smear examination and 14 447 (8%) were found to be smear-positive. ACF resulted in the detection of a large number of persons with presumptive pulmonary TB and smear-positive TB. Ensuring sputum examination of all those with presumptive TB was a major challenge.

En Inde, le projet Axshya (soutenu par le Fonds Mondial) a mis en œuvre une recherche active des cas (ACF) afin d'en augmenter la détection sous l'égide du Programme Révisé National Contre la Tuberculose auprès des groupes à risque dans 300 districts. Entre avril 2013 et décembre 2014, 4,9 millions de foyers, soit environ 20 millions de personnes, ont été visités. De 350 047 cas présumés de tuberculose (TB) pulmonaire (toux ⩾2 semaines) identifiés, 187 586 (54%) ont bénéficié d'un examen de frottis de crachats et 14 447 (8%) ont eu un frottis positif. L'ACF a abouti à la détection d'un grand nombre de personnes présumées atteintes de TB pulmonaire et de TB à frottis positif. Assurer l'examen des crachats de tous les cas avec suspicion de TB a été un défi majeur.

Con el propósito de aumentar la detección de casos en la India, el Proyecto Axshya (financiado por el Fondo Mundial) introdujo un mecanismo de búsqueda activa de casos (ACF), dirigido a los grupos de alto riesgo en 300 distritos, en el marco del Programa Nacional Revisado Contra la Tuberculosis. De abril del 2013 a diciembre del 2014 se visitaron 4,9 millones de hogares, que cubrían una población cercana a 20 millones de personas. Se detectaron 350 047 casos con presunción de tuberculosis (TB) pulmonar (tos con una duración de ⩾2 semanas), se practicó la baciloscopia del esputo a 187 586 personas (54%), de las cuales 14 447 obtuvieron un resultado positivo (8%). La ACF dio lugar a la detección de un gran número de personas con presunción de TB pulmonar y baciloscopia positiva del esputo. La realización del examen microscópico del esputo en todas estas personas representó un gran desafío.

Promoting operational research through fellowships: a case study from the South-East Asia Union Office.

In 2009, the International Union Against Tuberculosis and Lung Disease (The Union) and Médecins Sans Frontières (MSF) jointly developed a new paradigm for operational research (OR) capacity building and started a new process of appointing and supporting OR fellows in the field. This case study describes 1) the appointment of two OR fellows in The Union South-East Asia Office (USEA), New Delhi, India; 2) how this led to the development of an OR unit in that organisation; 3) achievements over the 5-year period from June 2009 to June 2014; and 4) challenges and lessons learnt. In June 2009, the first OR fellow in India was appointed on a full-time basis and the second was appointed in February 2012-both had limited previous experience in OR. From 2009 to 2014, annual research output and capacity building initiatives rose exponentially, and included 1) facilitation at 61 OR training courses/modules; 2) publication of 96 papers, several of which had a lasting impact on national policy and practice; 3) providing technical assistance in promoting OR; 4) building the capacity of medical college professionals in data management; 5) support to programme staff for disseminating their research findings; 6) reviewing 28 scientific papers for national or international peer-reviewed journals; and 7) developing 45 scientific abstracts for presentation at national and international conferences. The reasons for this success are highlighted along with ongoing challenges. This experience from India provides good evidence for promoting similar models elsewhere.

En 2009, L'Union Internationale contre la Tuberculose et les Maladies respiratoires (L'Union) et Médecins Sans Frontières (MSF) ont élaboré conjointement un nouveau paradigme de renforcement des capacités en recherche opérationnelle et démarré un nouveau processus de recrutement et de soutien de chercheurs en recherche opérationnelle sur le terrain. Cette étude de cas décrit 1) le recrutement de deux chercheurs en recherche opérationnelle dans le bureau de l'Union du Sud-est asiatique (USEA), à New Delhi, Inde ; 2) comment ceci a abouti à l'élaboration d'une unité de recherche opérationnelle dans cette organisation ; 3) les accomplissements sur une période de cinq ans de juin 2009 à juin 2014 ; et 4) les défis et les leçons apprises. En juin 2009, le premier chercheur en recherche opérationnelle (OR) en Inde a été recruté à temps plein et le deuxième a été recruté en février 2012­les deux chercheurs avaient une expérience préalable limitée en OR. De 2009 à 2014, les résultats annuels de la recherche et les initiatives de renforcement des capacités se sont accrues de façon exponentielle et ont inclus : 1) la facilitation de 61 cours/modules de formation à la OR ; 2) la publication de 96 articles, dont plusieurs ont eu un impact durable sur la politique et les pratiques nationales ; 3) la fourniture d'assistance technique à la promotion de l'OR ; 4) un renforcement des capacités des professionnels du collège médical dans la gestion des données ; 5) un soutien au personnel du programme dans la diffusion des résultats de leur recherche ; 6) une revue de 28 articles scientifiques pour les journaux nationaux or internationaux revus par leurs pairs ; et 7) l'élaboration de 45 résumés scientifiques destinés à être présentés lors de conférences nationales et internationales. Les raisons de ce succès sont mises en lumière en même temps que les défis persistants. Cette expérience émanant d'Inde offre des données suffisantes pour promouvoir des modèles similaires ailleurs.

En el 2009, la Unión Internacional contra la Tuberculosis y las Enfermedades Respiratorias (La Unión) y Médicos Sin Fronteras establecieron de manera conjunta un nuevo paradigma de fortalecimiento de la capacidad de practicar la investigación operativa (OR) y pusieron en marcha nuevos mecanismos de nombramiento de los becarios de OR y de respaldo a esta actividad en el terreno. En el presente estudio de casos se describen los siguientes aspectos: 1) el nombramiento de dos becarios de OR en la oficina de La Unión para la Región del Sudeste Asiático de Nueva Delhi en India; 2) la manera como este nombramiento condujo a la creación de una unidad de OR en esta organización; 3) los logros alcanzados durante un período de 5 años entre junio de 2009 y junio del 2014; y 4) las dificultades y las enseñanzas extraídas. En junio del 2009 se nombró el primer becario con dedicación exclusiva a la OR en la India y el segundo nombramiento tuvo lugar en febrero del 2012; ambos investigadores contaban con poca experiencia en esta esfera. Del 2009 al 2014, la producción científica anual y las iniciativas de fortalecimiento de la capacidad investigativa aumentaron de manera exponencial; se pusieron en marcha las siguientes actividades: 1) la facilitación en 61 cursos o módulos de capacitación en OR; 2) la publicación de 96 artículos científicos, algunos de los cuales tuvieron una repercusión duradera en las políticas y las prácticas a escala nacional; 3) la prestación de asistencia técnica encaminada a fomentar la OR; 4) el reforzamiento de la capacidad de gestión de los datos, dirigido a los profesionales de la facultad de medicina; 5) el respaldo a la difusión de los resultados de las investigaciones del personal del programa; 6) la evaluación de 28 artículos científicos para revistas con comité de lectura nacionales e internacionales; y 7) la elaboración de 45 resúmenes científicos que se presentaron en conferencias nacionales e internacionales. En el presente artículo se destacan las razones del éxito de esta iniciativa y las dificultades actuales del proyecto. Esta experiencia en la India aporta datos convincentes en favor de la promoción de modelos similares en otros entornos.

High and equitable tuberculosis awareness coverage in the community-driven Axshya TB control project in India.

Data from surveys on knowledge, attitudes and practice (KAP) on tuberculosis (TB) conducted under the Axshya project at two time points (baseline 2010-2011 and mid-line 2012-2013) were analysed for changes in coverage and equity of TB awareness after project interventions. Overall coverage increased from 84% at baseline to 88% at midline (5% increase, P < 0.05). In comparison to baseline results, coverage at the midline survey had significantly increased, from 81% to 87% among the rural population, from 81% to 86% among women, from 73% to 85% in the ⩾55 years age group, from 71% to 80% among illiterates and from 73% to 81% in the south zone (P < 0.05). The equity gap among the different study groups (settlement, sex, age, education and zones) decreased from 6-23% at baseline to 3-11% during the midline survey. The maximum decline was observed for type of settlement (rural vs. urban), from 10% to 3% (P < 0.05). This community-driven TB control project has achieved high and equitable coverage of TB awareness, offering valuable lessons for the global community.

Des données émanant d'enquêtes « connaissances, attitudes, pratiques ¼ (KAP) en matière de tuberculose (TB) réalisées dans le cadre du projet « Axshya ¼ à deux périodes (de 2010 à 2011 au départ et de 2012 à 2013 à mi-parcours) ont été analysées à la recherche de modifications dans la couverture et l'équité en matière de connaissances de la TB à la suite des interventions du projet. La couverture d'ensemble a augmenté de 84% au départ à 88% à mi-parcours (augmentation de 5% ; P < 0,05). En comparaison au point de départ, la couverture de l'enquête à mi-parcours a augmenté significativement de 81% à 87% dans la population rurale, de 81% à 86% chez les femmes, de 73% à 85% dans la tranche d'âge ⩾55 ans, de 71% à 80% chez les personnes illettrées et de 73% à 81% dans la zone sud (P < 0,05). La différence en termes d'équité parmi les divers groupes d'étude (lieu, sexe, âge, instruction et zones) a diminué de 6% à 23% au départ jusqu'à 3% à 11% lors de l'enquête à mi-parcours. Le déclin maximal a été observé pour la localisation (rurale contre urbaine), de 10% à 3% (P < 0,05). Le projet à base communautaire de lutte contre la TB a abouti à une couverture élevée et équitable des connaissances en matière de TB, ce qui offre des leçons à portée universelle.

Se llevó a cabo un análisis de la evolución de la cobertura y la equidad en la sensibilización a la tuberculosis (TB) después de las intervenciones realizadas en el marco del Proyecto Axshya, a partir de los resultados de las encuestas del proyecto sobre los conocimientos, las actitudes y las prácticas en materia de TB que se realizaron al comienzo entre el 2010 y el 2011 y a medio término de la intervención, del 2012 al 2013. La cobertura global aumentó de 84% al comienzo del proyecto a 88% a medio término (aumento de un 5% ; P < 0,05). En comparación con los datos iniciales, en la encuesta de mitad del período, la cobertura observada aumentó de manera considerable en la población rural de 81% a 87%, en las mujeres de 81% a 86%, en el grupo de ⩾55 años de 73% a 85%, en la población analfabeta de 71% a 80% y en la región del sur aumentó de 73% a 81% (P < 0,05). La amplitud de la brecha de equidad en los diferentes grupos del estudio (en función del asentamiento, el sexo, la edad, la educación y las zonas) disminuyó de 6% a 23% al comienzo hasta 3% a 11% en la encuesta de medio término. La máxima disminución se observó con respecto al asentamiento (rural contra urbano), de 10% a 3% (P < 0,05). Este proyecto de control de la TB dirigido por la comunidad ha logrado una alta cobertura y gran equidad en la sensibilización sobre la TB y ofrece enseñanzas valiosas a otros entornos similares en todo el mundo.

Revised national TB control programme in India.

The Revised National TB Control Programme (RNTCP), an application in India of the Directly Observed Treatment, Short Course (DOTS) strategy to control TB is being implemented in the country since 1997. The goal of the RNTCP is to decrease mortality and morbidity due to TB and cut transmission of infection until TB ceases to be a major public health problem in India Since 1999, achievements of the RNTCP have largely determined the global DOTS progress. It has been cited as the fastest expansion in the history of DOTS and in terms of patients being treated, it is the largest programme in the world. More than 50-fold expansion in RNTCP coverage has occurred since 1998 thus making DOTS accessible to more than 83% of the country's population. Quality of services has been maintained during this rapid expansion. As a result, the proportion of sputum positive cases confirmed in the laboratory is on par with international standards. By September 2005, the programme has initiated more than 3.5 million patients on treatment, thus saving over 600,000 additional lives. In 2003, new sputum positive case detection rate of 69% was achieved against target of at least 70% and treatment success rate of 86% has been achieved above the target of 85% Aggressive steps are being taken to meet global TB control targets by covering the entire country with RNTCP by 2005. Despite these achievements, there are many challenges for the RNTCP. Implementing DOTS in a diverse and large country, maintaining the quality of services during rapid expansion phase, decentralization of programme management to the states and, widening the reach of the programme to reach all sections of the society are some of the major challenges.

Involvement of non-governmental organisations in the RNTCP.

To get the maximum benefit from Revised National TB Control Programme (RNTCP) developing partnership with private health providers outside government health system is very important. RNTCP actively seeks the participation of the NGOs by sensitising them with DOTS strategy. A broad framework for involvement of NGOs has been evolved by RNTCP Schemes for NGOs and RNTCP collaboration are elaborated. Over 514 NGOs are currently participating in the programme under one or another scheme. In addition to the guidelines developed by Government of India, innovative forms of partnership between RNTCP, NGOs and other private health providers should be encouraged.