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GUIDELINES FOR MANAGEMENT OF TB,

DR-TB

AND LEPROSY IN ETHIOPIA

SIXTH EDITION

August 2018

Addis Ababa

GUIDELINES FOR MANAGEMENT OF TB,

DR-TB AND LEPROSY IN ETHIOPIA

SIXTH EDITION

November 2017

Addis Ababa

Page i

NATIONAL GUIDELINES FOR TB, DR-TB AND LEPROSY IN ETHIOPIA

FOREWORD

Tuberculosis (TB) is a major public health problem throughout the world by infecting an estimated one-third of the world's population and putting them at risk of developing active disease during their lifetime. Tuberculosis is the leading cause of deaths every year among the infectious disease worldwide alongside HIV. It kills more than five thousand children, women and men each day. According to the Global TB Report 2017, 10.6 million people are estimated to have fallen ill with TB in 2016 while an estimated 1.3 million people died of TB. In addition, an estimated 4.1% of these new TB cases and 19% of the previously treated cases are believed to harbour Drug resistant-TB with an estimated 240 000 deaths annually due to Drug resistant-TB. Ethiopia is among the 30 High TB, HIV and MDR-TB Burden Countries, with annual estimated TB incidence of 177/100,000 populations and death rate of 25 per 100,000 populations for 2016. Among the notified TB cases in 2016, 2.7%) of new TB cases and 14% among previously treated TB cases were also estimated to harbour drug resistant TB. Ethiopia has notified 125,836 new TB cases and enrolled 702 drug-resistant TB case in 2016. Although the majority of TB cases has affected the productive age group, 15

100 (12%) cases were reported among children aged under 15 year. HIV co-infection

impedes the TB control efforts contributing to around 8% of annually notified TB cases. Ethiopia has successfully achieved the millennium development goals set for TB in

2015. The country's has expressed its commitment to accelerate the fight to end TB

epidemic by 2035 by endorsing the new post-2015 Global "END TB strategy" and has already aligned the National TB Strategic Plan within the framework of National Health

Sector Transformation Plan.

The National End TB strategy aims to end the TB epidemic by reducing TB related deaths by 95% and by cutting incident TB cases by 90% between 2015 and 2035; and to ensure that no family is burdened with catastrophic expenses due to TB. The strate gy calls for use of robust TB case finding strategies and use of rapid diagnostic tech nologies to address the gap in finding the missed TB cases and threat of Drug resis tant TB. The program is committed to improve access and equitable TB services to vulnerable and marginalized population groups where TB burden concentrates and most delays happen due to socio-economic and legal barriers. The program has also recognized the need for research and innovations to sharply bend the TB epidemic curve to meet the ambitious targets for 2035. This guideline expresses the strong governmental commitment by introducing the most up-to-date National strategies, recommendations, clinical and progr ammatic

Page ii

NATIONAL GUIDELINES FOR TB, DR-TB AND LEPROSY IN ETHIOPIA practices towards provision of patient-centered quality TB/DR-TB care. The national leprosy control strategy, programmatic recommendations and clinical care guidance is also provided in separate section. Finally, I would like to call all actors of Tuberculosis in the country to actively engage in their concerted efforts towards ending the TB epidemic by 2020 in Ethiopia to achieve universal health coverage for all segments of the population as in the coun- try "s transformation plan to join the middle income countries.

Kebede Worku MD, MPH

State minister of Health, FDRE

Page ii

NATIONAL GUIDELINES FOR TB, DR-TB AND LEPROSY IN ETHIOPIA practices towards provision of patient-centered quality TB/DR-TB care. The national leprosy control strategy, programmatic recommendations and clinical care guidance is also provided in separate section. Finally, I would like to call all actors of Tuberculosis in the country to actively engage in their concerted efforts towards ending the TB epidemic by 2020 in Ethiopia to achieve universal health coverage for all segments of the population as in the coun- try"s transformation plan to join the middle income countries.

Kebede Worku MD, MPH

State minister of Health, FDRE

Page iii

ACKNOWLEDGEMENT

NATIONAL GUIDELINES FOR TB, DR-TB AND LEPROSY IN ETHIOPIA The revision process of this sixth edition of national guideline has undergone multiple consultations and continuous involvement of experts on TB, DR-TB, TB/HIV and Leprosy(see annex 1 for the list of contributors). I would like to acknowledge experts working at the National TB control program for their outstanding contributions and coordination efforts for the realization of this guideline. The Ministry also owes appreciation for the below mentioned senior experts on development and reviewing of the section of the guidelines: Dr Amsalu Bekele (consultant pulmonologist/Addis Ababa university college of health sciences), Dr Aschalew Worku (Pulmonary and critical care physician/Ad- dis Ababa university college of health sciences), Dr Tewodros Haile (Pulmonary and critical care physician/Addis Ababa university college of health sciences) and Dr Fraser Wares( USAID/challenge TB/KNCV) on the development of this guide- lines. Dr Ahmed Bedru, Dr Lemma Ketema and Dr Workabeba Abebe from Ethiopian pediatric society reviewed the childhood TB section of the guideline Dr Abebe Bekelem FCS (ECSA) Associate professor of surgery, Addis Ababa University College of health sciences, developed the surgical intervention of

TB/DR-TB patients.

The core writing group leading the revision of this guidelines consist of Dr Anteneh Kassa, Dr Eshetu Kebede, Addisalem yilma, Dr Blen Ayele, Dr Andargachew Kumsa, Dr Daniel Kokebu, Dr Yohannes Molla, Dr yewilsew Kassie, Dr Beniam Feleke and Dr

Kassa Hailu.

Finally, the Federal Ministry of Health of Ethiopia is thankful to all the TB partner organizations for their limitless technical and financial support in the revision of this guideline and covering the printing cost of the document.

Biruck Kebede, BSc, MPH

A/Director, Diseases Prevention and control Directorate

FDRE Ministry of Health

NATIONAL GUIDELINES FOR TB, DR-TB AND LEPROSY IN ETHIOPIA practices towards provision of patient-centered quality TB/DR-TB care. The national leprosy control strategy, programmatic recommendations and clinical care guidance is also provided in separate section. Finally, I would like to call all actors of Tuberculosis in the country to actively engage in their concerted efforts towards ending the TB epidemic by 2020 in Ethiopia to achieve universal health coverage for all segments of the population as in the coun- try's transformation plan to join the middle income countries.

Kebede Worku MD, MPH

State minister of Health, FDRE

Page iv

ACRONYMS

NATIONAL GUIDELINES FOR TB, DR-TB AND LEPROSY IN ETHIOPIA AIDS Acquired Immunodeficiency Syndrome

ART Anti-Retroviral Treatment

COPD Chronic Obstructive Pulmonary Disorders

CSOs Civil Society Organizations

CPT Cotrimoxazole Preventive Treatment

DOT Directly Observed Treatment

DOTs Directly Observed Treatment, Short-Course

DST Drug Susceptibility Test

EPHI Ethiopian Public Health Institute

EPTB Extra-Pulmonary Tuberculosis

EQA External Quality Assurance

FMOH Federal Ministry of Health

HAART Highly Active Anti-Retroviral Treatment

HCT HIV Counseling and Testing

HEP Health Extension Program

HEW Health Extension W orker

HIV Human Immunodeficiency V irus

HMIS Health Management Information System

IGRA Interferon gamma release Assay

IPT Isoniazid Preventive Therapy

IPLS Integrated pharmaceutical Logistic system IRIS Immune Reconstitution Inflammatory Syndrome

MB Multi-Bacillary leprosy

MDR-TB Multi-Drug Resistant TB

MDT Multi-Drug Therapy

OI Opportunistic Infection

PB Pauci-Bacillaryleprosy

PLHIV People Living With HIV/AIDS

POD Prevention of Disability in Leprosy

PPM Public-Private /Public-Public Mix

QA Quality Assurance

RHB Regional Health Bureau

RRL Regional Reference Laboratory

SCC Short Course Chemotherapy

SLD Second line anti-TB drugs

SOPs Standard Operating Procedures

TB Tuberculosis

TST Tuberculin skin test

XDR-TB Extensively Drug Resistant Tuberculosis

Page iv

ACRONYMS

NATIONAL GUIDELINES FOR TB, DR-TB AND LEPROSY IN ETHIOPIA AIDS Acquired Immunodeficiency Syndrome

ART Anti-Retroviral Treatment

COPD Chronic Obstructive Pulmonary Disorders,

CSOs Civil Society Organizations

CPT Cotrimoxazole Preventive Treatment

DOT Directly Observed Treatment

DOTs Directly Observed Treatment, Short-Course

DST Drug Susceptibility Test

EPHI Ethiopian Public Health Institute

EPTB Extra-Pulmonary Tuberculosis

EQA External Quality Assurance

FMOH Federal Ministry of Health

HAART Highly Active Anti-Retroviral Treatment

HCT HIV Counseling and Testing

HEP Health Extension Program

HEW Health Extension W orker

HIV Human Immunodeficiency V irus

HMIS Health Management Information System

IGRA Interferon gamma release Assay

IPT Isoniazid Preventive Therapy

IPLS Integrated pharmaceutical Logistic system IRIS Immune Reconstitution Inflammatory Syndrome

MB Multi-Bacillary

MDR-TB Multi-Drug Resistant TB

MDT Multi-Drug Therapy

OI Opportunistic Infection

PB Pauci-Bacillary

PLHIV People Living With HIV/AIDS

POD Prevention of Disability in Leprosy

PPM Public-Private Mix

QA Quality Assurance

RHB Regional Health Bureau

RRL Regional Reference Laboratory

SCC Short Course Chemotherapy

SLD Second line anti-TB drugs

SOPs Standard Operating Procedures

TB Tuberculosis

TST Tuberculin skin test

XDR-TB Extensively Drug Resistant Tuberculosis

Page v

NATIONAL GUIDELINES FOR TB, DR-TB AND LEPROSY IN ETHIOPIA

TABLE OF CONTENTS

TITLES PAGE

FOREWORD---------------------------------------------------------------------------------------- I

TABLE OF CONTENTS---------------------------------------------------------------------------- LIST OF TABLES------------------------------------------------------------------------------------- LIST OF FIGURES----------------------------------------------------------------------------------- LIST OF BOXES/DIAGRAMS---------------------------------------------------------------------

1 KEY RECOMMENDATIONS OF THE GUIDELINE----------------------------------------

2 INTRODUCTION TO TUBERCULOSIS AND NATIONAL STRATEGY---------------

2.1 Overview of Tuberculosis------------------------------------------------------------------

2.2 Tuberculosis Situation in Ethiopia-------------------------------------------------------

2.3 Finding Missed TB Cases in Ethiopia--------------------------------------------------

2.4 Addressing the Dual TB and HIV Burden----------------------------------------------

2.5 Emergence of Threats of Drug Resistant TB-----------------------------------------

2.6 History of National TB Control Program------------------------------------------------

2.7 National TB Control Strategy--------------------------------------------------------------

3 BASIC CONCEPTS AND CLINICAL PRESENTATION OF TUBERCULOSIS-----

3.1 Transmission and Pathogenesis--------------------------------------------------------

3.2 Evolution of TB Infection and Disease-------------------------------------------------

3.3 Determinants of Transmission of TB Bacilli-------------------------------------------

3.4 Risk Factors for Developing Active TB-------------------------------------------------

3.5 Clinical Presentation of Tuberculosis---------------------------------------------------

4 DIAGNOSIS OF TUBERCULOSIS AND TB CASE FINDING---------------------------

4.1 Tuberculosis Diagnostic Methods-------------------------------------------------------

4.2 Additional Supportive Methods-----------------------------------------------------------

4.3 TB Case Finding Strategies---------------------------------------------------------------

5 APPROACH TO DIAGNOS OF TBUBERCULOSIS------------------------------------------

5.1 Diagnosis of Pulmonary Tuberculosis in Adults and Adolescents---------------

5.2 Diagnosis of Extra-Pulmonary Tuberculosis in Adults and Adolescents-------

5.3 Diagnosis of TB Among HIV Positives-------------------------------------------------

5.4 Diagnosis of Drug Resistant Tuberculosis--------------------------------------------

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