SOCIAL AND SERVICE DELIVERLY FACTORS ASSOCIATED    WITH COMPLIANCE AND OUTCOMES OF TUBERCULOSIS TREATMENT IN AN URBAN SLUM, NAIROBI KENYA

JOYCE KANANU KINGORI

MASTER OF SCIENCE

(Public Health)

JOMO KENYATTA UNIVERSITY OF
 
AGRICULTURE AND TECHNOLOGY

2011
Social and service delivery factors associated with compliance and

outcomes of Tuberculosis treatment in an urban slum, Nairobi Kenya

Joyce Kananu Kingori

A thesis submitted in partial fulfillment for the degree of Master of

Science in Public Health in the Jomo Kenyatta University of

Agriculture and Technology

2011

DECLARATION

This thesis is my original work and has not been presented for a degree in any other university
Signature…………………..                               Date………………
                        Joyce Kananu Kingori
This thesis has been submitted for examination with our approval as University supervisors
1.	Signature………………………                     Date……………
                   Dr Yeri Kombe
                   KEMRI, Kenya

2.	Signature …………………….                       Date…………….
                  Dr. Willie A. Githui
                  KEMRI, Kenya

3.	Signature……………………….                   Date………………
                Professor Zipporah Ng’ang’a
                            JKUAT, Kenya

    4.  Signature …………………..........                   Date………………
               Dr Johnson Musomi
               AMREF, Kenya   
                                                    
DEDICATION
This thesis is dedicated to my late father Japhet and  my late mother Harriet who were always there when the ship was embarking on its voyage, when it sailed, sometimes through storms and when it docked.   Enrollment for any new course was received with applauds and pride that will forever be treasured beyond any words can describe.

ACKNOWLEDGEMENT
I would like to most earnestly thank my supervisors, Dr. W. Githui of KEMRI Dr. Y. Kombe of KEMRI, Professor Z. Ng’ang’a of JKUAT and Dr J.Musomi of AMREF for guiding, encouraging and supporting me through each and every step of this work.

I acknowledge Dr. J. Sitienei of the Division of Leprosy, TB and lung Disease, health staff at the Kangemi Health Centre, and the research assistants who participated in one way or the other as key informers or data collectors. 

I would like to convey gratitude to Mr. Mutunga, Mr.Mbakaya, Moses Mwangi of KEMRI Dr. Jane Carter and Judy Mwangi of AMREF, Dr. Meme of CRDR who offered valuable guidance and inputs through one stage of my work or the other. The assistance and administrative support of Dr. Kiptoo and other staffs at ITROMID-KEMRI and ITROMID –JKUAT, is highly appreciated.

I wish to thank my family, King’ori, Ofio, and Nyambura who kindly allowed me use of family resources to partially fund the programme amidst competing priorities, to AMREF, Kenya for financial support and to the men, women and guardians who consented to and participated in the study, I salute you for making it possible for others to learn from your experiences and insights.

TABLE OF CONTENTS

DECLARATION........................................................................................................ii
DEDICATION…………………………………………………………………….iii
ACKNOWLEDGEMENT………………………………………………………..iv
TABLE OF CONTENTS………………………………………………………….v
LIST OF TABLES………………………………………………………………....x
LIST OF FIGURES………………………………………………………………xi
LIST OF APPENDICES……………………………………………………...…xii
LIST OF TERMS…………………………………………………………….....xiii
LIST OF ABBREVIATIONS…………………………………………………..xvi
ABSTRACT…………………………………………………………………….xvii
CHAPTER ONE…………………………………………………………………..1
INTRODUCTION………………………………………………………………...1
1.1 Background Information……………………………………………………….1
1.2 Problem statement……………………………………………………………...2
1.3 Justification of the study……………………………………………………….3
1.4 Research questions…………………………………………………………….4
1.5 Study objectives……………………………………………………………….5
1.6 Application of the study……………………………………………………….5
CHAPTER TWO………………………………………………………………....7
LITERATURE REVIEW………………………………………………………..7
2.1 Epidemiology of tuberculosis………………………………………………….7
2.2 Transmission of Tuberculosis…………………………………………………7
2.3 Diagnosis of Tuberculosis	8
2.4 The burden of Tuberculosis	9
2.5 Strategies for TB treatment and control	10
2.5.1 The classical approach:	10
2.5.2 The sanatorium approach:	10
2.5.3 Chemotherapy:	10
2.6 Current approaches in TB treatment and management	11
2.6.1 Directly Observed Treatment, short -course (DOTs)	12
2.7 Role of DOTS in improving compliance and treatment outcomes	12
2.8 Factors that determine successful DOTS	13
2.8.1 Accessibility	 ..........................................................................................................13                                                                                                         13
2.8.2 Monitoring and Supervision	13
2.9 Compliance to Tuberculosis treatment	14
2.9.1 Social and demographic factors associated with TB treatment compliance and           
         outcomes	15									15
2.9.2 Patient Education and compliance to Tuberculosis treatment	16
2.9.3 Anatomical/biochemical factors associated with compliance to TB treatment	16
2.10 Importance of compliance to TB treatment	18
2.11 Studies on compliance to TB treatment and gaps	18
CHAPTER THREE	22
MATERIALS AND METHODS	22
3.1 Study area.	22
3.2 Study design	.22
3.3 Sample determination and sampling procedure	22
3.3.1 Study population	23								23
3.3.2 Key Informant Interviews with TB treatment managers and supporters	23
3.4 Data collection tools	24
3.5 Inclusion criteria	24
3.6 Exclusion Criteria	24
3.7 Ethical considerations	25
3.8 Data Analysis	25
3.9 Limitations of the study	26
CHAPTER 4	27
RESULTS	27
4.1 Social-demographic characteristics of the respondents	27
4.1.1 Distribution of respondents by age	27
4.2.1 Disease classification	30
4.2.2 Patient classification	31
4.2.3 HIV status of the respondents	31
4.3  TB treatment compliance among respondents	32
4.3.1  TB treatment outcome by compliance	33
4.4 Social Demographic factors of respondents and Compliance to TB treatment	33
4.4.1: Age of respondents and compliance to TB treatment	33
4.4.2:  Gender  of respondents and compliance to TB treatment	34
4.4.3 Marital status of respondents and compliance to TB treatment	35
4.4.4 Education level of respondents and compliance to TB treatment.	35
4.4.5 Occupation and compliance to TB treatment among respondents	36
4.5 Epidemiological factors and compliance	37
4.5.1 Disease classification of respondents and compliance to TB treatment	37
4.5.2HIV status and compliance to treatment among respondents	37
4.5.3 Presence of other morbidities and compliance to TB treatment among 
         respondents	38
4.5.4 Treatment phase and compliance to treatment among respondents	38
4.5.5 Other drug abuse and compliance to TB treatment among respondents	39
4.6 Service delivery factors and TB treatment compliance	40
4.6.1 Direct observation of treatment and compliance to TB treatment among 
         respondents	40
4.6.2 Relation between where TB treatment was obtained & compliance to treatment	41
4.6.3 Accessibility to health facility and compliance to treatment among respondents	42
4.6.4 Free versus paid services and compliance to treatment among respondents	42
4.6. 8 Predictor variables to TB treatment compliance among respondents.	44
CHAPTER FIVE	46
DISCUSSION	46
5.1 The TB treatment compliance and outcomes in Kangemi slums of Nairobi Kenya	46
5.2 The Social factors associated with compliance to TB treatment and final 
      outcomes	46
5.3 The service delivery factor associated with TB treatment compliance and final 
      outcomes	50
CHAPTER 6	52
CONCLUSIONS AND RECOMMENDATIONS	52
6.2 RECOMMENDATIONS	54
6.2.1 Measures to improve compliance and final treatment outcomes	54
6.2.2 Measures to improve the social factors affecting compliance to TB treatment.	54
6.2.3 Measures to improve service delivery that influence compliance to TB 
         treatment	55
REFERENCES	56
APPENDICES	62

LIST OF TABLES
Table 4. 1:       Distribution of respondents by disease classification
Table 2.4 :       Distributions of the respondents by patient classification
Table 4.3:        Distribution of TB treatment outcome and compliance to treatment
Table 4. 4:       Age of respondents and compliance to TB treatment
Table 4.5:      Gender of respondents and compliance to TB treatment
Table 4. 6:      Marital status of respondents and compliance to TB treatment
Table 4. 7:      Education level and compliance to TB treatment
Table 4.8:       Occupation and compliance to TB treatment

LIST OF FIGURES
Figure  4.1:    Level of education among respondents
Figure  4.2:     Marital Status of respondent
Figure  4.3:      Occupation of Respondent
Figure  4.4:       Religious Affiliations of respondents
Figure  4.5:      HIV Status of Respondents
Figure  4.6:      Distribution of TB treatment compliance

 LIST OF APPENDICES
Apendix  1 :      Individual Interview questionnaire
Appendix 2:       Key Informant Interview Guide (KIIG) 
Appendix 3:      Questionnaire for TB treatment supporters
Appendix 4:      Consent explanation form-Notes for intended participants

Appendix 5:      SSC Clearance 

Appendix 6:	   ERC Clearance

LIST OF TERMS
Tuberculosis (TB)   		Is an infectious disease caused by the micro-organism,
Mycobacterium tuberculosis or tubercle bacillus. Although primarily an infection of the lungs, any organ is susceptible.

Pulmonary TB        	           Tuberculosis that involves the lungs. 

Extra Pulmonary TB           TB that involves other organs other than the lungs
i.e. the lymph nodes, abdomen, genitourinary, skin, bones, joints and excluding the central nervous systems.

Multidrug Resistant TB        Is TB treatment that is resistant to two first line drugs 
			namely, Isoniazid (INH) and Rifampicin (RMP).
	
Smear Positive (PTB+)	Is a finding from sputum examination where
two or more initial sputum smear examinations are   positive of AFB or one sputum smear Positive of AFB plus radiographic abnormalities consistent with active PTB or one sputum Smear + for AFB plus sputum + for mycobacterium tuberculosis

Smear Negative (PTB-)    	TB  cases without Smear results
Cohort                        	Is a group of patients diagnosed and registered for treatment during a specific time period.
Compliance                           Observance, fulfillment of, obedience or agreement with guidelines, rule, pattern, advice. Taking the prescribe treatment regimens as prescribed by the clinician in the dosage, timing, and for the length of time that has been advised. 

Cured	Patient who is Sputum Smear negative in the last month of treatment and on atlas one previous occasion

Treatment complete    	Patient who has completed treatment but who does not meet the criteria to be classified as cure or failure
Treatment failure       	 Patient who is Smear Positive at five months or later during   the treatment

Died	 Patient who dies for any reason during the course of TB treatment

Defaulter                               Patient whose treatment was interrupted fro two      
Consecutive months or more during to treatment

Transferred out     	         A patient transferred to another TB register to
        continue treatment

Out of control      	Patients who mix up prescribed regimens with other traditional 
 medicines and therapies and who eventually abandon       treatment without being traced

DOTS		            Direct Observation of Treatment (short course)

LIST OF ABBREVIATIONS
AMREF 	African Medical and Research Foundation
BIG 		Breastfeeding Information Group
CBS 		Central Bureau of Statistics
CHVS 	Community Health Volunteers
CDC		Centers for Disease Control and Prevention
CRDR		Centre for Respiratory Diseases Research
DOTS		Directly Observed of Treatment (short course) 
EPTB		Extra Pulmonary Tuberculosis
HIV/AIDS 	Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome 
KEMRI          Kenya Medical Research Institute
KWEC           Kangemi Women Empowerment Centre
MDR	           Multi Drug Resistance
NCC              Nairobi City Council
NLTCP         National Leprosy and Tuberculosis Control Programme
PTB               Pulmonary Tuberculosis
TB 	          Tuberculosis
WHO 	         World Health Organization

ABSTRACT
Non-compliance to prescribed drug regimens is a major challenge to attainment of Tuberculosis (TB) treatment goal which is to cure patients once they start treatment. Compliance to treatment is important to reduce risks of treatment failure and drug resistance, morbidity that further strains already burdened national health systems.  In Kenya, the extent of the problem remains understudied and more so in urban slums which contributes to over 60% of all new cases of TB. This retrospective cohort study was carried out in Kangemi slums in Nairobi to establish the extent of compliance and outcomes of treatment and to establish the associated social and service delivery factors. The study established that compliance to TB treatment which was (85.7%) was slightly lower than the global target of 87 % set by WHO and above the estimated national average of 80%.  However given the nature of informal settlement, the study considered that 14.3% non-compliance is still significant and especially at the intensive phase as it increased possibilities of harboring infectious cases in a crowded environment and chances of cross infection and Multi-Drug resistance. Observation of treatment by self or close family members significantly improved compliance as shown by a (P<0.001) which was a different from many similar studies which showed that compliance was better among patients who had direct observation of their short course therapy at the facility by health workers or trained TB treatment supporters Extensive compliance education directed to patients, family members and community at large is recommended. Current DOTS strategy should enlist family members and guardians as partners in treatment and especially at the intensive phase. 
 
CHAPTER ONE
1.0  INTRODUCTION
1.1 Background Information
Tuberculosis (abbreviated as TB for Tubercle Bacillus) is one of the world’s deadliest disease. One third of the world’s population is infected and each year 9 million people get sick (CDC, 2009).  In Sub-Saharan Africa, TB is one of the important causes of morbidity and mortality, where the high burden is fueled by the concurrent HIV epidemic. Swaziland is one of the countries with the highest incidence with 1,200 cases for 100,000 people (WHO, 2006).  Recognizing the resurgence of the TB disease, the World Health Organization in 1993 declared it a disaster and initiated mechanisms to accelerate its management and control. 

Current strategies for TB management and control combine a well-organized health system that ensures government support to sputum examination (Sputum smear microscopy), availability and consistent drug supply, Directly Observed Treatment, short- course (DOTS), monitoring and supervision of treatment. Where this package is well managed, success rate of up to 95% has been recorded (WHO, 2009), while the reverse has also been noted where services are poorly organized and where, DOTS services are either not a vailable or where there are logistical difficulties. In such circumstances outcomes have been sub optimal, negating the goal of TB treatment which is to render the infective cases non-infective within the shortest time possible and then proceed on to completely cure the cases ( Fieden., 2005 ;CDC, 2009 and Canadian Lung Association 2010)
In spite of concerted efforts by the World Health Organization, funding partners and governments to develop and finance well-researched strategies for TB treatment, poor outcomes are still noted in developed and developing countries alike. A study carried out on non-compliance to treatment in the United States of America, spanning back to 25 years, established that non compliance was indeed a significant medical problem affecting large proportions of patients and costing billions of dollars in hospital costs. The study linked non-compliance with patient’s lack of conviction about the need for treatment, fear of adverse effects, difficulty in managing more than one dose of drugs or multiple drug regimens. From the provider poor DOTS management, observer attitudes, attitudes of the health care providers were also indicated as some reasons for poor compliance, (Wertheimer et al., 2003).
Non-compliance to prescribed drug regimen is widely associated with Multi-Drug Resistance TB (MDR-TB), which is a form of TB in which the bacteria can no longer be managed using the two most commonly used anti-biotics (WHO, 2009). The consequences are grave in poor communities as patients who get this strain of TB have to stay in hospital between 18 months to 2 years. It is also a leading cause of disability and mortality.

1.2 Problem statement
This study is motivated by the broad understanding of Tuberculosis (TB) as a priority public health problem in Kenya and more so in the urban slums. Many studies indicate that urban slums like other poor resource environments have related factors that impede early detection, promote non compliance to treatment among detected cases, low case holding and return to clinic testing to determine outcomes, ( WHO., 2009, Hasker et al., 2008) . Even where TB treatment and DOTS services are available accessibility to these services is constrained by factors including poor transport infrastructure poor access to TB treatment centers, lack of resources and logistics to access the services, social cultural barriers, lack of information about the availability of DOT services, nature of patients occupations and stigma attached to seeking TB diagnosis and treatment impede optimal utilization. The study therefore set out to investigate the extent to which the above observations were true of the Kangemi urban slums. 

Compliance with the recommended drug regimen is an important prerequisite to successful treatment outcomes yet it is the greatest challenge in TB treatment and control (CDC, 2010). Poor service delivery aspects including treatment supervision are as important to social factors and patient characteristics for compliance and successful outcomes. Poorly supervised or incomplete treatment is worse than no treatment at all. This study was designed and established the compliance among the respondents in the Kangemi urban slums as well as the final treatment outcomes, establish and documented the social and service delivery factors that bear on the compliance observed.

1.3 Justification of the study  
Tuberculosis is an important public health problem and studies towards further understanding of its prevention, management and control will be an added knowledge to development practitioners in country specific contexts as well as towards enriching the global fight against tuberculosis. Kenya is among the top 22 countries with a high burden of Tuberculosis, which in the recent past has been fuelled by the HIV infection in the backdrop of urban and rural poverty, (USAID, 2009).  
The DOTS strategy has been widely documented as a successful strategy for improving treatment compliance and success rates. Its continuous evaluation, learning of lessons, constraints and context specific coping mechanisms is important for its implementation and improvement. Other factors within the treatment contexts which are significant to the treatment compliance other than the infrastructure also need to be documented to provide a better platform for supporting the DOTs strategy. Research gaps exist in the modalities of implementing DOTS in urban slum contexts. Most studies have been carried out in rural areas which are well endowed with social infrastructure for observation of treatment and continuous social and emotional support. These studies however limit the application of the findings to urban slum areas in particular because of the complex social relationships. Even in well-organized social economic contexts where infrastructure is well organized, compliance to treatment is still a significant medical problem. In TB control, the benefits of cure go beyond the individual patient since is a significant step towards breaking the transmission chain and consequently controlling the epidemic. This therefore underscores the importance of the study to establish the compliance levels and to recommend strategies for improvement.   

1.4 	Research questions
1.	What is the level of compliance to Tuberculosis treatment in Kangemi urban Slums?
2.	 What are the effects of compliance on the outcome of treatment?
3.	What social and service delivery factors have a bearing on compliance?

1.5  Study objectives
The main objective of the study was to establish the social and service delivery factors associated with compliance and outcomes of TB treatment in Kangemi slums in Nairobi, Kenya

Specific objectives 
1)	To establish the  level of compliance and final outcomes of TB treatment 
2)	To establish the social factors associated with compliance, and final outcomes of TB treatment
3)	To establish the service delivery factors  associated with compliance and final outcomes of TB treatment

1.6 Application of the study	
The findings of the study will give insights into the extent of compliance to TB treatment and its effect on final outcomes compared to national average and WHO recommended in addition to that observed in other studies and documentation. Factors that promote compliance and those that adversely affect compliance will be documented and recommended for use by government, non-government and community based organizations to enrich policy, planning, management and control of TB and lung disease in urban slums and other similar set ups in Kenya and beyond. Understanding of how the DOT strategy works in the urban slums and the problems encountered in its implementation (supply side) and accessibility (demand side) will contribute to evidence based war against Tuberculosis and also curb the emerging threat of Multidrug Resistance (MDR).  The study will stimulate further research into specific variables that strongly predict compliance to TB treatment.

CHAPTER TWO
LITERATURE REVIEW

2.1 Epidemiology of tuberculosis
 Tuberculosis, abbreviated as TB for Tubercle Bacilli is a bacterial disease caused by Mycobacterium tuberculosis. Its transmission occurs by airborne spread of infectious droplets. The source of the infection is a person with TB of the lungs also referred to as Pulmonary Tuberculosis (PTB). Coughing produces infectious droplets (droplet nuclei). One cough or sneeze can produce over 3, 000 droplet nuclei  (WHO, 2009).

2.2 Transmission of Tuberculosis
Transmission of TB usually occurs indoors or where the droplet nuclei can stay for a long time in the air. A well-ventilated room aids removal of the droplet nuclei while darkness harbors them for several hours. Direct sunlight quickly kills tubercle bacilli. Factors that determine an individual’s risk of exposure are the concentration of the droplets nuclei in the contaminated air and the length of time the person breathes that air. Other factors include the extent of the exposure and the susceptibility of the individual to infection. The risk of transmission of the infection from a person with sputum smear positive PTB to susceptible individual is high with closed indoor exposure while that of transmission with smear negative PTB is lower and lowest with extra-pulmonary TB (Hurries et al, 1996). Risk of e disease progression is relatively low among the majority of the population but increases with other debilitating chronic conditions like HIV/AIDS among others
2.3 Diagnosis of Tuberculosis
Clinical screening by assessment of symptoms identifies Pulmonary Tuberculosis (PTB) suspects among patients attending health facilities. The most cost effective method of screening of suspects is by sputum smear microscopy. When a suspect has a positive sputum smear, s/he has smear positive PTB. Such a person is supposed to be immediately registered in the nearest TB treatment center and started on treatment. Chest x-rays has no role for patients diagnosed with smear positive TB. It only becomes necessary in adults suspected to have smear negative or Extra Pulmonary TB.  A false negative tuberculin test may also be necessitated by other factors like HIV infection, malnutrition or military TB. 
The important symptoms in the diagnosis of PTB are cough which continues for three weeks, sputum production, and weight loss. Other respiratory or general systemic symptoms are also associated with PTB. The main features of Extra Pulmonary Tuberculosis (EPTB) include, constitutional fever, and local features related to the site of the disease. Definitive diagnosis of EPTB is often difficult and may be presumptive provided you exclude other conditions. Specialized diagnostic tool like x-rays and biopsy procedures may be used to confirm EPTB with a fairly high degree of certainty (WHO, 2009).  Diagnosis of TB among children is difficult because in most cases sputum cannot be obtained and where it is available, the bacterial load is usually low. TB in children is therefore suspected with clinical signs and symptoms and history of contact with adults suffering from PTB. 

2.4 The burden of Tuberculosis
By the year 2007, there were 13.7 million chronic active cases of Tuberculosis worldwide, with 9.3 million new cases and 1.8 million deaths which mainly occurred in third world countries (CDC, 2009). Developing countries bear the bigger burden of the TB disease accounting for about 91% of all TB cases in the world while Sub-Saharan Africa has the highest rate of TB in the world with over 1.5 million TB cases occurring per year. According to WHO, 22 countries contribute over 80% of the global burden of TB and eleven of these are in Africa (USAID, 2009).
In Kenya, TB combined with malaria and HIV/AIDS are the leading causes of mortality and morbidity. The three diseases have a disproportionate impact on women and children, which is also worsened by disabling social-cultural factors and poverty conditions. In the year 2002, the National Leprosy and Tuberculosis Control Programme (NLTP), reported 82,114 TB cases among whom 34,337(42%) were smear positive PTB. The country continues to experience a generalized TB epidemic, which is mainly affecting the population aged 15-44 years, inarguably the most economically productive age group in the country (NLTP, 2004). Since the early nineties, TB cases in Kenya have increased almost ten- fold, mainly due to impact of the HIV/AIDS epidemic. In the year 2004, a total of 106,000 TB cases of all forms were notified compared to 96,000 in the previous year. By classification, pulmonary tuberculosis (PTB) forms 81% of all the TB cases reported in Kenya and 43% of these are smear positive, 38% smear negative, 15% are Extra – Pulmonary while 4% were re-treatment cases (NLTP, 2003).  A high rate of   PTB makes all strategies for treatment, prevention and control paramount in order to contain the infections.
2.5 Strategies for TB treatment and control
The development of treatment for TB can be roughly classified into three stages.

2.5.1 The classical approach: This traditional method was used before the discovery of the TB germ and was based on belief systems attached to the causes of TB. It included setting out of blood, avoidance of meat and alcoholic beverages to keep the body fluids in balance. Patients were also removed from crowded living environments and taken to temperate areas.

2.5.2 The sanatorium approach: In the 1850s, sanatoria were built in Western Europe and America. They could provide environment with high altitude, fresh air and nutritious food for TB patients. At that time, surgical treatment was quite widely used for treating TB patients, such as pneumothorax, lobectomy, and pneumonectomy. These surgical procedures are no longer used as a routine procedure except in the management of MDR TB that has resulted in the destruction of a portion of the lung. 

2.5.3 Chemotherapy: During different time periods, various agents were tried for treatment of TB. These included mercury, iodine and creosote. In 1890, Dr, Robert Koch discovered tuberculin and tried it for treatment of TB. In 1938, Rich and follies reported that sulfanilamide could inhibit the growth of TB germs in guinea pigs. This drug could however not be applied for treatment of human beings. In 1945, streptomycin was discovered. This marked a big step forward for the treatment of tuberculosis although initial response was marked by deterioration and development of drug resistance. Other drugs were discovered subsequently with continuous research and the realization that several anti-TB drugs needed to be used together for treatment.   The advent of Rifampicin in the late 1970s marks the beginning of the short course therapy and the reduction of treatment duration from more than 24 months to 18 months. The availability of effective treatment has over the last three decades led to a marked reduction of both the incidence and death rates from TB (CDC, 2005).

2.6 Current approaches in TB treatment and management
In the past decade there has been substantial progress in the development and implementation of the strategies necessary for effective tuberculosis control and management.  Treatment using a four-drug regimen is preferred for initial empirical treatment pending culture and sensitivity results. The initial phase should consist of two months of isoniazid, Rifampicin, pyrazinamide and ethambutol *.  The preferred continuation phase consists of isoniazid and Rifampicin given for four months. Isoniazid and ethambutol given for six months is an alternative continuation phase regimen that may be used when adherence cannot be assessed but associated with a higher rate of failure and relapse, especially among patients with HIV infection (TBCA, 2006)
*Ethambutol may be omitted in the initial phase of treatment for adults and children who have negative sputum smears without extensive EPTB or those who are HIV negative.
2.6.1 Directly Observed Treatment, short -course (DOTs)
This TB control strategy was pioneered by the International Union against TB and Lung diseases (IUTLD) and recommended by World Health organization.  The strategy utilizes simple technology and packages it with good management practices for worldwide use. The strategy can be integrated into existing health services. Its implementation however may vary from to country to country or region to region within the same country. The implementation of DOTS therefore requires flexibility in its adoption according to the local situation and circumstances. The five essential elements for the success of this strategy include, government commitment to TB control, sputum smear microscopy to detect the infectious cases among those people attending the health care facilities with symptoms of pulmonary TB, standardized short cause anti-TB treatment for at least all sputum smear positive pulmonary TB cases, with direct observation of treatment for at least the first two months and regular uninterrupted supply of TB drugs and diagnosis (WHO, 2002) 

2.7 Role of DOTS in improving compliance and treatment outcomes
Direct observation of TB treatment can be carried out at the household by a trained TB treatment supporter, Community Health Care worker (CHCW), or a family member who is nominated or appointed by the patient. It can also be done at the facility by a health care provider (AMREF, 2004). Utilization of either methods of treatment supervision is associated with high compliance and good treatment outcomes in many parts of the world (WHO, 2003).  Direct observation of treatment is credited with more positive treatment outcomes especially in rural set ups. It is also credited with better access, and is more cost effective than facility DOTS as an in-patient or as an outpatient. DOTS is said to be a strategy that works and is credited with the facilitating effective treatment to 1.7 million infectious TB patients since its introduction on a global scale.  In areas where DOTS are implemented, cure rate is said to be 95% even in very poor countries. The success stories credit the strategy with prevention of transmission of new infections and the prevention of Multi-Drug resistance TB (MDR-TB). Further, DOTS strategy has been ranked by the World Bank as one of the most cost effective of all health interventions (WHO, 2000).
2.8 Factors that determine successful DOTS	
2.8.1 Accessibility
Directly Observed Treatment is best carried out at times and in locations that are as convenient as possible for the individual patient. Therapy may be directly observed in a medical office or clinic setting, but can also be observed by an outreach worker in the field , the patient’s home, and place of employment, school, or other mutually agreed-upon place. In some situations, staff of correctional facilities or of drug treatment programs, home health care workers, maternal and child health staff, or designated community members may provide DOTS.
2.8.2 Monitoring and Supervision 
Monitoring is one of the cornerstones of the DOTS strategy that ensures that noncompliant patients are identified and traced so that they can continue with treatment. Effective monitoring is dependent on management of logistics and personnel and this has been noted as one of the challenges of implementing successful DOTS especially in poor resource countries (WHO, 2003)
2.9 Compliance to Tuberculosis treatment

Tuberculosis medicines should be taken according to the doctor or nurses instructions, and for the duration recommended even if one feels better after sometime because the TB germs are difficult to kill (Canadian Lung Association, 2010) .Compliance to prescribed drug regimen is however identified as one of the main challenges to TB treatment and control world over. 
A study in the United States indicated that over 14% of patients who were started on treatment had not completed a full course in a period of four years (CDC, 1998). Similarly most health departments in the USA recognizing that most patients do not comply with TB treatment have recruited public health nurses or community outreach workers who work with patients and clinicians to help them comply with the prescribed regimen. Whenever possible, a worker who has the same cultural and linguistic background as the patient should be assigned to help develop individualized treatment compliance. A similar study in Tashkent Uzbekistan, and South Africa respectively identified that about 28% and 22% of the patients had defaulted from treatment during the intensive phase (Hasker et al, 2008; Pract, 2007) .In Kenya like other Low and Middle Income Countries, individualized treatment plans have found difficult due to shortage of health personnel, treatment supporters and the way health services are organized (AMREF, 2004 and WHO, 2010)

2.9.1 Social and demographic factors associated with TB treatment compliance 
        and outcomes
Treatment of patients with tuberculosis is most successful within a comprehensive framework that addresses both clinical and social issues of relevance to the patient. It is essential that treatment and supervision are tailored according to the patient's clinical and social circumstances (patient-centered care). Patients may be managed in the private or public health sectors, or jointly, but in all cases the health department is ultimately responsible for ensuring that adequate, appropriate diagnostic and treatment services are available, and for monitoring the results of therapy. 
Homelessness and illicit drug use was identified as major reasons for non-compliance to prescribed regimen among patients undergoing treatment in a study in New York City. The study found out that even an approach as intense as commitment to a health facility in the intensive phase did not ensure that patients were cured as some of them still did not comply upon release. The findings further suggest that commitment for periods less than the full course of therapy may be ineffective (American Thoracic Society/CDC, 1992). 
A longitudinal study on compliance to TB treatment carried out over twenty five years identified demographic factors like age, gender, race, marital status, as well as social risk factors such as type of household, alcoholism, religious affiliation and beliefs about TB treatment cure as factors that influenced compliance and final outcomes (Cyrus et al ,1997).
2.9.2 Patient Education and compliance to Tuberculosis treatment
 Most treatment programmes emphasize on education about TB, the dosing of medication, duration and possible adverse reactions of the medications as well as importance of taking drugs as prescribed.  Health care workers are expected to take time to explain clearly to patients when the medication should be taken, how much, and how often, especially if the patient is not receiving directly observed treatment. Written instructions should also be provided if relevant. Despite these clear messages, low levels of education among the patients, inadequate personnel in the treatment centers, low motivation among the treatment supporters, poor logistics have been observed as constraints to effective patient education in urban areas (AMREF, 2003 and Kruk et al, 2008).
 2.9.3 Anatomical/biochemical factors associated with compliance to TB treatment
Some times patients are unable to comply with prescribed drug regimen due to complex bacterial, environmental (anatomical, biochemical factors) and pharmacological factors which are important to note but will not be the scope of investigation in this study.
2.9.3.1 Bacterial: This depends on the number of tubercle bacilli, the bacterial population in the body, the number of resistant mutant strains and the metabolic factors including persistors, which exist in the residual lesions in a dormant state (CDC, 1998)
2.9.3.2 Environmental: The tissues harboring tubercle bacilli may also affect the drug reaction. Not all drugs penetrate all tissues and cells or permeate biological membranes including the normal blood barriers. Isoniazid, Rifampicin and pyrazinamide have the features of failing to enter many cell membranes and are hence not effective against intercellular bacilli. They are however more effective with extra cellular bacilli or those bacilli in the cavity lesions. The effectiveness of the drug is also affected by the other biochemical factors including the environmental PH and the PO2 (the partial oxidation pressure and its important microbial effect of the drug (McDonald et al, 1982)
2.9.3.3 Pharmacological factors: The dosage given must be large enough to produce an inhibitory concentration at the sites where the bacilli are found. The combination of three and not one drug should be used .A single drug should not be added to a failing regimen (Fieden, 2005).		
2.9.3.4 Other co-morbidities
A number of medical conditions may alter immune responsiveness and predispose a person to TB. Such disorders include HIV infection, immunosuppressive therapy, hematological or reticuloendothelial malignancies, chronic renal failure, diabetes, and malnutrition. These conditions may influence the outcome of therapy. Therapeutic decisions for the impaired host must be individualized. Patients with partial impairment of renal function should avoid streptomycin, kanamycin, and capreomycin if possible. If renal function is severely impaired, reduced doses or increased dosing intervals of other TB drugs may be necessary. For patients who abuse alcohol or who have neuropsychiatry disorders, close supervision — preferably using DOT — is necessary to ensure adherence and to monitor for adverse reactions to medications Burman et al ( 1997).
2.10 Importance of compliance to TB treatment
Compliance to TB treatment cannot be overemphasized due to the eminent danger of retaining infectious cases and more so in crowded environments like urban slums and the consequences of spread of TB. Drug resistant TB is an outcome of non-compliance with TB treatment regimen among target populations, increased chances of mortality and further strain to already burdened national health systems (WHO, 2009). Drug resistance can only be averted if factors that may make patients stop treatment are understood.

2.11 Studies on compliance to TB treatment and gaps
There are no current studies in Kenya on compliance to TB treatment. With the increase of   Multi-Drug Resistance TB, it is imperative that such studies are conducted to build knowledge and evidence to enhance compliance and successful treatment (WHO, 2006)
Operational studies that have been carried out in  Sub-Saharan Africa , and which have been largely programme based have suggested that service delivery factors including  decentralization of the provision of TB care beyond the hospitals into the communities could contribute to effective programme performance. Such studies lack systematic methodologies, scientific soundness and are therefore difficult limited in their ability to generalize to the general population.
Findings from a WHO study in eight projects in Africa including Kenya, Uganda, Malawi, Uganda, Zambia, Tanzania, Ethiopia and South Africa concluded that successful collaboration between the general health services and community health workers improved the treatment outcomes for TB patients. The studies were carried out in four urban settings and the other four in rural areas. The main method of study was historical comparisons in five of the sites while the others used prospective controlled studies (WHO, 2000).Although the studies recorded better treatment outcomes among patients who utilized community DOTS compared to those who utilized the clinic DOTS. This was among the new smear positive TB and the re-treatment smear positive TB cases. Factors, which contributed to the results other than observation of the treatment, are not recorded in these studies to provide insights to other countries wanting to improve their DOTS services. 
A study carried out in Guguletu in South Africa, which is a low-income urban settlement in Cape Town to determine the effectiveness and costs of providing DOTS by community volunteers as an option in TB control .The method utilized in this study was historical comparisons .The study found out that the overall successful treatment among smear positive patients with the community DOTS was recorded, as 81% while among those where community DOTs was no used was 53% (WHO, 2004). 
In a separate study carried out in Ndola Zambia (prospective controlled study) Lilongwe, Malawi, Kiboga in Uganda, Ndola in Zambia and Machakos in Kenya (all utilizing historical comparisons) recorded marked differences in treatment outcomes where community DOTs were utilized compared to where the conventional treatment method was used  (Fredrick et al ,2004) All the studied however do not expound on the factors other that DOTS which led to the differential outcomes nor do they comment on the non successful cases and the factors that led to the observed outcomes. Most of these studies are operations research studies, which lack a detailed methodology and process and cannot hence be conclusively applied to other set ups.
A study to establish the cause of low cure rates and non compliance to TB treatment in a district TB control programme in Malawi was carried out in 1990-1991.The study utilized a before and after study design to compare the results of cohort analysis in 1990-1991 versus 1992, 1993.The study established marked treatment outcome success as a result of improved service delivery and other programmatic improvements in areas which been identified as a problem in the earlier study. Causality was however not established because of the inability of the study to control for other intervening variables ( Kelly P.M., 2001).

A study in Uganda identified complexity of health services provision, and the lack of cohesiveness in urban communities compared to rural communities as a challenge to successful TB treatment outcomes. Acceptance to community DOTS was found to be lower than expected and reasons associated with this included, unwillingness of TB patients to accept DOTs, inadequate process of recruitment of treatment supporters, lack of confidence in adequate provision of care form the health unit. Lack of acceptance of community DOT supervision still remains inadequately unexplored from both the supply side and the demand side (WHO, 2002).

A study conducted in Jakarta, Bogor, Tangerald and Bekasi, Indonesia among 144 Patients in health centers found that age, marital status, low education level, unemployment and distance to the health centers as main factors determining compliance. The study also found that individual decisions were more likely to lead to non-compliance, as different from family based decisions to get treatment. Also, those who considered TB to be hereditary were more than 5 times more likely to be non compliant. Inadequate knowledge of treatment was shown to have a significant impact on non-compliance. This study will compare findings of this study will look at the similarities in the findings of this study to an urban situation (Simanjutak, 2002).

A study carried out in four districts representing North and South Vietnam and representing both rural and urban areas showed that women were more compliant to treatment than men. Insufficient knowledge and individual costs during treatment were reported as main obstacles to compliance among men (poor patient compliance), while sensitivity to interaction with health staff and stigma in society (poor health staff and system compliance) were reported as the main obstacles among women, Johansson et al (1996). This study will make comparisons to build further evidence for enhancement of compliance in urban slums.

CHAPTER THREE
MATERIALS AND METHODS

3.1 Study area.
Kangemi is an urban slum, 12 km to the west of Nairobi City. It has a population of 59,000 people distributed over an area of 20.1 square kilometers (CBS, 1999). The slum is divided into twelve villages.  Majority of the residents are low-income earners who make their living out of paid wage labor or small skill business. There’s  one Health Center, which is run by the Nairobi City council (NCC) .The TB control activities  are run in the collaboration with partners among them Malteser,  AMREF, and the Ministry of Health and the  National Leprosy and TB control programme.

3.2 Study design
This was a descriptive retrospective cohort study that utilized a group of patients who initiated treatment at the Kangemi TB treatment and re-treatment centre between January and December 2004. The follow up period ranged between 4-6 months 

3.3 Sample determination and sampling procedure
A sample calculation was based on the national TB treatment rate of 80% at 95% confidence interval. The minimum sample size required was 295 respondents

                        N=z2 p (1-p)    
d 
N= sample size
P = national treatment success rates @ 80% 
d – The probability of obtaining a sample, which is a true representative of the population
Z2 =1.96 = Level of confidence limits
N             = 295
Formulae-standard calculation of prevalence (Fisher et al, 1998) 
3.3.1 Study population
The sampling frame was all patients who started treatment between 1st January to –31st December 2004. Individual cases notified were the units of analysis. The treatment register containing four hundred and fourteen (414) was used as a sampling frame . All the 59 non-compliant cases were included in the sample and using a table of random numbers, 238 compliant patients were selected for the study to make the sample of 295. 

 3.3.2 Key Informant Interviews with TB treatment managers and supporters 
In order to validate the information on service delivery factors, interviews were carried out with one nurse, one laboratory technologists, one clinician at the Kangemi TB treatment and re-treatment centre. 28 laboratory technologists were interviewed in other laboratories in Kangemi, the national TB and Leprosy Programme Manger and six Community Health Workers who worked as TB treatment supporters and mainly tasked with DOTS .
3.4 Data collection tools
A structured questionnaire was used to collect data on social demographic, characteristics, epidemiological characteristics, compliance and outcomes of treatment and social and service delivery variables (Appendix 1).
A key informant interview guide (Appendix 2) was administered to TB treatment two managers at the national leprosy and TB control programme, the Clinical Officer and nurse in chare of the TB clinic in Kangemi and the Laboratory technician. This was administered by the Principal Investigator to collect information on service delivery support and how services are organized.
A Focus Group Discussion (FGD) guide was used to interview TB treatment supporters. (Appendix 3) on how they support DOTS 

3.5 Inclusion criteria 
All adults over eighteen years and children below 18 years notified in the Kangemi TB treatment centre between 1st January 2004-and completed treatment by 31st December 2004.
All Health workers, TB treatment supporters and Managers, Laboratory Technicians, clinicians in the study area who consented. 

3.6 Exclusion Criteria
Exclusion included adults over 18 years, parents or guardians of  children below 18 years ,TB treatment supporters, mangers and laboratory technologists  who did not consent.
3.7 Ethical considerationsd
Approval of the study was obtained from Kenya Medical Research Institutes (KEMRI), see (Appendix 5 ) Scientific Steering Committee (SSC) and Ethical Review Committees (ERC) see ( Appendix 6). A written consent form was read and explained to the respondents who signed or thump stamped. The consent explanation entailed a detailed introduction of the interviewer, the purpose of the study, the benefits of the study to the individuals, the community and the country. Respondents were assured of data confidentiality and security.
Written or verbal consent was sought from all the respondents after a thorough explanation of the objectives and methods, the benefits and how the study would be utilized. Respondents were informed that they were free to withdraw from the study at any stage should they decide to.
The data collection instruments were coded for anonymity and data collected was kept confidential to protect the identity of the respondents and avoid any negative consequences on those who participated.
The respondents were not coerced or induced to participate in the study. Those found to be in any condition requiring attention medical were referred to the Kangemi health center or brought to the attention of the TB treatment supporters or managers for treatment or referral.
 
3.8 Data Analysis 
Data was coded and entered into a data base using SPPS version 11.5.   Categorical data was analyzed using Chi-square. Binary logistic regression was used to model compliance to TB Treatment (0= Non compliant, 1= Compliant) using fourteen candidate predictive factors. 
3.9 Limitations of the study
The study utilized a retrospective cohort. Data from dropouts due to death and those respondents who were transferred out of the treatment centre to other centers was not easily recoverable within the study period and this reduced the sample size. Responses suffered from recall bias, as the study utilized a group, which was registered for treatment in the last 12 months before the study. Unlike most cohort studies which would separate the different respondents by patient category as new patients, PTB+,PTB- and MDR), this study evaluated all the patients together and the specific outcomes of the minority of the respondents  especially the last two categories were not given attention..The time and resources available for the study limited the depth with which social cultural factors relating to treatment compliance and the outcomes were explored. Since the DOTS system had been initiated in the study area that same year, most of the people in the study cohort came from outside the study area and this made tracing limiting due to time and distances involved. Some of the people came from as far as Kiambu District, and other parts of the country.
The quality of data collection and register maintenance at the Kangemi TB treatment center which was used as the sampling frame and where the compliance and non-compliance and final outcome data was collected was presumed to be accurate.  However, the register relating to the study cohort was incomplete in regard to some variables as these were not emphasized during the initial stages of community tuberculosis management and control programmes. 
CHAPTER 4
RESULTS

4.1 Social-demographic characteristics of the respondents
4.1.1 Distribution of respondents by age 
Majority of the respondents (66%) were between ages 21-40 years, twenty (22.9%) were over forty years, while 12 (11.1%) were below 20 years. The mean age was 32.8+10.8 years. The age range was 6 to 66 years (Table 4.1 ).
Table 4.1 Distribution of the respondents by age

Category	Frequency	%	
<20	16	11.1	
21-40	95	65.9	
< 40	33	22.9	
Totals	N=144	100	

4.1.2 Distribution of respondents by gender
Males were 59.3% of the respondents while females represented 40.3%.This is possibly a representation of the patterns of migration in Kenya where more males than females move to the towns to seek for employment and settle in the slums (Table 2).

Table 4.2 Distribution of the respondents by gender
Gender	Frequency	%	
Male 	86	59.3	
Female	58	40.7	
Totals	N=144	100	

4.1.3	 Distribution of respondents by level of education
Majority of the respondents had primary (46.5) primary school education followed by secondary education (39.6%). Only (3.6%) had post secondary education while (8.3 %) had no formal education (Figure 4.1). Respondents level of education

 

 

 

8.3%

46.5%

39.6%

3.6%

None

Primary

Secondary

Post secondary

Figure 4.1: Level of education among respondents
4.1.4 	Marital status of respondents
The respondents were either single 49(34%), married 80 (55.9%), widowed 5(3.5), divorced 7(4.9%) or separated 3 (2.1%) of the respondents were married, 33% were single while the rest were widowed, divorced or separated (Figure 4.2).

Percentage

Marital Status

0

10

20

30

40

50

60

%

Single

Married

Widowed

Divorced

Separated

Figure 4.2: Marital Status of respondent
4.1.5 Occupation of respondents
Majority of the respondents 50 (34.7%) indicated that they were in business, 33 (22.9%) did casual work, 31 (21.5 %) were in salaried employment, 10 (6.9%) were students while 20(13.9%) indicated they were un-employed (Figure 4.3).

Percentage

0

5

10

15

20

25

30

35

Occupation

Not employed

Business

Salaried employee

Casual worker

Student

Figure 4.3: Occupation of Respondent
4.1.6 Respondents Religious affiliation of repodents
Majority of the respondents 138(95.8%) were Christians, 2 (1.4%) were Muslims and 4 (2.8%) followed traditional religions (Figure 4.4).

Figure 4.4: Religious Affiliations of respondents
 4.2 	Respondents epidemiological characteristics 
4.2.1 	Disease classification 
Majority of the respondents 268 (90.2%) had Pulmonary Tuberculosis while 29 (9.8%) had Extra Pulmonary Tuberculosis.  See (Table 4:3).

Table 4. 1: Distribution of respondents by disease classification
Disease classification	Frequency	%	
EPTB	29	9.8	
PTB (+/-)	268	90.2	
Total	N=297	100	

4.2.2 	Patient classification 
288 (97%) of the respondents were new patients , 6 (2.0 %) had been transferred from other districts or treatment centers and 3(1.0%) were relapses who had started treatment all over again  (Table 4:4).

Table 2:4 Distributions of the respondents by patient classification
Patient classification	Frequency	%	
New patient	288	97.0	
Relapse	3	1.0	
Transfer in	6	2.0	
Total	N=297	100	

4.2.3 	HIV status of the respondents
Most of  the respondents 102 (34.3%) did not have their HIV status known,
58 (19.5%) were HIV positive and 137 (46.2 %) were not. The study noted although knowing ones   HIV status was important prior to commencement of treatment, counseling and testing  had not been seriously initiated at the time of the study and 34% of the respondents did not have their HIV status known (Figure 4.5). 
Figure 4.5: HIV Status of Respondents
4.3	 TB treatment compliance among respondents
Out of the 414 people in the studies cohort 355 (85.7%) complied with treatment while 59 (14.3) did not (Figure 4.6).

Figure 4.6: Distribution of TB treatment compliance

14.3%

85.7%

Compliant

Non compliant

4.3.1 	TB treatment outcome by compliance
Those respondents who complied with treatment were 160, (67.2%) ,those were  cured or had their treatment completed  were 67, (28.2%) and only one  patient was reported to have died after the treatment. The contrast was reported of the non-compliant respondents of whom 64.4% were out of control, while 38, (35.6%) had died (Table 4:5).

Table 4:3 Distribution of TB treatment outcome among the repodents and compliance to treatment
Recorded final treatment outcome	Compliant	Non compliant	
	N	%	n	%	
Cured	160	67.2	0	0	
Treatment completed	67	28.2	0	0	
Transferred out	10	4.2	0	0	
Out of control	0	0	38	64.4	
Death	1	0.4	21	35.6	
Total	238	100	59	100	

4.4 Social Demographic factors of respondents and Compliance to TB treatment
4.4.1: Age of respondents and compliance to TB treatment
 Age did not have any influence on compliance to TB treatment (P>0.05). Patients aged < 20 years are 4.04 times more likely to be complaint compared to those aged more than 40 years. The likelihood reduced to 2.06 times for patients aged 21 to 40 years compared to those aged more than 40 years (Table 4:6).
Table 4: 4 Age of respondents and compliance to TB treatment
Age 	Compliant (n=125)	Non compliant (n=19)	Odds ratio	95% C.I. of Odds ratio	P value	
	n	%	n	%		Lower	Upper		
< /= 20	15	93.8	1	6.3	4.04	0.42	95.95	0.245	
21-40	84	88.4	11	11.6	2.06	0.64	6.52	0.243	
> 40	26	78.8	7	21.2	1.00				

4.4.2: 	Gender  of respondents and compliance to TB treatment 
The gender of the respondents did not influence compliance to TB treatment (P>0.862) (Table 7).

Table 4: 5  Gender of respondents and compliance to TB treatment
Gender	Compliant (n=125)	Non compliant (n=19)	Odds ratio	95% C.I. of Odds ratio	P value	
	n	%	n	%		Lower	Upper		
Male	75	87.2	11	12.8	1.09	0.37	3.19	0.862	
Female	50	86.2	8	13.8	1.00				
4.4.3 Marital status of respondents and compliance to TB treatment  
Marital status had a significant association with compliance to TB treatment (P<0.05). Married people were 15.64 times more likely to comply with treatment compared to those who were single, divorced, separated or widowed as shown on  (Table 4: 8).
Table 4: 6 Marital status of respondents and compliance to TB treatment
Marital status	Compliant (n=125)	Non compliant (n=19)	Odds ratio	95% C.I. of Odds ratio	P value	
	n	%	n	%		Lower	Upper		
Married	73	91.3	7	8.8	15.64	1.69	169.21	0.011	
Single	43	87.8	6	12.2	10.75	1.11	122.70	0.028	
Divorced	5	71.4	2	28.6	3.75	0.20	101.03	0.558	
Separated	2	66.7	1	33.3	3.00	<0.01	197.11	1.000	
Widowed	2	40.0	3	60.0	1.00				
4.4.4 Education level of respondents and compliance to TB treatment. 
The level of education was significantly associated with compliance (P<0.05). Patients who had post secondary and secondary education were more likely to comply with treatment than those who had primary school education and below (Table 4:7).

Table 4: 7 Education level and compliance to TB treatment
Education level	Compliant (n=125)	Non compliant (n=19)	Odds ratio	95% C.I. of Odds ratio	P value	
	n	%	n	%		Lower	Upper		
Tertiary	8	100	0	0.0	UD	UD	UD	UD	
Secondary	53	93.0	4	7.0	6.63	1.09	41.90	0.026	
Primary	56	83.6	11	16.4	2.55	0.53	11.86	0.227	
None	8	66.7	4	33.3	1.00	 	 	 	
UD – Undefined	
4.4.5 Occupation and compliance to TB treatment among respondents 
Most of the respondents were casual employees, self employed or in small scale businesses. The type of occupation did not indicate any significant association with compliance to TB treatment (P>0.05) (Table 4:8).
Table 4:8 Occupation and compliance to TB treatment
Marital status	Compliant (n=125)	Non compliant (n=19)	Odds ratio	95% C.I. of Odds ratio	P value	
	n	%	n	%		Lower	Upper		
Not employed	20	100	0	0.0	UD	UD	UD	UD	
Student	9	90.0	1	10.0	1.98	0.20	46.86	1.000	
Salaried employee	27	87.1	4	12.9	1.48	0.36	6.43	0.757	
Casual worker	28	84.8	5	15.2	1.23	0.33	4.78	0.968	
Business	41	82.0	9	18.0	1.00	 	 	 	
4.5 	Epidemiological factors and compliance
4.5.1 Disease classification of respondents and compliance to TB treatment
Patients with Pulmonary Tuberculosis were 3.32 times more likely to be compliant than those who had Extra Pulmonary Tuberculosis (Table 4:11). 
Table 4.11 Disease classification and compliance
TB classification 	Compliant (n=238)	Non compliant (n=59)	OR	95% C.I. of O.R.	P value	
	n	%	n	%		Lower	Upper		
PTB	221	82.5	47	17.5	3.32	1.38	7.93	0.005	
EPTB	17	58.6	12	41.4	1.00	 	 	 	

4.5.2	 HIV status and compliance to treatment among respondents 
The HIV Status of a patient did not have any influence on compliance to TB treatment (P>0.05). This result is however not conclusive given that a significant number of the respondents did not know their HIV status (Table 4:12).
Table 4:12 HIV status of respondents and compliance to TB treatment
HIV status 	Compliant (n=238)	Non compliant (n=59)	OR	95% C.I. of O.R.	P value	
	n	%	n	%		Lower	Upper		
Positive	47	81.0	11	19.0	1.04	0.43	2.56	0.922	
Negative	109	79.6	28	20.4	0.95	0.48	1.89	0.874	
Not known	82	80.4	20	19.6	1.00	 	 	 	
4.5.3 Presence of other morbidities and compliance to TB treatment among respondents 
There was a significant relationship between presence of other morbidity co-existing with TB and treatment compliance shown by (P<0.05). Patients without other morbidities were 11.85 more likely to be compliant with TB treatment than those who had other morbidities (Table 4:13).

Table 4:13 Presence of other Co-morbidities among respondents and compliance to TB treatment
Other co-morbidity	Compliant (n=125)	Non compliant (n=19)	OR	95% C.I. of O.R.	P value	
	n	%	N	%		Lower	Upper		
Co-morbidity absent	112	93.3	8	45.8	11.85	4.04	34.77	<0.001	
Co- morbidity present	13	54.2	11	6.7	1.00	 	 	 	

4.5.4 	Treatment phase and compliance to treatment among respondents
Compliance was higher at the continuation phase (98.3%) compared to the intensive phase (86.7%). The reduction of acute symptoms is associated with an assumption of recovery making patients not to continue with the prescribed medicines, see (Table 4:14).
Table 4:14 Treatment phase and compliance to TB treatment among respondents
Factors	Compliant	Non compliant	OR	95% C.I. of O.R.	P  value	
	n	%	N	%		Lower	Upper		
Intensive phase (first two months)	
Yes	235	86.7	36	13.3	50.05	13.31	221.55	<0.001	
No	3	11.5	23	88.5	1.00				
Total	238	80.1	59	19.9	 	 	 	 	

Continuation phase	
Yes	232	98.3	4	1.7	618.67	112.64	4300.45	<0.001	
No	6	9.8	55	90.2	1.00				
Total	238	80.1	59	19.9	 	 	 	 	

4.5.5 Other drug abuse and compliance to TB treatment among respondents
There was a significant association between lack of TB treatment compliance and use of alcohol and other drugs (P<0.05). Non Alcohol users were 3.6 times more likely to comply with treatment compared to those who abused alcohol. Similarly, those who did not abuse other drugs were 11.6 times more likely to be compliant compared to abusers. However, cigarette smoking did not associate significantly with compliance with (P>0.05) .See (Table 4:15).
Table 4:15 Drug Abuse among respondents and compliance to TB treatment
Factors	Compliant (n=125)	Non compliant (n=19)	OR	95% C.I. of O.R.	P value	
	n	%	n	%		Lower	Upper		
Alcohol	 	 	 	 	 	 	 	 	
No	85	92.4	7	7.6	3.6	1.3	10.0	0.011	
Yes	40	76.9	12	23.1	1.0				
Smoker									
No	96	88.9	12	11.1	1.9	0.7	5.4	0.254	
Yes	29	80.6	7	19.4	1.0				
Other drugs									
No	119	90.8	12	9.2	11.6	3.3	40.0	<0.001	
Yes	6	46.2	7	53.8	1.0	 	 	 	

4.6 	Service delivery factors and TB treatment compliance
4.6.1 	Direct observation of treatment and compliance to TB treatment among respondents
Direct Observation of Treatment during the intensive phase influenced compliance to TB treatment as shown by a  (P<0.05). Compliance was 33 times higher among patients whose treatment at the intensive phase was observed by themselves, a relative or friend at home compared to observation by Community Health Workers at the facility (Table 4:16).

Table 4:16 DOTS and compliance to treatment
Dot observation	Compliant (n=125)	Non compliant (n=19)	OR	95% C.I. of O.R.	P value	
	n	%	n	%		Lower	Upper		
Self/ relative/ Non relative	120	93.7	8.0	6.3	33.00	7.97	147.94	<0.001	
Dot facility/ CHW	5	31.2	11	68.8	1.00				

4.6.2 	Relation between where TB treatment was obtained & compliance to treatment
The place where TB treatment was sought first influenced compliance (P<0.05). Patients who sought treatment from government health facilities /hospitals were 11.68 times more likely to become compliant than those who visited other private clinics, self medicate or saw traditional or faith healers (Table 4:17).

Table 4:17 Where patient first sought TB treatment and compliance 
Where 1st  TB treatment was sought	Compliant (n=125)	Non compliant (n=19)	OR	95% C.I. of O.R.	P value	
	n	%	N	%		Lower	Upper		
H/C/Hospital	109	94.0	7	6.0	11.68	3.59	39.28	<0.001	
Others	16	57.1	12	42.9	1.00				
4.6.3 Accessibility to health facility and compliance to treatment among respondents
There was a significant association between TB treatment compliance and accessibility to the health facility (P= 0.010). A patient who stayed within the slum area where the treatment centre was located was  6 times more likely to comply with TB treatment compared with one who came to the facility from other districts or urban slums (Table 4:18).
Table 4.18: Accessibility to the health facility by respondents and compliance to treatment

Accessibility	Compliant (n=125)	Non compliant (n=19)	OR	95% C.I. of O.R.	P value	
	n	%	N	%		Lower	Upper		
Easily accessible	118	89.4	14	10.6	6.0	1.7	21.5	0.010	
Not easily accessible	7	58.3	5	41.7	1.00				

4.6.4 	Free versus paid services and compliance to treatment among respondents
Those respondents who never incurred any costs for TB treatment were 7.08 times more compliant than those who incurred other costs. These most like are the people who had to travel from other places and incurred transport costs and those who had to close their businesses to go to the TB treatment centre (Table 4:19).
Table 4:19 Free versus paid services and compliance to TB treatment among respondents
Other hidden costs	Compliant (n=125)	Non compliant (n=19)	OR	95% C.I. of O.R.	P value	
	n	%	N	%		Lower	Upper		
Free	119	89.5	14	10.5	7.08	1.61	31.28	0.007	
Not free	6	54.5	5	45.5	1.00				

4.6.6 Side effect  of treatment among respondents and  compliance to treatment 
Side effects included headaches, yellow urine, and swollen legs. Those who did not experience
 side effects were 5.8 more times more compliant as shown on Table 4:21 below
Table 4:21  Respondents experience of side effects and their compliance to treatment 
Other hidden costs	
Compliant (n=125)	
Non compliant (n=19)	
OR	
95% C.I. of O.R.	
P value	

n	
%	
N	
%	
	
Lower	
Upper	

No	
76	
95.0	
4	
5.0	
5.81	
1.82	
18.55	
0.002	

Yes	
49	
76.6	
15	
23.4	
1.00	

	

	
									
4.6.7 Respondents experience of discrimination and compliance to treatment
Whether one experienced discrimination or not had an association with compliance to treatment. Those who did not experience discrimination were 5 times more likely to be compliant than those who did. Discrimination necessitated fear among respondents and delay in seeking of treatment from designated health facilities. Frequenting the health facility and attendance to support groups where compliance education was disseminated was also compromised due to stigma as on Table 4:22 below
Table 4:22 Respondents experience of stigma and compliance to treatment
Other hidden costs	
Compliant (n=125)	
Non compliant (n=19)	
OR	
95% C.I. of O.R.	
P value	

n	
%	
N	
%	
	
Lower	
Upper	

No	
106	
91.4	
10	
8.6	
5.02	
1.80	
13.99	
0.003	

Yes	
19	
67.9	
9	
32.1	
1.00	

 	

	

	

	

	

	

	

									
4.6. 8 Predictor variables to TB treatment compliance among respondents.
Binary logistic regression was used to model compliance to TB treatment in order to arrive at the actual predictors using fourteen candidate predictive factors.
Table 4:23 shows the factors that  observation of treatment by self or relatives ,those who attended government health facilities ,high knowledge about TB and non-experience of discrimination were found to be predictors of  compliance and successful outcomes of TB treatment 

Table 4:23: Predictors of TB compliance among respondents
Predictor variables		
Compliant              (n=125) S.E. ()	df	P value	ratio	Non
Compliant 
( n=19)
95.0% C.I. of P 
    O.R.	
						Lower	Upper	
Treatment/DOT observation	
Self/ relative	4.46	1.09	1	<0.001*	86.1	10.1	736.2	
First place of TB treatment	
H/C/Hospital	2.47	0.97	1	0.011*	11.8	1.8	79.8	
Distance to the nearest health facility	
Easily accessible	2.93	1.31	1	0.025*	18.8	1.4	244.0	
Knowledge on TB treatment	
Adequate knowledge	2.63	1.18	1	0.026*	13.9	1.4	140.8	
Experience of Discrimination 	
Not discriminated	2.21	0.95	1	0.020*	9.1	1.4	58.5	

CHAPTER FIVE
DISCUSSION
5.1 The TB treatment compliance and outcomes in Kangemi slums of Nairobi Kenya 
In this study compliance to treatment was 85.7 % which was above the estimated national average in Kenya. The rate is comparable to that observed in countries like Bangladesh, China, Nepal, Maldives of up to 85% and matched the WHO global target as early as 1990 (WHO, 2000).Other studies carried out in Sub-Saharan Africa including Kenya, Uganda, Zambia, Ethiopia and South Africa indicated that collaborative efforts between health workers were more likely than not to improve compliance and treatment outcomes.
A similar study in an urban slum in GuGuletu a small urban slum in Cape Town recorded success rate of 81% where community DOTS strategy was used compared to 53% where DOTS was not used (WHO, 2004). The final treatment outcomes were also better among respondents who complied to treatment and these were (.67.2%) cured, (28%) completed treatment and only (0.4%) died. Among the non-compliant respondents, 39 (64.4%) went out of control while 20 (35.6%) died. This clearly established that compliance had a bearing on successful outcomes of treatment while non-compliance increased mortality, abandonment of treatment and unsuccessful treatment.
5.2 The Social factors associated with compliance to TB treatment and final outcomes
In terms of social-demographic factors, marital status influenced treatment with better compliance among married people.  This compares well to a study that was carried out among 144 patients in health centres in Jakarta, Bogor, Tangerald, Bekasi and Indonesia and that singled out spousal support among married couples as a factor in compliance (Simanjutak, 2002). where men are the ones, taking treatment, women in their traditional care roles could most likely be behind reminding their spouses to take their medication and to provide other supportive therapies to mitigate advance side effects of medication.Soceital support was indicated as an important predictor of compliance in separate studies in South Africa and in Uzbekistani in South Africa (Cramn et al 2010., Afari-Twumasi et al 2005., Hasker et al., 2008).
Education level was another factor that was associated with improved compliance to treatment with people with post secondary education more likely to be compliant than those with below secondary education. Community TB programmes world over are built on  the combination of treatment, prevention and promotion .Education  about TB, the dozing medication, duration and possible side effects, importance of compliance and what one should do if they miss medication are all  important in the promotion of compliance.. Whereas written instructions and take home messages have been associated with improved compliance and successful outcomes and have been found to be a barrier in urban slums (AMREF, 2003). People with better education levels are also more likely to be in better paying jobs and can afford other supportive therapies including nutrition to improve compliance than those in casual and other erratic types of employment. It is possible that people with better education can also negotiate their treatment terms including taking time off during the intensive phase, time off for support groups and rest. The finding is also supported by a study in seven countries in South East Asia, which showed that low level of education was a major predictor of non-compliance to TB treatment (Samanjutal, 2002). In a study in Ndola Zambia, ( Fredrick et al., 2004 ) found out that 29.8% of the patients had stopped treatment within the first two months and those with low education levels were the majority of the ones who did not adhere to treatment.
Closely related to education and significant to TB treatment compliance was the knowledge about TB from the parameters of its causes, relationship with HIV/AIDS, whether its curable or not, effectiveness of drugs, if it can be transmitted, awareness about DOT supervision, information about drugs, food intakes during treatment, timing, dealing with missed drugs, consequences of missing a doze, benefits of compliance and effects of drug to drug interaction. 
 Lack of knowledge has been associated in other studies with non-compliance where those people who did not know the actual causes of TB and thought that TB was a hereditary were 5 times more unlikely to comply with treatment (Simanjautak, 2002).  Insufficient knowledge has further been identified as a barrier to compliance to treatment especially among men in a study in rural Vietnam (Johansson et al, 1996).

 Experience of discrimination in the community was a main reason for non-compliance. The effect of discrimination has been documented in many studies and it has been associated with failure t seek treatment early, inability to seek social support during treatment and failure to show up for follow-up and continuous medical education.  In a study in four districts representing both rural and urban populations in Vietnam, stigma in society was reported as major reason for non-compliance to TB treatment among women (Johansson et al, 1996). Sensitivity to interaction with health staff was singled out as a factor that made women unable to turn up for DOTs freely in addition to stigma by other outpatients (Cramn et al., 2010). The study established that beliefs held by the patients about TB influenced compliance. This is supported by (Cyrus et al, 1997) in a longitudinal study that continued for  25 years, which showed that those people who believe that TB is curable were more compliant than those who did not. The finding is rather common in other chronic long term illnesses which are associated with supernatural other than biological causes. Such people also tend to visit traditional and faith healers and until the problem becomes unmanageable they do not get attention of the formal health system. Even when treatment is finally initiated, they are likely complying with treatment for a short while and when acute symptoms reduce, they abandon treatment (Ndetei et al, 2007).

Other co -morbidities co-existing with TB were asthma, mental and neurological disorders, HIV/AIDs and cancer and those subjects who did not have other  co-morbidities present were more likely to be compliant. Some of the conditions co-existing with TB have been on record in altering the immune responsiveness and have the capacity to render one non-compliant and also to influence outcome of therapy. People with neuropsychiatric disorders alter therapeutic decisions and such people require very close supervision to ensure compliance and to monitor treatment side effects (Burman., et al, 1997; Ndetei et al., 2005). The study found out that use of alcohol inhibited compliance to treatment. Those respondents who did not abuse alcohol were more likely to be compliant. This compares with other studies in  developed and developing countries alike  among patients on Tuberculosis treatment that have established that illicit drugs and alcoholism had were a barrier to compliance as this led to forgetfulness, poor judgment , increased side effects and contraindications of treatment ( CDC., 1992; Hasker et al .,2008; WHO, 2008)

5.3 The service delivery factor associated with TB treatment compliance and final outcomes
The study established that although the government of Kenya through the National TB and Leprosy Control Programme (NTLCP) supported delivery of DOT services there wasn’t enough capacity to by either the heath workers or TB treatment supporter to observe treatment during the intensive phase.
The   study established that those patients who had their treatment observed in the home by self or relatives were more likely to be compliant than those who had their treatment observed at the facility. The finding from this study is a departure from what many studies that have been carried out on Directly Observed Treatment that have associated high success of treatment to the DOTS strategy that is usually built around facility and community linkages ( WHO.; 2006., WHO,2008., Kumar.,et al 2007.; Pract.;  2007).
The place where first treatment for TB was first received was significantly associated with compliance to treatment. Compliance was higher among those who sought treatment from a government health facility as opposed to private clinics and traditional and faith healers. A study on the practice of faith and traditional healers in Kangemi slum established that  that many patients first attempt treatment from traditional sources before going to health facilities and even when they initiate treatment, they still take herbal and other remedies which inhibit compliance to treatment  (Ndetei et al, 2007, Thiam et al 2008) .
Although the TB diagnosis, prescription, medication and treatment support was free and provided by the government through the National Leprosy and Tuberculosis Control Programme (NLTCP), patients still had other hidden costs which inhibited compliance to treatment which ranged from  transport , costs of additional food requirements to tolerate the drugs, social and opportunity costs due to log time taken to go for medication especially during the intensive phase and care costs especially for patients with other co-morbidities. A study in Vietnam identified cost of treatment as a main hindrance to compliance to treatment especially among male adults (Johansson et al, 1996). 

CHAPTER 6
CONCLUSIONS AND RECOMMENDATIONS

6.1.1 	Compliance and outcomes of TB treatment in Kangemi slums
The study concludes that compliance to TB treatment among the respondents which was   85.7 % was below the WHO recommended  rate of 87 % and that 14.3% non-compliance is significant for a congested slum where effects of harboring infectious people within the community can not be underestimated. The study concludes that those who complied with treatment had successful treatment outcomes while those who did not comply either died, absconded from treatment all together. Non-compliance to treatment negated the goal of treatment for the study population which in line of the global goals for TB treatment and that is to cure all cases that are identified within a given period of time. 
6.1.2 	Service delivery factors associated with compliance to TB treatment
Direct observation of treatment by the patients themselves or their close relatives was an important predictor of compliance indicating that there’s merit in investing in direct patient centered approaches to TB treatment.  Accessibility to TB treatment was an important factor in enabling compliance and this was not merely from the physical distance but also availability of time, and opportunity gains. Government health facilities offered better treatment and promoted compliance compared to traditional, faith healers or private clinics. Existence of proper diagnostic and treatment services was the most probable motivating factor for the preference. 

6.1.3 	Social factors and compliance to TB treatment
 Respondents complied with treatment better when they did not experience discrimination within their communities. Discrimination inhibited early seeking of treatment, participation in support groups and free attendance of education sessions both at the facility and the community where compliance education were taught and reinforced.
Knowledge about TB was an important predictor of compliance to treatment. Assessed from the perspectives of  what patients knew about causes, curability, the treatment regimen, importance of compliance and what one should do when they have missed to take their medication, those respondents with accurate knowledge  complied to treatment better than those who did not have this knowledge. 

6.2 	RECOMMENDATIONS
6.2.1 	Measures to improve compliance and final treatment outcomes
The study recommends an overall enhancement of human resource capacity in the slums to support, supervise and monitor the implementation of DOTS. The human resource capacity should not be limited to health service providers but also to Community Volunteers, family members and patients themselves. The National Tuberculosis and Lung Diseases (NTBLDP)  needs to step up compliance to match or even exceed national and global estimates in Kagemi and other urban slums not only as a measure towards improving treatment outcomes but also to prevent Multiple Drug Resistance (MDR) which is a current threat to TB treatment management and control.  Measures to monitor treatment compliance during the intensive phase must be put in place as the study established that most to the respondents became non-compliant during the intensive phase. 

6.2.2 	Measures to improve the social factors affecting compliance to TB treatment. 
The government of Kenya through the Division of Leprosy, Tuberculosis and Lung Diseases (DLTBLD) and other partners in TB care and management must invest in the training of individuals, relatives and family members to manage TB especially Directly Observed Treatment .
 Education targeted at improving knowledge about TB should be packaged alongside treatment to improve compliance. The study has clearly demonstrated that once people have correct knowledge they are likely to comply. This knowledge should not be limited to the patients only but also to their relatives, family members who as the study have shown participate in the treatment.
Measures to reduce stigma and discrimination associated with TB should be put in place fight stigma and enhance compliance.

6.2.3 	Measures to improve service delivery that influence compliance to TB treatment
The study has identified that patients and their close relatives are central to improved DOTS and recommends that future programme must invest in their training and support to partner in TB treatment and management.
Accessibility to treatment should not just be looked at from the physical and cost element. Other barriers to accessibility should be identified and addressed to improve compliance. In particular accessibility aspects should be considered from the timing, other competing priorities like business, employment which are salient and yet if not considered may impact on accessibility.
The study has established that those patients who first seek treatment in government facilities are more compliant. The study recommends that whereas it is important to educate communities to seek care in the designated health facilities, it is also important to identify the other providers ( private clinics, laboratories, traditional and faith healers, herbalists ) that are being utilized in the slum and bring them on board to improve overall service provision. 

REFERENCES
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Afari-Twumasi K.Nel M.Hiemstara L.A. & Keller-Man T. ( 2005).Tuberculosis knowledge and reasons for non-adherence to treatment in Bisho-Zwelitsha districts.The South African journal of epidemiology and infection 20(1) :23-25

AMREF, (2003 ). Training of community health workers on Tuberculosis and leprosy control. Training report

AMREF, (2004). Baseline survey on status of health facilities in hard to reach districts in Kenya. 

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Bjorkman A.P. & Howard P.A. (1990). Drug anti malaria mechanism of development and inferences in malaria control.  Transitions of Royal society of Tropical Medicine and Hygiene, 84 (3): 323-324. 

Burman W.J., Dalton C.D., Cohn D.L., Butler J.R.G. & Reves R.R (1997).  A cost-effectiveness analysis of directly observed therapy vs. self-administered therapy for treatment of tuberculosis. Chest, 112:63-70.

Centers of Disease Control and Prevention (1998 a).  Report of the NIH panel to define principles of therapy of HIV infection and guidelines on the use of antiretroviral agents in HIV – infected adults and adolescents. MMWR 47 (No. RR-5): 1 – 63) CDC htt;//www.cdc.gov, June 2009 

Centers for Disease Control and Prevention (1998 b). Reported Tuberculosis in the United States.
Centres for Disease Control and Prevention (2005 c) .Trends in Tuberculosis in the United States.

Central Bureau of Statistics, Kenya (1999) .Population and Housing Census

Cramn, J. M.; Finkenflugel, H. J.M.; Moller, V.;and Nieboer A. (2010).TB treatment initiation and adherence in a South African community influenced more by perceptions than knowledge of Tuberculosis.http:www.biomedcentral.com/1471-2458/10/72

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Fieden T.T., (2005).Tuberculosis case detection, treatment and monitoring, Questions and Answers, 2nd edition, WHO, Geneva, pg 125.

Gikunda S.M. (2005). Utilization of Amodiaquine, Sulphadoxine pyrimethamine and prevalence of anti malarial drugs resistance in Bungoma District, Kenya. Unpublished MSC thesis

Hasker E.Maksad K.Shakhhno Z.U.Umid A.Ummida Y.Marieke J. Gulnoz U. & Jaap V. (2008).BMC Infectious diseases 8-7 doc.10.11861, 1471-2334-8-97.

Holger S. (2002). TB and poverty in the context of global TB control. WHO report, WHO/CDS/TB/ 2002.295 pg 2.

Hurries D.H. & Maher D. (1996).TB/HIV; a clinical manual. WHO, pg. 19-21, 37-39.

Johansson, E., Diwan, VK., Houng, N.D and Ahlberg, BM, (1996) staff and patient attitudes to tuberculosis and compliance with treatment.Tubercle and Lung Diseases-77,178-183

Kaona, F.A.;Tuba, M. Siziya S. and Sikaona, S. (2004).An assessment of factors contributing to treatment and adherence and knowledge of TB transmission among patients on TB treatment in Ndola Zambia, research report.

Kelly, P.M. (2001).Local problems, local solutions improving tuberculosis control at district level in Malawi. Bulleting of the World Health Organization.

Khan M.A. & Newell J.N. (2000). TB in Pakistan, Socio-cultural constraints and opportunities in treatment. Journal of Social Sciences and Medicine. Vol. 50, Issue 2, Pg. 247-254. 

Kruk M.E.Schwalbe N.R. Agular A. (2008) .Timing of Tuberculosis treatment, a systematic review .Tropical medicine and international health. 13:703-12.

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National Leprosy and Tuberculosis Programme (NLTP). (2004 edition (Pg.16) 

Ndetei D.M., Khashakala, Oginga, A.O, Kingori J.K, Walioli R. & Raja S., (2007).The practice of traditional and faith healers in Kangemi informal settlements in Nairobi, Kenya. Thematic study report.

Reviglione M.C. (1997) Tuberculosis and HIV: current Status Africa: AIDS, Vol. 11 Suppl B:S115-23.

Thiam S. , Andrea M. , Levre, Fotumata H, Santella BS , (2008) ,  Effectiveness of a strategy to improve TB treatment in a Resource  –Poor Setting ,research article

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Weis S.E., Slocum P.C. & Blais F.X. (1994).  The effect of directly observed therapy on the rate of drug resistance and relapse in tuberculosis. New England Journal of Medicine 330(17); 1179-1184.
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APPENDICES

APPENDIX 1:	Individual Interview questionnaire

Serial No___________

Date recorded_____________________ Recorders initials ____________________

A. Demographic data 

1.	Patients’ file no. _____________Date  treatment started____________ 

2.	Village__________ Current district ___________________ District of origin _____________

3. Gender		Male 		Female   

4. Body weight in kg_____________________

5. Age group (years)_______________

6. Tribe ___________________________
7. Marital status

Single 		Married 	Widowed 		Divorced/separated 

Other (specify) __________________________	

8. Number of children____________________

9. Education attained___________________________________                                                   

10. Occupation
Casual worker 	 Officer 	House help           Businessman/woman	 

Other (specify)_____________________________________________________________

11. Religious affiliation
 
Christian 	Muslim   Traditionalist      	 Heathist 

B. 	EPIDEMIOLOGICAL DATA

1. Disease classification 

PTB smear positive       PTB smear negative       Extra pulmonary TB (EPTB)  
Other   (specify)__________________________

2. Patients’ classification

New patient        Relapse    	Transfer in  	       Treatment resumed 
Other (specify ____________________________

3.  HIV positive				Yes 	 			No	 ...  No records  

4.  Alcohol drinker			Yes 				No	 No records
5.  Smoker				Yes 				No	 No records
6.  Other drugs user 			Yes 				No	 No records
7.  Other co-morbidities
Diabetes 		Cancer 	Asthma  	Neurological/ mental illness 

Other (specify)______________________________________

8.  Hospitalization required		Yes 			No 
9. Treatment/DOT observation

Facility Dot 	Dot by CHW  	    Dot by relative 	  Dot by non/relative 

Self-administered 	   Other (specify)___________________________

10. Adverse affects			Yes 			No 

If yes, please list these effects_____________________________________________

______________________________________________________

C. 	COMPLIANCE

1.	Intensive phase (First two months) 
Ethambutol (E). ……………………………………….   Tablets 
Rifampicin/Isoniazid/Pyrazinamid (RHZ)…………….   Tablets
Streptomycin …………………………………………… Tablets
Sputum test for compliance----------------------------------------
Reasons for non compliance in the records if any ______________________________
____________________________________________________________________
____________________________________________________________________
2.	Continuation phase (next 6 months)
Ethambutol/Isoniazid (EH). ………………………………Tablets 
Rifampicin/Isoniazid (RH)………………...…………….    Tablets

Reasons for non compliance in the records if any ____________________________
____________________________________________________________________

____________________________________________________________________

3.	Remarks from the clinician on the four weekly drug collection_________________________________________________________

D.	 FINAL TREATMENT OUTCOME

1) Cured (Smear + ve) 	2.) Treatment completed (smear -ve)                  7) Death 
3) Transferred out 	4)   Treatment failure (Smear +ve) 
5) Out of control 		6) Multi drug resistance 
Date cured (where applicable) _______________________day □     month □   year □
Remarks _____________________________________________________________

_________________________________________________________________

E. 	SOCIAL DATA (Household survey)	    
    Date………………………..

Interviewers name……….………………    Village…………………………….  

1. Number of years in the residence_______________________________________

2.	Household characteristics

2.1 Number of rooms _________________         
2.2 Number of widows   _______________
2.3 Number of occupants ______________  
2.4 Any other observation___________________________________________________    

3. Health seeking patterns	
3.1 	Where did you go first for treatment 	H/C            Clinic         Self medicated     	
3.2 	Who directed you to treatment centre 	Self               CHW           Neighbours      Administration         Other(specify) 	
3.3.	Do you go for review                                    	Yes                                No      	
3.4 	If yes why                                                     	Complications             Review         Collect drugs                                                                      Other (specify) 	
4. Beliefs about TB disease	
4.1 	Cause of TB                                                  	Germs                 Witchcraft                 Hereditary                                                         Other (specify)	
4.2	Does TB patient have HIV too                  	Yes                              No 	
4.3 	IS TB curable                                                 	Yes                              No 	
4.4 	Are drugs effective                                        	Yes                              No 	
4.5 	Can TB be transmitted    	Yes                              No 	
5. Choice of DOT supervisor	
5.1	Do you believe in DOT                               	Yes                               No 	
5.2	Who was your DOT supervisor                   	Facility            CHW             Relatives 	
5.3	Reason for selecting DOT supervisor 	Confidence      Convenience     Forced          Workload    	

6. What is your opinion on your DOT supervisors (fill under the applicable DOTs)     
 
Health workers			1) Poor  		2) Good    		2) Very good       

Community health workers          1) Poor  		2) Good  		3) Very good      

Relatives 			1) Poor 		2) Good  		3) Very good     

Friends/neighbors		1) Poor 		2) Good 		3) Very good      

Any other                                    1) Poor 		2) Good 		3) Very good   

7.  What is the main reason for the answer above? (Multiple answeres)______________________________

____________________________________________________________________

8. What is your role in TB treatment and control (Can have more than one role)

1) Suspect       2) Present self for treatment        3) Take drugs          4) Report complications 
5) Nutrition          6) Education                     7) Housing arrangements 
8) Other specify _______________________________________________              	
9. What is the role of employers? (Can have more than one reason)

   1) Provide time off       2) Provide food support            3) Education       4) Counselling support  

5) Other (specify) ____________________

10. Treatment support groups          
      1) Education  			   2) Counselling support 	
      3) Other (specify) __________________________________________________________

11. What is role of government (can have more than one answer)

1) Provide drugs 	2) Education 		3) Home visits 	       4) Provide food 		
5) Support business            
6) Other (specify)________________________________________
12. Who else should be involved in TB control activities (more than one answer)

1) Community members 		2) Family 		 3) Ngos  	4) Church	

Others (specify)__________________________________________________________

13.  Are you happy with the TB treatment services in your area?      Yes 	       No 

Please give reasons for this ____________________________________________________

 ____________________________________________________________________

14. Behavioral characteristics

Please indicate whether you know the following 

Information about the drugs          		Yes 		No                         
Food requirements                         		Yes 		No                         
Fluid intake                           		  	Yes 		No                         
Timing                                     			Yes 		No                         
Dealing with missed	drugs	                          Yes 		No                                
Consequences of missing a dose        		 Yes 			No                 
Benefits of compliance              	 		 yes 			No                         
Effects of drug-to-drug interaction   	 	 yes 			No                         
                                            
15.  Do you know of any obstacles to taking drugs regularly?     Yes 	No                         

Explain________________________________________________________
______________________________________________________________

16. Have you faced any discrimination as a TB patient  Yes 	 No                         

Explain________________________________________________________
______________________________________________________________

17. Are there any support groups for people suffering from TB in this community? 

Yes 		No                         

18. Do you belong to one? 	

Yes 		No                         
         If yes list the benefits you get from this group

APPENDIX 2: Key Informant Interview Guide (KIIG) on Health service delivery factors

 Good morning/afternoon, my names are Joyce Ikiara Kingori am conducting a study entitled social and health service delivery factors associated with compliance and outcomes of Tuberculosis treatment in an urban slum, Nairobi. The study is going to be carried out in Kangemi .The study is a partial fulfillment of an MSC in Public Health of the Jomo Kenyatta University .The information collected will also assist the government and other programmes working here to improve services and also design education programmes to improve compliance and final outcomes of TB treatment . Your participation in this research is voluntary. Please indicate to me your consent of Yes or No for this interview by signing this form before we start 

Yes I consent __________________sign.___________________

No, I do not consent ____________   sign___________________

Respondent number ______________________________________

Name of facility _____________________________________________

		
1.	Is the government committed to TB control activities in urban slums 
	 Funding 
	 Staffing 
	 Training
	 Equipment  	1.1	
1.		1.2	
1.		1.3	
1.		1.4	
2.	Are there sufficient facilities for Sputum smear microscopy (probe)
	Lab established
	Equipment
	Reagents
	Lab-stuffing/training
	TB/HIV (VCT) room, staff 	2.1	
1.		2.2	
1.		2.3	
1.		2.4	
1.		2.5	
3.	Are the DOT services available? (Probe)
	Are there standardized short course anti-TB therapy for all mean positive cases
	Drug combinations, patient packs
	DOTs for 1st 2 months
	Drug store (space availability)
	Other collaborating agencies	3.1	
1.		3.2	
1.		3.3	
1.		3.4	
1.		3.5	
1.			
4.	Do you have regular drug supply? 
	Availability 
	Frequency of supply
	Storage space
	Constraints 	4.1 	
1.		4.2 	
1.		4.3 
4.4 	
5.	Do you monitor treatment at facility level?
	Government to facility (frequency)
•	Frequency 
•	By whom 
•	Evidence 
•	challenges	Yes                      No 	
1.		Yes                      No	
1.			
	Facility to community
•	Frequency
•	By whom 
•	Challenges 	Yes                      No	
			
	Community to facility
•	Frequency 
•	By whom	Yes                      No	
			
	 Do you collaborate with other agencies?
•	Meeting (frequency)
•	Evidence	Yes                      No	
			
6.0 Is compliance to treatment a   problem in this area? 
6.1 Perceived Magnitude 
      6.2 Reasons for non compliance  
            from the patients side
6.3 Reasons at facility level
6.4 Recommendations 	Yes                      No	
	6.1	
	6.2	
	6.3	
	6.4	

APPENDIX 3: 	Questionnaire for TB treatment supporters

Respondent No._________

1.	Who recruited   you as a treatment supporter? 
____________________________________________________

2.	Have you undergone any training on TB management and control?
        Yes    		        No 

3.	How many patients do you take care of (actual number)________
4.	What actual care do you provide 
DOTs                      HBC
5.	Do you know of any patients who did not comply with treatment in the last year’s treatment period? 
Yes    		        No 

6.	What were the reasons for non-compliance?
____________________________________________________
____________________________________________________
____________________________________________________

7.	What were the outcomes of non-compliance? 
____________________________________________________
____________________________________________________
____________________________________________________

8.	Do the patients know the consequences of non-compliance?    
Yes 		No
9.	What should be done to improve compliance to treatment at 
•	Household level ______________________________
•	Facility level_________________________________
•	Individual level_______________________________
•	Community level______________________________
10.	What do you like most about TB treatment support work
____________________________________________________
____________________________________________________
____________________________________________________

11.	What is the greatest challenge?
____________________________________________________
____________________________________________________
____________________________________________________

APPENDIX 4:	Consent explanation form-Notes for intended participants

Greetings, I am conducting a study to find out the social and health service delivery factors associated with compliance to TB treatment among patients in Kangemi and the final treatment outcomes. I intend to use this information as a partial fulfillment of a MSC degree in Public Health of the Jomo Kenyatta University. The findings of this study will be used by the various stakeholders including the families and those who have benefited from the TB programmes to strengthen TB control activities in Kangemi and other urban set ups a sharing similar characteristics.
To be able to implement this study, I need you to help me in this research activity. If you decide that you do not want the information collected here to be used for the purposes explained above, you may do so now or in future or any time you feel like. 
What is the study about?
The study is about how people notified in the TB treatment centre in the year 2004 took the drugs that were prescribed or not and how the treatment ended after the recommended period. The study will also ask people questions about their social habits which may have influenced the way they handled the drugs and the results at the end. The study will finally talk with the health service providers at the Kangemi health centre and other people who they work with to find out how they support TB treatment in this area. This approach will ensure that all the factors are well understood to enable the government make improvements targeting the right places and people. 

What you will be asked to do if you join
I will ask for about thirty to forty minutes of your time to answer some questions related to the study .I will ask you the questions and write down the answers. I will read the answer again before proceeding to the next question to ensure a common understanding.
Risks and Benefits
This is a social study with no foreseeable risks. The outcomes of the study will however be of benefit to you in that it will improve the TB programmes here as well as help the government know the specific intervenevtions to make to improve TB treatment compliance. By so doing the community will benefit from fully recovering patients and therefore reduce risks of further spread of TB due to half treated people. The results of this study can be used to design community specific health promotion activities on compliance, benefits and risks of non-compliance which apply to other drugs as well.
Privacy
Any information we receive from you will be kept confidential and will not be exposed to any other persons except those working directly in the study. The questionnaires will use codes instead of names to protect your identity.
CONSENT FORM
I -----------------------------------------------------------------Name (S) have been explained and /or read about this study and I understand the reasons for which it is being carried out. The questions that I had regarding the study have been adequately answered and I can state here that I have freedom over the following.
1. Choice to participate in this study or not. It is all up to me.
2. Even if my initial choice is to participate and in due course I choose otherwise, I will be at liberty to terminate my participation during the study at any time without notice. Whether I choose not to join at all or to terminate my participation during the study, there will not be any form of penalty or restraint as relates to my work or treatment.
My signature below signifies my consent to participate in this study only in the way I have been explained and understood as stated above.

--------------------------------------    ----	-----------------------------------	---------------
(Name of participant)                     (Participants signature)                             (Date)
For any questions, clarifications in the course of this study contact the following:
Joyce Ikiara Kingori (principal investigator)
Cell phone: 0722 973781   

The chairman,
Ethical Review Committee
Kenya Medical Research Institute (KEMRI)
P.O Box 54840-00100
Nairobi, Kenya 
Telephone: 2722541 or 2713349