The United Republic of Tanzania

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The United Republic of Tanzania Ministry Of Health Community Development, Gender, Elderly and Children National Tuberculosis and leprosy Programme, Annual report for 2014 National TB and Leprosy Programme (NTLP) Department of Preventive Services Ministry of Health Community Development, Gender, Elderly and Children 6Samora Machel Avenue P. O. Box 9083,1147 Dar es Salaam Tanzania Tel/Fax: +255-22-2124500 Web:www.ntlp.go.tz

Table of Contents List of tables... 4 List of figure... 5 List of annexes... 6 List of abbreviations... 7 Acknowledgement... 9 1 GENERAL BACKGROUND... 10 1.1 Demographic and social economic profile... 10 1.2 Summary of health services... 10 1.3 Summary of NTLP activities... 10 1.4 Financial Support... 11 2 HUMAN RESOURCE DEVELOPMENT... 12 2.1 Staff establishment... 12 2.1.1 Tuberculosis and Leprosy Central Unit (TLCU)... 12 2.1.2 Regional Tuberculosis and Leprosy Coordinators (RTLCs)... 14 2.2 Training activities, meetings and conferences... 15 2.2.1 Trainings... 15 2.2.2 Meetings... 15 3 TUBERCULOSIS CONTROL SERVICES... 15 3.1 Tuberculosis case notification 2014... 15 3.2 Tuberculosis treatment outcome for cohort notified in 2013... 19 3.2.1 New and relapse cases... 19 3.2.2 Treatment outcome of previously treated TB cases notified in 2013... 20 3.3 TB/HIV case finding 2014... 22 3.4 Management of Pediatric TB... 23 3.4.1 Childhood TB notifications 2014... 23 3.4.2 Childhood TB/HIV notifications 2014... 24 3.5 Management of MDR-TB... 24 4 LEPROSY CONTROL SERVICES... 28 4.1 Leprosy Case Notification... 28 2

4.2 Leprosy treatment outcome... 34 4.2.1 Treatment outcome of PB leprosy... 34 4.2.2 Treatment outcome of MB leprosy... 35 4.3 Activities related to acceleration of leprosy elimination efforts... 36 Conducted one leprosy elimination campaign (LEC) at Mkinga DC. The campaign was one of the activities during the commemorations of world leprosy day in Tanga region. In one week, 22 new cases were actively found and initiated on MDT.... 37 Started preparatory activities to introduce leprosy post-exposure prophylaxis (LPEP) in Tanzania in three pilot districts of Kilombero, Liwale and Nanyumbu. Through this programme, family members of the index case will be screened to rule out leprosy disease and being given a single dose rifampicin. The intervention will largely contribute to efforts to detect leprosy disease early and cut down the transmission chain.... 37 4.4 Activities related to prevention of disabilities (POD)... 37 4.4.1 People with leprosy related disabilities... 37 4.4.2 Leprosy reactions... 37 4.4.3 Specialized care of people with disabilities... 39 4.4.4 Footwear Programme... 39 5 LABORATORY SERVICES... 41 5.1 Summary of services... 41 6 PROGRAMME SUPPORT ACTIVITIES... 50 6.1 Procurement and Supply Management of Anti-TB and Anti-Leprosy Medicines... 50 6.2 Community empowerment activities... 52 6.3 Advocacy, Communication and Social Mobilization (ACSM) activities... 54 6.4 Logistic Support... 56 6.4.1 Transport... 56 6.5 Public and Private Partnership (PPP)... 56 6.6 TB in Mining sector... 57 6.7 Supportive Supervision... 57 6.8 Data Quality Assessment (DQA)... 58 6.9 TB epidemiological and Impact Analysis... 59 6.10 NTLP External Programme Review... 60 3

List of tables Table 1: Source of Funds in 2014 Table 2: Tuberculosis cases notified in Tanzania 2013 2014 Table 3: Tuberculosis treatment of all forms of TB new and relapses notified in 2013 Table 4: Treatment outcomes of previously treated cases notified in 2013 Table 5: Treatment outcomes of MDR TB enrolled for treatment, 2009-2012 Table 6: New leprosy cases detected by indicators in 2014 by regions Table 7: Districts with prevalence rate greater than 1/10,000 Population in 2014 Table 8: Treatment outcome of PB leprosy reported in 2013 Table 9: Treatment outcome of MB leprosy notified in 2012 Table 10: Leprosy cases started treatment with corticosteroid in 2014 Table 11: Number of leprosy admissions in hospitals 2014 Table 12: Materials and tools distributed for fabrication of special and local shoes production per region in 2014 Table 13: Total number of specimens received at the CTRL Table 14: Number of Specimens Received per Month per Case Table 15: Number of Specimens per Case category by Regions Table 16: Culture results Table 17: Microscopy-Culture correlation Table 18: DST 1st LINE profile Table 19: DST 2nd LINE profile Table 20: DST Profile key Table 21: Molecular method Table 22: Molecular method Table 23: Xpert MTB/Rif results per type of specimen Table 24: Xpert MTB/Rif results per Quarterly comparison Table 25: The table below summarizes the stocks of anti-tb and anti-leprosy drugs distributed in the country in 2014. 4

Table 26: Community contribution to TB control and Patient care for 2013 and 2014 List of figure Figure 1: Distribution of TB cases notified by regions in 2014 Figure 2: Age and Sex distribution of new bacteriologically confirmed TB cases notified in 2014 Figure 3: TB notification rate (new and relapses) by region for 2014 Figure 4: Trend of Previously Treated TB cases notified form 2005 to 2014 Figure 5: Treatment outcomes of previously treated cases notified in 2013 Figure 6: Trend of TB patients counseling and testing for HIV, initiated CPT and ART: 2007 2014 Figure 7: HIV testing among TB patients in 2014 by regions Figure 8: MDR TB patients enrolment by Year Figure 9: Age and Sex distribution of MDR TB cases enrolled on treatment in 2010 Figure 10: Distribution of MDR-TB cases enrolled on treatment by regions in 2014 Figure 11: MDR TB outcomes in 2009-2012 Figure 12: The contribution of regions of new cases detected in 2014 Figure 13: Trend of new leprosy cases reported: 2005 2014 Figure 14: Trend of MB cases, children and females among new leprosy cases: 2005 - Figure 15: Trend of disability grade 2, percentage among new cases and rates per 1,000,000 populations Figure 16: Trend of new leprosy cases detected and registered: 2005 2014 Figure 17: Trend of leprosy cases completed treatment: 2004 2013 Figure 18: Total specimen received at CTRL in 2014 per month per case Figure 19: smear culture results, 2014 Figure 20: Map showing Xpert sites in the country Figure 21: Xpert MTB/Rif results per type of specimen 5

List of annexes Annex 1: Tuberculosis patients (all forms) notified in Tanzania by region in 2014 Annex 2: Age and sex distribution of new and relapse TB cases notified in 2014 Annex 3: Treatment results of new and relapse TB cases notified in 2013 Annex 4: Treatment results of all re-treatment TB cases except relapse notified in 2013 Annex 5: Tuberculosis and HIV positive patients notified 2014 Annex 6: Leprosy Patients reported by regions in 2014 Annex 7: Age and sex distribution for newly detected leprosy patients in 2014 Annex 8: Disability grading of newly detected leprosy patients by region in 2014 Annex 9: Leprosy Patients Registered by region at the end of 2014 6

List of abbreviations ACSM Advocacy Communication and Social Mobilization AFB Acid Fast Bacilli AIDS Acquired Immuno-Deficiency Syndrome BMRC British Medical Research Council CDC Centres for Disease Control CPL Central Pathology Laboratory CTRL Central Tuberculosis Reference Laboratory DDH District Designated Hospital DOTS Directly Observed Treatment Short Course DST Drug Susceptibility Testing DTLC District Tuberculosis and Leprosy Coordinator EQA External Quality Assessment ETH Ethambutol FDC Fixed Dose Combination FIND Foundation for Innovative New Diagnostics GFATM Global Fund to fight AIDS/HIV Tuberculosis and Malaria GLRA German Leprosy and TB Relief Association HFN High False Negative HFP High False Positive HIV Human Immunodeficiency Virus HMIS Health Management Information System IEC Information Education and Communication INH Isoniazid IUATLD International Union Against Tuberculosis and Lung Diseases KNCV Royal Netherlands TB Association LEC Leprosy Elimination Campaign LED Light Emitting Diode LFN Low False Negative LFP Low False Positive LPA Line Probe Assay MB Multi bacillary (leprosy MDR-TB Multi Drug Resistant Tuberculosis MNH Muhimbili National Hospital 7

MoHSW MSD MSH NGO NIMR NRA NTLP PALs PATH PB PCT PEPFAR PLHIV PoD RTLC QE RIF RR RSS SDC STR TB TLCU WHO Ministry of Health and Social Welfare Medical Store Department Management Science for Health Non- Governmental Organization National Institute for Medical Research Royal Netherland Association National Tuberculosis and Leprosy Program People affected by leprosy Programme for Appropriate Technology in Health Pauci bacillary (leprosy) Patient Centred Treatment President s Emergency Plan Funds or AIDS Relief People Living with HIV Prevention of Disabilities Regional Tuberculosis and Leprosy Co-ordinator Quantification Error Rifampicin Rifampicin Resistance Routine Surveillance System Swiss Development for International Cooperation Streptomycin Tuberculosis Tuberculosis and Leprosy Central Unit World Health Organisation 8

Acknowledgement This report is the work of different stakeholders involved in the control of tuberculosis and leprosy in the country. The data presented in this report is generated by the general health workers and compiled by the district TB and leprosy coordinators under the supervision of the regional and national levels. I take this opportunity to acknowledge their dedication to the control of the two diseases especially now when there is emergency of drug resistance tuberculosis (DR TB) and there is a global movement to eradicate leprosy as a public health problem. I would also like to thank the Government of Tanzania for the dedicated commitment to control the two diseases and for mobilising resources from development partners to support the National TB and leprosy programme. In particular, I would like to recognise the financial support from: Germany Leprosy and Tuberculosis Relief Association (DAHW/GLRA) World Health Organization (WHO) The Global Fund to Fight HIV/AIDS, Tuberculosis and Malaria (GFATM) Centre for Disease Control (CDC) International Union Against TB and Lung Disease (IUATLD) United State Agency for International Development (USAID) Funds for Innovative New Diagnostic (UNITAID/FIND) Novartis Foundation (NF) Management Science for Health (MSH) Global Drug Facility (GDF) The Netherlands Tuberculosis Foundation (KNCV) On behalf of the programme, I would like to express my sincere gratitude for the support and encouragement given to us by the Permanent Secretary, Chief Medical Officer and all of the directors. Dr Beatrice Mutayoba 9

Programme Manager (NTLP) October 2015 1 GENERAL BACKGROUND 1.1 Demographic and social economic profile In 2014 is Tanzania projected to have a population of 47,431, 812 with 51% of the population being female while male were 49%. This is based on the projection from the 2012 census. The population of urban inhabitant was 29.6 % of total population. About 52% of the population are the working age (15 64); 44% are young (0 14 years) while 4% are elderly (65+ years). The annual growth rate is estimated at 2.7% from 2002 to 2012 census. The population of Zanzibar is projected at 1,341,713 with a growth rate of 2.8%. Agriculture is still a major source of livelihood for majority of the population in Tanzania According to World Bank report, 2013 per capita income (GDP per capita) is US $ 694.77 categorizing Tanzania as a low income country. However, in the past five years the country has enjoyed good progress in economic growth averaging above 6%. 1.2 Summary of health services Health care delivery system in the country is well established with more than 7,214 health facilities. 3,500 health facilities have at least one TB patients receiving TB treatment while 1,500 health facilities had at least one leprosy patient receiving treatment. The major provider of health services is the government, which own or run 69% of all the health facilities including the Designated District Hospitals (DDH). Tanzania is classified as one of the least developed countries, with total expenditure on health per capita of US$ 126 (WHO). Data from Health Information Management System (HMIS) of the Ministry of Health and Social Welfare shows that communicable diseases are still the major cause of morbidity and mortality in the country driven by HIV epidemic with national prevalence of 5.1% in the population aged 15-49 years. TB has continued to be among the top ten cause of death and is ranked 6th among admission aged five years and above in the country. 1.3 Summary of NTLP activities In the period of January December 2014, NTLP implemented its annual plan in line with NSP IV (2009-2015). All activities conducted focused on addressing six NSP 10

strategic objectives i.e. (i) Achieve universal access to quality DOTS and MDT services in both public and private sectors. (ii) Reduce the burden of TB/HIV and drug resistant TB with special emphasis on vulnerable populations. (iii) contribute to health system strengthening based on primary health care (iv) scaling up involvement of more private health care providers (v) empowering patients and community members to take active participation in TB prevention and care (vi) collaborating with internal and external partners in conducting relevant operational research. Other major activities that were implemented includes: conducting Tanzania National Tuberculosis and Leprosy Programme External Review; Development of new National Strategic Plan for Tuberculosis and leprosy control (2015 2020); and TB epidemiological and impact assessment. Leprosy elimination activities were conducted by performing a number of leprosy elimination campaigns in targeted areas. 1.4 Financial Support The Ministry of Health and Social Welfare through National Tuberculosis and Leprosy Programme (NTLP) received US$ 8,125,333.63 through government consolidated funds, external grants and loans in year 2014. Government resources channeled through the programme for programme management and at lower levels to support the health system and infrastructure maintenance as well as staff remuneration for staff working (nurses, clinicians and lab staff a lower levels we made a full time equivalent approximation) for TB. Direct cash was received from Centers for Disease Control and Prevention (CDC) grant, The Global Fund (GFR6 TFM & BF) grant, The World Bank (IDA) loan, German TB and Leprosy Relief Association (GLRA) grant and World Health Organization (WHO) grant as detailed below. Many other local research institutions, academia, private sector organizations and community based Civil Society Organizations (CSSOs) not herein mentioned were also active partners/collaborators in various TB interventions: Table 1: Source of Funds S/N Source of Funds Amount in US$ 1. Government Contribution 2,083,440.00 2. Germany Leprosy Relief Association GLRA 385,400.00 3. Centre for Disease Control and Prevention CDC 2,677,149.00 4. World Health Organization TDR (carried forward from previous period) 9,114.35 5. GFATM (carried forward from previous period) 2,655,998.07 11

6. World Bank (IDA) 33,333.33 7. Basket Fund 280,898.88 TOTAL FUNDS 8,125,333.63 2 HUMAN RESOURCE DEVELOPMENT The Programme is composed of both government and contract employees at central unit (TLCU) with focus on strengthening TB/HIV and Leprosy services in the country. Contract employees were recruited through various grant support including GFATM and CDC/PEPFAR at the central level. TB/HIV Officers who were recruited through PATH support had to be absorbed in the government payroll through district councils following phasing out of the organization. During this reporting year, the programme strengthened its effort in building capacity of staff through various trainings such as TB/HIV, Paediatric TB, ACSM, community TB, DHIS2 user training and Laboratory with funding sources from WHO, GF and CDC PEPFAR according to the national guidelines. 2.1 Staff establishment In this reporting year there were 33 staffs at central level and 30 staffs at regional level identified as Regional Tuberculosis and Leprosy Programme Coordinators (RTLC). New RTLCs were recruited for Katavi, Geita, Tabora, Kigoma, Mtwara, Rukwa, and Iringa. New DTLCs were also deployed in the district councils. For those regions and councils which were not fully established, RTLCS and DTLCS from the mother regions and councils continued to oversee and coordinate TB and leprosy control activities in the newly established regions and district councils until when they are fully fledged to own their coordinators. During this period, Dr Beatrice Mutayoba was appointed to be the Programme Manager, four staff were transferred to other units within the Ministry namely Mr Jerome Ngowi, Ms Evaline Mapunda, and Ms Grace Hatibu. Mr Jumanne Mkumbo, Ms Neema Voniatis, Ms Elda Magawa, and Mr. Joachim Kizuri joined the Programme as a transfer also within the Ministry. 2.1.1 Tuberculosis and Leprosy Central Unit (TLCU) The list of TLCU staff by December 2014 was as follows: 1. Dr B. Mutayoba - Programme Manager 12

2. Dr L. Mleoh Deputy Programme Manager 3. Dr M. Nyamkara TB/HIV Coordinator 4. Mr B. Msuya Head Accountant 5. Mr L. Ross Accounts Assistant 6. Mr J. Ngowi Programme Pharmacist 7. Mr J. Mkumbo Programme Pharmacist 8. Mr B. Bariki Programme Pharmacist 9. Dr J. Lyimo - MDR Coordinator 10. Mr D. Kayumba Administrator 11. Ms D. Semu Prevention of Disabilities Coordinator 12. Mr P. Shunda - Orthopaedic Technologist 13. Ms D. Kasembe Training Coordinator 14. Ms B. Doula Head, National TB Reference Laboratory 15. Ms L. Ghasia Health Secretary 16. Mr S. Bossy Senior Laboratory Technician 17. Ms D. Mtunga Laboratory Technician 18. Dr A. Tarimo PPP Coordinator 19. Dr V. Mboneko Programme Officer 20. Ms L. Ishengoma Community TB care Coordinator 21. Ms A. Mshanga ACSM Coordinator 22. Mr E. Nkiligi Data Manager 23. Mr N. Mwangaba Data analyst 24. Ms K. Kadege Assistant Accountant 25. Ms E. Mapunda - Assistant Accountant 26. Ms C. Chipaga - Data entry clerk 27. Ms J. Goodluck - Data entry clerk 28. Ms G. Tairo - Data entry clerk 29. Ms K. Kassim - Data entry clerk 30. Mr M. Penza - Data entry clerk 31. Ms A. Ponera - Secretary 32. Ms M. Haule - Secretary 33. Mr P. Kalombora Office Attendant 34. Mr E. Mdika - Driver 35. Mr A. Shabani Driver 36. Mr D. Kanyandeko Driver 37. Mr B. Tayari - Driver 13

2.1.2 Regional Tuberculosis and Leprosy Coordinators (RTLCs) At the end of the reporting period, there were 28 RTLCs who coordinated TB and Leprosy control services at regional level in Tanzania mainland and 2 RTLCs from Zanzibar. Their names and respective regions are listed below: 1. Dr E. Ntulwe Arusha 2. Dr M. Lupinda - Kinondoni 3. Dr M.Chigwire Temeke 4. Dr S. Mbarouk Ilala I 5. Dr I. Mteza Ilala II (MNH & Private Hospital Dar es Salaam) 6. Dr M. Massimba Dodoma 7. Dr T. Orio Iringa 8. Dr M. Ndyeshobora - Kagera 9. Dr D. Leonard/Dr F. Baranuba Kigoma 10. Dr M. Chelangwa Kilimanjaro 11. Dr A. Pegwa Lindi 12. Dr M. Khan Mara 13. Dr Q. Qawoga Manyara 14. Dr Y. Msuya Mbeya 15. Dr E. Tenga Morogoro 16. Dr W. Byemelwa Mwanza 17. Dr. M. Kodi - Mtwara 18. Dr A. Mpangile Pwani 19. Dr D. Buhili - Rukwa 20. Dr W. Mtumbuka Ruvuma 21. Dr J. Majigwa Shinyanga 22. Dr M. Kimala Singida 23. Dr P. Pima - Tabora 24. Dr S. Kiluwa Tanga 25. Dr J. Mshana Unguja 26. Dr S. Hamad Pemba 27. Dr E. John - Simiyu 28. Dr D. Kalaso - Njombe 29. Mr. J. Mollel - Katavi 30. Dr M. Mashala - Geita 14

2.2 Training activities, meetings and conferences 2.2.1 Trainings During this year, various trainings were conducted among health care workers. The trainings covered mostly TB/HIV collaborative activities, Pediatric TB management, Laboratory EQA, DHIS2 users and different trainings on surveillance of communicable diseases, TB included which were conducted in and outside the country. The purpose of these trainings was to build capacity of health care workers towards improving quality of care in those areas. These trainings were supported by CDC/PEPFAR, GF ATM and SADC. 2.2.2 Meetings Quarterly meetings were conducted for RTLCs and DTLCs in the regions and districts respectively. Various conferences were attended both in and outside the country where by Coordinators presented experience in the control of TB and Leprosy from Tanzania. 3 TUBERCULOSIS CONTROL SERVICES 3.1 Tuberculosis case notification 2014 A total of 63,151 cases of all forms were notified in 2014, which shows a decline of 3.9% or 2,581 cases compared to the year 2013. Among the cases notified, new cases were 60,575 (95.9%) and the retreatment cases were 2,576 (4.1%) which is almost the same proportions for the past three years. Among the new TB cases, 23,447 (37%) were bacteriologically confirmed, 23,587 (37%) were clinically diagnosed and 13,441 (21%) were extra-pulmonary TB. Table 2 below shows the comparison of TB notification in 2013 and 2014 by TB category groups. Table 2: Tuberculosis cases notified in Tanzania 2013 2014 Indicators 2013 2014 Change Cases % Cases % cases % All forms 65,732 63,151-2,581-3.9 New forms - Bacteriologic confirmed 24,565 37.4 23,547 37.3-1,018-4.1 - Clinically diagnosed 23,371 35.6 23,587 37.4 216 0.9 - Extra-pulmonary 15,016 22.8 13,441 21.3-1,575-10.5 Total 62,952 95.8 60,575 95.9-2,377-3.8 Previously treated - Relapse 1,101 1.7 998 1.6-103 -9.4 15

- Failure 133 0.2 126 0.2-7 -5.3 - Return to control 251 0.4 295 0.5 44 17.5 - others 1,295 2.0 1,157 1.8-138 -10.7 Total 2,780 4.2 2,576 4.1-204 -7.3 Tuberculosis notification by regions Although the proportion of cases notified in Dar es Salaam city is progressively declining, but the region has remained to be the major contributor with 22%, followed by Mwanza region-7% and Mbeya 6%. A list of regions which contributed more than 4% remained the same as for the past three year with some other major cities increasing their contribution. Figure 1 below shows individual regions contribution by percentage and it indicates that over 66% or two third of cases notified during the reporting year came from only 10 regions in the United Republic of Tanzania. The remaining 20 regions contributed only a third of all TB cases notified. The reasons for such huge variations in among the regions need to be explored and investigated. Figure 1: Distribution of TB cases notified by regions in 2014 Other regions 34% Dar es Salaam 22% Mwanza 7% Mbeya 6% Kilimanjaro 4% Tanga Manyara 4% 4% Mara 4% Arusha 5% Morogoro 5% Shinyanga 5% Tuberculosis case notifications disaggregated by sex and age 16

The age-sex distribution of the new and relapse TB cases notified in 2014 shows that 36,772 (60%) cases were males and 24,801 (40%) females with a sex ratio of over 1:1.5. The number of children aged 0 14 years old notified among new and relapse cases were 6,489 (10.5%). Age-sex distribution of the new and relapse cases also shows that, the highest number of TB cases notified was in the age groups of 25-34 years and 35-44 years for both males and females as summarised in Figure 2 below. Figure 2: Age and Sex distribution of new bacteriologically confirmed TB cases notified in 2013 Tuberculosis notification rate The notification rate of all forms of tuberculosis new and relapses was 130 cases per 100,000 population. Notification rate of all cases new and previously treated cases including the failure, other and return after lost to follow up was 133 which were smaller compared to 142 cases per 100,000 in 2013. Dar es Salaam region had the highest TB notification rates in the country at 272 cases per 100,000, Kigoma region has the lowest TB case notification rate of 34 cases per 100,000, followed by Pemba Island (42) and Rukwa region (44). The figure below shows notification of TB cases by region. 17

Figure 3: TB notification rate (new and relapses) by region for 2014 Tuberculosis re-treatment cases Previously treated TB cases notified in 2014 were 2,576 cases which is 4.1% of all cases notified in the country. For the past five years, gradual decline of previously treated patients have been noted. Most of the previously treated TB cases were in the categories of others 1,157 (45%) and relapse 998 (39%). The categories of loss to follow up and failure were 295 and 126 cases respectively. Relapses and other cases shows downward trends while return after lost to follow up and failure show a slender upward increase from years 2009. The figure 5 below shows the trend of re-treatment cases for the past ten years. 18

Figure 4: Trends of Previously Treated TB cases notified form 2005 to 2014 3.2 Tuberculosis treatment outcome for cohort notified in 2013 3.2.1 New and relapse cases Analysis of the 64,053 TB cases notified in 2013 shows that the overall treatment success for new and relapse cases was 90.3%, almost the same result as of 2012 cohort. 3,650 (5.6%) died while still on treatment, 118 (0.2%) failed treatment and 721 (1.1%) lost to follow up. During the same reporting year, the number of TB cases which were not evaluated due to being transferred out of their respective regions was noted still higher at 1,575 (2.6%) The treatment outcomes for individual groups of TB vary from 91% treatment success rate for new smear positive TB to 86% of TB relapses. The table below summarizes treatment outcomes of groups. 19

Table 3: TB treatment outcome of all forms of new and relapses notified in 2013 Treatment Outcomes new smear positive new smear negative Extrapulmonary Relapse all forms number % number % number % number % number % Cured 20,414 83.1 889 80.7 21,303 33 Treatment 1,801 Completed 7.3 21,302 91.1 13,404 89.3 59 5.4 36,566 57 Treatment Success 22,215 90.4 21,302 91.1 13,404 89.3 948 86.1 57,869 90.3 Failure 104 0.4 14 1.3 118 0 Died 1,133 4.6 1,404 6.0 1,036 6.9 77 7.0 3,650 6 Out of Control 306 1.2 193 0.8 192 1.3 30 2.7 721 1 Total Evaluated 23,878 97.2 22,899 98.0 14,632 97.4 1,069 97.1 62,358 97 Notified 24,565 100.0 23,371 100.0 15,016 100.0 1,101 100 64,053 100 The trend of treatment outcomes of the new and relapse cases for over decade, the treatment success rates have improved from about 80% in 2001 to 90% in 2013 and consistently maintained above 85% since 2005. Similarly the death rate has progressively been declining since 2006 from 8% to 5.64% in 2013. 3.2.2 Treatment outcome of previously treated TB cases notified in 2013 In 2013, 1,679 previously treated TB cases excluding the relapse were notified, 1,585 (94.4%) cases their treatment outcomes are available. Among the evaluated cases: 1,334 (80%) were treated successfully; 21 (1.3%) failed treated while 165(9.8%) cases died while in still on TB treatment. Number of TB cases lost to follow up were 65 (3.9%) of all previously treated cases. Table 4 and figure 5 below summarizes the treatment outcomes for each category of the re-treatment cases. 20

Table 4: Treatment outcomes of previously treated (except relapse) cases notified in 2013 Treatment Outcomes Failure Return after lost to follow up Others all forms number % number % number % number % Cured 78 58.6 147 58.6 26 2.0 251 14.9 Treatment Completed 7 5.3 31 12.4 1,045 80.7 1,083 64.5 Treatment Success 85 63.9 178 70.9 1,071 82.7 1,334 79.5 Failure 12 9.0 4 1.6 5 0.4 21 1.3 Died 20 15.0 20 8.0 125 9.7 165 9.8 Out of Control 10 7.5 34 13.5 21 1.6 65 3.9 Total Evaluated 127 95.5 236 94.0 1,222 94.4 1,585 94.4 Notified 133 100.0 251 100.0 1,295 100.0 1,679 100.0 Figure 5: Treatment outcomes of previously treated cases notified in 2013 21

3.3 TB/HIV case finding 2014 In the year 2014 63,151 TB cases were notified, among the notified cases 55,686 (88%) were counseled and tested for HIV status. The testing results shows that 19,890 (36%) cases were found to be co-infected with HIV which is less by 1% compared to the co-infection rate in 2013. Furthermore, analysis shows that of the coinfected cases 19,131 (96%) cases were registered at HIV care and Treatment clinics (CTCs) for care and treatment services. Among them 19,222 (97%) were put on Cotrimoxazole Preventive Therapy (CPT) while 16,437 (83%) were initiated ART in both TB clinic and CTCs within the three months reporting period after a two weeks tolerance period following starting TB treatment. There was a big improvement in the proportion of those initiated with ART from 73% in 2013 to 83% in 2014. The noted improvement would be contributed by the introduction of one stop-shop model in TB clinics since the year 2010. Figure 6 below summarizes the trend of TB/HIV indicators in the country from 2007 to 2014 Figure 6: Trend of TB patients counseling and testing for HIV, initiated CPT and ART: 2007 2014 Regional performance on HIV testing and counseling and ART uptake 22

HIV counseling is entry point for accessing HIV care, treatment and preventive services. In 2014 the national average was 88% which is below WHO target of 100%. The majority of the regions are above the national average and few regions are below the average which included: Dar Temeke, Mtwara, Pemba, Dar Ilala I, Kilimanjaro, Mwanza, Iringa, Simiyu and Shinyanga. Figure 7: HIV testing among TB patients in 2014 by regions 3.4 Management of Pediatric TB 3.4.1 Childhood TB notifications 2014 The 2014 data shows that of the 61,573 new and relapse TB cases notified, 6,489 (10.5%) were children. This notification has been increasing from the 2012 report which was at 8.6%. Among children (under 15 years) notified 3,078 (47%) were children under the age of 5, while 1,731 (27%) cases were children between age group of 5-9 years and 1,680 (26%) were children of the age-group 10 14 years. The distribution of children under age of 15 notified according to forms of TB shows that new clinically diagnosed TB cases were 3,493 (53.8%) forming a larger part, followed by new extra-pulmonary TB cases that were 2,337 (36.0%) while new bacteriologically confirmed TB cases and relapse were 645 (9.9%) and 14 (0.2%) respectively. 23

3.4.2 Childhood TB/HIV notifications 2014 Testing and counseling for HIV is also done to children (under the age of 15) attending the TB clinics. In 2014 data shows that 5,543 (85%) of notified children were tested for HIV and 1,649 (30%) were HIV co-infected cases. Among all co-infected cases notified in 2014, children make up 8.3% of all cases. 3.5 Management of MDR-TB MDR TB enrolment A total of 143 MDR TB patients were enrolled to start second line treatment at Kibong'oto TB hospital in 2014, showing a 43% increase from the previous year, where by 95 patients were enrolled. Among enrolled patients, a male predominant continued to be observed as only 51 (35.7%) were women. Among enrolled cases, 65 (45%) were HIV positive which is an increase from previous years: 39% (2013), 27% (2012) and 19% (2011). The increase in HIV notification among the MDR cohort may be attributable to early detection of MDR TB cases obtained by the scale up of Expert MTB RIF technology in the country. Figure 8 MDR TB Patients enrolment by Year As in the previous year, the age-sex distribution of new MDR TB cases enrolled on treatment showed that most cases were males and were in the age group of 35 44 24

years, however, females were more predominant in the ages 0-24 years (Figure xxx below). Figure 9: Age and Sex distribution of MDR TB cases enrolled on treatment in 2010 MDR TB patients by region in 2014 A total of 22 regions notified MDR TB patients that were ultimately started on MDR TB treatment in 2014, an increment of 100% (11 regions) from the previous year. As in previous years, the majority of MDR TB cases detected and enrolled on treatment were from Dar es salaam (36%) followed by Kilimanjaro (8), Tanga (6%), Mbeya (6%) and Manyara (5%) as illustrated in figure 10 below Figure 10: Distribution of MDR TB cases enrolled on treatment by regions in 2014 25

Treatment outcomes of MDR TB cases enrolled in 2012 In 2014, the programme continued to conduct quarterly cohort and expert review meetings. Cohort reviews aim at reviewing interim results of every patient enrolled in the targeted quarter and the reviews are conducted at 6, 12 and 24 months (final review) whereas expert review panels focus on problem solving for MDR-TB cases whose management is challenging. Final outcomes analysis was completed for on 45 patients enrolled in 2012. The results were; 32 patients (71%) were cured, seven patients (16%) completed treatment, two patients (4%) died during the course of treatment, three patients (7%) were recorded as lost to follow up and one patient (2%) was not evaluated. Overall, the treatment success rate (cured + treatment completed) for the 2012 cohort was reported at 87% which is higher than the global MDR TB treatment success target of 75%. Cumulatively, between 2009 and 2014, outcomes of 116 MDR TB patients initiated on treatment country wide were available and the cumulative treatment success rate was reported at 79.3 and the death rate at 10.3%. This is above the 75% globally recommended annual target for MDR TB treatment success rates. See table 5 Table 5: Treatment outcomes of MDR TB patients enrolled for treatment, 2009-2012 26

Year enrolled Enrolled for treatment Cured completed treatment Failed Died Lost to follow up Not Evaluated % - successfully treated % - death 2009 15 9 2 1 3 0 0 73.3 20 2010 24 15 3 0 3 2 1 75 12.5 2011 32 22 2 0 4 4 0 75 12.5 2012 45 32 7 0 2 3 1 86.7 4.4 Overall 116 78 14 1 12 9 2 79.3 10.3 MDR TB treatment outcomes were also compared for 2009, to 2012. Overall, there was an increase of good outcomes such as; enrolment and cure rates and overall reduction in poor outcomes such as death and lost to follow up in the Tanzanian MDR TB programme over the period. Figure 11; MDR TB outcomes in 2009-2012 27

4 LEPROSY CONTROL SERVICES 4.1 Leprosy Case Notification A total of 2,153 leprosy cases (all forms) were notified in 2014, of which 2,037 (94.6%) were new cases and 67(3.3%) were relapses and 49 (2.1%) were return after default. The number of cases notified was 10 (0.5%) less than those in 2013. The number of relapses in Tanzania has persistently remained very high as of the past 15 years and this pose a challenge of whether the notified cases were all truly leprosy diseased. Both the annual national notification rate (case detection rate) and registered prevalence were calculated at 4/100,000 and 0.4/10,000 population respectively and remained almost the same as compared to those of the year 2013. Among new cases notified, 1,632 (81%) were MB and 387 (19%) were PB. Females were 701 (35%) giving a female to male ratio of 1:1.8 suggesting that being male continues to be suggestive of risk factor. The number of children among the new cases remained higher at 90 or 4% like those reported in 2013. New leprosy cases notified with disability grade II were 239 or 12% which was slightly lower than those reported 2013 at 12.9% indicating that many cases continue to be detected late. Table 5 below summarizes indicator data on new leprosy cases notified in 2014 by regions and those having disability grade II according to WHO classification. However, the trend of new leprosy cases detected for the past 20 years shows tremendous decline country wide as is displayed in table 6 below. Table 6: New leprosy cases detected by indicators in 2014 by regions Region New cases MB Female Children Disability grade II number % number % number % number % Dar Ilala I 63 58 92 17 27 1 2 1 2 Dar Ilala II 3 3 100 4 133 0 0 1 33 Dar Kinondoni 79 73 92 19 24 4 5 13 16 Dar Temeke 89 83 93 19 21 5 6 10 11 Dar es Salaam 234 217 93 59 25 10 4 25 11 Arusha 2 2 100 0 0 0 0 0 0 Dodoma 39 39 100 17 44 0 0 1 3 Geita 86 75 87 42 49 3 3 8 9 Iringa 10 9 90 2 20 0 0 3 30 Kagera 60 55 92 25 42 1 2 4 7 Katavi 12 12 100 12 100 0 0 2 17 Kigoma 59 49 83 18 31 0 0 18 31 Kilimanjaro 7 7 100 1 14 0 0 3 43 Lindi 226 152 67 108 48 8 4 22 10 28

Region New cases MB Female Children Disability grade II number % number % number % number % Manyara 2 2 100 0 0 0 0 0 0 Mara 25 11 44 17 68 1 4 6 24 Mbeya 38 38 100 14 37 0 0 7 18 Morogoro 267 222 83 75 28 10 4 15 6 Mtwara 135 104 77 59 44 1 1 14 10 Mwanza 50 48 96 15 30 0 0 10 20 Njombe 2 2 100 2 100 0 0 0 0 Pwani 97 81 84 32 33 4 4 18 19 Rukwa 154 127 82 68 44 5 3 1 1 Ruvuma 69 56 81 31 45 1 1 5 7 Shinyanga 28 22 79 8 29 0 0 5 18 Simiyu 9 7 78 3 33 0 0 2 22 Singida 8 7 88 3 38 1 13 3 38 Tabora 80 74 93 34 43 3 4 18 23 Tanga 140 110 79 43 31 7 5 18 13 Mainland 1,839 1,548 83 683 37 55 3 208 11 Pemba 3 3 100 1 33 1 33 1 33 Unguja 177 98 57 17 10 34 19 30 17 Zanzibar 180 101 58 18 10 35 19 31 17 Tanzania 2,019 1,649 81 701 35 90 4 239 12 A figure 8 below summarizes the contribution of new leprosy cases by different regions. It shows that 72% of cases which were detected in 2014 were from only 10 regions. Figure 12: The contribution of regions of new cases detected in 2014 29

Since 1990, the proportion of new MB cases detected annually has been slowly increasing from 68% to over 80% while the proportion of females and children detected has been declining slowly from 44% down to 36% and 10% to 4.6% respectively. The changes in proportion of MB cases and children notified annually suggest reduction in the prevalence of the disease in the country with reduced disease transmission. Moreover, the data also suggest that females could be utilizing less the available leprosy services compared to their male partners. This is summarized in the figures 9 and 10. Figure 13: Trends of new leprosy cases reported: 2005 2014 30

The trend of leprosy case notification over years shows a progressive decrease for both PB and MB from over 5,000 cases in 2003 down to just around 2000 in 2014. However, the proportions of MB cases remain high above 80% and have been on the increase while the number and proportions of PB cases were gradually declining as shown below in figure 10. This indicate that most of those diagnosed and brought into MDT treatment include old cases. Figure 14: Trends of MB cases, children and females among new leprosy cases: 2005-2014 31

During this reporting period, the proportion of disability grade 2 among new detected cases has remained higher at 12%, however, there has been a gradual decrease in rates due to change and growth of population as shown in figure 18 below. Figure 15: Trend of disability grade 2, percentage among new cases and rates per 1,000,000 populations Registered prevalence Overall, the prevalence of leprosy has showed a steady decline since 2002. The prevalence detection ratio has remained around 1 between 2004 and 2014 suggesting that patients are timely removed from the registers after completing their MDT treatment. There are still 18 districts from 10 different regions with prevalence rates higher than 1/10,000, as shown in table 8 below. These data show that the regions of Lindi and Morogoro had most of their districts still endemic and remain at high risk of increased disease burden. 32

Figure 16: Trends of new leprosy cases detected and registered: 2005 2014 Table 7: Districts with prevalence or detection rate greater than 1/10,000 Population in 2014 S/N District Region Population registered cases prevalence rate 1 Liwale DC Lindi 93,032 115 12.4 2 South & Central Unguja Unguja 120,258 106 8.8 3 Nkasi DC Rukwa 299,485 220 7.3 4 Mkinga DC Tanga 123,317 76 6.2 5 Nanyumbu DC Mtwara 154,499 84 5.4 6 Lindi MC Lindi 80,267 23 2.9 7 Chato DC Geita 388,869 90 2.3 8 Ruangwa DC Lindi 133,450 26 1.9 9 Masasi TC Mtwara 359,156 58 1.6 10 Rufiji DC Pwani 226,939 36 1.6 11 Muheza DC Tanga 213,556 33 1.5 12 Tunduru DC Ruvuma 310,938 48 1.5 13 Newala DC Mtwara 210,453 31 1.5 14 Korogwe DC Tanga 324,151 40 1.2 33

15 Lindi DC Lindi 197,653 24 1.2 16 Musoma DC Mara 141,127 16 1.1 17 Namtumbo DC Ruvuma 210,197 21 1.0 18 Shinyanga MC Shinyanga 168,241 16 1.0 4.2 Leprosy treatment outcome 4.2.1 Treatment outcome of PB leprosy The treatment outcome of PB leprosy cases who started treatment in 2013 shows that, 368 (95%) completed treatment while 8 (2.1%) defaulted from treatment and there was no death reported. Table 9 below summarizes treatment outcome of PB leprosy cases notified in 2013 by region. Table 8: Treatment outcome of PB leprosy reported in 2013 Region Treatment Died Transferred Out of Total completed Out Control Reported in 2013 % completed Dar Ilala I 3 0 0 0 3 3 100 Dar Ilala II 0 0 0 0 0 0 Dar Kinondoni 10 0 0 2 12 12 83 Dar Temeke 18 0 1 2 21 21 86 Dar Es Salaam 31 0 1 4 36 36 86 Arusha 0 0 Dodoma 3 0 0 0 3 3 100 Iringa 2 0 0 0 2 2 100 Kagera 11 0 0 0 11 11 100 Kigoma 13 0 0 0 13 13 100 Kilimanjaro 2 0 0 1 3 2 100 Lindi 46 0 0 0 46 46 100 Manyara 1 0 0 0 1 2 50 Mara 12 0 0 0 12 12 100 Mbeya 1 0 0 0 1 2 50 Morogoro 54 0 0 0 54 54 100 Mtwara 67 0 1 0 68 68 99 Mwanza 2 0 0 0 2 3 67 Pwani 6 0 0 1 7 7 86 Rukwa 12 0 0 0 12 12 100 Ruvuma 39 0 0 0 39 44 89 Shinyanga 8 0 0 0 8 8 100 Singida 3 0 0 0 3 4 75 Tabora 18 0 0 0 18 18 100 Tanga 14 0 0 0 14 15 93 34

Mainland 345 0 2 6 353 362 95 Pemba 2 0 0 0 2 2 100 Unguja 21 0 0 2 23 23 91 Zanzibar 23 0 0 2 25 25 92 Tanzania 368 0 2 8 378 387 95 4.2.2 Treatment outcome of MB leprosy Treatment outcome of MB leprosy cases notified in 2012 shows that, 2,060 (93%) completed treatment while 8 (0.4%) patients died during treatment period. However, the data also shows that 83 patients did not complete their treatment due to various reasons: 50 (2.0%) defaulted from treatment and 33 (1.0%) cases were transferred out during treatment. Table 10 below summarizes treatment results of MB cases notified in 2012. Table 09: Treatment outcome of MB leprosy notified in 2012 Region Treatment completed Died Transferred Out Out of Control Total Reported in 2012 % completed Dar Ilala I 60 0 1 3 64 64 94 Dar Ilala II 5 0 2 0 7 7 71 Dar Kinondoni 73 0 1 0 74 75 97 Dar Temeke 77 1 2 10 90 92 84 Dar Es Salaam 215 1 6 13 235 238 90 Arusha 6 0 0 1 7 7 86 Dodoma 87 0 2 0 89 91 96 Iringa 18 0 0 0 18 18 100 Kagera 87 0 0 0 87 87 100 Kigoma 92 1 1 0 94 95 97 Kilimanjaro 8 0 0 2 10 10 80 Lindi 226 0 2 7 235 256 88 Manyara 3 0 0 0 3 3 100 Mara 14 0 1 0 15 14 100 Mbeya 42 0 0 0 42 35 120 Morogoro 236 0 8 0 244 251 94 Mtwara 116 1 2 4 123 143 81 Mwanza 115 2 5 4 126 126 91 Pwani 88 1 0 3 92 92 96 Rukwa 228 0 0 0 228 238 96 Ruvuma 83 0 0 1 84 84 99 Shinyanga 74 0 1 0 75 75 99 Singida 21 0 0 0 21 21 100 Tabora 70 2 1 7 80 84 83 Tanga 151 0 2 4 157 165 92 35

Mainland 1,980 8 31 46 2,065 2,133 93 Pemba 11 0 0 2 13 13 85 Unguja 69 0 2 2 73 73 95 Zanzibar 80 0 2 4 86 86 93 Tanzania 2,060 8 33 50 2,151 2,219 93 Figure 17: Trends of leprosy cases completed treatment: 2004 2013 4.3 Activities related to acceleration of leprosy elimination efforts Tanzania is among 17 countries in the world reporting high number of leprosy cases of more than 1,000 cases. It is also one of the signatories of the Bangkok declaration to accelerate leprosy elimination among the high burden countries and those at high risk of increasing disease burden. During this reporting year, the programme in collaboration with traditional partners like WHO, GLRA and Novartis Foundation has:- 36

Conducted one leprosy elimination campaign (LEC) at Mkinga DC. The campaign was one of the activities during the commemorations of world leprosy day in Tanga region. In one week, 22 new cases were actively found and initiated on MDT. Started preparatory activities to introduce leprosy post-exposure prophylaxis (LPEP) in Tanzania in three pilot districts of Kilombero, Liwale and Nanyumbu. Through this programme, family members of the index case will be screened to rule out leprosy disease and being given a single dose rifampicin. The intervention will largely contribute to efforts to detect leprosy disease early and cut down the transmission chain. Preparation of protocol to access funds to implement Bang kok decleration to promote early case detection and addressing challenges facing PALs with disabilities. The proposed protcol will mainly focus on active case finding efforts, promoting increased community involvment and social mobilization. The funds to implement the Bang kok decleration were donated by the Nippon Foundation of the Sasakawa initiative and are being managed by WHO leprosy global programme. 4.4 Activities related to prevention of disabilities (POD) 4.4.1 People with leprosy related disabilities In 2014, a total of 1,836 people affected by leprosy (PALs) with disabilities were registered. Among them, 448 (24.4%) were staying in care centres. A total of 1,533 (83.5 %) were reviewed to assess their physical impairments and only 19 (1.2%) PALs had their condition deteriorated and 20.8% did not change on the course of their treatment. 4.4.2 Leprosy reactions A total of 572 leprosy patients were reported with reactions and started on treatment. Out of them, adults MB cases were 84.3% (482) and for PB 90 (15.7%). cases. Children from both types were 1.6% (9). Of all the reported cases, 97 were admitted because of severe reactions. The table below shows patients reported with reactions by region per category. The availability of sufficient prednisolone drugs for PALs in need at health facilities in the country remain a big challenge. 37

Table 10: Leprosy cases started treatment with corticosteroid in 2014 Region MB (A) MB ( C) PB (A) PB ( C) Total Arusha 0 0 0 0 0 Dar Ilala I 10 0 0 0 10 Dar Ilala II 8 0 0 0 8 Dar Kinondoni 40 0 0 0 40 Dar Temeke 37 0 0 0 37 Dar es Salaam 95 3 1 0 99 Dodoma 6 0 0 0 6 Geita 19 0 0 0 19 Iringa 8 0 0 0 8 Kagera 6 0 0 0 6 Katavi 7 0 0 0 7 Kigoma 8 0 1 0 9 Kilimanjaro 3 0 0 0 3 Lindi 108 1 45 3 157 Manyara 1 0 0 0 1 Mara 20 0 9 0 29 Mbeya 10 0 0 0 10 Morogoro 42 1 10 0 53 Mtwara 40 0 10 0 50 Mwanza 14 0 0 0 14 Njombe 0 0 0 0 0 Pwani 33 0 3 0 36 Rukwa 12 0 0 0 12 Ruvuma 8 0 5 0 13 38

Region MB (A) MB ( C) PB (A) PB ( C) Total Shinyanga 12 0 2 0 14 Simiyu 2 0 1 0 3 Singida 5 0 1 0 6 Tabora 17 0 0 0 17 Tanga 47 1 2 0 50 Mainland 523 6 90 3 622 Pemba 2 0 0 0 2 Unguja 65 2 4 0 71 Zanzibar 67 2 4 0 73 Tanzania 590 8 94 3 695 4.4.3 Specialized care of people with disabilities During the year 2014, a total of 188 persons affected by leprosy (PALs) were admitted to different hospitals in the country. Ulcers and wounds ranked high as the main reason for admission by 98 (52.1%) followed by reactions 35 (18.6%). Eye pathology ranked third and accounted for 11 (5.8%), and the least was constructive surgery 4(.1%). Eye pathology which was 10 (5.6 %). In addition, 33 PALs were fitted with prostheses. The table 12 below summarises the number of surgeries done, prosthesis fitted and prosthess repaired for people affected by leprosy in 2014 by regions. Table 11: Number of leprosy admissions in hospitals 2014 Number of leprosy admissions in hospital(s) Ulcers/wound treatment 98 Reactions 35 Indications for admission (Reconstruction) Surgery 4 eye pathology 11 Others 40 Number of Amputation done 3 Number of referred for rehabilitation outside the regions 4 Number of PALs given Prosthesis 33 4.4.4 Footwear Programme In 2014, a total of 3500 pairs of special boots were produced centrally and distributed to regions country wide. By the end of the year 1,537 pairs of protective sandals were distributed to people affected by leprosy. This is only 50% of the protective sandals reaching PALs in need. To complement these efforts, 211 pairs of shoes were made locally in several regions by the local shoemakers. In the case of special boots, 88 pairs were fabricated and 264 footwear repairs were done for PALs with foot deformities. The table below shows the amount of footwear distributed to people affected by leprosy by 39

region in 2014. This includes factory made sandals, locally produced shoes, special boots and repairs done. Table 12: Materials and tools distributed for fabrication of special and local shoes production per region in 2014 Regions Leather MCR H.rubber GLUE L.Leather Thread S.Riverts Zanzibar 15 2 1 2 0 200 Morogoro Chazi 15 2 3 3 0 1 100 Morogoro Nazareth 50 3 3 4 10 3 300 Tanga Misufini 30 2 2 2 0 2 100 Mara Shirati 30 2 2 8 8 2 300 Shinyanga Busanda 30 2 2 2 0 2 100 Kagera Biharamuro 30 2 2 2 0 2 100 Pwani Kindwitwi 30 2 2 2 0 2 100 Tabora Sikonge 50 2 2 3 8 2 200 Mwanza Bukumbi 30 2 2 2 0 2 200 Ruvuma 30 2 2 2 0 2 200 40

5 LABORATORY SERVICES 5.1 Summary of services In microscopy services, the Central TB Reference Laboratory (CTRL) trains, supervises and evaluates the performances as well as the External Quality Assurance (EQA) administration for all the AFB smear microscopy facilities in the country. The total number of AFB smear microscopy facilities in the country currently stands at 945. The Routine Surveillance System (RSS) operations involve performing microscopic examinations, culture and DST for specimens from all the regions. The CTRL is also responsible for supervision of the roll out of MTB RIF technique, a new diagnostic method using the Xpert MTB/RIF assay introduced recently. The Xpert MTB/RIF is a cartridge-based, automated diagnostic test that can identify Mycobacterium tuberculosis (MTB) DNA and resistance to rifampicin (RIF) by nucleic acid amplification technique (NAAT). In the year 2014, the total number of specimens received at the CTRL were 5,515 out of this 1,666 (30%) were from routine specimen from Muhimbili National Hospital (MNH), Apopo was 1,375 (25%) while specimen from up countries were 45% as summarized in Table 13 below. Table 13: Total number of specimens received at the CTRL Scheme N % MNH 1,666 30.21 41

All other regions 2,474 44.86 Apopo 1,375 24.93 Total 5,515 100.00 Microscopy The CTRL performs smear microscopy using LED microscopes for the MNH specimens as well as those from other regions. In the year, 1,666 specimens were received from the Muhimbili National Hospital. It must be noted that specimens from new presumptive cases and are from sites without Xpert machines are tested using Xpert MTB/RIF technique while those from retreatment cases or from sites with Xpert machines or from the Kibong oto TB hospital undergo microscopy. All the specimens underwent culture except those from the MNH. The number of specimens received is detailed in table 14, Figure 14 and Table 15 below. Table 14: Number of Specimens Received per Month per Case Case Month New Retreatment Other Total January 335 146 26 507 Feb 246 85 14 345 March 283 87 5 375 April 280 88 10 378 May 226 77 82 385 June 267 92 19 378 July 179 59 18 256 August 237 76 29 342 September 191 84 68 343 October 232 70 23 325 November 192 64 29 285 December 140 80 1 221 Total 2,808 1,008 324 4,140 Figure 18: Total specimen received at CTRL in 2014 per month per case 42

43

Table 15: Number of Specimens per Case category by Regions Cases Region New Retreatment Other Unknown Total Arusha 263 22 285 Dodoma 12 2 15 29 Ilala I 13 81 1 95 Ilala II 1,417 23 68 206 1,714 Iringa 63 41 104 Kagera 50 39 89 Kigoma 33 5 38 Kilimanjaro 46 141 36 223 Kinondoni 69 176 245 Lindi 17 17 34 Manyara 5 2 7 Mara 3 18 21 Mbeya 2 2 Morogoro 122 30 2 154 Mtwara 3 4 7 Mwanza 419 90 509 Pemba 15 15 Pwani 9 33 42 Rukwa 4 2 6 Ruvuma 48 12 60 Shinyanga 8 14 22 Singida 5 12 17 Tabora 7 13 20 Tanga 143 39 182 Temeke 35 138 1 174 Unguja 2 3 3 8 Unknown 13 13 12 38 Grand Total 2,809 972 153 206 4,140 44

Culture Culture is performed using both the liquid (BACTEC MGIT ) media and the solid (Löwenstein Jensen medium). The results are as shown in Table 16 below Table 16: Culture results Culture result N % CON 63 1.54 NEG 1,133 27.63 TBC 1,013 24.71 Not for culture 1,708 41.66 Unknown 183 4.47 Total 4,100 100.00 The relationship between microscopy and culture examinations at the CTRL for 2014 is summarised in Table 17 and figure 15 below. Table 17: Microscopy-Culture correlation Microscopy results Culture results Negative Positive Contaminated Unknown Total Negative 755 184 20 42 1,001 Positive 354 811 43 86 1,294 Not Done 24 18 137 179 Total 1,133 1,013 63 265 2,474 Figure 19: Smear culture results, 2014 45

DRUG SUSCEPTIBILITY TESTING (DST) Drug susceptibility tests are processed at the CTRL by proportional method for both first and second line drugs. The conventional TB drug susceptibility testing (phenotype), involving the culturing of M. tuberculosis in the presence of anti TB drugs in order to detect growth (indicating drug resistance) or inhibition of drug, (indicating drug susceptibility). The methods used are to perform direct or indirect tests on either solid or liquid media. It is also used for diagnosing patients after treatment failure and relapse. Table 18 and 19 below show the results of DST for 2014 Table 18: DST 1st LINE profile DST 1st Line Profile N % ---- 92 65.25 H--- 3 2.13 HR-- 6 4.26 HRE- 2 1.42 HRES 20 14.18 HR-S 11 7.80 -R-- 5 3.55 -RES 1 0.71 -R-S 1 0.71 Grand Total 141 100 Table 19: DST 2nd LINE profile DST 2nd Line Profile N % OKUU 2 10 --UU 18 90 Total 20 100 46

Table 20: DST Profile key Profile Letter Meaning - Susceptible H Resistant to ISONIAZID R Resistant to RIFAMPICIN E Resistant to ETHAMBUTOL S Resistant to STREPTOMYCIN O Resistant to OFLOXACIN K Resistant to KANAMYCIN U UNKNOWN Molecular methods At the CTRL, the HAIN test, which is an LPA used in Identification of the M. tuberculosis complex and its resistance to Rifampicin and/or Isoniazid from pulmonary clinical specimens or cultivated material, is done as confirmatory test. Sixty-one specimens were examined; results are show in Table 21 and 22 below Table 21: HAIN test results for Identification MTB Results N % MTB not detected 9 14.8 MTB detected 52 85.2 Total 61 100 Table 22: HAIN test results for resistance to R&I Results N % Resistant to I & R 11 18.0 Sensitive to all 43 70.5 MTB not detected 7 11.5 Total 61 100 Apopo is a project looking at diagnosing TB using rats. The project received 1,375 specimens during the year (Table 1). These specimens are examined microscopically, both solid and liquid cultures, and would have an LPA and Rapid test as a confirmatory test. GeneXpert (Xpert) MTB/RIF Tanzania was an early adopter of the technology, with Xpert MTB/RIF testing commencing in 2009. However, the majority of sites became operational in 2011 and 2012. The NTLP introduced country Xpert focal person who oversees its activities in the 47

country. Therefore the NTLP requests sites the GeneXpert focal person at the CTRL be provided with monthly indicators from all sites undertaking patient testing with GeneXpert by the 7 th of each month. Figure 20: Map to show Xpert sites in the country. A summary of results for the Xpert both at the CTRL and for the whole country is shown in Tables 25 and 26 below Table 23: Xpert MTB/Rif results per type of specimen RESULTS NEW PREVIOUS TOTAL Xpert tests MTB negative 832 297 1,129 Xpert tests MTB positive RIF sensitive 397 155 552 Xpert tests MTB positive RIF resistant 9 43 52 Xpert tests MTB positive RIF indeterminate 10 9 19 Error results 29 13 42 Invalid results 8 9 17 No result 2 0 2 Total 1,287 526 1,813 48