Umeå International School of Public Health

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1 Umeå International School of Public Health Delay in health care seeking, diagnosis and treatment initiation among TB patients in Yemen: A study protocol Abdullah Alosaimi Supervisor: Dr. Anna-Karin Hurtig Master Thesis in Public Health, 20 Points 2007 Epidemiology and Public Health Science Department of Public Health and Clinical Medicine Umeå University Sweden

2 CONTENTS Acknowledgement iv Abstract v List of abbreviations vi List of table vii List of figures vii Definition of terms viii Ι. INTRODUCTION Tuberculosis facts TB in global perspective Adherence to TB control HIV and TB Drug-resistance and TB Global strategy to control TB Public private partnership in TB control 5 П. BACKGROUND Yemen country profile Location Population Economic overview Health situation overview Health system in Yemen Private health system in Yemen Health Sector Reform TB epidemiology in Yemen TB control in Yemen National Tuberculosis control Program Tuberculosis case detection and treatment Justification of the study Objectives General objective Specific objectives Research framework 17 i

3 3.4 Literature review Identifications of TB management delay types Factors influencing patient health care seeking delay Factors influencing early diagnosis Factors influencing early proper treatment Factors influencing total delay Conclusion Study methodology The study design Description of the study setting Study participants and methods Data collection methods Studied variables The methods used to test for the validity The methods used to test for the reliability Study population and sample size Data management and analysis Limitation of the study Ethical consideration Validity and trustworthiness of data Qualitative study part Qualitative methodology Focus group discussion Sampling Management of focus group interviews Focus group interviews Focus group discussion size Number of focus group discussion Focus group discussion documentation Description and analysis of the data Validity and Trustworthiness of data Time plan Time plan for the quantitative study, ii

4 Time plan for the qualitative study, Budget References 38 Appendix (i): Proposed consent form 46 Appendix (ii): Proposed interview questionnaire 47 iii

5 ACKNOWLEDGEMENT It was a great opportunity for me to pursue my master programme in the Umeå International School of Public Health (UISPH), where I learned various skills and knowledge in public health field not only from the very educated and skilled faculty, but also from my admirable classmates. I would like to express my sincere gratitude to all those who have in one way or another contributed and supported this work and especially to my supervisor Dr. Anna-Karin Hurtig for her continuous support, guidance, assistance and expertise, which have been invaluable in accomplishment of the thesis. A special acknowledgement is due to all staff of the department of Epidemiology and Public health particularly Birgitta Astrom and Karin Johansson for their assistance in different ways, which have contributed greatly to the completion of this thesis. I am particularly thankful to excellence Dr. Abdullah Nashir ambassador of Republic of Yemen in Canada for his personal support and advice made it possible for me to pursue my graduate study. My dad passed away in Sana'a-Yemen in a car accident while I am doing my master. May Allah bless him and grant him a place in the heaven. I was fortunate in having a dad with great vision and outstanding leadership. He gave me the best advice ever about working and building my career. In all of my life he was give me responsibilities and chores. When I decided to become a doctor he have been supported me no matter what. My Dad has to be one of the most perfect men in the world. Well maybe he isn't but that is how I think of him and how I will always think of him. I will keep remember him in my prayers and make a Dua for him. Finally, I wish to express my everlasting love to all members of my family, especially my mother s, wife and children, all whom I have had to sacrifice for the entire period that I have been pursue my study programme. I wish to appreciate them for their standing for my absence and being source of joy and satisfaction. iv

6 Abstract Tuberculosis is among the top ten causes of global mortality and affects low-income countries in particular. In developing countries, TB remains as a major public health threat. Delays in diagnosis and initiation of effective treatment increase morbidity and mortality from tuberculosis as well as the risk of transmission in the community. The aims of this study are to conduct literature review of the factors and determinants influence TB early management from patients and private practitioner s perspective, and develop a study protocol to assess the length of delays and identify factors affecting the delays from the onset of symptoms to the commencement of treatment in Yemen. Quantitative as well as qualitative methodologies will be used in order to generate more convenience information and better insight. We will conduct a cross sectional study from November 1, 2007 to April 15, 2008 among new smear-positive pulmonary TB patients visiting National TB Control Institute in Sana a city and the main TB control center in Ta izz governorate. Delay will be analysis from the onset of symptoms to the first presentation to a health care provider (Patients delay), and the time taken from the first health care visit to the initiation of anti-tuberculosis treatment (Health care system delay). In addition, health care system delay will be analysis further detail as diagnosis delay and treatment delay. Cases will interviewed according to a pre tested structured questionnaire. For the qualitative section, we will conduct focus group discussions for private practitioners in the same areas to collect and analysis information about their knowledge and attitude regarding the management of TB cases. The factors that appear to contribute to patients delay include patient characteristics as gender, age, education, poverty, individual s perception of TB, severity of case, knowledge and beliefs. On the other hand, the factors that appear to contribute to health care system delay are access to health care, expertise of the health personals, inadequate integration of private and public sector, the type of first line health services consulted include private health care services. In many countries, a large private health care sector has emerged, and a large proportion of TB suspects and patients are managed in that sector. We conclude that, private sector has an affect on patient health care seeking decision and on early TB diagnosis and treatment as many patients often favor private practitioners. We expected that the result of this proposed study will have implications on disease control in term of better understanding of the different barriers to TB health care and improving case-detection and treatment outcome. Also, it will provide a plenty information about the magnitude and the risk factors for delays which will be useful in estimating the impact of DOTS strategy over time, as well as for developing appropriate strategies to reduce diagnostic and treatment delays. v

7 LIST OF ABBREVIATIONS TB Tuberculosis LTBI Latent Tuberculosis Infection HIV Human Immune deficiency Virus AIDS Acquired immune deficiency syndrome MDR TB Multidrug-resistant tuberculosis WHA World Health Assembly DOTS Directly Observation Therapy NTPs National tuberculosis control programmes MDG Millennium Development Goal GDP General Domestic Product MoPH&P Ministry of Public Health and Population NTI National Tuberculosis Institute NTP Tuberculosis Control Programme INH Isoniazid PHCU Primary Health Care Units TD Total delay PTB Pulmonary tuberculosis SPSS Statistical Package for Social Science PPs private practitioners FGDs Focus group discussion WHO World Health Organization HSR Health Sector Reform DHS District Health Systems NGOs Non-governmental Organizations. YDMCHS Yemen Demographic Maternal and Child Health Survey GFATM PPM XDR TB Global Fund to Fight AIDS, Tuberculosis and Malaria Public Private Mix Extensively drug-resistant tuberculosis vi

8 List of tables 1. Health indicators in Yemen Tuberculosis burden in Yemen (2004 estimates) Tuberculosis Surveillance and DOTS implementation in Yemen (2004) 13 List of figures 1. Different delay durations contributing to the total delay ix 2. TB journey model Map of Yemen Republic 24 vii

9 Definition of terms Definitions of terms are adapted from the EuroTB programme and World Health Organization (Rieder et al., 1996; WHO 2001). Tuberculosis (simply called TB) is an infectious disease primarily caused by Mycobacterium tuberculosis: it affects mainly the lungs (pulmonary TB) but can attack any part of the body (extrapulmonary TB) Diagnostic delay is the period between the first patient health care visit and confirming the tuberculosis diagnosis (Figure 1). Treatment delay is the time interval between tuberculosis diagnosis and initiation of anti-tuberculosis drugs (Figure 1). Patient delay is the period from the onset of symptom to the first presentation to a health care provider(figure 1). Health care system delay is the time taken from the first health care visit to the initiation of antituberculosis treatment (Figure 1). Total delay is the period from the onset of the symptoms to the initiation of anti-tuberculosis treatment. Also, it is known as the sum of patient and healthcare system delays (Figure 1). Pulmonary TB: defined as a laboratory confirmed case (positive smear, histology, or culture) with or without radiological abnormalities consistent with active pulmonary TB or a decision taken by a physician that the patient s clinical and/or radiological features were compatible with pulmonary TB. Pulmonary TB included TB of the lung parenchyma and/or bronchial tree. Extra-pulmonary TB: defined as a patient with a smear culture, or histology specimen from an extrapulmonary site positive for M. Tuberculosis complex or with clinical signs of active extra-pulmonary disease who was treated with a full curative course of anti- Tuberculosis chemotherapy. Smear positive tuberculosis: Two or more initial sputum smear examinations positive for Acid-Fast bacilli or one sputum smear examination positive for Acid-Fast bacilli plus radiographic abnormalities consistent with active pulmonary tuberculosis as determined by a clinician or one sputum smear positive for Acid-Fast bacilli plus sputum culture positive for M. Tuberculosis. viii

10 Smear negative tuberculosis: Two Case of pulmonary tuberculosis which dose not meet the definition of smear positive tuberculosis. Diagnostic criteria should include at leas three sputum negative for Acid-Fast bacilli, and radiographic abnormalities consistent with active pulmonary tuberculosis and no response to a course of broad spectrum of antibiotics, and decision by a clinician to treat with a full course of anti-tuberculosis chemotherapy. New case: newly diagnosed sputum smear positive pulmonary TB (at least two positive specimens), aged 15 years or more. Patients were defined as having TB on the basis of any positive smear or culture Tuberculosis Case: a patient with sputum smear examinations positive for acid-fast bacilli is a definite case. Multidrug-resistant tuberculosis (MDR TB) is a form of tuberculosis that is resistant to two or more of the primary drugs used for the treatment of tuberculosis. Figure 1: Different delay durations contributing to the total delay First presentation Confirming Initiation of anti-tb Onset of symptoms. to a health care provider. tuberculosis diagnosis. treatment Patients delay Diagnosis delay Treatment delay Total delay Health system delay ix

11 Ι. INTRODUCTION 1.1 Tuberculosis facts Tuberculosis (TB) is a contagious disease caused by a bacteria called Mycobacterium tuberculosis. The bacteria can attack any part of the human body, but it usually attacks the lungs. It spreads through the air. People sick with pulmonary TB are infectious, while other TB types are not infectious. Untreated patient with active TB will infect on average between 10 and 15 people every year. However, people infected with TB bacilli will not necessarily become sick with the disease. When someone's immune system is weakened, the chances of becoming sick are greater. Therefore, early detection of infectious cases, and proper treatment, are essential for successful tuberculosis control. Delay in seeking care and proper diagnosis and treatment cause spread of infection in the society, increase out pocket expenditure, treatment failure, and is accompanied with a high risk of mortality (Bustamante et al, 2000). People with TB disease can be treated and cured if they seek medical help. Even better, people who have Latent TB Infection (LTBI) but are not yet sick can take medicine so that they will never develop TB disease. 1.2 TB in global perspective Tuberculosis kills nearly two million people a year 5000 every day mainly in the poorest communities in the developing world. It afflicts millions more. About one third of the world s population is infected with TB that is, they have a latent TB infection that may later cause disease to develop. Nearly nine million new cases develop every year. Someone in the world is newly infected with TB bacilli every second. Almost 5-10% of people who are infected with TB bacilli (but who are not infected with Human Immune deficiency Virus) become sick or infectious at some time during their life. People with Human Immune deficiency Virus (HIV) and TB infection are much more likely to develop TB (WHO, 2006a). The World Health Organization declared the disease a global emergency as long ago as TB has a profoundly damaging economic impact on patients and their families, through spending on diagnosis and treatment, transport to get to health facilities, and time lost from work. Yet it can be cured with drugs that cost as little as US$ per patient. In spite of the importance of TB as a global public health problem, diagnosis and treatment of TB still rely on old and imperfect technologies. New tools diagnostic tests, drugs and vaccines are urgently needed, particularly for use where the epidemics of human 1

12 immunodeficiency virus (HIV) and multidrug-resistant TB are most severe. A critical problem is that still not enough is being done to stop TB (WHO, 2006b). 1.3 Adherence to TB control Many factors influence the prevalence and prognosis of TB and its socioeconomic consequences. A better understanding of these factors within people and communities affected by tuberculosis is essential in providing more effective and efficient care for tuberculosis patient. A study conducted by Date and Okita in Yemen highlights the importance and complexity of such factors. For instance, lack of education does not hinder women from receiving TB diagnosis and treatment. The concept of traditional illness, however, causes a longer diagnostic delay among illiterate patients, and the role of male relatives positively influences treatment outcomes for female patients (Date, and Okita, 2005). The extent and risk factors for patient and health system delays have been well acknowledged in a number of countries (Mori et. al., 1992; Beyers et. al., 1994; Franco et. al., 1996; Gulbaran et. al., 1996; Liam, and Tang, 1997; Enkhbat et. al., 1997; Steen, and Mazone 1998; Lawn et. al., 1998; Long et. al., 1999; Lonnroth et. al.,1999; Bustamante et. al., 2000 Calder et. al., 2000; Creek et. al., 2000; Salaniponi et. al., 2000; Needham et. al., 2001). However, the national tuberculosis programme in Yemen know little about these factors. Baseline information about the extent and risk factors for delay in the diagnosis of tuberculosis well be helpful in estimating the impact of the Directly Observation Therapy (DOTS) strategy over time as well as for developing suitable strategies to diminish diagnostic delay. Factors related to patient as gender, economical status, age, poverty, literacy, access to health care, stigma of TB, unemployment, homelessness, and visit to traditional healers contribute to delay in seeking health care and diagnosis (Rajeswari et. al., 2002; Yamasaki-Nakagawa et. al., 2001; Uplekar et. al., 2001). Delay in early diagnosis and treatment happens as result of factors as health workers attitude, limitation of physicians experience, and low index of clinicians suspicion. Rapid institution of respiratory isolation, and early initiation of effective treatment are factors among the key component of TB control (Venkatarama et. al.,1999; Byrd et. al., 1977; Mahmoudi, and Iseman, 1993; Sumartojo et. al., 1997; American Thoracic Society, 1992; The American Lung Association Conference, 1996). The paper by Rao V K et al shows a significant delay commonly occurred in institution of treatment, not in initial suspicion of tuberculosis (Centers for Disease Control and Prevention, 1994). Therefore, this delay more likely related to the experience and practical styles of individual clinicians, which should be modifiable with education. Continued efforts to educate clinicians on appropriate management are factors among the key component of TB control (Venkatarama et. al., 1999). 2

13 It has been reported that TB is more prevalent in men than in women. Moreover, it has been known that male to female ratio based on passive case finding is 2:1(Johansson et. al., 1999; Kumaresan et. al., 1999; Dolin et. al.,1998). On the other hand, relatively more female cases have been found in active case finding (Johansson et al., 1999 Styblo et. al., 1967; Cassels et. al., 1982). This raises a question about the difference in health care accessibility and quality of care given. What s more, there is a increasing evidence of undesirable differences between men and women regarding health care accessibility and quality of care given (Johansson et al., 1999). 1.4 HIV and TB The interaction of TB with human immunodeficiency virus infection has pernicious effects. TB has become the leading cause of death among people with HIV, while infection with HIV is the most potent risk factor for a latent TB infection to convert to active TB. According to WHO TB accounts for about 13% of Acquired immune deficiency syndrome (AIDS) deaths worldwide. When someone is infected with TB, the likelihood of them becoming sick with the disease is increased many times if they are also HIV positive. That happen because HIV is weakening the immune system of them. On the other hand, people with latent TB are more likely to become infected with HIV. Co-infected people with both HIV and latent TB are 800 times more likely to develp TB compared to HIV negative people (WHO,2007a). TB is an HIV related opportunistic infection. A person that has both HIV and active TB has an AIDSdefining illness. There are several important associations between epidemics of HIV and TB: as it is obvious that TB is harder to diagnose in HIV positive people, and TB progresses faster in HIV-infected people. At the same time, TB in HIV positive people is more likely to be fatal if undiagnosed or left untreated. Furthermore, TB occurs earlier in the course of HIV infection than other opportunistic infections. Finaly, TB is the only major AIDS-related opportunistic infection that poses a risk to HIVnegative people. 1.5 Drug-resistance and TB Multidrug-resistant tuberculosis (MDR-TB) is a form of tuberculosis that is resistant to two or more of the primary drugs used for the treatment of tuberculosis. Drug Resistance occurs when the bacteria develops the ability to withstand antibiotic attack and relay that ability to newly produced bacteria. Since that entire strain of bacteria inherits this capacity to resist the effects of the various treatments, resistance can spread from one person to another. On an individual basis, however, inconsistent or partial treatment or improper 3

14 use of the anti-tuberculosis medications remains an important cause of drug-resistant tuberculosis. As a consequence of poor treatment, strains of Mycobacterium tuberculosis the bacillus that causes TB have evolved that do not respond to treatment with the standard combination of first line drugs. Multidrugresistant TB has now emerged in nearly every country of the world. According to WHO, it is estimate that up to 50 million persons worldwide may be infected with drug resistant strains of TB. In addition, 300,000 new cases of MDR-TB are diagnosed around the world each year and 79 percent of the MDR-TB cases now show resistance to three or more drugs (WHO, 2003). There are several important associations with MDR-TB. One of these associations that it requires extensive chemotherapy that is often very expensive, and more toxic to patients. Also, MDR-TB diagnosis is expensive and time consuming. nosocomial (hospital-based) is highly possible with MDR-TB. For treatment that is more successful hospitalization is mandatory. However, chance of treatment failure and relapse are high (Asif et al, 2005). Recently, research demonstrating the extent of a rare type of multidrug-resistant tuberculosis called extensively drug-resistant tuberculosis (XDR TB), a newly identified TB threat which leaves patients (including many people living with HIV) virtually untreatable using currently available anti-tb drugs.it is resistant to almost all drugs used to treat TB, including the two best first-line drugs: isoniazid and rifampin(who,2007b). XDR TB is also resistant to the best second-line medications: fluoroquinolones and at least one of three injectable drugs (i.e., amikacin, kanamycin, or capreomycin) (CDC, 2007). 1.6 Global strategy to control TB In 1991, the World Health Assembly (WHA) resolution recognized TB as a major worldwide public health problem and Global efforts to control TB reinvigorated (WHA, 1993). The goals for TB control were detection of 70% of new smear positive cases, and cure of 85% of such cases, by the year These goals would lead to reduction in the incidence rate of TB by 11% per year and in the TB mortality rate by 12% per year. Later on in 1994, a new strategy named Directly Observation Therapy (DOTS) to control TB was recommended. DOTS strategy has five key components: political commitment, case detection mainly through passive case finding, standardized short-course chemotherapy to at least all confirmed sputum smear-positive cases, ensuring patient adherence to treatment, and adequate drug supply, and a monitoring system for programme supervision and evaluation (WHO, 1994). The DOTS strategy has been became widely accepted and has been implemented in many countries. The national TB control programmes (NTPs) make remarkable achievement in TB control. The number of patients whom 4

15 had been treated under DOTS was more than 20 million by 2004 (WHO, 2006a). What s more, more than 16 million of them had been cured. The universal cure rate among new smear-positive TB cases had reached 83% by 2003, and in 2004 the case detection rate was 53% (WHO, 2005). However, applying the DOTS strategy for case management needs efficient health system and an organization, that fit with specific country contexts (Macq et al., 2003; Mahendradhata et al., 2003). The first Global Plan to Stop TB defined the efforts for TB control and, by the end of 2003, over three-quarters of the world s population lived in countries that had officially adopted DOTS (WHO, 2006b). In 2006, WHO initiated the new Stop TB Strategy. The core of this strategy is DOTS, the TB control approach introduced by WHO in Since then, the number of patients who have been treated under DOTS-based services has been increased. The new Stop TB Strategy builds on the major progress in global TB control in the past decade. The new Stop TB Strategy addressing the key challenges of TB/HIV and MDR-TB, responds to access, equity and quality constraints, and adopts evidence-based innovations in engaging with private health-care providers, empowering patents and communities and contributing to strengthen health systems and promoting research (WHO, 2006a). The strategy is to be implemented over the next 10 years as described in the Global Plan to Stop TB, The Global Plan is a comprehensive assessment of the action and resources needed to implement the Stop TB Strategy and to achieve the following targets: Millennium Development Goal (MDG) 6, Target 8: Halt and begin to reverse the incidence of TB by 2015, by 2005: detect at least 70% of new sputum smear-positive TB cases and cure at least 85% of these cases, and by 2015: reduce TB prevalence and death rates by 50% relative to 1990 (WHO, 2006a). 1.7 Public private partnership in TB control In the majority of low-income countries, private health care providers play a major role in delivering health services(bennett et al., 1997; Brugha et al., 1998; WHO, 2000; Smith et al., 2001; Mills et al., 2002). At the same time, it has been noted that, NTP implementation of quality assured and subsidized TB diagnosis and treatment has been limited largely to public sector services in most of the countries. Nevertheless, many of TB patients seek and receive care from a wide variety of health-care providers outside the network of NTP services. However, these care services are often of questionable quality at a high cost to patients (WHO, 2000; Uplekar et al., 2001). Furthermore, they are often the first-line health 5

16 care for a large number of patients and manage a significant number of patients(bennett et al., 1997; Brugha et al., 1998; Smith et al., 2001; Mills et al., 2002). Indeed, many private providers are known to diagnose and treat inappropriately a range of public important diseases, such as tuberculosis (TB) and others (Uplekar et al., 2001). A number of studies have descriped that private providers rarely monitor the effects of treatment, maintain clinical records, or notify diseases to the public health system (Cong et al., 1998; Brugha et al., 1999; Chuc et al., 1999; WHO, 2000; Kamat et al., 2001; Uplekar et al., 2001; Voeten et al., 2001; Mills et al., 2002; Sheikh et al., 2006). They also tend to prescribe antibiotics irrationally (Bennett et al., 1997; Brugha et al., 1998; Chuc et al., 1999; Smith et al., 2001; Mills et al., 2002;). The DOTS strategy had some obvious achievements in term of increasing the rate of TB detection and treatment. However, progress toward the targets was slow. As result of that DOTS expansion strategies were developed. One such strategy is public-private mix. However, private health providers are currently poorly regulated, as low-income country governments do not have the facilities to supervise the quality of private health providers services. Public private partnership for health services delivery is often perceived as an alternative mechanism for governments to withdraw from their commitment to health-care provision and a way to improve efficiency of health-care provision by introducing market mechanisms (McPake et al., 1994; Perrot et al., 2004;). In the context of the existing private health care provider s situation, partnerships can instead be used as a mechanism for governments to reach out and create a working collaboration with existing private providers and to guarantee that they provide high quality and more affordable services to patients. The number of private provider s initiatives involving in TB control has been increased during the last decade to help upgrading private provider s practices with national and international standards of TB care (WHO, 2006c). 6

17 П. BACKGROUND 2.1 Yemen country profile The modern Republic of Yemen was born in 1990 when traditionalist North Yemen and Marxist South Yemen merged. Since unification, Yemen has been modernizing and opening up to the world, but it still maintains much of its tribal character and old ways Location Yemen is located in the Middle East at the southern tip of the Arabian Peninsula between Oman and Saudi Arabia. It is situated at the entrance to the Bab el Mandeb strait, which links the Red Sea to the Indian Ocean (via the Gulf of Aden) and is one of the most active and strategic shipping lanes in the world. Yemen has an area of 527,970 square kilometers, including the islands of Perim at the southern end of the Red Sea and Socotra at the entrance to the Gulf of Aden (The Library of Congress, 2006) Population Yemen s latest census, conducted in December 2004, reported a population of million persons, reflecting an average annual population growth rate of more than 3 percent. Yemen s population in 2005 was percent urban and percent rural; population density was 40 persons per square kilometer (Central Statistical Organization, 2004). Yemen has many Administrative Divisions, which divide it into 20 governorates. For electoral and administrative purposes, the capital city of Sana a is treated as an additional governorate (Central Statistical Organization, 2004) Economic overview Yemen, one of the poorest countries in the Arab world, reported strong growth in the mid-1990s with the onset of oil production but has been harmed by periodic declines in oil prices. A high population growth rate and internal political dissension complicate the government's task. For 2005 Yemen s general domestic product (GDP) was estimated to be US$15.7 billion. GDP per capita was estimated to be US$900. Economists have calculated a real growth rate of percent in 2004, increasing to a range of percent in 2005, and estimate real GDP growth in 2006 to be in a range of percent. The increase is attributed to increased oil production, which will slightly boost export 7

18 growth, coupled with investment in new capital projects. All of these rates, however, fall far short of Yemen s five-year ( ) development plan for sustained average annual real GDP growth of 7 percent. The World Bank has set a target of 7 percent GDP growth rate per year in order for Yemen to achieve sustained economic development (The Library of Congress, 2006) Health situation overview Yemen has made significant progress in improving the health of its population since One of the main successes of Yemen s health system is the significant progresses in the area of child vaccination. Children less than one year of age coverage have increased from 27% in 1997 to 72% in 1999 and 2000 In addition, the available data suggests that there is reason to believe that poliomyelitis is close to being eliminated in Yemen (Health Sector Reform in the Republic of Yemen, 1998). Although an increase of 14 years in the last decade, life expectancy at birth in Yemen at 60 years is below the average of 63 years for developing countries. At the same time, although mortality rates for infants (71) and children under five years of age (96) in Yemen have declined, they are still high. Diarrhoeal diseases and acute respiratory infections are the major causes of children morbidity and mortality. Moreover, vaccine preventable diseases cause one-third of all deaths among under-fives (UNDP, 2006). The prevalence of communicable diseases, including malaria and tuberculosis, remain high. Injuries and deaths due to road accidents and firearms are particularly high in Yemen; however, few reliable statistics are available. In general, people have low levels of awareness with respect to health and hygiene and public health education is an important need. Yemen health system must address that need. The officially accepted estimate of maternal mortality is 351. Maternal mortality and morbidity are high because of restricted pre-, peri- and post-natal care. Also, exceptionally high fertility, early pregnancy, and low rates of modern contraceptive use contribute to high maternal mortality and morbidity rate (UNDP, 2006). Access to safe drinking water and adequate sanitation facilities are key component of people health status. Less than half the population has access to safe water and sanitation. Only half of Yemen s water sources are considered to be safe, others need either treatment or should be completely avoided. People have very restricted access to sanitation. For defecation, 45% of the population uses an open pit or none at all. Although 92% of the urban population has access to some sort of sanitation facility, this is the case for only 43.2% of the rural population (UNDP, 2006). 8

19 2.2 Health system in Yemen The Ministry of public health and Population (MoPH&P) operates a four-tiered system of health care facilities, delivering primary health care in health centers and health units at the village and district levels, secondary care at rural (district) and governorate hospitals, and tertiary care at referral hospitals in Sana a and Aden. However, a number of serious problems have characterized the system, many of which are addressed by the Health Reform Strategy adopted in Despite the significant progress Yemen has made to expand and improve its health care system over the past decade, the system remains severely underdeveloped and the total coverage in term of accessibility to health facilities remains very low. The proportion of the total population coverage has increased from 10% in 1970 to 45% in 1992, and to close to 50% at present (MoPH&P) On the other hand, health care services are particularly scarce in rural areas; only 25 percent of rural areas are covered by health services, as compared with 80 percent of urban areas. Furthermore, there is a severe shortage of health manpower in Yemen, and health manpower is unequally distributed between governorates, and even within governorates themselves, so that some areas are over-served, and some under-served (The Library of Congress, 2006). In Yemen, there is 1 nurse for 2,913 persons and only 1 trained midwife for 14,465 persons. Together Aden and Sana a lay claim to 50% of all physicians. According to the World Bank, the number of doctors in Yemen rose by an average of more than 7 percent between 1995 and 2000, but as of 2004, there were still only three doctors per 10,000 persons. In 2003, Yemen had only 0.6 hospital beds available per 1,000 persons. The city of Sana a has a total of 4 public tertiary health care facilities whereas 14 out of 20 governorates have no such facility. Total expenditures on health care in 2002 constituted 3.7 percent of gross domestic product. In the same year, the per capita expenditure for health care was very low, as compared with other Middle Eastern countries US$58 according to United Nations statistics and US$23 according to the World Health Organization. Out-of-pocket expenses by Yemeni health care consumers are high and prove to be an important constraint to accessing health care. Emergency services, such as ambulance service and blood banks, are non-existent. Most childhood deaths are caused by illnesses for which vaccines exist or that are otherwise preventable (The Library of Congress, 2006). 9

20 The situation at present indicates that several health institutions, particularly those in rural areas, do not provide adequate primary health care services. They are staffed by inadequately trained personnel, are poorly equipped and have insufficient availability of drugs and medical supplies. The system of outreach/emergency activities is insufficiently developed. Monitoring and registering epidemics and spread of leading infectious diseases or disease patterns (malaria, tuberculosis, HIV/AIDS, Rift Valley Fever, etc.) needs considerable improvement. According to the Joint United Nations Programme (UNP) on HIV/AIDS, in 2003 an estimated 12,000 people in Yemen were living with (human immunodeficiency virus/acquired immune deficiency syndrome) (HIV/AIDS) (Table 1). Table 1: Health indicators in Yemen Key indicator Estimation Maternal mortality rate 1,000-1,400/100,000 births Total fertility rate 7.4 Prenatal care 26% Postnatal care 5% Contraceptive prevalence rate 7% HIV/AIDS cases 12,000 Sources: MoPH, 1995; UNICEF, Private health system in Yemen Yemen like many other developing countries has a large private health sector that exists in both rural and urban areas. The private sector consists of formal and informal individual private practitioners as well as private commercial and non-for profit institutions. The government has provided health care services free of charge for a long period of time. In early 1990s, many changes happen: increase in the level and variety of health problems; unprecedented growth rate of population; increase demand for quality and quantity of health services; and lack of financial resources. All of these changes made the Ministry of Public Health & Population (MoPH&P) to approve the ownership of health facilities by investors. The new strategy made improvements in the access to the basic health services and modern healthcare for more people. At the same time, it reduced the excessive demand for public services, which lead to more funds available for under-served areas and preventive services. However, the presently large and unregulated private health sector in Yemen has many drawbacks. The private health sector concentrates in urban areas and has a higher cost than the public sector does. Not only that but also provide little of preventive services and 10

21 training of its staff. After years of having this situation, the MoPH&P realized that inequalities in access to health services have been reinforced between urban and rural areas and between poor people and better off. Furthermore, drain of the public hospitals of qualified staff and mal practice has occurred. As a result of the weak institutional framework of Yemeni health sector the private health sector grown rapidly. Private health facilities distributed among governorates. A total of 92 hospitals, 336 polyclinics, 534 physician s clinics, 709 specialty clinics, 744 laboratories, and 1,601 pharmacies, among other entities, are operating among different governorates (USAID, 2006). Even though there is a considerable expansion of the private sector involvement over the last decade, The MoPH&P did not pay adequate attention to it. In turn, the MoPH&P private sector department did not receive the needed support to accomplish its responsibilities (MoPH&P, 2004) 2.4 Health Sector Reform In 1998, the MoPH&P has put forward a Health Sector Reform (HSR) Strategy, designed to address the failures of the current health system. Health Sector Reforms concentrate on greatly improved management systems, decentralization of numerous management functions to the level of the district, cost sharing with the users of health services, a stronger policy and management role for the MoPH&P, and a smaller role in direct service provision. The key elements of the Health Sector Reforms that are planning to be implemented are decentralization, redefinition of the role of the public Sector, district Health Systems (DHS), community co-management, Cost Sharing, essential drugs policy and realignment of the Logistics System outcome-based Management System with an Integrated Focus on Gender, hospital Autonomy, and Intersectoral Cooperation. Furthermore, encouragement of Participation by the Private Sector and Non-Governmental Organizations (NGOs), encouragement of innovation, and sector wide approach to donor funding and programming. The Health Sector Reforms especially targets the poor, through a variety of mechanisms designed to meet their needs. The long-term objectives of the health sector reform program are as follows: adequate/universal access to health care services equity in both the delivery and eventually the financing of health care. improved allocative and technical efficiency of the service delivery system. improved quality of health services. 11

22 system's long run financial sustainability. 2.5 TB epidemiology in Yemen Tuberculosis is an important public health and development problem in Yemen. The estimated incidence of all forms of tuberculosis is 89 per 100,000 populations (table 2). The current prevalence of tuberculosis in Yemen is around 1.5 cases per 1,000 people for all TB cases. Medical reports estimate that between 2,000 and 2,500 Yemenis die from TB every year, making it the fourth cause of death in Yemen (table 2). This estimation seems in synchronize with several hospital statistics. In reality, most deaths in Yemen occur outside of hospitals, especially in rural areas where the majority of the population lives (National Tuberculosis Control Programme, 2005). About 9,063 cases of tuberculosis had registered at the National Tuberculosis Institute (NTI) in According to NTI and National Tuberculosis Control Programme (NTP) statistics, many cases have had a relapse after being treated because of their ignorance and misuse of the medication. Al-Hodeidah governorate has 603 cases, the highest number in the country. While, Sayoun governorate has the fewest number of cases which only ten during In spite of the fact that TB is one of the major public health problems in Yemen, the media does not help to eliminate this problem by educating people about the dangers of this disease, its causes and means of avoiding infection. Furthermore, the available resources are insufficient. The government and the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM) try to help but it is still not enough. Table 2: Tuberculosis burden in Yemen (2004 estimates) Key indicator Estimation Population Incidence (all cases/ pop/yr) 89 Trend in incidence (%/yr) -3.1 Incidence (ss+/ /yr) 40 Prevalence (all cases/ pop/yr) 144 Mortality (deaths/ pop/yr) 11 Prevalence of HIV in adult TB patients (15-49yrs, %) 0.7 New TB cases multidrug-resistant (%) 1.8 Previously treated TB cases multidrug-resistant(%) 28 Source: WHO (2006c). 12

23 Table 3: Tuberculosis Surveillance and DOTS implementation in Yemen (2004) Key indicator Estimation Notification rate (new and relapse/ pop/yr) 49 Notification rate (new ss+/ pop/yr) 17 Case detection rate (new and relapse, %) 55 Case detection rate (new ss+ cases, %) 42 DOTS notification rate (new and relapse/ pop/yr) 34 DOTS notification rate (new ss+/ pop/yr) 16 DOTS case detection rate (new and relapse, %) 38 DOTS case detection rate (ss+ cases, %) 40 DOTS treatment success (2003 cohort, %) 82 Source: WHO (2006c). 2.6 TB control in Yemen National Tuberculosis control Program Efforts to reduce TB incidence rates were modest in the 1990s. Therefore, in cooperation with international organizations, the Yemeni government is conducting a National Tuberculosis Programme aimed at eliminating TB in Yemen. Anti-TB centers have been established in many governorates to receive patients and examine, treat and provide them drugs. Despite the fact that the national tuberculosis programme is functioning well, the estimated incidence of all forms of tuberculosis is 89 per 100,000 persons (National Tuberculosis Control Programme, 2004). This indicates that the TB Control Programme is still not accessible to most of the patients despite the fact that the coverage rates for contagious tuberculosis have increased significantly from 28% in 1990 to 70.2% in The national tuberculosis control programme has introduced the DOTS strategy in Yemen in Science then, the national tuberculosis control programme has accomplished a rapid expansion of the strategy. Afterward, 98% of the country s districts were covered with the new strategy by 2002, (National Tuberculosis Control Programme, 2004). The remaining 2% is an area, which is not accessible due to security instability. This remarkable improvement on expansion of TB coverage was a result of the adoption of the World Health Organization (WHO) strategy, designed to discover 70% of the existing cases and to treat 85% of the reported cases by the year 2005, through the implementation of Directly Observation Therapy (DOTS), which has achieved a high 83% rate during 1990s (Central Statistic Organization, 2003). Treatment outcomes have improved dramatically under DOTS in 2001, 80% of the smear-positive cases treated under DOTS had successful treatment outcome. In the same year, the success rate for cases that had not 13

24 yet access to the DOS strategy was only 57%. These results make it very important that all cases should be treated under DOTS strategy. On the other hand, the DOTS case detection rate was only 49% of all estimated smear-positive cases in The latest treatment success and case detection are 82% and 65%, respectively (National Tuberculosis Control Programme, 2004). In order to improve the national tuberculosis programme function, many needs have been realized by the programme to be conducted as; strengthen DOTS key activities, started further decentralization of DOTS activities to the peripheral level, improvement of quality assurance for the laboratory network and contribution of different health sectors particularly the private health sector. Moreover, the programme started anti-tuberculosis drug resistance survey. The results of this survey are expected to be on hand soon (National Tuberculosis Control Programme, 2004). The treatment regimen adopted by NTP in Yemen for adult new smear positive pulmonary tuberculosis cases is 8 month of chemotherapy using isoniazd (INH), rifampicin (RMP), pyrazinamide (PZA), and either streptomycin injection or ethambutol (EMB) during the initial 2 month intenccive phase, followed by INH and thioacetazone (INN) during the 6 month continuation phase(date and Okita, 2005) Tuberculosis case detection and treatment In order to achieve the global targets and the MDG, in addition to eliminate TB as a health problem the NTP has developed a five years strategic plan from 2004 to 2009 that combines both the strengthening of the existing activities and the introduction of innovative approaches for case detection and treatment. The five years NTP strategic plan has two main principles: increasing the treatment success rates, and improving of case detection. On one hand, to increase the treatment success rates, the NTP provided adequate infrastructure in term of staff and buildings on national level. In addition to binocular microscopic and vehicles, which are required to improve the quality of diagnosis and the frequency of supervision. Further more, the NTP undertaken many procedures for programme management strengthening through training of the available staff and recruitment of TB specialists and focal point from existing Ministry of public health and Population staff, in addition to the help of international technical assistance. What s more, the NTP conducted a comprehensive quality assurance program to ensure the adequate training of new staff, a regular training pack age and supervision of the staff at all level, monitoring of the performance and communal problem solving, and laboratory quality assurance. In order to enhance patient convenience and compliance the programme implemented a comprehensive logistic system covering drugs, laboratory supplies and stationery. At the same time, the NTP obtains two innovation approaches to ensure the direct treatment observation for all patients. First, the treatment supervision broadly enhanced by the training of 14

25 community members and health volunteers to act as treatment supervisors. Second, the provision of food incentives expands to all ambulatory patients to improve treatment rate. In order to provide a countrywide data on both drug resistance and TB/HIV co-infection the NTP implements an epidemiological monitoring for both of them (National Tuberculosis Control Programme, 2004). On the other one hand, to improve case detection the NTP made expansion of DOTS coverage to the remaining districts that have not yet introduced the DOTS strategy as well as the inclusion of primary health care units (PHCU) into the DOTS system in all districts. PHCU has the greatly potential to improve patient accessibility to the programme which can lead to increase in case detection. Also, the NTP has already achieved the successful collaboration with other public institutions and facilities (public/ public mix). Recently the NTP expand the providers network through training of private providers to act as referral agent while others to act as treatment monitoring following the NTP recording and reporting standards (public/private mix). From the past experience the advocacy and education activities for the NTP have been very limited in Yemen, most likely contributing to low public acceptance of the programme resulting in low case detection. To improve case detection the NTP called for the production of a set of education and information materials for both patients and public. Moreover, regular radio and television spots complement these, advocacy meeting with policy makers at all level and annual world TB day advocacy activities. It is known that global targets for TB case detection are based on estimates of underlying case incidence rates. These estimates required regular updating with empirical data. The NTP conducted Annual risk of infection surveys (ARI surveys) in five yearly intervals (National Tuberculosis Control Programme, 2004). 3.1 Justification of the study In Yemen, where tuberculosis remains to be a major public health problem with a high TB burden and high incidence of new cases, a study conducted by Date et al. describes the important of gender and literacy as risk factor of tuberculosis diagnosis and treatment delay (Date et al., 2005). In addition, a multicountry study of the health-seeking behaviour of patients and health system response in seven countries of the Eastern Mediterranean Region conducted by WHO and Yemen was one of these countries (WHO, 2005). A considerable proportion of patients are managed in the private health facilities in Yemen. Consequently, tuberculosis control can not be achieved without the involvement of the private sector in control activities. Current WHO recommendation include the need for private practitioners to be engaged in national TB strategies, and other work supports the involvement of the private sector as an essential component of successful implementation of TB control programme in Yemen. Therefore, studies are needed to derminate other factors that influence health seeking behaviour, diagnosis, and treatment 15