Impact and operational feasibility of TrueNat™ MTB/Rif under India's RNTCP.

BACKGROUND: The Revised National Tuberculosis Control Programme (RNTCP) in Andhra Pradesh, India, introduced TrueNat™ MTB/Rif, a rapid molecular test for detecting Mycobacterium tuberculosis (MTB) and rifampicin (RIF) resistance at 193 TB units (TUs) in October 2018. We evaluated its impact on TB diagnosis and assessed the operational feasibility of its deployment at point-of-care (POC) settings. METHODS: We compared the number of presumptive TB cases tested and the number (proportion) of microbiologically positive before (January-August 2018) and after (January-August 2019) the deployment of TrueNat. We interviewed laboratory technicians and Senior TB Laboratory Supervisor from 25 randomly selected TUs to assess operational feasibility. RESULTS: In 2018, 10.5% (range 8.9-13.1) of 245,989 presumptive cases tested were positive. In 2019, of the 185,435 presumptive cases tested, 13.7% (range 9.6-18.9) were positive. The proportion of presumptive TB cases in whom MTB was detected using TrueNat was 14.4% (range 10.0-21.2). TrueNat significantly increased case detection (incidence rate ratio [IRR] 1.30; 95%CI 1.15-1.46), yielding an additional 18 TB cases per 100 000 population. Laboratory technicians became comfortable in performing TrueNat after a median of 10 tests (interquartile range 5-17.5). Invalid reports declined from 6.8% to 3.6%. CONCLUSION: The deployment of TrueNat as POC diagnostic test improved case detection and was operationally feasible under RNTCP.

Modelling the potential impact of adherence technologies on tuberculosis in India.

BACKGROUND: For patients taking standard first-line tuberculosis treatment, missing 10% or more of their doses increases the risk of relapse six-fold. Digital technologies offer new approaches to adherence support for TB patients. We estimated the potential impact of new adherence technologies in India.METHOD: We developed a mathematical model of TB transmission dynamics in India, capturing the independent effects of missed doses and treatment default on post-treatment recurrence. We simulated the impact of interventions to address both missed doses and treatment default in the public and private healthcare sector.RESULTS: Adherence interventions, if deployed optimally in the public sector alone, would reduce cumulative TB incidence by 7.3% (95% credible intervals [CrI] 4.7-11) between 2020 and 2030, and by 16% (95% CrI 11-23) if also deployed in the private sector. This impact is roughly proportional to the effectiveness of the interventions. Reducing missed doses reduced incidence by 12% (95% CrI 7.0-18), while reducing treatment default reduced incidence by 7.9% (95% CrI 3.2-13).CONCLUSION: Minimising missed doses is at least as important as promoting treatment completion. Our results suggest that emerging technologies to improve treatment adherence could have a substantial impact on TB incidence and mortality in India.

Public-private mix for TB care in India: Concept, evolution, progress.

To achieve "Universal access to TB care and treatment for all", Revised National Tuberculosis Control Programme (RNTCP) has taken steps to reach the unreached by synergizing the efforts of all partners and stakeholders. RNTCP is engaging with private sector partners in major cities of India with primary focus on notification through innovative partnership mechanisms. The manuscript details the concept behind the public-private mix for TB Care in RNTCP, its evolution and progress over the decades in India.

Transitioning to daily treatment for drug-sensitive TB in India.

World Health Organization in its treatment guideline for tuberculosis 2010 recommended daily dosing as the preferred regimen in treatment of drug-sensitive TB patients. The Revised National Tuberculosis Control Program took a decision to implement daily regimen in five states of India in 2015. This article describes the policy-making chronology, evidences used, stakeholders involved, and process of decision making.

Follow-up examinations: are multidrug-resistant tuberculosis patients in Uttar Pradesh, India, on track?

SETTING: All multidrug-resistant tuberculosis (MDR-TB) patients who had completed 6 months of treatment under the Revised National Tuberculosis Control Programme (RNTCP) in Uttar Pradesh, the largest state in northern India. OBJECTIVE: To determine the proportion of MDR-TB patients with regular follow-up examinations, and underlying provider and patient perspectives of follow-up services. METHODS: A retrospective cohort study was undertaken involving record reviews of 64 eligible MDR-TB patients registered during April-June 2013 in 11 districts of the state. Patients and programme personnel from the selected districts were interviewed using a semi-structured questionnaire. RESULTS: A total of 34 (53.1%) patients underwent follow-up sputum culture at month 3, 43 (67.2%) at month 4, 36 (56.3%) at month 5 and 37 (57.8%) at month 6. Themes associated with irregular follow-up that emerged from the interviews were multiple visits, long travel distances, shortages of equipment at the facility and lack of knowledge among patients regarding the follow-up schedule. CONCLUSION: The majority of the MDR-TB patients had irregular follow-up visits. Provider-related factors outweigh patient-related factors on the poor follow-up examinations. The programme should focus on the decentralisation of follow-up services and ensure logistics and patient-centred counselling to improve the regularisation of follow up.

Contexte : Tous les patients atteints de tuberculose multirésistante (TB-MDR) qui avaient achevé 6 mois de traitement dans le cadre du Programme National Révisé de Lutte contre la Tuberculose (RNTCP) dans l'Uttar Pradesh, le plus grand état dans le nord de l'Inde.Objectif : Déterminer la proportion de patients TB-MDR bénéficiant d'examens de suivi régulier et la vision des prestataires et des patients sur ces services de suivi.Méthodes : Une étude rétrospective de cohorte a été réalisée grâce à la revue des dossiers de 64 patients TB-MDR éligibles enregistrés entre avril et juin 2013 dans 11 districts de l'état. Les patients et le personnel du RNTCP des districts sélectionnés ont également été interviewés grâce à un questionnaire semi-structuré.Résultats : Au total, 34 (53,1%) patients ont bénéficié d'examens de culture de crachats au 3e mois, 43 (67,2%) au 4e mois, 36 (56,3%) au 5e mois et 37 (57,8%) au 6e mois. Les principaux facteurs associés à un suivi irrégulier émanant des entretiens étaient le nombre élevé de consultations, la distance à parcourir, les ruptures de stock dans les structures et le manque de connaissances des patients vis-à-vis du programme de suivi.Conclusion : La majorité des patients TB-MDR ont eu un suivi irrégulier. Les facteurs liés aux prestataires dépassent ceux liés aux patients en matière d'examens de suivi médiocres. Le RNTCP devrait se concentrer sur la décentralisation des services de suivi, assurer la logistique et le conseil centré sur le patient afin d'accroitre la régularité du suivi.

Marco de referencia: Todos los pacientes con diagnóstico de tuberculosis multidrogorresistente (TB-MDR) después de haber completado los 6 meses de tratamiento en el contexto del Programa Nacional de Control de la Tuberculosis (RNTCP) en Uttar Pradesh, la provincia más grande del norte de la India.Objetivo: Determinar la proporción de pacientes con TB-MDR en quienes se practicaron exámenes periódicos de seguimiento y conocer las opiniones de los profesionales y de los pacientes sobre los servicios de seguimiento.Métodos: Se llevó a cabo un estudio de cohortes retrospectivo a partir del examen de las historias clínicas de 64 pacientes con diagnóstico de TB-MDR, que cumplían con los requisitos de inclusión, registrados entre abril y junio del 2013 en 11 distritos del estado. Se realizaron además entrevistas a los pacientes y al personal del RNTCP de algunos distritos mediante un cuestionario semi-estructurado.Resultados: En 34 pacientes se practicó el seguimiento del cultivo de esputo al tercer mes (53,1%), en 43 casos al cuarto mes (67,2%), en 36 al quinto mes (56,3%) y en 37 pacientes al sexto mes de tratamiento (57,8%). Los principales factores asociados con la irregularidad del seguimiento que revelaron las entrevistas fueron la multiplicidad de las citas, la larga distancia de los desplazamientos, la carencia de insumos en los centros y el desconocimiento del calendario del seguimiento por parte de los pacientes.Conclusión: El seguimiento de la mayoría de los pacientes con diagnóstico de TB-MDR fue irregular. En las causas de la deficiencia del seguimiento predominaron los factores dependientes de los profesionales en comparación con los factores propios a los pacientes. El RNTCP debe considerar seriamente la descentralización de los servicios de seguimiento, suministrarlos materiales necesarios y proveer una orientación centrada en los pacientes con el objeto de mejorar la regularidad de los seguimientos.

Composite indicator: new tool for monitoring RNTCP performance in India.

India's Revised National Tuberculosis Control Programme (RNTCP) used the international benchmarks of 70% case detection rate and 85% treatment success rate among new smear-positive tuberculosis (TB) cases for assessing programme performance. This approach overemphasises outcomes and focuses on quantitative benchmarks without sufficient regard to developing systems to monitor appropriate programme practice to achieve a minimum standard of TB care services. The RNTCP has developed a novel composite indicator tool based on a logical framework pathway to move beyond narrow-focused outcome indicators such as case detection to encourage a broad-based analysis of programme implementation. The constituent indicators are from routinely monitored information, spanning input, process, output and outcome indicators across various thematic categories of the RNTCP.

Proficiency panel testing--a reliable tool in external quality assessment of sputum smear microscopy services in Gujarat, India.

OBJECTIVE: To assess the proficiency of Senior TB Laboratory Supervisors (STLSs) and district level Laboratory Technicians (LTs) in sputum smear microscopy. METHOD: Intermediate Reference Laboratory (IRL), Ahmedabad had manufactured and validated Proficiency Panel Testing slides from sputum samples, made On Site Evaluation (OSE) visits of District TB Centres (DTCs) in two rounds, and conducted Proficiency Panel Testing of STLSs & DTC-LTs from January 2005 to June 2009. RESULTS: High level of concordance in Z-N smear grading was found between Microbiologist and district laboratory staff. DTC readers reported overall consistency level of more than 98% in Z-N grade agreement during both the IRL, EQA, OSE visits. The tendency to over-grade the panel slides was much higher (more than 22%) as compared to under-grade (less than 2%) them in "correct slides". High False Positive (HFP) error was not observed in the present study. CONCLUSION: Laboratory supervisor's proficiency can be quickly assessed by Proficiency Panel Testing, under multi-level quality assurance network system of sputum smear microscopy in public health programmes like the RNTCP. Proficiency Panel Testing is highly replicable and reproducible tool for quick and reliable assessment of proficiency of the staff and it can be made more effective by raising the proportion of lower grade positive slides in panel set of each reader. DTC readers' overall agreement level of more than 98% in Z-N grade suggests high level of precision and excellent consistency during both the IRL, EQA, OSE rounds. It is concluded that even for a large network of sputum smear microscopy centres under public health programmes like the RNTCP in order to take corrective action, Proficiency Panel Testing can be effectively used for quick identification of suboptimal- technical performance of the supervisory staff.