Monitoring and evaluation for viral hepatitis B and C: recommended indicators and framework

MONITORING AND EVALUATION FOR VIRAL HEPATITIS B AND C: RECOMMENDED INDICATORS AND FRAMEWORK

TECHNICAL REPORT

MONITORING AND EVALUATION FOR VIRAL HEPATITIS B AND C: RECOMMENDED INDICATORS AND FRAMEWORK

TECHNICAL REPORT

WHO Library Cataloguing-in-Publication Data Monitoring and evaluation for viral hepatitis B and C: recommended indicators and framework. 1.Hepatitis C – prevention and control. 2.Hepatitis B – prevention and control. 3.Hepatitis, Viral, Human. I.World Health Organization. ISBN 978 92 4 151028 8 © World Health Organization 2016 All rights reserved. Publications of the World Health Organization are available on the WHO website (www.who. int) or can be purchased from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; Email: bookorders@who.int). Requests for permission to reproduce or translate WHO publications – whether for sale or for non-commercial distribution – should be addressed to WHO Press through the WHO website (www.who.int/about/licensing/ copyright_form/en/index.html). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. Design and layout: blossoming.it (NLM classification: WC 536)

3

TABLE OF CONTENTS

Acknowledgements5 Abbreviations and acronyms Executive summary 1. Introduction 6 8 10 Terminology7

1.1 Purpose10 1.2 Objectives 10 1.3 Content  10 1.4 Audience 11 1.5 Scope 11 1.6 Companion documents 11 1.7 Elimination agenda and global targets 11

2. Methods and processes

13

2.1 Incremental approach: adding to the result chain M&E framework developed for HIV and other programmes 13 2.2 Process and criteria for selecting indicators (18)13 a. Core indicators for global and national monitoring and reporting: 13 b. Additional indicators for national-level monitoring and reporting 13 2.3 Indicator classification 14 2.4 Indicator metadata 14

3. Methodology for monitoring and evaluation of activities for viral hepatitis 3.1 Monitoring systems for viral hepatitis: an integrated incremental approach 3.2 Measurement methods and sources of data 3.3 Confidentiality and ethical considerations

15 15 15 15

4. Monitoring and evaluation indicators  4.1 Summary of indicators 4.2 Ten core indicators The 10 indicators at a glance Metadata for the 10 core indicators 4.3 Additional indicators: metadata table Viral hepatitis-specific indicators Indicators already formulated and/or collected through national health system or other programmes

16 16 17 17 17 26 26 29

5. References

32

4

TABLES AND FIGURES

Fig. 1: Monitoring and evaluation framework: minimum set of 10 core indicators to monitor and evaluate the health sector response to viral hepatitis B and C along the result chain in countries Table 1: Targets of the WHO Global Health Sector Strategy on viral hepatitis, 2016–2021 Table 2: Summary of indicators for monitoring and evaluation of viral hepatitis B and C Table 3: Metadata tables for each of the 10 core indicators for viral hepatitis B and C Table 4: List and metadata of additional indicators specific to viral hepatitis B and C Table 5: List and metadata of additional indicators for viral hepatitis B and C already formulated and/ or collected through other programmes or national health system

5

ACKNOWLEDGEMENTS

Writing committee Isabel Bergeri and Yvan Hutin (WHO Geneva) WHO headquarters, regional offices and country offices, and International Agency for Research on Cancer (IARC) WHO Global Hepatitis Programme team, Geneva: Stefan Wiktor, Yvan Hutin, Hande Harmanci, Isabel Bergeri WHO Geneva: Karen Hennessey, Benedetta Allegranzi, Arshad Altaf, Bassim Zayed, Selma Khamassi, Junping Yu, Nicolas Clark WHO Regional Office for the Western Pacific: Nick Walsh, Linh-vi Le, Eric Wiesen WHO Regional Office for the Americas: Monica Alonso Gonzalez WHO Regional Office for Europe: Antons Mozalevskis, Annemarie Stengaard WHO Regional Office for South-East Asia: Dongbao Yu WHO Regional Office for the Eastern Mediterranean: Matti Parry, Hamida Khattabi, Mondher Letaief WHO Country Office China: Po-Lin Chan WHO Country Office Viet Nam: Amitabh Suthar IARC: Jacques Ferlay, Iacopo Baussano Reviews were also provided by: Rosmawati Mohamed (Asian-Pacific Association for the Study of the Liver, Malaysian Society of Gastroenterology and Hepatology, Malaysia) Janus Ong (Hepatology Society of the Philippines, the Philippines) John Ward (United States Centers for Disease Control and Prevention) Representatives of civil society reference groups: Isabelle Meyer-Andrieux (MSF Switzerland), Samuel So (Asian Liver Center, Stanford University School of Medicine, USA) Technical editing and layout Leitmotif company (editing), Blossom company (layout) Financial acknowledgement The development of these guidelines was financially supported by the French Ministry of Foreign Affairs and United States Centers for Disease Control and Prevention.

6

ABBREVIATIONS AND ACRONYMS

Ag ANC anti-HAV anti-HBc anti-HCV anti-HDV anti-HEV CRVS DAA DBS DHS DNA EIA EML EPI GHSS HAV HBsAg HBV HCV HCW HDV HepB_BD HepB3 HEV HIV IARC ICD-10 IHP+ IPC M&E MICS MSM NCD NSP OST POC PWID RNA SDG SIGN STI SVR TTI VL WHO

antigen antenatal care antibody against hepatitis A virus antibody against hepatitis B core antigen antibody against hepatitis C virus antibody against hepatitis D virus antibody against hepatitis E virus civil registration and vital statistics direct-acting antiviral (drug) dried blood spot Demographic and Health Survey deoxyribonucleic acid enzyme immunoassay Essential Medicines List Expanded Programme on Immunization WHO Global Health Sector Strategy (on viral hepatitis) hepatitis A virus hepatitis B surface antigen hepatitis B virus hepatitis C virus health-care worker hepatitis D virus hepatitis B birth-dose vaccination in newborns (within first 24 hours of life) hepatitis B vaccination with 3 doses in infants hepatitis E virus human immunodeficiency virus International Agency for Research on Cancer International Statistical Classification of Diseases and Related Health Problems, tenth revision International Health Partnership infection prevention and control monitoring and evaluation Multiple Indicator Cluster Survey men who have sex with men noncommunicable disease needle and syringe programme opioid substitution therapy point of care people who inject drugs ribonucleic acid Sustainable Development Goal Safe Injection Global Network (Alliance) sexually transmitted infection sustained virological response transfusion-transmissible infection viral load World Health Organization

7

TERMINOLOGY

High-risk/-burden populations for viral hepatitis refer to populations at higher epidemiological risk for acquiring and transmitting viral hepatitis or to populations where the prevalence of infection is high. It includes the four key populations for acquiring HIV (i.e. sex workers, men who have sex with men [MSM], people who inject drugs [PWID], transgender persons), and populations specific to viral hepatitis, such as the general population in some settings. Viral hepatitis terminology • Viral hepatitis: inflammation of the liver that results from an infection with a hepatitis virus • Acute viral hepatitis: discrete-onset clinical manifestations of a recent infection with a hepatitis virus • Chronic viral hepatitis: chronic inflammation of the liver that results from a chronic infection with a hepatitis virus • Recent infection: a newly acquired infection, regardless of whether symptomatic or asymptomatic • Chronic infection: persistence of replication of a hepatitis virus in the body six months after the initial infection Strategic information: information interpreted and used for planning and decision-making to improve the direction of a programme. The data that constitute strategic information can come from a wide variety of sources – for example, monitoring systems, evaluations, programme reviews, surveillance, surveys and case studies. Monitoring is the routine tracking of service and programme performance using input, process and outcome information collected on a regular and ongoing basis from policy guidelines, routine record-keeping, surveillance and, occasionally, from observational surveys of health facilities and clients. This information is used to assess the extent to which a policy or programme is achieving its intended activity targets on time. In a well-designed monitoring and evaluation system, monitoring will contribute greatly to evaluation. “Monitor” comes from the Latin word “to warn”. Evaluation is the periodic assessment of results that can be attributed to programme activities; it uses monitoring data and often indicators that are not collected through routine information systems. Evaluation allows exploration of the causes of failure to achieve the expected results on schedule, and any necessary corrections to be applied. Monitoring and evaluation (M&E) system: a set of mechanisms built into the routine operations of a programme to generate data or information on a periodic and ongoing basis to provide evidence for programme decisions Indicator: in the context of M&E, a quantitative or qualitative variable that provides a valid and reliable way to measure achievement, assess performance or reflect changes connected to an activity, project or programme Result chain: a logical framework built along a sequence of context analysis, inputs, outputs, outcomes and impact. This framework shows how inputs into the system (e.g. resources, infrastructure) and processes (e.g. training, logistics systems) translate into outputs (e.g. availability of services and interventions) that lead to outcomes (e.g. intervention coverage) and, ultimately, to impact (e.g. mortality). Cascade (or continuum of care): health services in the cascade encompass prevention, treatment and care interventions. The term “cascade” emphasizes that a sequence of services is needed to achieve the desired impacts. The “cascade” concept also informs tracking of patients from one service to the next, and highlights the gradual attrition of coverage of the eligible population over the steps of the sequence. Monitoring the cascade of services requires a consolidated set of indicators that cover the entire sequence. Metadata are data that provide information about other data.

8

EXECUTIVE SUMMARY

A monitoring and evaluation framework for the Global Health Sector Strategy on viral hepatitis To monitor and evaluate the Global Health Sector Strategy (GHSS) on viral hepatitis, the World Health Organization (WHO) proposes a monitoring and evaluation framework. This framework should facilitate collection and analysis of standardized data with a balance between the need to remain parsimonious and obtain the minimum information required. Objectives of this framework • Guide monitoring of the response nationally and globally. • Reduce excessive data collection and/or reporting requirements. • Enhance the availability and quality of data. • Improve transparency and accountability. Thirty-seven indicators along the result chain The result chain is a logical framework built along a sequence of inputs (e.g. resources, infrastructure) and processes (e.g. training, logistics systems) that translate into outputs (e.g. availability of services and interventions), which lead to outcomes (e.g. intervention coverage) and, ultimately, to impact (e.g. mortality). WHO has selected 10 core indicators (Fig. 1) that are (1) prominent in the monitoring of international public health initiatives or used by international organizations; (2) robust, useful, accessible and understandable; (3) documented by some past experience in data collection, analysis and use; and (4) used by countries for the monitoring of national plans and programmes. WHO has also selected 27 additional indicators. Of these, 10 indicators are specific to viral hepatitis and 17 have been used in the past by other programmes, including HIV/sexually transmitted infection (STI) (four indicators), immunization (two indicators), blood safety (two indicators), injection safety and infection control, harm reduction (two indicators) and noncommunicable diseases, cancer (two indicators). Data sources Data sources for these indicators will include biomarker surveys (specific or combined), cancer registries, vital registration statistics, health-care facility surveys, surveillance and estimates through mathematical modelling.

9

FIGURE 1 Monitoring and evaluation framework: minimum set of 10 core indicators to monitor and evaluate the health sector response to viral hepatitis B and C along the result chain in countries

CONTEXT AND NEED

INPUTS

OUTPUTS & OUTCOMES

IMPACT

Epidemic pattern, stigma and populations in need

Policy, laws, health system inputs and financing

Cascade for care New infections, deaths, equity Prevention Testing Care & treatment Cure

1. Prevalence

2. Infrastructure for testing

3. Vaccination coverage hepatitis B: -newborns -infants 4. Needle–syringe distribution 5. Facility-level injection safety

6. People diagnosed

7. Treatment coverage/ initiation

8. Cure (HCV) or viral suppression (HBV)

9. Incidence 10. Attributable mortality HCC and cirrhosis and chronic liver diseases

10 CORE INDICATORS

10

1. INTRODUCTION

1.1 Purpose This document supports the strategy of elimination of viral hepatitis B and C, which was prepared in response to the World Health Assembly’s request to examine “the feasibility of and strategies needed for the elimination of hepatitis B and hepatitis C” (1–4). It presents a minimum set of indicators and a monitoring and evaluation (M&E) framework for assessing the health sector’s response to viral hepatitis B and C. The set of indicators provides concise information on the health situation and trends, including responses at the national and global levels. This document is intended to facilitate collection of standardized data and to help in analysing these data, so that interpretation and dissemination of this information improves the health sector response at the subnational and national levels, and evidence-based decision-making at the global level. The World Health Organization (WHO) attempted to find the right balance between remaining parsimonious and obtaining the minimum information required (5). This document proposes to consider only the most important and critical indicators for measuring the health sector’s response to viral hepatitis B and C. It also encourages countries to build on existing indicators that are already collected through other disease or programme monitoring systems via an incremental approach.

1.2 Objectives The objectives of this document are: • to guide monitoring of the health sector’s response to viral hepatitis B and C nationally and globally; • to reduce excessive and duplicative data collection and/or reporting requirements; • to enhance the availability and quality of data; and • to improve the transparency and accountability of viral hepatitis programmes.

1.3 Content The document presents: (1) a minimum set of core indicators that can become the basis for streamlining WHO and partners’ country data requests and needs; (2) a list of additional indicators that are divided in two categories: (2a) consists of indicators specific to hepatitis B and C; and (2b) consists of previously published indicators that have been used to monitor and evaluate infections with bloodborne pathogens (e.g. in the field of injection safety, harm reduction and HIV) or noncommunicable diseases (NCDs; e.g. cancers).

11

National country programmes may choose among these additional indicators to further strengthen their M&E framework for viral hepatitis B and C (6). Overall, as much of the data are currently not collected, implementation of this framework will require setting up new data-collection mechanisms.

1.4 Audience The proposed audience for this document is persons who will coordinate the national response to hepatitis B and C. However, this document should also be useful for consultants and international partners who may be advising national health officials on the M&E of their national response plans.

1.5 Scope This document focuses on hepatitis B (7) and C (8), which constitute most of the burden of disease associated with viral hepatitis. Although not explicitly addressed in this document, elimination of hepatitis caused by hepatitis D virus (HDV)1 is directly linked to successful elimination of hepatitis B virus (HBV) (9). Hence, elimination of hepatitis B through immunization should ultimately eliminate hepatitis D. It does not address the M&E of programmes that may target hepatitis A (10) and hepatitis E (11). However, the WHO Technical considerations and case definitions to improve surveillance for viral hepatitis (12) can be used to improve or set up surveillance for hepatitis A and E. If the vaccine against hepatitis A virus (HAV) is included in the Expanded Programme on Immunization (EPI), the key indicators will be vaccine coverage (outcome) and reported rates of hepatitis A (impact). Hepatitis due to the hepatitis E virus (HEV) is rarely the focus of a dedicated national programme; however, reported rates of hepatitis E and/or occurrence of outbreaks may be a useful outcome indicator of water and sanitation programmes in countries where hepatitis E is highly endemic.

1.6 Companion documents Additional information that may be useful to users of this document include (i) Technical considerations and case definitions to improve surveillance for viral hepatitis (12)  and (ii) the WHO Manual for the development and assessment of national viral hepatitis plans (13). • The surveillance document provides resources that should be useful to evaluate, set up, or improve viral hepatitis surveillance, including (a) acute hepatitis, (b) chronic infections with hepatitis viruses, and (c) sequelae (hepatocellular carcinoma and cirrhosis). • The manual on development of national plans outlines the process of engaging stakeholders, assessing the situation and formulating a plan.

1.7 Elimination agenda and global targets In 2016, WHO proposed a Global health sector strategy on viral hepatitis, 2016–2021 (14) that aims to eliminate hepatitis B and C as public health problems. It includes a set of a few focused targets that cover impact, including incidence, prevalence and mortality. These impact targets will be supported by key intervention targets, and associated with equity and financing targets. This document provides the indicators that will help monitor and evaluate this strategy. Table 1 summarizes the list of targets of the Global Health Sector Strategy on viral hepatitis (GHSS) and related indicators. 1

Hepatitis D replicates only in presence of hepatitis B virus (HBV). Transmission of HDV can occur either via simultaneous infection with HBV (coinfection) or superimposed on chronic HBV infection (superinfection). Both superinfection and coinfection with HDV results in more severe complications compared to infection with HBV alone.

12

TABLE 1. Targets of the WHO Global Health Sector Strategy on viral hepatitis, 2016–2021 (14)

Impact Targets Indicators proposed C.9.a: Cumulated incidence of HBV infection in children 5 years of age

Incidence: Reduce new cases of chronic viral hepatitis B and C infections

C.9.b: Incidence of HCV infection C.10: Deaths from hepatocellular carcinoma (HCC), cirrhosis and chronic liver diseases attributable to HBV and HCV infections

Mortality: Reduce deaths due to viral hepatitis B and C

Intervention: expand and enhance services Targets 1. Hepatitis B vaccination: Give three doses to infants 2. Prevention of mother-to-child transmission of hepatitis B virus: Use birth-dose vaccination or other approach to prevent mother-to-child transmission 3. Injection safety: Administer injections with safety-engineered devices in and out of health facilities 4. Blood safety: Reduce rates of transmission of transfusiontransmissible infections (TTIs) 5. Harm reduction: Provide sterile needles and syringes for persons who inject drugs (PWID)

Indicators proposed C.3.b: Coverage of third dose of hepatitis B vaccine among infants C.3.a: Coverage of timely hepatitis B vaccine birth dose (within 24 hours) and other interventions to prevent mother-tochild transmission of HBV C.4: Facility-level injection safety

A.18: Blood screening coverage

C.5: Needle–syringe distribution

6. Viral hepatitis B and C diagnosis: C.6: People living with HCV and/or HBV Diagnose persons with chronic hepatitis infections diagnosed C.7.a and C.7.b: Treatment coverage/ initiation for HBV /HCV infections C.8.a and C.8.b: Viral suppression (HBV) and cure (HCV)

7. Viral hepatitis B and C treatment: Treat persons with chronic hepatitis infection

13

2. METHODS AND PROCESSES

2.1 Incremental approach: adding to the result chain M&E framework developed for HIV and other programmes Information on viral hepatitis is collected from different sources, including immunization/EPI, HIV and sexually transmitted infection (STI), cancer, injection safety, blood transfusion safety programmes and others. National response plans to hepatitis only build upon already existing programmes such as those cited above; hence, many indicators already exist. WHO selected relevant existing indicators and then created new ones to fill the gaps identified. As a result, this document details only new indicators proposed for viral hepatitis B and C. Other already existing indicators from various M&E guidelines are cross-referenced. This is especially the case for the HIV indicators from the WHO Consolidated strategic information guidelines for HIV in the health sector (15). WHO also developed this document using a result chain framework and a cascade approach that are identical to those used for HIV (Fig. 1) (16,17). More detailed description of these concepts is included in other guidance (15,16).

2.2 Process and criteria for selecting indicators (18) Methods used in the WHO 2015 Global reference list of 100 core health indicators (19) guided the process of selecting indicators for viral hepatitis B and C. • The approach must be parsimonious while reflecting the full spectrum of public health priorities across the epidemiological history of disease and continuum of care so as to address all aspects of the M&E result chain (input through impact). • The indicators must be as robust, useful, accessible and understandable as possible. Very few indicators meet all the criteria and the ultimate choice is a trade-off. • Existing indicator sets are drawn from global health initiatives, such as EPI, IARC Globocan (20), IARC Cancer Incidence in Five Continents (21), Safe Injection Global Network (SIGN) (22), and from other programme-specific M&E and technical evaluation groups. a. Core indicators for global and national monitoring and reporting: Ten indicators that meet the following criteria are prioritized as “core”:1 1. The indicator is prominent in the monitoring of international public health initiatives (e.g. Sustainable Development Goals [SDGs], World Health Assembly viral hepatitis resolutions (2,3) or the WHO GHSS on viral hepatitis (14), EPI)   or is used by international organizations (e.g. IARC (23), WHO Regional Office for the Americas (24)). 2. The indicator is robust, useful, accessible and understandable. 3. There is a track record of measurement experience with the indicator, possibly supported by an international database. 4. Countries use the indicator for the monitoring of national plans and programmes. The symbol 1

identifies the core indicators along the document.

Adapted from criteria used by the Global reference list of 100 core health indicators. WHO, 2015.

14

If reporting countries and partners adhere to the definitions of these indicators, this will ensure comparability. b. Additional indicators for national-level monitoring and reporting Indicators are considered as “additional” if they meet at least one of the four criteria, but do not fully meet the full set. Countries may choose to collect data on those additional indicators to inform their health sector viral hepatitis programme. They may be considered at the national or subnational level in case this additional information is useful to understand a particular country’s epidemic context, needs and capacity. Countries can choose and adapt these indicators to meet their specific needs.

2.3 Indicator classification This document presents the lists of indicators according to multiple dimensions (5). • First, indicators are presented according to levels of the result chain framework (input, output, outcome and impact), called M&E domains (16).  • Second, indicators are further categorized into health domains. These include: populations in need, stigma and discrimination, policy, health systems, prevention, testing, treatment and care, morbidity, mortality and equity. • Third, indicators are further categorized according to sub-health domains (e.g. harm reduction, injection safety, vaccination, blood safety, condom use, prevalence, incidence).

2.4 Indicator metadata Metadata are data that provide information about other data. For all the indicators in this document, a simple metadata set includes the following: • definition, including numerator and denominator; • disaggregation that includes equity categories such as age and sex, geography, socioeconomic status, and place of residence, among others; • data sources that specify the main data source or data collection methods (e.g. biomarker surveys, surveillance, cancer registry, health facility surveys, programme records, Demographic and Health Surveys [DHS], immunization validation surveys, mathematical modelling); • relevance and interpretation that discuss the strengths and limitations of the indicators; • reporting periodicity (to be added by country according to context) – rationalization of an indicator framework includes rationalization of reporting requirements. For some indicators that matter for decision-making, can change rapidly and can be measured with great accuracy, annual reporting by the local and national levels is desirable.

15

3. METHODOLOGY FOR MONITORING AND EVALUATION OF ACTIVITIES FOR VIRAL HEPATITIS 3.1 Monitoring systems for viral hepatitis: an integrated incremental approach As for HIV (15) or TB/HIV (25), M&E ensures that resources going into a programme are being utilized, services are being accessed, activities are occurring in a timely manner, and expected results are being achieved. This management function facilitates the most effective and efficient use of human and financial resources for maximizing the health benefit to the population served. This is especially relevant in resource-limited settings. The M&E framework for viral hepatitis B and C (Fig. 1) is a visual concept of how the elements of the programme fit together. However, in the post-2015 era characterized by the SDGs – health systems strengthening and universal health coverage – M&E of viral hepatitis programmes will attempt to make the most of data gathered by other programmes. Independent M&E systems, such as those that have been put in place for TB and HIV might be harder to implement for viral hepatitis.

3.2 Measurement methods and sources of data Most health sector data on viral hepatitis B and C are obtained through either routine (continuous) or periodic data collection mechanisms. The main measurement methods or data sources to monitor and report on the 10 core indicators are given below: 1. Biomarker surveys conducted either specifically for viral hepatitis or in combination with other health programmes (e.g. DHS, Multiple Indicator Cluster Survey [MICS]). These surveys address infections with o HBV, conducted among children 5 years of age; o HCV, in the general population or special populations. 2. Cancer registries/case reporting for hepatocellular carcinoma (HCC) and cirrhosis; 3. Programme data (e.g. needle–syringe programme, laboratory infrastructure for testing, clinical patient records of health care, laboratory records); 4. Specific surveys (e.g. immunization, injection safety); 5. Routine surveillance system for acute and chronic hepatitis B and C cases; 6. Estimates through mathematical modelling.

3.3 Confidentiality and ethical considerations Providing optimal care for viral hepatitis B and C involves knowing patientsensitive information. M&E for viral hepatitis needs to comply with principles of confidentiality and ethical considerations (12,15).

16

4. MONITORING AND EVALUATION INDICATORS 4.1 Summary of indicators Table 2 summarizes core indicators (Section 1) and the 27 additional indicators (Section 2). TABLE 2. Summary of indicators for monitoring and evaluation of viral hepatitis B and C Section 1. Core indicators: essential indicators to monitor and report progress at global and national levels Indicator Programmatic Indicator name number area C.1 a Prevalence of chronic HBV infection b Prevalence of chronic HCV infection Viral hepatitis C.2 Infrastructure for HBV and HCV testing C.3 a Coverage of timely hepatitis B vaccine birth dose (within 24 hours) and other Immunization interventions to prevent mother-to-child transmission of HBV b Coverage of third-dose hepatitis B vaccine among infants Immunization C.4 Facility-level injection safety Injection safety C.5 Needle–syringe distribution HIV, harm reduction C.6 People living with HCV and/or HBV diagnosed C.7 a Treatment coverage for hepatitis B patients b Treatment initiation for hepatitis C patients C.8 a Viral hepatitis Viral suppression for chronic hepatitis B patients treated b Cure for chronic hepatitis C patients treated C.9 a Cumulated incidence of HBV infection in children 5 years of age b Incidence of HCV infection C.10 Deaths from hepatocellular carcinoma (HCC), cirrhosis and liver diseases Noncommunicable attributable to HBV and HCV infection diseases, cancer Section 2. Additional indicators: for national- or local-level monitoring and reporting Indicator Programmatic Indicator name number area 2.a Viral hepatitis-specific indicators not yet collected A.1 Hepatitis D coinfection among people living with chronic HBV infection A.2 Experience with discrimination against people living with viral hepatitis A.3 Availability of essential medicines and commodities A.4 National system for viral hepatitis surveillance A.5 Hepatitis B testing Viral hepatitis A.6 Hepatitis C testing A.7 HCV genotyping A.8 Viral hepatitis B and C care coverage A.9 Equitable access to hepatitis treatment A.10 Documentation of treatment effectiveness 2.b Indicators already formulated and sometimes collected through other programmes and national health system A.11 Estimated size of key populations (HIV) A.12 Key population experience with discrimination (HIV) HIV, STI A.13 Hepatitis coinfections among persons with HIV infection A.14 Condom use in key populations (HIV) A.15 National provision of a birth dose of hepatitis B vaccine Immunization A.16 Hepatitis B vaccination among health-care workers A.17 Facility-level blood safety Blood safety A.18 Blood screening coverage A.19 National policy for infection prevention and control programmes A.20 Supply of needles–syringes Injection safety, A.21 Procurement of reuse prevention devices infection control A.22 Reuse of injection equipment A.23 Needle-stick injuries (NSIs) among health-care workers A.24 Opioid substitution therapy (OST) coverage Harm reduction, HIV A.25 Retention in OST A.26 Incidence of cancer, by cancer type Noncommunicable diseases, cancer A.27 Total alcohol per capita (age 15+ years) consumption

17

4.2 Ten core indicators The 10 indicators at a glance Figure 1 (page 9) describes the minimum set of 10 core indicators needed in every country, as described in Section 2: Methods and processes. Metadata for the 10 core indicators TABLE 3. Metadata tables for each of the 10 core indicators for viral hepatitis B and C Indicator C.1.a Indicator category M&E domain Health domain (sub-domain) Definition Numerator Denominator Prevalence of chronic HBV infection Core Context and needs Morbidity (prevalence) Number and proportion of people living with chronic HBV infection (hepatitis B surface antigen [HBsAg] positive) Number of persons with chronic HBV infection defined by HBsAg-positive serological status Number of persons (total population) Sex/gender, age groups, pregnancy status, high-risk/-burden populations for viral hepatitis B If possible, separate: - current infection (HBsAg) versus evidence of past or present infection (antibody against hepatitis B core antigen [anti-HBc]) - persons coinfected with hepatitis D virus (HDV), and - persons coinfected with HIV Information for this indicator is derived ideally from surveys, but can be derived from programme data, special studies and modelling. This indicator reflects epidemic and service needs, as it serves as numerator or denominator for several other indicators along the result chain and cascade (coverage and impact indicators). The biomarker of HBV infection is HBsAg. Given the low incidence of HBV infection, any person who is HBsAg positive during a cross-sectional survey is most likely to have chronic HBV infection (the probability of coming across a recent infection is low). Prevalence of chronic HCV infection Core Context and needs Morbidity (prevalence) Number and proportion of people living with chronic HCV infection (HCV RNA positive or HCV antigen [Ag] positive) Number of persons with chronic HCV infection defined as positive for HCV RNA or positive for HCV Ag Number of persons (total population) Sex, age, pregnancy status, high-risk/-burden populations for viral hepatitis C Information for this indicator is derived ideally from surveys, but can be derived from programme data, special studies and modelling. Modelling may be used initially, if data are available only for anti-HCV. This indicator reflects epidemic and service needs, as it serves as numerator or denominator for several other indicators along the result chain and cascade (coverage and impact indicators). Presence of anti-HCV antibodies provides evidence of past or present HCV infection, without distinction between either past/resolved or present/active infection. Recommended biomarkers of chronic HCV infection include HCV RNA and HCV core antigen (HCV Ag).

Disaggregation

Measurement method, sources of data Programme relevance and interpretation Indicator C.1.b Indicator category M&E domain Health domain (sub-domain) Definition Numerator Denominator Disaggregation Measurement method, sources of data

Programme relevance and interpretation

18

Indicator C.2 Indicator category M&E domain Health domain (sub-domain) Definition

Infrastructure for HBV and HCV testing Core Input Technology and commodities (in vitro diagnostics) Ratio of facilities with capacity to test individuals for chronic hepatitis HBV and/or HCV per 100 000 population according to the following testing methods: - molecular methods (HCV RNA, HBV DNA) - serological methods (HBsAg, anti-HBc, anti-HCV) Number of facilities with capacity to test for chronic hepatitis - Tests to be used depend on national recommendations based on WHO guidelines. - Facilities include health workers using point-of-care (POC) testing, health facilities, laboratories. Number of persons (total population) - Chronic HBV and chronic HCV infection testing capacity - Testing facility (e.g. clinical laboratory, etc.) - Geographical location - Participation in an external quality assurance programme Information for this indicator is derived from programme data. Tests to be used depend on national recommendations based on WHO guidelines. Measures trends in availability of laboratory services for viral hepatitis B and C testing

Numerator Denominator Disaggregation Measurement method, sources of data Programme relevance and interpretation

19

Indicator C.3.a Indicator category M&E domain Health domain (sub-domain) Definition

Coverage of timely hepatitis B vaccine birth dose (within 24 hours) and other interventions to prevent mother-to-child transmission of HBV Core Outcome Prevention (vaccination) Proportion of newborns who have benefited from timely birth dose of hepatitis vaccine (within 24 hours) or from other interventions to prevent mother-to-child transmission of HBV (percentage) Number of newborns receiving timely birth dose of hepatitis vaccine within 24 hours (HepB_BD) or benefiting from other interventions to prevent mother-to-child transmission of HBV (e.g. testing of the mother followed by immunoprophylaxis,1 or in the future, treatment) Number of live births Age, place of residence, sex, socioeconomic status (26) Routinely collected from programme data (vaccine administrative coverage data, facility information systems) or through periodic immunization validation surveys (household surveys) and disseminated by WHO and United Nations Children’s Fund (UNICEF) (http:// apps.who.int/immunization_monitoring/globalsummary/timeseries/tswucoveragedtp3.html). This indicator monitors and guides immunization programmes and other activities to prevent mother-to-child transmission of HBV. - An explanatory remark or footnote should be added when a country uses a strategy based on screening of pregnant women to target vaccination at children born to HBsAg-positive mothers. - Another remark or footnote should also identify countries that have no HepB_BD vaccination policy at all. Coverage of timely hepatitis B vaccine birth dose is extracted from an article published in 2008: WHO and UNICEF estimates of national infant immunization coverage: methods and processes (27–29). This indicator was also cited as one of the WHO Global reference list of 100 core health indicators and is referenced there as “Immunization coverage by vaccine for each vaccine in the national schedule” (26,30,31). In the context of the new plans to eliminate viral hepatitis as a public health problem, the scope of this indicator is being expanded from timely birth dose only to other interventions to prevent mother-to-child transmission of HBV. Coverage of third dose of hepatitis B vaccine among infants Core Outcome Prevention (vaccination) Proportion of infants (<12 months of age) who received the third dose of hepatitis B vaccine (HepB3) (percentage) Number of infants (<12 months of age) who received the third dose of hepatitis B vaccine (HepB3) Number of infants (<12 months of age in a year) surviving to age 1 year (26) Age, place of residence, sex, socioeconomic status (26) Routinely collected from programme data (vaccine administrative coverage data, facility information systems) or through periodic immunization validation surveys (household surveys) and disseminated by WHO and UNICEF (http://apps.who.int/immunization_ monitoring/globalsummary/timeseries/tswucoveragedtp3.html). This indicator monitors and guides immunization programmes as proposed by WHO and UNICEF (27,29,32). It is also included in the WHO Global reference list of 100 core health indicators (19) where it is referenced as “Immunization coverage rate by vaccine for each vaccine in the national schedule” (26,30,31).

Numerator Denominator Disaggregation Measurement method, sources of data

Programme relevance and interpretation

Indicator C.3.b Indicator category M&E domain Health domain (sub-domain) Definition Numerator Denominator Disaggregation Measurement method, sources of data Programme relevance and interpretation

1

In the case of testing of the mother followed by immunoprophylaxis, “newborns benefiting from other interventions to prevent mother-to-child transmission of HBV” would include children born to HBsAg-negative mothers and children born to HBsAg-positive mothers and who received immunoprophylaxis. Children born to mothers who were not tested and children born to HBsAg-positive mothers and who did not receive immunoprophylaxis would be excluded.

20

Indicator C.4 Indicator category M&E domain Health domain (sub-domain) Definition Numerator Denominator Disaggregation Measurement method, sources of data

Facility-level injection safety Core Outcome Prevention (injection safety) Proportion of health-care facilities where all therapeutic injections are given with new, disposable, single-use injection equipment Number of sampled health-care facilities where all therapeutic injections are given with new, disposable, single-use injection equipment Number of facilities sampled Facility type

- This indicator is measured through health facility surveys (facility data). - An alternate approach is to use population surveys. DHS estimate the proportion of the last injections received that have been given from a new, unopened package on the basis of individual data. Even though the source of data and measurement differ, the estimates of the frequency of reuse of injection equipment from population surveys are often comparable to data from health facility surveys. Assesses the implementation of policies to ensure that all health facilities implement injection safety WHO and the Safe Injection Global Network (SIGN) Alliance have designed a tool for the assessment of injection safety and the safety of phlebotomy, lancet procedures, intravenous injections and infusions (33). The indicator proposed comes from this tool, which has been used successfully to conduct national injection safety surveys. This indicator is cited as “PREV.6” in the WHO Consolidated strategic information guideline for HIV (15). Needle–syringe distribution Core Outcome Prevention (PWID) Number of needles–syringes distributed per person who injects drugs Number of sterile needles–syringes distributed in the past 12 months by needle–syringe programmes (NSPs) Number of people who inject drugs Sex, age, type of setting (community, prison/closed setting) Numerator: programme records, e.g. NSP logbooks Denominator: population size estimation exercises (34) This indicator is cited as “KPOP.2” in the WHO Consolidated strategic information guidelines for HIV (15). 1

Programme relevance and interpretation

Indicator C.5 Indicator category M&E domain Health domain (sub-domain) Definition Numerator Denominator Disaggregation Measurement method, sources of data Programme relevance and interpretation

1

More information on this indicator is available in the WHO, UNODC, UNAIDS technical guide for countries to set targets for universal access to HIV prevention, treatment and care for injecting drug users, 2012 revision, available at: http://apps.who.int/iris/ bitstream/10665/77969/1/9789241504379_eng.pdf (Indicator NSP.C.1c).

21

Indicator C.6 Indicator category M&E domain Health domain (sub-domain) Definition Numerator Denominator Disaggregation

People living with HCV and/or HBV diagnosed Core Output Testing Proportion of people living with chronic HBV and/or HCV infection who have been diagnosed with HBV and/or HCV Number of persons with chronic HBV and/or HCV infection who have been diagnosed Estimated number of persons with chronic HBV and/or HCV infection Sex, age (adults/children, more than 15 and less 15 years), high-risk/-burden population for viral hepatitis B and C, pregnant women HIV infection Two measurement methods are possible: 1) Counting persons reported with chronic infection and dividing this number by the estimated size of the population infected. In that case, the numerator is the number of persons reported with chronic HBV and/or HCV infection from health-care facilities (case reporting) and/or laboratories, while the denominator is the estimated size of the population infected (modelled or estimated from a biomarker survey). This method estimates the number of persons newly identified or newly reported, which, after identification of duplicates, may be cumulated over time. 2) Using survey data where persons are asked if they are aware of their viral hepatitis infection status in population surveys. In that case, the numerator is the number of persons reporting that they are aware of their chronic HBV and/or HCV infection during the survey, while the denominator is the number of persons identified as infected during the survey. This method estimates the cumulated number of persons aware of their status. Estimating the proportion of persons with chronic HBV and/or HCV infection who know their infection status measures the entry point to the continuum of care. Disaggregated estimates can point to gaps in diagnosing people chronically infected with viral hepatitis.

Measurement method, sources of data

Programme relevance and interpretation

22

Indicator C.7.a Indicator category M&E domain Health domain (sub-domain) Definition Numerator Denominator Disaggregation

Treatment coverage for hepatitis B Core Outcome Treatment and care Proportion of HBV-infected persons who are currently on treatment Number of persons with chronic HBV infection (defined by HBsAg-positive serological status) who are currently receiving treatment Number of persons with chronic HBV infection Sex, age, high-risk/-burden populations, HIV status Numerator: programme records (clinical records of health-care facilities providing hepatitis treatment and care)

Measurement method, sources of data

Note: Data on treatment in developing countries may not be easy to obtain where there is no centralized treatment programme. Additional data on treatment courses sold in the country (from pharmaceutical companies/pharmacies) could provide an indication on treatment coverage. Denominator: modelling estimates of the number of HBV-infected persons Treatment initiation for hepatitis C Core Outcome Treatment and care Proportion of persons diagnosed with chronic HCV infection started on treatment during a specified time frame (e.g. 12 months) Number of persons already diagnosed with chronic HCV infection (defined as positive for HCV RNA or positive for HCV Ag) who initiated treatment during a specified time frame (e.g. 12 months) Number of persons already diagnosed with chronic HCV infection (defined as positive for HCV RNA or positive for HCV Ag) for the specified time period (12 months) Note: All those already diagnosed to date but treated and cured would be excluded. Sex, age, high-risk/-burden populations, medicine type (interferon or based on direct-acting antivirals [DAAs]), HIV status Numerator: programme records (clinical records of health-care facilities providing hepatitis treatment and care) Denominator: programme records and/or modelling estimates This C.7 indicator measures the number of people living with HBV/HCV infection who were evaluated for hepatitis disease progression, found to be eligible for and placed on treatment. Disaggregation can indicate degree of equity in enrolment of specific priority populations. Trends over time reflect on progress in treating patients. National representativeness: if this indicator is measured only in a subset of facilities, comments should be added on the source of information, sample size and whether the information is representative of all sites where hepatitis treatment and care are delivered.

Indicator C.7.b Indicator category M&E domain Health domain (sub-domain) Definition Numerator

Denominator Disaggregation Measurement method, sources of data

Programme relevance and interpretation

23

Indicator C.8.a Indicator category M&E domain Health domain (sub-domain) Definition Numerator Denominator Disaggregation Measurement method, sources of data

Viral suppression for chronic hepatitis B patients treated Core Outcome Treatment and care Proportion of patients with chronic HBV infection on treatment in whom HBV viral load (VL) is suppressed Number of patients with chronic HBV infection on treatment who have a suppressed VL (HBV DNA not detectable), based on VL measurement in the past 12 months Number of patients with chronic HBV infection on treatment and assessed for VL in the past 12 months Sex, age Programme records, cohort studies, patient records, combined with estimates for the population with no VL data Measures virological suppression achieved among all those currently on treatment, regardless of when they started

Programme relevance and interpretation

This indicator does not give the coverage of VL testing. It is recommended that this indicator should include information on whether VL is tested in all or only a few patients, and give the proportion of VL testing coverage (Indicator A.10.a). The denominator for the indicator C.8.a is the numerator for indicators A.10.a (Documentation of treatment effectiveness).

Indicator C.8.b Indicator category M&E domain Health domain (sub-domain) Definition Numerator Denominator Disaggregation Measurement method, sources of data Programme relevance and interpretation

Cure for chronic hepatitis C patients treated Core Outcome Treatment and care Proportion of patients with chronic hepatitis C cured among those who completed treatment Number of patients who completed hepatitis C treatment and had a sustained virological response (SVR) based on VL measurement 12–24 weeks after the end of treatment (in the past 12 months) Number of patients who completed hepatitis C treatment and were assessed for SVR 12– 24 weeks after the end of treatment (in the past 12 months) Sex, age, medicine type (interferon or DAA based) Programme records, cohort studies, patient records, combined with best estimates for the population with no VL data Measures how many are cured among all those who completed treatment This indicator does not give the coverage of assessment for SVR. It is recommended that this indicator should include information on whether SVR is assessed in all or only a few patients, and give the proportion of SVR assessment coverage (Indicator A.10.b). The denominator for the indicator C.8.b is the numerator for indicator A.10.b (Documentation of treatment effectiveness).

24

Indicator C.9.a Indicator category M&E domain Health domain (sub-domain) Definition Numerator Denominator Disaggregation Measurement method, sources of data

Cumulated incidence of HBV infection in children 5 years of age Core Impact Morbidity (incidence) Proportion of children 5 years of age with serological evidence of past or present HBV infection (anti-HBc positive) and/or chronic infection (HBsAg positive) (35). Number of survey children 5 years of age living with biomarkers of past or present infection and/or chronic infection (35)  Number of children aged 5 years of age in surveys (35)  Sex, place of residence, exposure to HepB_BD (immunization records), exposure to HepB3 HBsAg biomarker prevalence survey in children 5 years of age (immunization coverage surveys and administrative vaccination coverage data) (35)  This indicator is referenced in the WHO Global reference list of 100 core health indicators as “Prevalence of hepatitis B surface antigen”(35).   Incidence data from children are most important. Infections acquired in the first 5 years of life lead to chronicity in 20–30% of cases and account for the majority of the burden of chronic infection in adults.

Programme relevance and interpretation

Children under the age of 5 years have not yet gone through the risk period during which infections are most likely to result in chronicity. Anti-HBc reflects the cumulated risk of infection over five years. This estimate is most useful from an epidemiological perspective. HBsAg estimates the proportion of children with chronic infection who are likely to develop chronic hepatitis and subsequent sequelae. This estimate is most useful from a public health perspective. Trends in the incidence of HBV infection in adults/general population are reflected through surveillance for acute hepatitis B. However, incidence in adults/general population is less informative, as infections at this age/in this population result in less chronicity than infections in children (12,36–38). Incidence of HCV infection Core Impact Morbidity (incidence) Number and rate of new infections with HCV (anti-HCV positive) Total number of new infections with HCV defined as anti-HCV positive per year Total population minus people living with hepatitis C Sex, age, defined populations Modelled with inputs from repeated surveys of HCV infection: - general population (in selected countries with a high prevalence) at least every 10 years - people who inject drugs (PWID), at least every 3 years - antenatal care (ANC), at least every 3 years - other relevant groups according to national context As estimates of incidence are hard to obtain, incidence may be modelled using point prevalence in the targeted population. In theory, incidence estimate must take into account primary infections, reinfections and spontaneous recoveries. An anti-HCV positive test will not distinguish between these three events. In practice, reinfection may be difficult to measure in routine surveys and may require cohorts of high-risk persons assessed in the context of research projects. This indicator reflects both the outcome and impact of hepatitis C prevention and treatment. It monitors trends, detects possible shifts in pattern and projects the future direction of the epidemic.

Indicator C.9.b Indicator category M&E domain Health domain (sub-domain) Definition Numerator Denominator Disaggregation Measurement method, sources of data

Programme relevance and interpretation

25

Indicator C.10 Indicator category M&E domain Health domain (sub-domain) Definition

Deaths attributable to HBV and HCV infection Core Impact Mortality Deaths from hepatocellular carcinoma (HCC), cirrhosis and chronic liver diseases attributable to HBV and HCV infections Number of deaths from HCC, cirrhosis and chronic liver diseases attributable to HBV and HCV infection: - number of hepatocellular carcinoma (ICD-10 code C22.0) deaths multiplied by the proportion of HCC with chronic HBV and HCV infections - number of cirrhosis deaths (ICD-10 codes K74.3, K74.4, K74.5, K74.6) multiplied by the proportion of cirrhosis with chronic HVB and HCV infections - number of chronic liver disease deaths (ICD-10 codes K72–K75) with chronic HBV and HCV infections Not applicable Sex, age (adults/children) - Country cancer registry files (39) - National civil registration and vital statistics (CRVS) including mortality registers - Hospital-/clinic-based registers monitoring service provision - Global databases (aggregated data): - WHO mortality databank (40) (liver cancer ICD-10 code C22 only) - IARC Cancer Incidence in Five Continents (CI5) databases (liver cancer and HCC data) (21) - Global estimated data (modelling) - IARC GLOBOCAN database (20) (liver cancer ICD-10 code C22 only) - Prevalence of HBV and HCV infections among patients with HCC, cirrhosis and chronic liver diseases in sentinel sites This indicator shows trends in deaths from chronic liver diseases among people infected with chronic hepatitis B or C. Interpretation of these indicators involves the estimation of an attributable fraction. Given the strong association between HBV and HCV infections and chronic liver disease, as a first approximation, the proportion of patients with HCC, cirrhosis and chronic liver disease who are chronically infected with HBV and HCV can be used as an estimate of the fraction of these sequelae that are attributable to HBV and HCV infections (41,42). This indicator measures the ultimate outcome of activities for prevention, testing, care and treatment of viral hepatitis. Ongoing improvement of vital registration will facilitate measurement of this indicator through the analysis of sample and site mortality data. Data may be available at the regional and sometimes national level for long time series. Improving cancer registration coverage worldwide will facilitate the measurement of the indicator and improve estimates available in the IARC GLOBOCAN database (20).

Numerator

Denominator Disaggregation

Measurement method, sources of data

Programme relevance and interpretation

ICD-10: International Statistical Classification of Diseases and Related Health Problems, tenth revision

26

4.3 Additional indicators: metadata table Viral hepatitis-specific indicators TABLE 4. List and metadata of additional indicators specific to viral hepatitis B and C Indicator category (Core or M&E Additional) domain and number A.1 Health domain (sub-domain) Indicator name and definition HDV coinfection among people living with chronic HBV infection Measurement Programme relevance and Denominator Disaggregation method, sources of data interpretation Number of people living with hepatitis B (HBsAg positive) Sex, age (adults/ children), pregnancy status, highrisk/-burden populations for viral hepatitis B and C - Survey - Programme data (e.g. presence of anti-HDV in people diagnosed with hepatitis B) Guides as to whether the frequency of HDV infection among people living with hepatitis B is such that a public health approach is needed to address HDV infection

Numerator

Context Morbidity and needs (prevalence)

Number of people living with hepatitis B (HBsAg positive) coinfected with hepatitis Number and D (antibody proportion of against people infected hepatitis D with HDV virus [antiamong those HDV positive]) living with hepatitis B Experience with discrimination against people living with viral hepatitis Proportion of people living with viral hepatitis who experienced discrimination Availability of essential medicines and commodities Number of people living with viral hepatitis who experienced discriminatory attitudes or actions towards them within the past 12 months

A.2

Context Stigma and and needs discrimination

Number of people living with viral hepatitis

Viral hepatitis virus type: B and C

- Population interviews

Measures stigma and discrimination against populations infected with viral hepatitis, which may prevent them from seeking care

A.3

Context Health system and needs (service access and availability)

Presence of the medicines for the treatment of hepatitis B Hepatitis C and C that direct-acting are included antiviral (DAA) in the WHO agents and model EML in hepatitis B the national medicines EML in national essential medicines list (EML) National system for viral hepatitis surveillance Existence of a system for viral hepatitis surveillance

Not applicable

- Programme data - Review of documents

In 2015, WHO updated its Model list of essential medicines (43) to include all medicines relevant for the treatment of hepatitis C and B. This indicator is adapted from the indicator named “Availability of essential medicines and commodities” (44) from the WHO Global reference list of 100 core health indicators (19).

A.4

Input

Policy (data collection system)

A national Not system for applicable viral hepatitis surveillance includes the following functions: - reporting of acute hepatitis - estimating the prevalence of chronic HBV and HCV infection - estimating the mortality from cirrhosis, hepatocellular carcinoma and chronic liver diseases that are attributable to HBV and HCV infections

Many countries have surveillance for acute hepatitis cases but few have chronic infections under surveillance. Some countries do not distinguish between acute and chronic hepatitis. Disaggregation by types of surveillance system when possible (acute hepatitis, chronic infections and sequelae)

- Desk review and interviews with selected stakeholders

Further information is available in the WHO Technical considerations and case definitions to improve surveillance for viral hepatitis (12).

27

Table 4: List and metadata of additional indicators specific to viral hepatitis B and C (continued) Indicator category (Core or M&E Additional) domain and number A.5 Output Health domain (sub-domain) Testing Indicator name and definition Hepatitis B testing Testing for hepatitis B Measurement Programme relevance and Denominator Disaggregation method, sources of data interpretation Population size Sex, age (adults/ children – more than 15 and less 15 years), highrisk/-burden population for viral hepatitis B, pregnant women, HIV status - Clinical and/ or laboratory records of health-care facilities, or - Programme data This indicator monitors progress of testing in a population – an intervention that is critical for assessing further needs related to the management of hepatitis B. Disaggregation by HIV status monitors hepatitis B testing activities among persons in HIV care. A.5 and A.6 are more suited for monitoring. They can be calculated with routine data. C.6 (The proportion of persons living with HBV or HCV diagnosed) is more suited for evaluation as it may require survey data. A.6 Output Testing Hepatitis C testing Testing for hepatitis C Number of persons who were tested for hepatitis C during the reporting period (e.g. 1 year) - using HCV RNA testing - using antiHCV testing Population size Sex, age (adults/ children – more than 15 and less 15 years), highrisk/-burden population for viral hepatitis C, pregnant women, HIV status - Clinical and/ or laboratory records of health-care facilities, or - Programme data This indicator monitors progress of testing in a population – an intervention that is critical for assessing further needs related to the management of hepatitis C. Disaggregation by HIV status monitors hepatitis C testing activities among persons in HIV care. A.5 and A.6 are more suited for monitoring. They can be calculated with routine data. C.6 (The proportion of persons living with HBV or HCV diagnosed) is more suited for evaluation as it may require survey data. A.7 Output Treatment and HCV genotyping care Proportion of chronic HCV infections with genotyping information Reported cases of chronic HCV infection that have been genotyped Reported cases of chronic HCV infection Sex, age (adults/ children – more than 15 and less 15 years), highrisk/-burden population for viral hepatitis C, pregnant women, HIV status - Programme data, or - Laboratory information systems, or - Special studies Pan-genomic treatments for HCV are not yet universally available. In the meantime, genotype distribution guides the choice of regimen, estimates treatment costs and advocates for faster introduction of pangenomic treatments. This indicator is used by the WHO Region for the Americas (24).

Numerator

Number of persons who were tested for hepatitis B during the reporting period (e.g. 1 year) using HBsAg testing

28

Table 4: List and metadata of additional indicators specific to viral hepatitis B and C (continued) Indicator category (Core or M&E Additional) domain and number A.8 Outcome Health domain (sub-domain) Indicator name and definition Measurement Programme relevance and Denominator Disaggregation method, sources of data interpretation Estimated population of persons with chronic HBV and HCV infection Age, sex, high-risk/burden populations for viral hepatitis, vaccination and treatment status -Numerator comes from programme records, visit records - Populationbased denominator: modellingbased estimates Even if this indicator is not available or feasible currently, it is an important element of the continuum-of-care cascade, as it reflects the linkage to care.

Numerator

Treatment and Viral hepatitis care (linkage B and C care to care) coverage Number and proportion of persons with chronic HBV and HCV infections who are receiving care

Number of HBV and/or HCV-infected persons who received care in the past 12 months; as proxied by receipt of at least one of the following: - clinical assessment of liver function/ staging OR -virological biomarker testing OR - treatment

This indicator helps to track global trends in coverage of care and treatment across populations of persons with chronic HBV Facility-based and HCV infection. It measures programme denominator: efforts to provide persons programme with chronic viral infection records, e.g. testing records acccess to counselling, care and clinical and mortality assessement. data Proxy of “care” could be derived from treatment/ laboratory/ patient monitoring database Adapted from LINK.2 indicators from WHO Consolidated strategic information guidelines for HIV (15)

A.9

Impact

Equity

Equitable access to hepatitis treatment Ratio of treatment access between highrisk/-burden populations and the general population

Number of persons from highrisk/-burden populations receiving HBV treatment/ initiated on HCV treatment during the reporting time (i.e. C.7.a and C.7.b indicators in highrisk/-burden populations)

Number Viral hepatitis of persons virus type: B from the and C general population receiving HBV treatment/ initiated on HCV treatment at a specified date (i.e. C.7.a and C.7.b indicators in the general population)

Programme records or surveys depending on the subpopulation group being compared Data on highrisk/-burden populations, such as PWID, are often collected through surveys. The type of high-risk/burden populations is to be chosen by country according to epidemic patterns. - Programme data

Equity in access to hepatitis treatment informs as to whether subgroups are accessing treatment or whether they are disadvantaged. Poor access to treatment may be due to stigma, prejudice, or to stock-outs of medicines in specific facilities. Analysis of the obstacles to treatment access informs policy improvements that could address these inequities.

A.10

Outcome

Treatment and Documentation care of treatment effectiveness Proportion of patients with documentation of treatment effectiveness

A.10.a. Number of patients with chronic HBV infection on treatment who have had a VL measurement in the past 12 months 1 A.10.b. Number of patients who completed hepatitis C treatment and were assessed for SVR 12–24 weeks after the end of treatment (in the past 12 months)

Number of patients with chronic HBV infection on treatment in the past 12 months Number of patients who completed hepatitis C treatment (in the past 12 months)

The numerators for indicators A.10.a and A.10.b are the denominators for the indicators C.8.a and C.8.b.

1

HBV DNA is the method to measure VL, but hepatitis B e antigen (HBeAg) or HBsAg may be used as surrogate methods if there is no access to HBV DNA.

29

Indicators already formulated and/or collected through national health system or other programmes TABLE 5. List and metadata of additional indicators for viral hepatitis B and C already formulated and/or collected through other programmes or national health system Indicator category (Core or M&E Additional) domain and number A.11 Context and needs Health domain (sub-domain) Population in need Indicator name and definition Estimated size of key populations (HIV) Estimated size of key populations Programmatic area HIV, STI

Reference

Relevance and remark

Indicator NEEDS.2 from the WHO Consolidated strategic information guidelines for HIV (15)

Most of the HIV key populations are also high-risk/burden populations for viral hepatitis B and C (depending on the national context). WHO and UNAIDS recommend an approach to estimating the size of populations most at risk for HIV (34). Most of the HIV key populations are also high-risk/burden populations for viral hepatitis B and C (depending on the national context).

A.12

Context and needs

Stigma and discrimination

Key population experience with discrimination (HIV) Proportion of people from key populations who have experienced discrimination by health workers Hepatitis coinfections among persons with HIV infection Number and proportion of people living with HIV who are coinfected with HBV and/ or HCV Condom use in key populations (HIV) Proportion of key populations for HIV reporting condom use

Indicator NEEDS.6 and KPOP.7 from the WHO Consolidated strategic information guidelines for HIV (15)

A.13

Context and needs

Morbidity (prevalence)

Indicator NEEDS.3 from the WHO Consolidated strategic information guidelines for HIV (15)

A national programme for testing and treatment of viral hepatitis needs to take into account the frequency of hepatitis coinfections among persons with HIV infection. This indicator serves as a basis for estimating national and subnational needs for and coverage of prevention, care and treatment of comorbidities of HIV (45).

A.14

Outcome

Prevention (condom use)

From the UNAIDS Global AIDS response progress reporting (46) and the WHO Consolidated strategic information guidelines for HIV (15), disaggregated into 4 subindicators: - PPREV.1.a: Condom use among sex workers - PPREV.1.b: Condom use among men who have sex with men - PPREV.1.c: Condom use among people who inject drugs - PPREV.1.d: Condom use among general population This indicator is also included in the WHO Global reference list of 100 core health indicators (19) (Condom use at last sex with high-risk partner (47)). Immunization WHO/UNICEF Joint reporting process (29) and Hepatitis B position paper (7,32)

Condom use in key populations guides interventions for safer sex that are relevant to viral hepatitis programmes.

A.15

Input

Policy (prevention – vaccination)

National provision of a birth dose of hepatitis B vaccine National policy, implementing rules and regulations for the provision of a birth dose of hepatitis B vaccine within 24 hours of birth

This policy indicator helps to interpret indicator C.3.a (Coverage of timely hepatitis B vaccine birth dose, within 24 hours). Coverage may be low in the absence of a policy and plans.

A.16

Outcome

Prevention (vaccination)

Hepatitis B vaccination among healthcare workers Proportion of healthcare workers who received three doses of hepatitis B vaccine

WHO/UNICEF Joint reporting process (29) and Hepatitis B position paper (7,32)

A 2007 World Health Assembly resolution has called for immunization of health-care workers. WHO recommends including this intervention in national viral hepatitis plans.

30

TABLE4: Table 5.List Listand andmetadata metadataof ofadditional additionalindicators indicatorsspecific for viralto hepatitis viral hepatitis B and C Balready and C formulated and/or collected through other programmes or national health system (continued) Indicator category (Core or M&E Additional) domain and number A.17 Outcome Health domain (sub-domain) Prevention (blood transfusion safety) Indicator name and definition Facility-level blood safety Proportion of health facilities providing blood transfusion that meets requirements for sufficient and safe blood transfusion Blood screening coverage Proportion of blood units screened for bloodborne diseases Injection safety, infection control Programmatic area Blood safety

Reference

Relevance and remark

Indicator PREV.8 from from the WHO Consolidated strategic information guidelines for HIV (15) reflecting blood transfusion safety (48–54)

This indicator reflects blood safety that is one of the prevention interventions of the Global Health Sector Strategy (GHSS) on viral hepatitis.

A.18

Outcome

Prevention (blood transfusion safety)

Indicator PREV.9 from the WHO Consolidated strategic information guidelines for HIV (15) reflecting screening of blood donations (48,55)

This indicator reflects blood safety that is one of the prevention interventions of the GHSS.

A.19

Input

National policy for infection (prevention prevention – infection and control prevention and programmes control [IPC]) Existence of national policy regarding IPC in health-care and other settings Policy Prevention (injection safety) Supply of needles–syringes Proportion of facilities with no stock-outs of quality-assured needles–syringes and matching quantities of safety boxes Procurement of reuse prevention devices Proportion of devices with safetyengineered features (for reuse prevention /sharps injury protection) among those procured at national and/or local level Reuse of injection equipment Rate of reuse of syringes Needle-stick injuries (NSIs) in health-care workers Reported incidence of needle-stick injuries in health-care workers OST coverage Proportion of people who inject drugs (PWID) receiving opioid substitution therapy (OST) Retention in OST Proportion of PWID receiving OST for 6 months

WHO Core components for infection This policy indicator reflects prevention and control programmes infection control that is one of (56,57) the prevention interventions of GHSS.

A.20

Output

Indicator PREV.7 from the WHO Consolidated strategic information guidelines for HIV (15) reflecting supply chain management for injection devices (58)

This output indicator helps to interpret indicator C.4 (Facility-level injection safety). Only single-use injection devices are considered. WHO no longer recommends the use of sterilizable injection devices.

A.21

Outcome

Prevention (injection safety)

WHO Injection safety guidelines 2015 This output indicator helps (57) to interpret indicator C.4 (Facility-level injection safety).

A.22

Output

Prevention (injection safety)

WHO Injection safety guidelines 2015 (57) reflecting safe injection practices (59)

This output indicator helps to interpret indicator C.4 (Facility-level injection safety).

A.23

Outcome

Prevention (injection safety)

WHO Injection safety guidelines 2015 This outcome indicator of (57) injection safety documents the risk to the injection provider.

A.24

Outcome

Prevention (PWID)

Harm reduction

Indicator KPOP.4 from the WHO Consolidated strategic information guidelines for HIV (15)

This outcome indicator adds on C.5 and further documents prevention activities among PWID, one of the prevention interventions of the GHSS. 1

A.25

Outcome

Prevention (PWID)

Indicator KPOP.5 from the WHO Consolidated strategic information guidelines for HIV (15)

This outcome indicator adds on C.5 and further documents prevention activities among PWID, one of the prevention interventions of the GHSS.1

1

OST is only for persons who are dependent on opioids (Though injection or other modes of administration). More information on this indicator is available in the WHO, UNODC, UNAIDS technical guide for countries to set targets for universal access to HIV prevention, treatment and care for injecting drug users, 2012 revision, available at: http://apps.who.int/iris/bitstream/10665/77969/1/9789241504379_eng.pdf (Indicators OST.C.1b and OST.Q.3c).

31

TABLE4: Table 5.List Listand andmetadata metadataof ofadditional additionalindicators indicatorsspecific for viralto hepatitis viral hepatitis B and C Balready and C formulated and/or collected through other programmes or national health system (continued) Indicator category (Core or M&E Additional) domain and number A.26 Impact Health domain (sub-domain) Morbidity (incidence) Indicator name and definition Cancer incidence, by cancer type Number of new cancers of a specific site/ type occurring per 100 000 population Programmatic area

Reference

Relevance and remark

Noncommunicable This indicator is included in the diseases (NCDs), WHO Global reference list of 100 cancer core health indicators (19) (Cancer incidence, by type of cancer (60))

Following disaggregation by type of cancer, the number of liver cancers obtained needs to be interpreted after applying the proportions of HCC among liver cancers from published studies. Most liver cancers are metastatic cancers (e.g. from colon and other gut cancers. The IARC Cancer Incidence in Five Continents (CI5) database provides data on liver cancer and HCC (21). As alcohol consumption is a risk factor for progression of cirrhosis and HCC among persons with chronic HBV and HCV infection, this indicator informs as to what extent alcohol consumption needs to be taken into account in national viral hepatitis plans.

A.27

Input

Prevention (risk factor)

Total alcohol per capita (age 15+ years) consumption Agestandardized prevalence of current alcohol use among persons aged 15+ years

This indicator is included in the WHO Global reference list of 100 core health indicators (19) (Total alcohol per capita (age 15+ years) consumption (61)).

32

REFERENCES 1. Resolution EB134/36. Hepatitis: improving the health of patients with viral hepatitis. In: One hundred thirty-fourth session of the Executive Board, Geneva, 20–24 January 2014. Geneva: World Health Organization; 2014 (http://apps.who.int/gb/ebwha/pdf_files/EB134/B134_36-en.pdf?ua=1&ua=1, accessed 03 March 2016). 2. Resolution WHA63.18. Viral hepatitis. In: Sixty-third World Health Assembly, Geneva, 17–21 May 2010. Geneva: World Health Organization; 2010 (apps.who.int/gb/ebwha/pdf_files/WHA63/A63_ R18-en.pdf, accessed 27 December 2015). 3. Resolution WHA67.6. Hepatitis. In Sixty-seventh World Health Assembly, Geneva, 19–24 May 2014. Geneva, World Health Organization; 2014 (http://www.who.int/hiv/mediacentre/ news/2014wharesolution_hepatitis/en/, accessed 27 December 2015). 4. Prevention and control of viral hepatitis infection: framework for global action. Geneva: World Health Organization; 2012 (http://apps.who.int/iris/bitstream/10665/130012/1/WHO_HSE_PED_HIP_ GHP_2012.1_eng.pdf, accessed 27 December 2015). 5. 2015 Global reference list of 100 core health indicators. Geneva: World Health Organization; 2015 (http://www.who.int/healthinfo/indicators/2015/en/, accessed 27 December 2015). 6. Global policy report on the prevention and control of viral hepatitis in WHO Member States. Geneva: World Health Organization; 2013. (http://apps.who.int/iris/bitstream/10665/85397/1/9789241564632_ eng.pdf, accessed 27 December 2015). 7. Hepatitis B: fact sheet no. 204. In: Media centre [website]. Geneva: World Health Organization; updated July 2015 (http://www.who.int/mediacentre/factsheets/fs204/en/, accessed 27 December 2015). 8. Hepatitis C: fact sheet no. 164. In: Media centre [website]. Geneva: World Health Organization; updated July 2015 (http://www.who.int/mediacentre/factsheets/fs164/en/index.html, accessed 27 December 2015). 9. Hepatitis D. Global alert and response (GAR) [website]. Geneva: World Health Organization (http:// www.who.int/csr/disease/hepatitis/whocdscsrncs20011/en/index1.html, accessed 26 December 2015). 10. Hepatitis A: fact sheet no. 328. In: Media centre [website]. Geneva: World Health Organization; updated July 2015 (http://www.who.int/mediacentre/factsheets/fs328/en/, accessed 26 December 2015). 11. Hepatitis E: fact sheet no. 280. In: Media centre [website]. Geneva: World Health Organization; updated July 2015 (http://www.who.int/mediacentre/factsheets/fs280/en/, accessed 27 December 2015). 12. Technical considerations and case definitions to improve surveillance for viral hepatitis. Geneva: World Health Organization; 2016 (http://www.who.int/hepatitis/publications/hep-surveillance-guidepub/en/, accessed 03 March 2016). 13. WHO manual for the development and assessment of national viral hepatitis plans: a provisional document. Geneva: World Health Organization; 2015 (http://www.who.int/hepatitis/publications/ manual-hep-plan/en/, accessed 27 December 2015). 14. Global health sector strategy on viral hepatitis, 2016–2021. Geneva: World Health Organization; 2016 for submission to WHO Executive Board (http://www.who.int/hepatitis/news-events/ strategy2016-2021/en/, accessed 27 December 2015).

33

15. Consolidated strategic information guidelines for HIV in the health sector. Geneva: World Health Organization; 2015 (http://who.int/hiv/pub/guidelines/strategic-information-guidelines/en/, accessed 27 December 2015). 16. International Health Partnership (IHP+)/WHO. Monitoring, evaluation and review of national health strategies: a country-led platform for information and accountability. Geneva: World Health Organization; 2011 (http://www.who.int/healthinfo/country_monitoring_evaluation/1085_ IER_131011_web.pdf, accessed 27 December 2015). 17. M onitoring progress towards universal health coverage at country and global levels: framework, measures and targets. Geneva: World Health Organization and The World Bank; 2014 (http://apps. who.int/iris/bitstream/10665/112824/1/WHO_HIS_HIA_14.1_eng.pdf, accessed 27 December 2015). 18. Indicator standards: operational guidelines for selecting indicators for the HIV response, Geneva: UNAIDS; 2010 (http://www.unaids.org/sites/default/files/sub_landing/files/4_3_MERG_Indicator_ Standards.pdf, accessed 27 December 2015). 19. 2 015 Global reference list of 100 core health indicators. Geneva: World Health Organization; 2015 (http://apps.who.int/iris/bitstream/10665/173589/1/WHO_HIS_HSI_2015.3_eng.pdf?ua=1, accessed 27 December 2015). 20. International Agency for Research on Cancer (IARC)/World Health Organization. GLOBOCAN 2012: estimated cancer incidence, mortality and prevalence worldwide in 2012 [online database]. Lyon, France: IARC; 2015 (http://globocan.iarc.fr/Default.aspx, accessed 27 December 2015). 21. International Agency for Research on Cancer (IARC)/World Health Organization. CI5: cancer incidence in five continents [online database]. Lyon, France: IARC; 2015 (http://ci5.iarc.fr/Default. aspx, accessed 27 December 2015). 22. Injection safety: new injection safety policy and global campaign [website]. Geneva: World Health Organization (http://www.who.int/injection_safety/en/, accessed 27 December 2015). 23. International Agency for Research on Cancer/WHO [website] (http://www.iarc.fr/, accessed 27 December 2015). 24. Surveillance and monitoring of viral hepatitis B and C: strategic information methods and indicators on viral hepatitis B and C in Latin America and the Caribbean. Washington, DC: WHO Regional Office for the Americas; March 2015 (unpublished). 25. A guide to monitoring and evaluation for collaborative TB/HIV activities. M&E for viral hepatitis needs to comply with principles of confidentiality and ethical considerations, as set out in the Universal Declaration of Human Rights. The Universal Declaration of Human Rights. Paris: United Nations; 1948 (http://www.un.org/en/universal-declaration-human-rights/index.html, accessed 19 March 2016). 26. Metadata table for indicator “Immunization coverage rate by vaccine for each vaccine in the national schedule” (http://www.who.int/healthinfo/indicators/2015/chi_2015_82_immunization.pdf?ua=1). In: Global Reference List of 100 Core Health Indicators). Geneva: World Health Organization; 2015 (http://www.who.int/healthinfo/indicators/2015/en, accessed 27 December 2015). 27. Burton A, Monasch R, Lautenbach B, Gacic-Dobo M, Neill M, Karimov R et al. WHO and UNICEF estimates of national infant immunization coverage: methods and processes. Bull World Health Organ.  2009;87:535–41. doi: 10.2471/BLT.08.053819 (http://www.who.int/bulletin/ volumes/87/7/08-053819/en/, accessed 27 December 2015). 28. Practices to improve coverage of the hepatitis B birth dose vaccine. Geneva: Department of Immunization, Vaccines and Biologicals, World Health Organization; 2012 [WHO/IVB/12.11 (http:// apps.who.int/iris/bitstream/10665/78616/1/WHO_IVB_12.11_eng.pdf).

34

29. WHO/UNICEF joint reporting process. In: Immunization, vaccines and biologicals [website]. Geneva: World Health Organization (http://www.who.int/immunization/monitoring_surveillance/routine/ reporting/en/, accessed 27 December 2015). 30. Countdown to 2015. Monitoring maternal, newborn and child health: understanding key progress indicators. Geneva: World Health Organization; 2011 (http://apps.who.int/iris/ bitstream/10665/44770/1/9789241502818_eng.pdf, accessed 29 March 2015). 31. IVB resources: documents. In: Immunization, Vaccines and Biologicals [website]. (http://www.who. int/immunization/documents/en/, accessed 03 March 2016). 32. WHO. Hepatitis B vaccines: WHO position paper. Wkly Epidemiol Rec. 2009;84:405–20 (http://www. who.int/wer/2009/wer8440.pdf?ua=1, accessed 27 December 2015). 33. Revised injection safety tool: tool for the assessment of injection safety and the safety of phlebotomy, lancet procedures, intravenous injections and infusions. Geneva: WHO; 2008 (http://www.who.int/ injection_safety/Injection_safety_final-web.pdf, accessed 19 March 2016). 34. UNAIDS/WHO Working Group on Global HIV/AIDS and STI Surveillance Guidelines on estimating the size of populations most at risk to HIV. Geneva: World Health Organization; 2010 (http:// www.who.int/hiv/pub/surveillance/final_estimating_populations_en.pdf, accessed 9 February 2016). 35. Metadata table for indicator “Prevalence of hepatitis B surface antigen” (http://www.who.int/ healthinfo/indicators/2015/chi_2015_50_hepatitsB.pdf?ua=1). In: Global reference list of 100 core health indicators. Geneva: World Health Organization; 2015 (http://www.who.int/healthinfo/ indicators/2015/en, accessed 27 December 2015). 36. Documenting the impact of hepatitis B immunization: best practices for conducting a serosurvey. Geneva: World Health Organization; 2011 (http://whqlibdoc.who.int/hq/2011/WHO_IVB_11.08_eng. pdf, accessed 28 December 2015). 37. Hepatitis B control through immunization: a reference guide. Manila: WHO Regional Office for the Western Pacific; 2014 (http://iris.wpro.who.int/bitstream/10665.1/10820/3/9789290616696_eng. pdf, accessed 28 December 2015). 38. Sample design and procedures for hepatitis B immunization surveys: a companion to the WHO cluster survey reference manual. Geneva: World Health Organization; 2012 (http://whqlibdoc.who. int/hq/2011/WHO_IVB_11.12_eng.pdf, accessed 28 December 2015). 39. Jensen OM, Parkin DM, MacLennan R, Muir CS, Skeet RG, editors. Cancer registration: principles and methods. Lyon, France: International Agency for Research on Cancer/WHO; 1991 [IARC Scientific Publication No. 95] (http://www.iarc.fr./en/publications/pdfs-online/epi/sp95/index.php, accessed 28 December 2015). 40. Health statistics and information systems. In: WHO mortality database [online database]. (http:// www.who.int/healthinfo/mortality_data/en/, accessed 28 December 2015). 41. Perz JF, Armstrong GL, Farrington LA, Hutin YJ, Bell BP. The contribution of hepatitis B virus and hepatitis C virus infections to cirrhosis and primary liver cancer, worldwide. J Hepatol. 2006;45:529–38. 42. de Martel C, Maucort-Boulch D, Plummer M, Franceschi S. World-wide relative contribution of hepatitis B and C viruses in hepatocellular carcinoma. Hepatology. 2015;62(4):1190–200. doi: 10.1002/hep.27969. 43. WHO Model lists of essential medicines, 19th list. Geneva: World Health Organization; 2015 (http:// www.who.int/medicines/publications/essentialmedicines/en/, accessed 28 December 2015).

35

44. Metadata table for indicator “Availability of essential medicines and commodities”. (http://www.who. int/healthinfo/indicators/2015/chi_2015_112_essential_meds.pdf?ua=1). In: Global reference list of 100 core health indicators. Geneva: World Health Organization; 2015 (http://www.who.int/healthinfo/ indicators/2015/en, accessed 27 December 2015). 45. Easterbrook P, Sands A, Harmanci H. Challenges and priorities in the management of HIV/HBV and HIV/HCV coinfection in resource-limited settings. Semin Liver Dis. 2012;32:147–57. 46. UNAIDS/UNICEF/WHO. Global AIDS reponse progress reporting 2014: construction of core indicators for monitoring the 2011 UN Political Declaration on HIV and AIDS. Geneva: UNAIDS; 2014 (http:// www.unaids.org/sites/default/files/media_asset/GARPR_2014_guidelines_en_0.pdf, accessed 28 December 2015). 47. Metadata table for indicator “Condom use at last sex with high-risk partner” (http://www.who.int/ healthinfo/indicators/2015/chi_2015_59_condom_use.pdf?ua=1). In: Global reference list of 100 core health indicators. Geneva: World Health Organization; 2015 (http://www.who.int/healthinfo/ indicators/2015/en, accessed 27 December 2015). 48. Blood safety and availability: WHO fact sheet no. 279. In: Media centre [website]. Geneva: World Health Organization; reviewed June 2015 (http://www.who.int/mediacentre/factsheets/fs279/en/, accessed 28 December 2015). This fact sheet is based on data obtained through the WHO Global Database on Blood Safety (GDBS) for the year 2011, which were reported by 163 countries. 49. Service availability and readiness assessment (SARA): indicators and questionnaire. Geneva: World Health Organization (http://www.who.int/healthinfo/systems/sara_indicators_questionnaire/en/, accessed 28 December 2015). 50. Universal access to safe blood transfusion. Geneva: World Health Organization; 2008 (http://www. who.int/bloodsafety/publications/en/, accessed 28 December 2015). 51. Safe blood and blood products: documentation centre. Geneva: World Health Organization (http:// www.who.int/bloodsafety/publications/en/, accessed 28 December 2015). 52. Screening donated blood for transfusion-transmissible infections. Geneva: WHO; 2010 (http://www. who.int/bloodsafety/publications/bts_screendondbloodtransf/en/, accessed 28 December 2015). 53. Towards 100% voluntary blood donation: a global framework for action. Geneva: WHO/IFRC; 2010 (http://apps.who.int/iris/bitstream/10665/44359/1/9789241599696_eng.pdf?ua=1, accessed 28 December 2015). 54. Blood donor selection: guidelines on assessing donor suitability for blood donation. Geneva: WHO; 2012 (http://apps.who.int/iris/bitstream/10665/76724/1/9789241548519_eng.pdf, accessed 28 December 2015). 55. Blood screening indicators: % of blood donations tested in laboratories without quality assurance; % of blood routinely tested for TTIs. In: WHO Global Database on Blood Safety. Summary report 2011. Geneva: World Health Organization (http://www.who.int/bloodsafety/global_database/GDBS_ Summary_Report_2011.pdf?ua=1, accessed 28 December 2015). 56. Core components for infection prevention and control programmes. Geneva: WHO; 2008 (http://www. who.int/csr/resources/publications/WHO_HSE_EPR_2009_1/en/, accessed 28 December 2015). 57. WHO guideline on the use of safety-engineered syringes for intramuscular, intradermal and subcutaneous injections in health-care settings. Geneva: World Health Organization; 2015 (http:// www.who.int/injection_safety/global-campaign/injection-safety_guidline.pdf, accessed 28 December 2015). 58. Guiding principles to ensure injection device security. Geneva: World Health Organization: 2003 (http://apps.who.int/medicinedocs/en/d/Js4886e, accessed 28 December 2015).

36

59. Best practices for injections and related procedures toolkit. Geneva: World Health Organization; 2010 (http://www.who.int/injection_safety/9789241599252/en/, accessed 28 December 2015). 60. Metadata table for indicator “Cancer incidence, by type of cancer” (http://www.who.int/healthinfo/ indicators/2015/chi_2015_49_cancer_incidence.pdf?ua=1. In: Global reference list of 100 core health indicators. Geneva: World Health Organization; 2015 (http://www.who.int/healthinfo/ indicators/2015/en, accessed 27 December 2015). 61. Metadata table for indicator “Total alcohol per capita (age 15+ years) consumption” (http://www.who. int/healthinfo/indicators/2015/chi_2015_64_alcohol_consumption.pdf?ua=1). In: Global reference list of 100 core health indicators. Geneva: World Health Organization; 2015 (http://www.who.int/ healthinfo/indicators/2015/en, accessed 27 December 2015).

III

Monitoring and evaluation for viral hepatitis B and C: recommended indicators and framework To monitor and evaluate the Global Health Sector Strategy (GHSS) on viral hepatitis, the World Health Organization (WHO) proposes a monitoring and evaluation framework along the result chain. The result chain is a logical framework built along a sequence of inputs (e.g. resources, infrastructure) and processes (e.g. training, logistics systems) that translate into outputs (e.g. availability of services and interventions), which lead to outcomes (e.g. intervention coverage) and, ultimately, to impact (e.g. mortality). WHO has selected 10 core indicators and 27 additional indicators. Of these, 10 indicators are specific to viral hepatitis and 17 have been used in the past by other programmes, including HIV/sexually transmitted infection (STI) (four indicators), immunization (two indicators), blood safety (two indicators), injection safety and infection control, harm reduction (two indicators) and noncommunicable diseases, cancer (two indicators).

Global Hepatitis Programme Department of HIV/AIDS 20, avenue Appia 1211 Geneva 27 Switzerland Email: hepatitis@who.int http://www.who.int/hiv/topics/hepatitis/en/ 978 92 4 151028 8