Report from the Stop TB Working Groups 2009

Report from the Stop TB Working Groups 2009 Dr J. M. Chakaya Stop TB Symposium "Addressing poverty through quality TB control and research" 3 December 2009, Cancun, Mexico 1

Outline presentation 1. Key messages Global Plan to Stop TB 20062015: progress report 2006 -2008 2. Achievements of the Stop TB Partnership Working Groups in 2009 & plans for 2010 -2011 2

The global plan to Stop TB 20062015: progress report 2006 -2008 Key messages: • Number of TB patients in DOTS programmes has increased, as has the case detection rate • However, progress in case detection of SS+ lags behind Global Plan expectations and gap is widening • Treatment success rate in DOTS programmes has surpassed the targets set in the Global Plan reaching 85% in 2006 3

The global plan to Stop TB 20062015: progress report 2006 -2008 Key messages: • Progress in scaling up diagnosis and treatment of MDRTB, but not enough. Less than 3% of estimated 500, 000 cases of MDR-TB that occurred in 2008 are diagnosed and treated in GLC approved projects or programmes. • Impressive progress in scaling up collaborative TB/HIV activities, particularly provision of HIV testing for TB patients in African countries. Nonetheless, the number of HIV positive patients started on CPT and ART is about one-third of the milestones set in the Global Plan, and provision of IPT for HIV-positive people without TB remains extremely limited. 4

The global plan to Stop TB 20062015: progress report 2006 -2008 Key messages: • The number of HBCs implementing ACSM has grown, but many countries are seeking further technical guidance. • Based on data provided for 101 Countries with 93% of the world's TB cases, the funding gap for implementation of TB control (excluding the Eastern European region) has been at least USD 1 billion in each year 2006 -2008. • Funding for DOTS implementation came closest to matching Global Plan milestones, especially in 2008. 5

STRUCTURE OF THE STOP TB PARTNERSHIP GLOBAL PARTNERS' FORUM Coordinating Board Partnership Secretariat Global Drug Facility W O R K I N DOTS expansion TB/HIV New TB Vaccines G G R MDR-TB New TB Diagnostics WHO Strategic and Technical Advisory Group O U P S GLI New TB Drugs 6

STRUCTURE DEWG 2009: 3 new subgroups DOTS EXPANSION ACSM subgroup Childhood TB subgroup HRD-TB subgroup Innovative approaches and new tools subgroup PPM subgroup TB& Poverty subgroup Overall focus: Achieving higher and earlier case detection and maintain high cure. 7

DEWG Plan of Action: Outline 10 outputs defined in the DEWG plan of action: 1. Reinforcing support to Countries 2. Monitoring Global plan implementation (WHO TB control report and Stop TB partnership report) 3. Funding TB control in Countries 4. Health system strengthening 5. Human resource development 6. ACSM & Involvement of communities and patients 7. TB and poverty 8. Control of childhood TB 9. Public Private Mix 10. Introduction to New Approaches and new Tools (INAT) 8

1. Reinforcing support to Countries: How has TBTEAM progressed? 2007 2008 2009 (Jan – Oct) Missions entered 281 456 1102 Requests successfully addressed 11/12 (92%) 57/66 (86%) 48/55 (87%) Focal points using web tool 7 14 30 Experts in roster ? performing missions 1/3 9

1. Reinforcing support to Countries: selection of TBCAP APA 4 supported activities Tool /project (Oct 2008 - September 2009) Lead TBCTA Partner Description Expanded use of planning and budgeting tool WHO 2 workshops: one for 16 francophone African countries and one for GLC consultants Dissemination of X-ray tool JATA Training workshops in use of the tool in Asia and Africa Tool to estimate patients' costs KNCV Information from Ghana, Vietnam and Dominican Republic Manual for TB specific DQA Tool WHO/ KNCV/ The Union Tool and guidelines - field testing in 4 Countries QUOTE TB Light - patient centered approach KNCV Tested in Nigeria and Brazil. Training workshops on TB Infection control, PAL, Lab culture & DST WHO and The Union Capacity building for several priority countries Institutional capacity building PMU 10 Support to training centres in Nigeria and Indonesia

2. Monitoring & Evaluation: achievements 2009 WHO Global TB control report 2009, an update An update of the global TB control report is being published in December, reporting data from 2008. From 2010 WHO is planning to publish the report towards the end of the year, reporting data of previous year. *See: http: //www. stoptb. org/tme/ Task force on Impact Measurement: 1. Strengthening routine surveillance through regional workshops & country missions 2. Implementation of prevalence surveys for TB disease in 22 Global Focus Countries (out of which 16 TB HBC) - Vietnam and the Philippines completed survey and analysis 3. Review of methods used to produce epidemiological estimates of the epidemiological burden of TB, TB/HIV and MDR-TB 11

3. Funding TB Control: achievements 2009 1. Global Fund Round 9 TB: 500 M for 2 years 54 Countries applied 32 approved (59%) 12

4. Health System Strengthening: achievements 2009 1. HSS framework used in Global Fund proposal preparation and in programme reviews 2. PAL implemented in 12 Countries (expansion phase) and more than 40 Countries are at different stages of implementation or preparation of PAL implementation. 13

5. Human Resource Development: achievements 2009 1. "Planning the development of human resources for health for implementation of the Stop TB Strategy - A handbook" disseminated 2. Training modules for Management of TB at Health Facility level revised to reflect all components of the Stop TB strategy including infection control 3. HRD on the website of the WHO Stop TB Department 4. Establishment of a HRD-TB subgroup under DEWG (October 2009) 14

5. Human Resource Development: orientation 2010 -2011 1. Annual meeting of the HRD-TB Subgroup & 2 core group meetings 2. HRD best practice Symposia at Union Conference 3. Training material for management of TB at district level and supervisory levels (including MDR-TB and TB-HIV) 4. Collaboration with partners in related fields: Human Resources for Health; Health System Development; the Global Health Workforce Alliance, etc. 5. Exchange of experiences in HRD-TB 6. TA to Countries for HRD planning, implementation and monitoring 7. Inclusion of HRD in all programme reviews 15

6. ACSM subgroup: achievements 2009 • ACSM Best Practices • Document on how to work with media for correct reporting of key TB messages to a wide audience • Revision of ACSM indicators with WHO/TME • Criteria for TBTEAM experts roster for ACSM TA providers were set to ensure quality and consistent TA 16

6. ACSM subgroup: orientation 2010 -2011 • • • Guidance on M&E for ACSM and community involvement (Rio Recommendation) Support strategic planning, design, implementation and evaluation of ACSM interventions Advocate ACSM as crosscutting issue affecting all components of Stop TB Strategy 17

7. TB & Poverty subgroup: achievements 2009 Advocacy • Debate on ‘Free Diagnosis’ in Partner's Forum, Rio de Janeiro, Brazil • Systematic review on interventions addressing socio-economic conditions which can potentially be replicated in TB control Research • Patient cost measurement tool piloted • Mechanisms to increase equity in access to TB diagnosis in China piloted (to eliminate patient up-front payment) • Measurement of equity impact through NDWG Blueprint and TREAT TB Support • Global Indigenous STOP TB Strategy presented at UN Permanent Forum on Indigenous Issues • Programme managers in 24 Chinese provinces trained on equity and gender • Health systems trials in Malawi and Sudan to increase access to TB and HIV services through close-to-community providers 18

7. TB & Poverty subgroup: orientation 2010 -2011 • By 2010 all Countries will: - have capacity to monitor extent to which TB control reaches the poor & vulnerable - have key strategies for improving access to TB control for the poor & vulnerable • Selected directions for 2010 -2011 - Promotion of concepts & practical implementation of free diagnosis - Papers on equity and PPM - Recruitment of indigenous TB focal person - Assessment of equity in access to MDR services 19

8. Childhood TB: achievements 2009 • Programme reviews (India, Bulgaria, Romania) • TA to develop training and national guidelines (Pakistan, Philippines, Papua New Guinea) • International Training Workshops in Cape Town (Sept 2009) & Bangalore, Delhi and Nepal (October 2009) • Post-Graduate courses at Union European conference in Dubrovnik (May 2009) & global conference in Cancun (December 2009) • Systematic literature reviews to update Childhood TB Guidance (2006) & revised instructions on the use of existing fixed-dose formulations Update of the Guidelines on INH Preventive Chemotherapy in HIVinfected children (work led by WHO HIV Department) Creation of a Childhood TB subgroup on New Diagnostics • • 20

8. Childhood TB: orientation 2010 -2011 • • • Finalize revision of Childhood TB Guidance TA to Countries developing training material and guidelines Participation in programme reviews Post-graduate courses and symposia at the Union's conferences (global and regional) Research agenda – trials in use of new diagnostics and new drugs in children 21

9. PPM subgroup: achievements 2009 • Grants awarded to 11 National Professional Associations to prepare ISTC implementation plans (ATS) • Guiding principles on linking hospitals (KNCV) • Pilot projects on "Engaging all care providers for TB/HIV collaborative activities" implemented in India and Namibia (Union/FHI) • Workplace TB and TB/HIV programmes were documented in Bangladesh, Cambodia, Kenya, Philippines & South Africa (WHO) • Experience on engaging social security organizations in TB control documented in Mexico, Peru and Philippines (MSH/WHO) 22

9. PPM subgroup: achievements 2009 • Guidance on measuring PPM contribution to TB control (WHO/MSH/Union) • "First consultation on engaging business sector in TB control" Geneva, 12 October 2009 (WHO) • Supply and use of anti-TB medicines documented in UR Tanzania, Zambia, Brazil and India (WHO) • PPM scale up documented in India and China (WHO) • Preliminary analysis of PPM components of Global Fund grants (WHO/GF) • PPM for MDR-TB management documented in Bangladesh and Philippines • Background paper on PPM for Beijing meeting • PPM Newsletter 23

9. PPM subgroup: orientation 2010 -2011 • • 6 th global meeting of the PPM Subgroup PPM tool-box on evidence-based strategies to engage different types of public and private care providers Framework to assist Countries implement PPM components of their Global Fund proposal Revise and update PPM guidance document Conduct a review of best practices on regulatory approaches to improve service delivery (e. g. TB drug availability, disease notification laws, certification and accreditation systems) TA to Countries for PPM planning and implementation & inclusion of PPM in programme reviews Guidance on engagement of large hospitals in TB control efforts Advocacy for PPM through quarterly E-updates and website 24

10. Introducing new approaches and tools Terms of Reference: • Facilitate Country planning to prepare for coming new approaches and technologies to improve case detection through documents and tools developed by the Retooling Task Force and the new Working Group on Introducing new approaches and tools (INAT) • Promote operational research or pilot programmes to develop algorithm and approaches to improve case detection 25

10. Introducing new approaches and tools: orientation 2010 -2011 • First working group meeting Feb 2010 • Regularly update pipeline for new diagnostics, drugs and vaccines • Solicit NTPs & implementing partners on the challenges of introducing new approaches & tools • Support Countries to develop a preparation plan for INAT • Lead and participate in Operational Research and/or pilot studies • Simulate TB control 2015 model to better advice Countries (To be confirmed by 1 st Working Group Meeting in Feb 2010) 26

GLI: Achievements 2009 • New WHO diagnostic policies (STAG, Nov 2009) LED microscopy; Same-day diagnosis "Front loading"; Selected noncommercial culture and drug susceptibility testing methods • EXPAND-TB project Accelerated uptake of new MDR-TB diagnostics in 27 Countries 2009 2013 with state-of the-art commodities (instruments, tests, reagents) funded by UNITAID (USD 87 million over five years) • TBCAP Laboratory Toolbox - Standard Operating Procedures (SOPs) - Logistics/Supply Management Tool - External Quality Assurance package (EQA) - Management Information System (MIS) - Culture & DST Package 27

GLI: Strategic priorities 2010 -2011 • Expanding access to new diagnostics (EXPAND-TB project): 15 Countries to be added by 2012 • WHO policy guidance on laboratory bio -safety, immune-based diagnostic tests, gene. Xpert molecular system • Expansion of the Supranational Reference Laboratory Network • Laboratory human resource development, in particular training of consultants in use of LED microscopy & selected non-commercial culture and DST methods 28

Working Group Highlights of activities in 2009: • Implementation TB/HIV collaborative activities expanded – By end of 2008, 1. 4 million TB patients tested for HIV and 1. 4 million PLHIV screened for TB – By 2008, 0. 11 million HIV positive TB patients put on ART and 0. 23 on CPT – Expansion in Asia Pacific – WG meeting in Bali in August 2009 • Raised TB/HIV research interest and investment • TB/HIV Indicators harmonised – WHO, PEPFAR, UNAIDS, Global Fund will now use same indicators • TB/HIV one of nine priority areas for UNAIDS 29

Working Group Areas of focus 2010 -2011: • Nationwide scale-up of TB/HIV activities in Asia and Africa including TB IC activities • European focus—Regional TB/HIV WG meeting in July 2010 in Vienna, Austria • Promote integrated models of TB and HIV programs and services • Focus on the implementation of the three I's for HIV/TB including WHO TB IC policy • Finalise the guidelines for reconceptualised implementation of TB screening with IPT 30

MDR-TB Working Group: Achievements 2009 • Support to WHO in conducting the Ministerial meeting of High MDR-TB burden countries, Beijing, PR China, April 2009 • As of September 2009, the GLC has approved 59, 274 patient treatments in 108 projects spanning 68 Countries • Assistance to GDF • Research agenda focusing on scale-up of PMDT updated • Research subgroup launches RESIST-TB and develops clinical trial protocols 31

MDR-TB Working Group: Plans for 2010 • MDR-TB Core Group - Monitor and review progress to Global Plan, including both progress made under and outside the GLC - Coordinate the response (i) to scale-up bottlenecks and (ii) imbalance between capacity to diagnose and treat - Strengthen advocacy at country- and global level - Strengthen collaboration with other STP WGs and sub-groups, especially GLI, INAT, HRD and IC • GLC - Revisit GLC modus operandi in light of scale up from pilot projects to country wide programs (including TA) 32

MDR-TB Working Group: Plans for 2010 • Research subgroup - Advocate for funding of clinical trials - Develop protocol for multi-country collection and analysis of DR surveillance data (causes of DR-TB) - Plan and advocate for programmatic cohort studies (diagnostic algorithms, treatment adherence and support) - Support GLC and Countries on analyses of SL treatment data and operational research proposals • Drug management subgroup - Assist GDF and BAC in addressing SLD problems - Further develop/monitor "streams of engagement" - Systematically collect and share Country experiences 33

Working Group on New Diagnostics: Achievements 2009 • Point-of-care diagnostics Sub-Group organized symposium at ESM 30 th annual congress Porto • Evidenced-based diagnostics Sub. Group established website: www. tbevidence. org • UNITAID project launched covering 27 endemic Countries (collaboration WHO/GLI, FIND and GDF) • Total membership doubled in the last year 34

Working Group on New Diagnostics: Achievements 2009 • LED-microscopy, front-loaded microscopy and sputum processing methods to improve microscopy submitted to STAG for endorsement • Non-commercial culture methods and mycobacteriophage-based assays for rapid DST submitted to STAG for endorsement • Publication Pathways to better diagnostics for tuberculosis: a blueprint for the development of TB diagnostics • New Paediatric TB Sub-Group established 35

Working Group on New Diagnostics: plans 2010 • Automated DNA detection for HIV/TB & MDR-TB to STAG for endorsement • Global Plan to Stop TB 2006 -2015 mid-term update • Wide dissemination of Pathways to better diagnostics for tuberculosis: a blueprint for the development of TB diagnostics • Workshop on TB diagnostic research in Montreal • Expansion of website to include Sub-Group activities 36

Working Group on New Drugs: achievements 2009 • Reorganization of the Working Group • Website updated to facilitate the coordination and communication of WGND activities: www. newtbdrugs. org • • Survey of TB drugs R&D community Launch online Global TB Drugs R&D Pipeline Communications/advocacy campaign Workshop on Pediatric TB Drug Development 37

Working Group on New Drugs: Plans 2010 • Online resource on target-based screening campaigns • Global survey of research activities in the area of tools for TB • Increase understanding of pyrazinamide • Develop a program to prepare clinical sites to conduct trials for drug-sensitive and drug-resistant TB 38

Working Group on New TB Vaccines: Achievements 2009 • 2 nd meeting Economics and Product Profiles Task Force • Small grants for development of community-based advocacy materials • Clinical trial site staff participated in Tuberculosis Vaccine Trial Sites Network (TBVACSIN) meeting in Uganda • Meeting on "Advancing live TB vaccines in clinical trials" (April 2009) & publication of proceedings submitted to Vaccine • Vaccine regulatory capacity strengthened through collaboration with the African Vaccine Regulators Forum (AVAREF) and the Developing Countries Vaccine Regulators Network (DCVRN) • Comprehensive survey of TB vaccine candidates • Updated TB Vaccines Pipeline overview 39

Working Group on New TB Vaccines: Focus in 2010 -2011 • Economic estimates for TB vaccine development & introduction • Consensus building on issues in clinical research • Increase awareness and support for new TB vaccines at the global and country level • Strengthening regulatory capacity in HBCs • Mobilizing resources for TB vaccine development • Planning and implementing the 2 nd Global Forum on TB Vaccine Research in 2010 40

Thank you! 41