Integrating pertmtb/rif into PMDT & PPM activities in India Dr R S Gupta Deputy Director General TB Central TB Division, Government of India, Ministry of Health & Family Welfare, New Delhi. India GLI Meeting- 30 th April -2 nd May 2014
Burden of DR TB in India India- world s highest MDR-TB burden country 64,000 emerging annually in notified PTB cases Sub-national drug-resistance surveys(2005-09) 2.4%MDRinnew,15%MDRinpreviouslytreatedcases 21-24% Ofx resistance, 4-7% DR in MDR isolates National drug resistance survey underway World s largest PMDT service expansion - Started in 2007, dramatically accelerated from 2011 to achieve nationwide rapid scale up in March 2013
Key Features of RNTCP PMDT Decentralized lab diagnosis and DST Specimen transport to LPA (45) or pertmtb/rif (89) site pertmtb/rif or LPA is preferred DST method and available across India Treatment with standardized regimen for M/DR TB largely ambulatory Scope of strengthening MDR-TB regimen in baseline Ofx/ Km resistance Base line Second Line DST started in 6 states (KA, TN, MH, KE, GJ, DL) Source: RNTCP Guidelines for PMDT in India May 12, www.tbcindia.nic.in
Introduction of Rapid Diagnostics in India 2009 Line Probe Assay 2007 Conventional Solid (LJ) Culture-DST 2011 High throughput GT Blot 2012 pert-mtb/rif - 18 site (27) RNTCP WHO FIND feasibility study - 10 (12) sites EPANDx TB Project 2013-14 pert-mtb/rif - 40 sites (43) RNTCP WHO UNITAID TBpert Project - 4 (6) sites for pediatric project- USAID pert-mtb/rif in private sector
C-DST Labs - 55 SLDST - 7 (3 NRLs and 3 IRLs, 1-NGO) RNTCP Culture & DST Labs Network (March, 2014) Jammu & Kashmir A Himachal Pradesh Punjab AIIMS-2 Chandigarh LRS Uttaranchal Haryana Gurgaon Delhi Sikkim Arunachal Pradesh Uttar Pradesh Rajasthan JALMA Assam Bihar Nagaland NDTC SLDST - 7 (NTI, NIRT, NITRD, IRL Ahmedabad, IRL Delhi, IRL Thiruvananthapuram, PD Hinduja) Gujarat Daman & Diu D&N Haveli Jharkhand Madhya Pradesh Chhatisgarh Orissa Maharashtra Andhra Pradesh Meghalaya Manipur West Bengal Mizoram Tripura IRL (Certified) IRL (Under Process) Med Col / NGO / Private Labs (Certified) Med Col / NGO / Private Labs (Under Process) Goa National Reference Labs By Technology - Solid Culture: 37 -LPA: 45 - Liquid Culture:14 - pert-mtb/rif : 89 Karnataka NTI Lakshadweep Kerala Tamil Nadu TRC Pondicherry pert-mtb/rif Sites A&N Islands
Policy for use of pert-mtb/rif in India Use of pert-mtb/rif in programmatic settings For Diagnosis of Rif Resistance Presumptive MDR TB cases Prioritize pert-mtb/rif to detect MTB in Presumptive TB cases among People living with HIV / AIDS Paediatric cases
pert-mtb/rif projects in India 18 sites under TB Unit feasibility and impact study (March 2012- December 2013) conducted to create in-country evidence on feasibility for rapid adoption and guide future scale-up of the technology to diagnose TB and DR TB 10 sites under EPANDx TB (till December 2014) for further accelerating services of PMDT to diagnose DR TB 40 sites under UNITAID (till December 2015) for scale-up and deployment of pert-mtb/rif as a decentralized tool and innovative PPM to diagnose TB and DR TB 4 sites under USAID (till June 2014) Accelerating access to quality TB and DR TB diagnosis for paediatric cases in 4 major cities in India 30 sites proposed under PEPFAR, USAID (till September 2015) Innovative intensified TB case finding and appropriate treatment at high burden ART centres in 4 states
1. RNTCP pert-mtb/rif Feasibility Project Aim o Collect evidence on the feasibility and impact of introducing pert- MTB/Rif for the detection of TB and rifampicin resistance Objectives o Feasibility: Establish the feasibility of decentralized deployment of routine pert-mtb/rif testing of all pulmonary TB & DR-TB suspects in selected geographic areas o Impact: Assess the impact of decentralized deployment of routine pert-mtb/rif testing of all pulmonary TB suspects on diagnosis of TB & DR-TB
pert-mtb/rif Feasibility Study Overall positivity of TB detection was 21.8% Total Total TB Suspects tested Intervention 104276 Bac +ve TB 21130 Clinically Diagnosed 1690 Total TB 22820 DR TB 2301 Additional Yield of MTB on pert over Smear Microscopy Total bacteriologically confirmed cases diagnosed Diagnosed on pert over smear Diagnosed on smear over pert Additional yield on pert Yield (%) 21130 7443 542 6901 32.7%
2. EPANDx Project sites (Diagnosis of DR TB) Established 12 pert-mtb-rif labs to supplement the efforts and capacity of the existing reference lab network of RNTCP
Quarterly Suspect Examination on CBNAAT across sites (Oct 2012-Mar 2014) Quarterly Suspect Examination on CBNAAT across sites 3500 3000 2500 2000 1500 15421525 15921756 1693 Suspects examined 45395 2006 2035 3005 2971 2840 27652754 2826 2542 248425142741 2482 2342 Rif +ve4432 1000 938 500 0 115 188 165 163 153 180 190 240 299 374 352 294 252 242 253 218 186 211 160 192 542 Q3 2012 Q4 2012 Q 1 2013 Q2 2013 Q3 2013 Q4 2013 Q 1 2014 Rif Resistant DR TB suspect
3. RNTCP TBpert Project (supported by WHO, STOP TB Partnership, UNITAID & USAID) Under this project, 43 pert MTB/Rif machines and cartridges are provided to the country to scale-up rapid molecular diagnosis of TB and Rif resistance Innovate to engage private sector through publicprivate mix (PPM) initiatives to improve access to rapid testing of patients who attend both public and private sector
Jammu & Kashmir TB pert Project Sites- UNITAID Gujarat Rajasthan Daman & Diu D&N Haveli Goa Punjab Chandigarh Haryana Maharashtra Himachal Pradesh Delhi Uttaranchal Madhya Pradesh Uttar Pradesh Andhra Pradesh Jharkhand Chhatisgarh Orissa Bihar Sikkim Meghalaya West Bengal Tripura Arunachal Pradesh Assam Mizoram Nagaland Manipur 10 urban sites Advocacy to have PPM All 40 sites innovate for PPM models Karnataka Lakshadweep Kerala Tamil Nadu Pondicherry A&N Islands
RNTCP TBpert Project-UNITAID Guidance document developed for use of pert-mtb/rif including innovative models for private sector engagement 2 National level trainings conducted (20 sites per training) to sensitize all sites. Onsite trainings at sites on technical aspects on handling and trouble shooting
Innovative PPM approaches Clear message to private providers Open access to tests and treatment - free of cost Clinical indications to test- Pedriatic, TB/HIV Notification and monitoring progress Using all medium of communications Standards for TB Care in India ICT solutions to bridge information gap
Outcome of TBpert Project (UNITAID) from 40 sites (Jul-Dec 2013)* 2500 2000 2052 1500 1000 500 570 0 MTB detected MTB Rif Detected * Data source from implementing sites
4. Accelerating access to quality TB diagnosis for pediatric cases in 4 major cities in India Establishment of pert-mtb/rif labs at Delhi, Chennai, Kolkata and Hyderabad Identification of key hospitals and private clinics catering to pediatric populations and establish referral network for pediatric Engaging more number of pediatricians for referrals Sensitization meeting for identified key personnel
5. Innovative intensified TB case finding and appropriate treatment at high burden ART centres in India (PEPFAR) Major Interventions ICF at ART centres (use of pert MTB/Rif) IPT among PLHIV Daily regimen for coinfected AIC at ART centres 4 high HIV burden states MH, KA, TN, AP 30 pert machines
PPM Initiatives to Integrate pert into RNTCP Public-Public Mix (pert from different source; sensitization, trainings, consumables and treatment from RNTCP) 4 pert in Government Medical Colleges (PGI Chandigarh, AIIMS New Delhi, SMS Jaipur, BJ Medical College Gujarat) 4 pert proposed in Railways Hospital (pert, sensitization and trainings from RNTCP; consumables from Ministry of Railways) Public-Private Mix (pert, consumables, trainings and treatment from RNTCP) pert in 1 Private Medical Colleges (CMC Vellore) Private-Private Mix (pert diagnosis at subsidized price by private providers with technical support from NGO; treatment support from RNTCP) 49 pert under IPAQT (Initiative for Promoting Affordable, Quality TB Tests)
Vision of National Strategic Plan for pert-mtb/rif Source 2012-13 2013-14 2014-15 2015-16 2016-17 GF SSF 300 300 GoI 100 200 Other sources 129 Total 529 500 Priority areas for deployment of pert-mtb/rif Medical Colleges with DR TB centers ART Centres Urban TB Districts High workload districts
Acknowledgements Ministry of Health & Family Welfare, GoI Central TB Division National Expert Committee National TB Institutes NIRT, Chennai NITRD, New Delhi NTI, Bangalore JALMA, Agra RMRC Bhubneswar BMHRC Bhopal State and District TB programme managers and staffs DR TB Centre committees Culture and DST laboratory staff World Health Organization Stop TB Partnership Global TB Programme Country Office for India RNTCP medical consultants UNITAID USAID World Bank The Global Fund FIND PATH
Many thanks to all