University of Ghana http://ugspace.ug.edu.gh SCHOOL OF PUBLIC HEALTH COLLEGE OF HEALTH SCIENCES UNIVERSITY OF GHANA, LEGON COMPARATIVE ASSESSMENT OF TB TREATMENT OUTCOMES BETWEEN COMMUNITY-BASED TB CARE AND FACILITY-BASED DIRECTLY OBSERVED THERAPY OF TUBERCULOSIS PATIENTS IN THE UPPER WEST REGION OF GHANA BY GERTRUDE DZIGBORDI AGBESHIE (10745149) THIS DISSERTATION IS SUBMITTED TO THE UNIVERSITY OF GHANA IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE AWARD OF A MASTER OF SCIENCE PUBLIC HEALTH MONITORING AND EVALUATION DEGREE. JULY, 2019 University of Ghana http://ugspace.ug.edu.gh University of Ghana http://ugspace.ug.edu.gh DECLARATION I, Gertrude Dzigbordi Agbeshie, declare that this work is the result of my own original research under the supervision of Professor Moses Aikins, and that inclusions of other peoples’ research by way of references and literature review have been duly acknowledged. This dissertation, either in whole or in part has not been presented elsewhere for another degree. …………………………… Date…………………………………… Gertrude Dzigbordi Agbeshie (PH M&E Student) ………………………….. Date ………………………………….. Professor Moses Aikins (Academic Supervisor) i University of Ghana http://ugspace.ug.edu.gh DEDICATION This work is dedicated to my whole family especially my dad Mr. Martin Atsu Agbeshie, for his immense support towards my education. ii University of Ghana http://ugspace.ug.edu.gh ACKNOWLEDGEMENT I give thanks to the Almighty God for seeing me through this course successfully. I appreciate the meticulous supervision and enormous support of my Supervisor, Professor Moses Aikins at the Department of Health Policy, Planning and Management (HPPM), School of Public Health, University of Ghana. I am grateful to Dr. Dwomoh Duah a lecturer at the Biostatistics Department, Dr. Patricia Akweongo Head of Department (HPPM), Dr. Nii Nortey-Hanson Nortey the Country Director of Aurum Institute Ghana, Ms. Mabel Tetteh Programme M&E Officer (NTP), Ms. Mercy A. Baah Regional Parent for Upper West (NTP) and Mr. Kojo Anniah and other staffs at the HPPM Department for their support. I am indebted to Dr. Abdulai Abukari, Deputy Director Public Health of Upper West Regional Health Directorate, for allowing me to take this course in the first place and also supported me to carry out this research in the entire region. I am also indebted to Mr. Kwame Mintah Yeboah, the Regional TB coordinator (UWR) and all institutional and district TB coordinators of Upper West for their immense support during my data extraction. To my research assistants, I am grateful for your time and energy spent in assisting me to collect data for the study. I am also grateful to the various authors from whose work important information were extracted for this study. Without your cooperation this study would not have been successful. Finally, to my course mates, especially Kojo Mensah Sedzro, Rabiatu Alawiye, Henry Emmanuel Sagoe, Dr. Ama Fosua Amponsem and Arif Mohammed I say I appreciate your company and it has been wonderful being with you. iii University of Ghana http://ugspace.ug.edu.gh ABSTRACT Background: Tuberculosis as a public health threat is one of the main infectious diseases globally. Decentralization of DOT to Community-Based TB Care (CBTC) had improved TB treatment coverage and reduced health facilities burden. Provision of quality care and patients treatment monitoring is the basis to improve and increase success rates for treatment outcomes evaluation. The study assessed TB treatment outcomes between CBTC and FBDOT of TB patients in the Upper West Region. Methods: A retrospective review of TB patients treatment cards was conducted from 2015 to 2017. Data extracted were on patients demographic characteristics, TB classification, patient type, BMI, weight, district, HIV status and treatment strategies. A census of 1,076 patients data extracted was obtained. Proportions of patients under CBTC or FBDOT and their treatment outcomes were determined. The outcome of interest was treatment outcomes with indicators of treatment success (cured or completed) and adverse (died, failure, default, or transferred out) outcomes. Treatment outcomes of patients between CBTC vs FBDOT were compared using chi square test in STATA 15.0. Results: The study had 67.8% (730) males and 94.1% (1,012) adults while the modal age was (35-44 years). CBTC accounted for 83.6% (899) TB patients. Of the patients who received CBTC, 41.3% (371) were cured, 42.6% (383) completed treatment which accounted for 83.4% (754) treatment success, 10.7% (96) died, 2.0% (18) failed, 3.0% (27) defaulted and < 1% transferred out. Of the patients who received FBDOT, 30.5% (54) were cured, 54.2% (96) completed treatment which accounted for 16.6% (150) treatment success, 9.0% (16) died, 1.1% (2) failed, and 5.1% (9) defaulted. Chi-square revealed that patients treatment outcomes under CTBC vs FBDOT had no significant difference (p = 0.08). iv University of Ghana http://ugspace.ug.edu.gh Conclusion: CBTC seems to have had higher treatment success rate compared to FBDOT but not significant so this requires further studies. Therefore, there is need for improvements in treatment monitoring, counselling, defaulter tracing and utilization of treatment supporters to enhance successful outcomes. v University of Ghana http://ugspace.ug.edu.gh TABLE OF CONTENTS DECLARATION ................................................................................................................. i DEDICATION .................................................................................................................... ii ACKNOWLEDGEMENT ................................................................................................. iii ABSTRACT ....................................................................................................................... iv TABLE OF CONTENTS ................................................................................................... vi LIST OF FIGURES .............................................................................................................x LIST OF ABBREVIATIONS ............................................................................................ xi DEFINITION OF TERMS .............................................................................................. xiii CHAPTER ONE ..................................................................................................................1 INRODUCTION ..................................................................................................................1 1.1 Background ............................................................................................................... 1 1.2 Problem statement ..................................................................................................... 4 1.3 Conceptual framework of tuberculosis treatment outcomes ..................................... 5 1.4 Justification ............................................................................................................... 7 1.5 Objectives .................................................................................................................. 8 1.5.1 General objective ................................................................................................ 8 1.5.2 Specific objectives .............................................................................................. 8 1.5.3 Research questions ............................................................................................. 9 CHAPTER TWO ...............................................................................................................10 LITERATURE REVIEW ..................................................................................................10 2.1 Introduction ............................................................................................................. 10 2.3.1 Tuberculosis burden in Ghana .......................................................................... 12 2.3.2 Tuberculosis and HIV infection ....................................................................... 13 2.4 Tuberculosis treatment ............................................................................................ 14 2.4.1 Tuberculosis treatment strategies ..................................................................... 15 2. 4.1.1 Directly Observed Treatment strategy .......................................................... 15 2.4.1.2 Community-Based TB Care strategy ............................................................. 16 2.4.2 Determinants to TB treatment outcomes .......................................................... 19 2.4.3 Tuberculosis treatment outcomes ..................................................................... 20 2.4.4 Comparison between CBTC and FBDOT strategies ........................................ 22 vi University of Ghana http://ugspace.ug.edu.gh 2.5 Summary ................................................................................................................. 24 CHAPTER THREE ...........................................................................................................25 METHODS ........................................................................................................................25 3.1 Study design ............................................................................................................ 25 3.2 Study area ................................................................................................................ 25 3.3 Study population ..................................................................................................... 27 3.4 Inclusion criteria ...................................................................................................... 27 3.5 Exclusion criteria..................................................................................................... 27 3.6 Variables.................................................................................................................. 27 3.7 Indicators ................................................................................................................. 31 3.8 Sampling.................................................................................................................. 35 3.8.1 Sample size determination ................................................................................ 35 3.8.2 Sampling method .............................................................................................. 35 3.8.3 Data collection techniques/Methods and tools ................................................. 35 3.8.4 Quality control .................................................................................................. 36 3.8.5 Training of field staff ........................................................................................ 37 3.8.6 Pre-testing of data collection tools ................................................................... 37 3.8.7 Revision of excel extraction template .............................................................. 37 3.8.8 Supervision of fieldwork .................................................................................. 37 3.9 Data / Statistical Analysis .................................................................................... 38 3.9.1 Background characteristics of TB patients ....................................................... 38 3.9.2 Determination of proportion of TB patients receiving CBTC .......................... 38 3.9.3 Determination of proportion of TB patients receiving FBDOT ....................... 38 3.9.4 Determination of treatment outcomes of TB patients receiving CBTC ........... 38 3.9.5 Determination of treatment outcomes of TB patients receiving FBDOT ........ 38 3.9.6 Comparison of treatment outcomes of TB patients .......................................... 39 4.0 Ethical considerations .......................................................................................... 39 4.1 Ethics clearance and approval .............................................................................. 39 4.2 Privacy and confidentiality .................................................................................. 40 4.3 Data storage / Security and usage ........................................................................ 40 4.4 Compensation ...................................................................................................... 40 vii University of Ghana http://ugspace.ug.edu.gh 4.5 Potential risk ........................................................................................................ 40 4.6 Benefits ................................................................................................................ 40 4.7 Research funding information ............................................................................. 41 CHAPTER FOUR ..............................................................................................................42 RESULTS ..........................................................................................................................42 4.1 General characteristics of TB patients .................................................................... 42 4.2 Demographic characteristics of TB patients with their treatment strategies ........... 46 4.3 Proportion of TB patients receiving CBTC and FBDOT ........................................ 50 4.4 Tuberculosis patients treatment outcomes under Facility-Based DOT (2015 -17) . 50 4.5 Tuberculosis patients treatment outcomes under CBTC (2015 -17) ....................... 52 4. 6 Tuberculosis patients treatment outcomes and treatment strategies ...................... 52 CHAPTER FIVE ...............................................................................................................54 DISCUSSIONS ..................................................................................................................54 5.1 Limitation of the study ............................................................................................ 57 5.2 Strengths .................................................................................................................. 58 CHAPTER SIX ..................................................................................................................59 CONCLUSION AND RECOMMENDATIONS ..............................................................59 6.1 Conclusion ............................................................................................................... 59 6.2 Recommendations ................................................................................................... 59 REFERENCE .....................................................................................................................60 APPENDICE......................................................................................................................64 Appendix 1: Excel extraction template form ............................................................... 64 Appendix 2: Ethics clearance and approval letter ......................................................... 64 viii University of Ghana http://ugspace.ug.edu.gh LIST OF TABLES Table 1: Summary of tuberculosis data for Upper West region from 2012 -14 ................26 Table 2: Variables and their measurement scale ................................................................28 Table 3: Indicators for TB treatment outcomes .................................................................32 Table 4: General patients characteristics ...........................................................................43 Table 5: Patients demographic characteristics with their treatment strategies (2015 – 17)47 Table 6: Proportion of TB patients receiving CBTC and FBDOT ....................................50 Table 7: Tuberculosis patients treatment outcomes and treatment strategies (2015 - 17).53 ix University of Ghana http://ugspace.ug.edu.gh LIST OF FIGURES Figure 1: Conceptual framework of TB treatment outcomes ..............................................6 Figure 2: Treatment outcomes of patients who received TB treatment under FBDOT .....51 Figure 3: Treatment outcomes of patients who received TB treatment under CBTC .......51 x University of Ghana http://ugspace.ug.edu.gh LIST OF ABBREVIATIONS ACSM - Advocacy Communication and Social Mobilization AFB - Acid-Fast Bacilli ART - Anti-Retroviral Therapy AIDS -Acquired Immuno- deficiency Syndrome BMI - Body Mass Index CBDOTS - Community-Based Directly Observed Treatment Short course CBTC - Community- Based Tuberculosis Care CDC - Centers for Disease Control and Prevention CHPS - Community Health – Based Planning and Services CHVs - Community Health Volunteers DOT -Directly Observed Treatment DOTS - Directly Observed Treatment Short course EPTB - Extra-Pulmonary Tuberculosis FBDOT - Facility-Based Directly Observed Therapy FBDOTS - Facility-Based Directly Observed Treatment Short course GBD - Global Burden of Diseases GHS - Ghana Health Service GHc - Ghana Cedis HIV - Human Immunodeficiency Virus LTBI - Latent Tuberculosis Infection LTFU - Lost to Follow Up MOH - Ministry of Health xi University of Ghana http://ugspace.ug.edu.gh MTB - Mycobacterium Tuberculosis MDR-TB - Multidrug Resistant Tuberculosis NTP - National Tuberculosis Control Programme NGOs - Non - Governmental Organizations PTB - Pulmonary Tuberculosis PLHIV - People Living with Human Immunodeficiency Virus PLOS - Public Library of Science SAT - Self – Administered Therapy SSA - Sub-Saharan Africa SSM - Sputum Smear Microscopy TB - Tuberculosis TB-DOTS - Tuberculosis Directly Observed Treatment Short course TC - Treatment Completed TF - Treatment Failure TO - Transferred Out UWRHD - Upper West Regional Health Directorate WHO -World Health Organization XDR-TB - Extensively Drug Resistant Tuberculosis xii University of Ghana http://ugspace.ug.edu.gh DEFINITION OF TERMS Adverse Outcome Unsuccessful Treatment: A patient who was loss to follow up, died or failed treatment. Complete data This is where all needed information on TB patient treatment cards are recorded and can be retrieved. Cured A patient that in the beginning was smear or culture positive who have completed treatment and is negative sputum or culture negative in the last month of treatment and on at least one previous occasion. Completed treatment A patient registered as pulmonary smear positive or culture positive, completed treatment, but had no sputum or culture at the end of treatment or one negative sputum smear at or after 5 months of treatment. OR A patient registered as pulmonary smear negative or extra pulmonary and received a full course of treatment. OR A patient registered as “smear not done” (e.g. children) and received a full course of treatment. Community-Based TB Care It is an approach in TB treatment where TB patients are assigned to their own treatment supported chosen by them; thus can be a relative or a lay volunteer who is attached to a health center or cli and lives within a reasonable proximity to the patient. xiii University of Ghana http://ugspace.ug.edu.gh TB Classification This is when a patient is being diagnosed of pulmonary positive TB or pulmonary negative TB or extra- pulmonary TB or smear not done. Died A patient who dies for any reason during the course of treatment. Extra Pulmonary TB that affects other parts of the body excluding the lungs. Facility-Based DOT It is a treatment strategy which requires patients visit daily to the health facility for supervised medicine intake by health workers, with continuous assessment of adherence to TB medication. GeneXpert/MTB/RIF Is a test that simultaneously detects Mycobacterium TB complex (MTBC) and resistance to Rifampin (RIF) in a susceptible patient within 2 hours. Incomplete data If any one of the information which will be retrieved on patients TB cards (e.g. age, sex, type of TB) is missing. Loss to Follow Up A patient whose treatment was interrupted for 2 consecutive months or more. Mycobacterium Tuberculosis Causative agent for tuberculosis disease. New Patient A patient who has never had treatment for TB or who has taken anti tuberculosis medicines for less than 1 month. Other They are patients who have been treated for TB before and has recurrent of the TB infection (retreatment cases) which includes smear positive previously treated, smear negative previously treated, EP previously treated. Pulmonary Tuberculosis TB that affects the lungs. xiv University of Ghana http://ugspace.ug.edu.gh Relapse A patient previously treated for TB, declared cured or treatment completed, and who is diagnosed with bacteriological (+) TB (smear or culture). Return After Treatment Failure A patient whose sputum smear or culture is positive at 5 months or later during treatment. Return After Default A patient who returns to treatment, positive bacteriologically, following interruption of treatment for 2 or more consecutive months. Sputum Smear Microscopy A laboratory diagnosis of TB in which the TB bacteria is observed in a sputum sample examined under a microscope. Treatment Outcome The end result of tuberculosis treatment of a patient. TB Patient Persons who sought TB treatment at the facility or community Treatment Failure Initially smear positive or culture positive patient who remained, or become smear positive again 5 months or later after commencing treatment. OR A sputum negative client found sputum positive at the end of 2nd month and at any point in the course of treatment if patient is found to have MDR-TB. Transferred out A client who transferred to another district while still on treatment and whose outcome is unknown. Treatment success A sum of cured and completed treatment in smear or culture positive patients only. xv University of Ghana http://ugspace.ug.edu.gh Source of Definitions World Health Organization Global Report, (2018) National TB Control Programme, Ghana, Training Manual, (2012). xvi University of Ghana http://ugspace.ug.edu.gh CHAPTER ONE INRODUCTION 1.1 Background Tuberculosis popularly known as an infectious disease can both be prevented and cured. It is caused by a bacterium organism called mycobacterium which usually affects the lungs (Pulmonary TB) and other parts of human body (Extra Pulmonary TB) such as the brains, kidneys, spine, abdomen, and lymph nodes (World Health Organization, 2018). Pulmonary TB, the commonest type of TB which is infectious and spreads from person to person occurs when a person coughs, sneeze or spit and propel the TB bacteria into the air. Tuberculosis can also be spread through infected cows and it milk. Individuals have mycobacterium TB in their human body, but will not necessarily develop active TB disease. This is referred as Latent TB Infection (LTBI). These persons perhaps become noninfectious, and are asymptomatic. Once an individual gets infected with the TB bacillus, a healthy adult person has 10% risk of developing the disease in his or her lifetime, unless the person’s immunity (ability to fight sickness) is weakened due to HIV infection or other disease conditions (CDC, 2018). Latent TB which has been estimated approximately by WHO, (2018) indicates that one- quarter of the world's population has it, which shows that individuals are already infected with the TB germ (mycobacterium) but are not ill with the disease and not infectious. However, about 5-15% of people with immune compromised system, such as PLHIV, malnutrition, diabetes, or tobacco users, are at risk of developing active TB disease in the future (CDC, 2018). With these factors, it is not surprising that poor people in society are those who get infected with TB. The common signs and symptoms of TB disease 1 University of Ghana http://ugspace.ug.edu.gh includes fever, weight loss, night sweats, weakness and others related to PTB like chest pain, coughing up of blood, shortness breath and appetite lost. Globally, the standard laboratory investigation for detecting TB is the Acid Fast Bacilli (AFB) known as Sputum Smear Microscopy (SSM) and culture (WHO, 2018). Sputum Smear Microscopy has a 60% sensitivity in detecting pulmonary TB cases but in recent times where the introduction of GeneXpert testing has taken massive lead over SSM in diagnosing TB in most countries including Ghana which is equally sensitive as culture has the ability in detecting pulmonary smear positive specimens but less sensitive with pulmonary smear negative and extra pulmonary specimens that include low numbers of bacilli and capable of also detecting rifampicin drug resistant TB (Zeka, Tasbakan, & Cavusoglu, 2011). In spite of the widespread, accessibility of effective TB treatment, it remains one of the top 10 causes of death worldwide. (Kathe, Barsch, & Honnef, 2003). Tuberculosis is a main cause of antimicrobial resistance related deaths and killer disease to persons living with HIV. Global Tuberculosis Report (2016), estimated that new TB cases of 10.4 million worldwide, of that figure 6.2 million were men, 3.2 million women, 1 million children and 10% constituted persons living with HIV. In 2016 incidence of TB cases estimated occurred most (45%, 25% and 17%) in WHO regions of South East Asia, Africa and Western regions respectively; lesser magnitudes of (7%) cases occurred in WHO Eastern Mediterranean Region, (3%) for both WHO European and Americas Regions. Globally, a decline rate of 37% TB mortality was seen between 2000 and 2016 (WHO, 2016). 2 University of Ghana http://ugspace.ug.edu.gh According to the annual Ghana TB report (2016), TB notification rate reported was (52.8 per 100, 000 population) with a total of 14,629 TB cases notified for the year. Proportion of cases notified in 2015 that had their treatment successfully reported was 85%. Deaths among cases detected was 10.3%, 2.5% were default, 1.1% failed and 1.2% cases not evaluated for any outcomes which accounted to 15% of adverse outcomes for the nation (GHS NTP, 2016). Upper West Region, for instance, reported 328 (2013), 307 (2014) and 356 (2015) of TB cases respectively. Even though the number of cases increased to 378 in 2016, it came down to 364 cases in the year 2017 (UWRHD, 2017). There are several levels of intervention beside the natural history of TB including prevention of the disease through vaccination, early diagnosis of pulmonary positive cases TB, and effective supply of medicines through DOT and CBTC care treatment delivery. Directly Observed Treatment as a cornerstone for TB control remains a global effort still date. Kotokey, Bhattacharya, Das, Azad, & De, (2007) indicates that, worldwide over 180 countries covering 69% of the world population in 2002 has used DOT as an effective tool for managing TB patients successful . In earlier times of DOT implementation, TB treatment in many resource constraint settings was chaotic, non- standardized, and poor monitoring as a result had slight effect on epidemiological incidence of the disease. The initiation of DOT strategy encompasses standardized regimen of six months. Which through it implementation has led to improvements of TB treatment outcomes for many patients. However, there were large variations in outcome across regions and countries. In much of Africa, treatment success rates remain below targets because of high death and default rates. 3 University of Ghana http://ugspace.ug.edu.gh According to Pablos-Méndez, Knirsch, Barr, Lerner, & Frieden, (1997) if public health intervention are not integrated into TB care and management then, half of TB patients will be loss to follow up during the first two months or longer and this will result in non- adherence which may contribute to the spread of the disease and emergence of drug resistance, leading to increase cost of treatment. Thus, a TB patient at increased risk of death or default needs to be identified to help in useful designing of extra measures in improvement of patient care and treatment. Through this approach it is expected that patients treatment adherence will improve in order to prevent the emergence of drug resistant TB. 1.2 Problem statement In the Upper West Region, there are two treatment strategies for TB patients namely, CBTC and FBDOT that complement each other. Facility-Based DOT is inconvenience for TB patients because of high transportation cost to the hospitals which are located in urban areas. This transportation cost brings about poor treatment compliance. Non- adherence leads not only to prolonged illness, but to the development of drug-resistant TB that are more difficult to treat and increases transmission of TB infection among the populace if not detected early. In spite of FBDOT, CBTC on the other hand, brings treatment to the door steps of patients. In view of all this, there is still low proportion of TB patients cured and treated completed. Over the years, the Upper West Regional Health Directorate has not been able to meet the NTP target of 90% treatment success rate and 85% cure rate because of many patients failure to TB treatment adherence and loss to follow (UWRHD Annual TB 4 University of Ghana http://ugspace.ug.edu.gh Report, 2016). For instance, the region recorded 68%, 71% and 72% cure rate from 2012 to 2014 (Upper West Regional Health Directorate Annual TB Report, 2016). In 2012 83% treatment success rate was achieved and improved slightly to 88% in 2013 and dropped to 87% in 2014 (UWRHD Annual TB Report, 2016). Hence, if there are truncations in treatment success rates then it means there are high percentages of adverse outcomes (default, treatment failure, replase and death) among clients on treatment. This situation threatens the effectiveness of TB Control Programmes with consequences such as Multidrug Resistance (MDR) as well as extensively drug- resistant TB (XDR) development which leads to prolonged treatment periods and increased cost and high incidence of morbidity and mortality (WHO, 2018). Therefore, the researcher aims to compare TB treatment outcomes between CBTC and FBDOT to ascertain their effectiveness in TB treatment and make recommendations for strengthening TB control implementation activities. 1.3 Conceptual framework of tuberculosis treatment outcomes Figure 1 is a conceptual framework demonstrating TB treatment outcomes in relation to CBTC and FBDOT. Tuberculosis treatment outcomes are end results for every TB patient but are evaluated into six possible outcomes thus, cure, treatment completed, died, failure, default, and transferred out. Depending on the treatment result a patient will be put on the effectiveness of DOT under community based or facility based with proper care and management. The disease classification; positive pulmonary, negative pulmonary, extra pulmonary and smear not done tuberculosis will also determine the treatment outcome of a patient. The 5 University of Ghana http://ugspace.ug.edu.gh type of patient (new or retreatment) could affect TB treatment outcomes. HIV as a factor in this conceptual framework is because of the tremendous effect the infection has on patients with TB. Most people infected with TB do not develop the HIV due to strong immunity. However, the possibility of an infected HIV person to develop TB in is always high since, HIV infection and TB are common and often co-occurring conditions that forms dangerous combination thus, each speeds the progress of other. Figure 1: Conceptual framework of TB treatment outcomes Treatment Strategies Treatment Outcomes Impact Community-Based  Cure TB Care  Treatment Reduced: completed - Drug  Died Resistance  Failure - Non- Facility-Based  Loss to adherence DOT follow up - Cost of  Transferred T reatme nt out 6 University of Ghana http://ugspace.ug.edu.gh 1.4 Justification Tuberculosis treatment and case management plays a vital role in the treatment results of TB patients. Findings from the study will help improve TB case management through the following: 1. Identifying the type of treatment management whether CBTC or FBDOT to select for the TB clients during their treatment. 2. Study results will be used to improve health service delivery in order to improve the proportion of treatment success outcomes (cure plus treatment complete) and reduce adverse outcomes (died, loss to follow up, replase, failure and transferred out). With this, achieving part of the 2015 Global Tuberculosis Strategy “a world free of tuberculosis”, expressed also as “zero deaths, disease and suffering due to tuberculosis” will be obtained. 3. The research will also add to existing knowledge on the differences in treatment outcomes under both CBTC and FBDOT. 4. It will support the establishment of the relationship between treatment outcomes and TB classification, type of patient, HIV status, age, sex, place of district. It is hoped that these findings would make significant contributions to improve TB care and management in the entire Upper West. 5. Evidence from the study on the outcomes of TB treatment under CBTC or FBDOT will help determine the effectiveness of both strategies in patients’ adherence to treatment. 7 University of Ghana http://ugspace.ug.edu.gh 1.5 Objectives 1.5.1 General objective The general objective of the study is to compare tuberculosis treatment outcomes between Community-Based TB Care and Facility-Based DOT of TB patients in the Upper West Region. 1.5.2 Specific objectives The specific objectives are: 1. To determine the proportion of TB patients receiving Community-Based TB Care intervention within the study period. 2. To determine the proportion of TB patients receiving Facility-Based Directly Observed Therapy intervention. 3. To determine treatment outcomes of TB patients receiving Community-Based TB Care 4. To determine treatment outcomes of TB patients receiving Facility-Based Directly Observed Therapy. 5. To compare treatment outcomes of TB patients receiving Community-Based TB Care and Facility-Based Directly Observed Therapy. 8 University of Ghana http://ugspace.ug.edu.gh 1.5.3 Research questions 1. What proportion of TB patients are receiving Community-Based TB Care intervention within the study period? 2. What is the proportion of TB patients receiving Facility-Based Directly Observed Therapy intervention? 3. What are the TB treatment outcomes of patients receiving Community-Based TB Care? 4. What are the TB treatment outcomes of patients receiving Facility-Based Directly Observed Therapy? 5. What are TB treatment outcomes of patients receiving Community-Based TB Care and Facility-Based Directly Observed Therapy when compare? 9 University of Ghana http://ugspace.ug.edu.gh CHAPTER TWO LITERATURE REVIEW 2.1 Introduction This section provides, firstly, a brief history about the disease TB, its prevalence and burden, the CBTC and DOT strategies and their approaches of treatment for TB, and then compares TB treatment outcomes between CBTC vs FBDOT of TB patients. The search engines used in this literature review were: PubMed, Google Scholar, PloS one and Science Direct where the following key words were inputted into the database for instance TB DOT treatment, CBTC, TB treatment and outcomes etc. The themes that emerged from the literature are: the global statistics of TB, burden of TB, treatment of TB, determinants to TB treatment outcomes, FBDOT strategy, CBTC strategy, treatment outcomes under FBDOT and CBTC and comparative assessment of TB treatment between CBTC and FBDOT of TB patients. Finally, this section will discuss the literature review classified under these main themes mentioned above based on current research. 2.2 Tuberculosis disease and diagnosis Tuberculosis (TB) is the world’s deadliest infectious disease which is airborne. About 13 decades ago, the famous Dr. Robert Koch whom discovered the germ that causes TB (Zeka et al., 2011). This causal agent thus; mycobacterium TB (the common known TB bacteria), which is highly infectious has seven closely related species namely: Bovis, Africanum, Microti, Caprae, Pinnipedii, Canetti and Mungi together known as mycobacterium TB complex (CDC, 2013). Most of these species have been found to 10 University of Ghana http://ugspace.ug.edu.gh cause diseases in humans but not all (CDC, 2013). The TB disease spreads from an infected person to another vulnerable host through coughing, sneezing or singing. When this bacteria expel into the air, by coughing for example 5-15% of the estimated 2-3 billion people infected with the bacteria will develop the disease during their lifetime. However, there is a higher chance for persons with HIV to develop TB. In Ghana there are three (3) main kinds of Clinical or Health Laboratories that provide TB laboratory services namely: Public Hospital-Based, Private Hospital-Based and Independent (Stand-alone) laboratories. In 2000 to 2001, situational analysis of TB microscopy indicates that there are 114 laboratories that performs sputum smear microscopy which is the most common laboratory investigation (MOH, National TB Health Sector Strategic Plan, 2014) followed by culture and the most recent Molecular Xpert MTB testing located in 126 districts and facilities in Ghana (NTP, Annual Report, 2017). In Upper West, there are 14 public facilities, 4 Quasi-Governmental and 3 private facilities that carry out TB diagnosis using SSM and 6 GeneXpert sites also into TB diagnosis. (UWRHD, 2018). 2.3 Global burden of TB Each year more than a million deaths are caused by TB and is the leading cause of death from Mycobacterium TB (WHO, 2016). Global Tuberculosis Programme and Global Burden of Diseases, Injuries, and Risk Factors (GBD) 2015 of WHO estimates the global burden of TB. In 2012, 8.6 million persons around the world were estimated to have developed active TB and 1.3 million died from the disease (WHO, 2013). 11 University of Ghana http://ugspace.ug.edu.gh Globally, TB incidence cases of 10.4 million in 2015, of which about 11 percent were HIV positive and 1.8 million TB deaths was reported of which; HIV positive contributed to 0.4 million (WHO, 2015). Tuberculosis mortality trends are on the decline by 22 percent from 2000 to 2015, but remain high as part of top 10 causes of mortality worldwide; now leading cause of more deaths than HIV despite effective short-course treatment regimens (WHO, 2015-2016a). Estimates by WHO (2018) indicates that, new TB cases of 558,000 with rifampicin resistance, of which 82% were Multi-Drug Resistant TB (MDR-TB) cases and 27% died from TB. In Africa, especially sub-Saharan regions the decline of deaths did not meet the 2015 Stop TB Partnership goal of 50% from 1990 to 2015 (National TB and Leprosy Programme, 2013). TB/HIV deaths that occurred in 2015 worldwide were from WHO African Regions with about 75 percent (WHO, 2016a). Among countries in the region, TB case fatality ratios varied from below 5 percent to over 20 percent (WHO, 2016a). 2.3.1 Tuberculosis burden in Ghana Tuberculosis in Ghana was the 5th cause of death among communicable, maternal, neonatal & nutritional diseases. The country by World Health Organization was ranked as part of the TB/HIV high burden country among 30 countries with an incidence rates of (36/100,000 population) of TB/HIV (WHO, 2016a). About 44,000 new + replase TB infected persons were recorded in 2018 with the rate of new infections at 152/100,000 population. The distribution of notified new and relapse TB in male and female were 26,000 and 18,000 but 42,000 was within (Age >14) and 2,200 within (Age <14) respectively (GHS-NTP Annual Report, 2018). 12 University of Ghana http://ugspace.ug.edu.gh As revealed in 2013 Ghana’s TB prevalence survey by National Tuberculosis Control Programme that, 282 per 100,000 population was the prevalence rate (NTP Survey Report, 2015). This prevalence survey on the contrary showed an increase as compared to World Health Organization (WHO) estimates of about 92 per 100,000 population (WHO TB Report, 2015). In view of the results stated in Ghana’s prevalence survey, it seems most cases were missed or undetected than what had been estimated earlier. Persons living with HIV/AIDS contributed to high prevalence of TB. Death rate of 7.5 per 1,000 people infected with TB is considered high in Ghana. In order to reduce this burden, there is the need for early case detection, addressing treatment and funding gaps and development of TB surveillance tools. The socioeconomic burden of TB ranges from stigmatization of family and community to poverty. Upper West is one of the regions with low TB case detection rate in the country based on a cases notified (346) and TB notification rate of (44.9 per 100, 000 population) in 2017 (Upper West Annual TB Report, 2017). 2.3.2 Tuberculosis and HIV infection Tuberculosis and HIV co-infections happens when a person has both active TB disease and HIV infection. TB/HIV infections lay a huge burden on the patients and health care systems. Human Immunodeficiency Virus infection is the most common known risk factor predisposing for mycobacterium TB infection and progression of latent TB to active TB disease, which increases the risk of active TB by 20 times in people living with HIV (PLHIV) than people without HIV (Pawlowski, Jansson, Sköld, Rottenberg, & Källenius, 2012). However, conversely the cause of most AIDS related death is TB 13 University of Ghana http://ugspace.ug.edu.gh disease. Thus, TB and HIV infection has a synergistic relationship that exists between them whereby TB, speeds up the advancement of HIV infection to acquired AIDS leading to successive death if not treated. TB is the leading cause of death in PLHIV; 1 in 3 PLHIV die from TB worldwide (WHO, 2019). 2.4 Tuberculosis treatment After diagnosis of TB through Xpert MTB or AFB test, the index case is then registered into the TB facility register and the DOT corner nurse explains the various treatment strategies available to the patient to decide. The patient receives counselling from the DOT nurse on the treatment and management and then advised on the options to make a choice between FBDOT and CBTC. Furthermore, the patient is educated on the availability of Self-Administration Treatment (SAT) if only the above mentioned treatment strategies for patient is not taken up. Patients who opt FBDOTS are educated to report daily at the facility for their medications through direct observation from a DOT nurse. This FBDOT usually follows some form of strict guidelines: provision of portable water, dispensing of TB medicines into cups for patients to swallow under the observation of a DOT nurse who then documents patients attendance and compliance on the treatment card (NTP Training Manual, 2012). Tuberculosis patients who decide on CBTC are assigned to a treatment supporter; thus can be a relative or a volunteer who is living close to the patient and in contact with a health center, clinic or Community Health-Based Planning and Services (CHPS Compound). The patient and treatment supporter then meet to decide which best ways would be convenient for the treatment each day. 14 University of Ghana http://ugspace.ug.edu.gh 2.4.1 Tuberculosis treatment strategies 2. 4.1.1 Directly Observed Treatment strategy Implementation of DOTS (Directly Observed Treatment, Short course) strategy been practiced in most countries as part of TB control was launched in 1995 by World Health Organization. It entails a 2 months intensive phase of daily doses under the direct observation of a health worker or treatment supporter and a continuation phase of 4 months of daily or self-administration. The strategy which is based on a short course treatment for a minimum of six months however, comprised with principles like commitment, proper case management, laboratory investigations, and treatment adherence through direct observation of doses. According to national guidelines, it is recommended that FBDOT requires the need of health workers in daily supervision of patients intake of anti-TB medications during the entire treatment course thus, 2 months intensive phase and 4 months of continuation phases (WHO 2015). While at the DOT corner, health education and clinical evaluation are done for patients by the clinicians and nurses. A study on DOT in the 1980s which was pioneered in Tanzania, showed improvement of cured rates from 60% to 80% (Deun & Rieder, 2012). Under the DOTS strategy both facility or community or home-based DOTS are applicable. For FBDOT strategy it involves the daily patients visit to the facility for health workers to supervise their medicines intake with continuous assessment of adherence to the treatment (WHO, 2015). On the other hand, this treatment strategic system puts some kind of burden to the DOT facility and the patient as well. (Lwilla et al., 2003). Due to that system of delivery of treatment brought about the necessity of decentralization of tuberculosis treatment to 15 University of Ghana http://ugspace.ug.edu.gh community level thus, home-based DOT (Maher, Floyd, Sharma, Jaramillo, Nkhoma & Nyarko 2003; Wandwalo, Makundi, Hasler & Morkve 2006). 2.4.1.2 Community-Based TB Care strategy The development of this strategy thus, patients taking TB treatment at comfort of their homes or communities came about through the innovations of DOT. In 1998, WHO established that “community involvement in TB care and a patient-centered approach need emphasis and promotion” (WHO, 1998). In spite of, the need, cost-effectiveness of CBTC interventions and remarkable efforts expended in recent years, CBTC interventions implementation and scalp up remains weak, (WHO, 2013). A wide range of activities such as TB notification, adherence treatment and improved treatment outcomes represents the contributions to CBTC interventions. Also, other included interventions for health promotion such as demand creation for TB prevention, TB diagnosis and treatment. Community-Based TB Care strategy covers wide range of interventions leading to TB prevention, diagnosis, improve treatment adherence and care that clearly influences the outcomes of drug-sensitivity, drug resistant and HIV related to TB. These interventions include others like community mobilization to promote effective communication and participation among community members to generate demand for TB prevention, diagnosis, treatment, care and support. In 2006, STOP TB Strategy by WHO was launched which consist of six main components to aid in achieving a scale up of DOTS. One of the strategies was “Empower people with TB, and communities through partnership” (WHO Stop TB Strategy, 2006). This treatment strategy objective was to increase advocacy communication and social 16 University of Ghana http://ugspace.ug.edu.gh mobilization (ACSM); increase communities and patients involvement in TB care and prevention, promote and enable health seeking behaviors among peoples in the country. The significance of community involvement was emphasized again in the End TB Strategy launched in 2015 (Huvila, 2018). Community-based TB care (CBTC), which aimed at involving communities in the prevention and care of TB as an essential component of the strategy particularly to persons living in remote areas or termed as hard-to-reach. Stanhope and Lancaster, (2000) defines CBTC as the decentralization, provision of basic TB control and management interventions to persons living with TB at their residence, workplace and school. The main goal of CBTC is to maximize TB patients treatment close to their homes or communities (WHO, 1997). The National Tuberculosis Control Program (NTP) and its partners from the local and international Non-Governmental Organizations (NGOs) provides CBTC implementation of TB control interventions through community health volunteers. These TB control interventions focuses on are four (4) main objectives: thus, to improve TB case finding, case management, increase community sensitization on TB and empowering communities on TB care. Baris, Hadeley and Maher, (2000) indicated in their studies that, an improved access to TB effective treatment rely on decentralizing of TB control interventions away from the health facilities. In view to the statement above there should be a full involvement of TB patients and their communities at large. Community treatment supporters such as blood relations of index cases and others been it a community health volunteers (CHVs) who are trained by health care workers or nurses to play the role as a TB treatment supporters and as well as supervisors. These key roles performed by the treatment supporters is to 17 University of Ghana http://ugspace.ug.edu.gh enhance TB treatment adherence in line with the tasks of encouraging, observing, daily documentation of treatment and providing health education talks on TB to communities where they live (Glatthaar & Barends, 1995). The important outcome of this CBTC is that it enables easy accessibility to treatment and avoidance of long distance travelling, long queues and long waiting time at the clinics, and interrupting of working time or household tasks (Balt et al., 1998). A study conducted in Zambia, which vary from Degraaf, (2012) study in Cambodia indicates that, an effective way of treating TB patients to become cured is through a vast support from CBDOTS. During the implementation of CBTC, a study conducted saw steady increase of 100% achievement of TB patients choosing this strategy. Similar studies on CBTC been suitable, available and acceptable to patients was seen in Edington (1999) study conducted in Northern Province of South Africa, showed that, the acceptability of decentralized TB DOT services to the community by TB patients were more than health facility. Community-Based TB Care opens wider opportunities for TB diagnosis and treatment availability or accessibility to the poor. Therefore, TB patients often do not choose health facilities available for their treatment because of dissatisfaction, long waiting hours, shortage of drugs and poor interrelationship between providers and patients (Ogden et al., 1999). The level of benefits to which CBDOTS as shown in Chesney, 2001; Porter and Medicine, (2002) study explains that the responsibility shared in TB treatment, lead in the cured rate of about 96 to 100% to TB patients whom fell within the adherence rate category and which formerly reports on default rate of 51.4%. 18 University of Ghana http://ugspace.ug.edu.gh This success from the study was similar to other results that revealed that the use of families as treatment supporters to care and encourage patients leads to greater changes of health behaviors in patients, improved treatment adherence and cured rates as compared to friends or co-workers. (Chesney, 2001; Porter & Medicine, 2002). Most patients satisfaction to CBTC confirms findings of Cameron, (1996) stated that, the direct effect to treatment adherence is patients satisfaction of the CBTC interventions. Also, another study revealed that if treatment supporters like volunteers are used for CTBC, it enables high treatment adherence rate, even in resource constrained places (Dick & Schoeman, 1996). 2.4.2 Determinants to TB treatment outcomes The basis for achieving effective TB treatment is combating non-adherence (Munro et al., 2007). Adherence is a complex, dynamic phenomenon with wide-ranging factors impacting treatment behaviors to the long course of treatment (Munro et al., 2007). Patient’s adherence is a major factor in TB treatment outcome; yet still, half of TB patients incomplete their medications (Cuneo & Snider, 1989) which results in relapse, drug resistance, long infectiousness and death. Factors influencing patients difficulty in following their treatment has raised the need for adherence as a complex behavioral issue (WHO, 2003). Lack of social support, drug side effects, skipping medication, be away from home, missing appointment dates, lack of transportation fare, poor communication between patients and health providers and medicines stock out are the main reasons for TB treatment non adherence (Tesfahuneygn, Medhin, & Legesse, 2015). 19 University of Ghana http://ugspace.ug.edu.gh Tuberculosis non-adherence is the major challenge in TB treatment which leads to Multidrug Resistance TB (MDR-TB) as well as Extensively Drug-Resistance TB (XDR- TB) (Munro et al., 2007) . Drug-resistant TB, includes MDR or XDR is a serious and fast growing public health problem in the world. Tuberculosis drug-resistant develops when patients are unable to complete their treatment successfully thus, (default), failed treatment due to inappropriate or low quality medications, or in close contact to an MDR- TB patients and then get diseased with the drug-resistant strain of TB. Similar studies shows the causes related to treatment adherence and loss to follow up are health facility distance to patients, complete or incomplete relapse of symptoms during treatment intensive phase, side effects, gender (male), age, use of toxic substances, detainment of clients, retreatment of pulmonary TB, default, TB/HIV co-infection, alcohol consumption, tobacco smoking, lack of treatment supervision and poor quality care of health facility (Gelmanova et al., 2007). Therefore, intensified case notification and observing patients while they are taking their treatment only are not sufficient to prevent TB treatment non-adherence and default. Ensuring TB patients complete their full course of treatment is one of the challenges for effective TB control (WHO, 2015). 2.4.3 Tuberculosis treatment outcomes The key indicator for evaluating performance of TB patients and TB Control Programmes is treatment outcomes. With regards to the main treatment outcomes they are expected to improve in line with WHO treatment outcomes benchmarks (Amo-Adjei, & Awusabo- Asare, 2013). Tuberculosis treatment aims at patients being cured, interrupting transmission of TB infection from persons-to- persons and preventing drug resistant. 20 University of Ghana http://ugspace.ug.edu.gh Regrettably these objectives are not achieved in many counties even when anti TB medicines are readily available (Tessema et al., 2009). According to WHO (2013), there are six possible TB treatment outcomes, they are: cure, treatment complete, default, treatment failure, died and transfer out. Evaluation of treatment outcome is central to the assessment of effectiveness of TB Control Programmes (Lisha et al., 2012). Treatment outcome of a patient can also be categorized as treatment success (cure plus treatment complete) or adverse outcome (died, failure, loss to follow up and transferred out). Tuberculosis treatment outcomes differ from one region to another and possibly from one facility to the other (WHO, 2010). The standardized short-course chemotherapy (SSC) for TB patients is an effective treatment taken between the periods of 6 to 8 months, thus: isoniazid, rifampicin, pyrazinamide, ethambutol and streptomycin, (Chaulk & Grady, 2000). These drugs are routinely used in all DOT and treatment health centers of Ghana Health Services facilities (NTP, 2018). When patients diagnosed of TB are not extremely ill, then close to 100% cure rate could be achieved if only the cause of microorganism is not drug-resistant TB (Enarson et al., 2000). After two weeks of commencement of TB treatment, TB patients have a lessened chance of infecting others with the M. tuberculosis (WHO, 2018). If there are no extensive infections of the disease spread then cost of treating new infections will be reduced. But then new infections can be caused by unknown TB patients because averagely 10–20 persons per annum are infected by people living pulmonary TB and of which six (6) will develop the TB disease (Knight, 2000). 21 University of Ghana http://ugspace.ug.edu.gh 2.4.4 Comparison between CBTC and FBDOT strategies A DOT study by Zwarenstein et al., (2000, p. 653) on an exit interviews conducted among 91.3% participated respondents in contrary to previous findings, the regular supervision on DOT does not make it “mechanical, impersonal or even authoritarian, isolating the patient and lessening the duty for self-care thus; removing patient's freedom”. The regular supervision of patients and treatment supporters in the study suggested sense obligation to adherence. Cured outcome by female TB patients was more achieved than male TB patients. This concurs findings by WHO, (2005, p. 5) that females diagnosed of TB disease are most likely to have a successful outcomes than their male counterparts. Community-Based TB Care cured rate of 90.0% was similar to Wilkinson, (1997) study which reported on CBTC programme at Hlabisa district of South Africa. Tuberculosis patients on CBTC strategy had improved chance in developing cured outcome than those patients on facility or self-administration treatment options in the study. Similarly, cured rates of TB shown in the study conducted at Kenya in a village called Manyatta indicates that CBDOT was effective even among migrants, where default rate decline by 5.0% and cured rate elevated to 80 to 88.0% (Sheik-Mohamed & Velema, 1999). CBTC default rate reported was about 0% but 1:8 for the facility or self- administration treatment strategy was reported. In the study, default rate would have been higher if not TB patients were on CBTC. A study undertook in Brazil looked at cost- effectiveness of TB treatment between FBDOTS vs CBDOTS (Prado Wada, Guidoni, Golub, Dietze, & Maciel, 2011). In this study, new (130) detected TB patients who were 22 University of Ghana http://ugspace.ug.edu.gh asked to select their preferred DOTS options, were they got monitored by researchers and intermittent interviews on treatment costs were conducted. Cost of cured patients on CBDOTS was US$398 per patient compared to health facility was US$548 per patient (Prado et al., 2011). The differences in cost seen was mainly transportations incurred to facility DOTS. Similar suggestions made by authors in study conducted at Swaziland, indicates that for more effective TB treatment, FBDOTS should be combined with CBDOTS (Prado et al., 2011). A study conducted by Cambodian Heath Committee, Non-Governmental Organization (NGO), suggested in their findings that a combined treatment options on FBDOTS vs CBDOTS resulted in an increased cured rate following patients TB treatment (Thim et al., 2004). Finally, the programme extended CBDOTS by adding poverty reduction as a component to its interventions. Food supplementary, loan funds and repayment program were used as a yardstick to improve the general wellbeing of the communities. Also, the organization focused on improved awareness creation on TB, its transmission and treatment (Thim et al., 2004). Decentralization of DOT to CBTC had led to the improvement of treatment coverage and reduced the burden of health care facilities (FBDOT). In Mhimbira et al., (2016), study revealed that, systematic reviews done on TB patients under CBTC showed similar or better TB results as compared to FBDOT. Following an interview conducted for Health care workers indicates that treatment adherence, medicines storage and lack of supervision are the main contributing factors leading to indefensible TB treatment outcomes at the facility. Findings from the study also alighted that patients that undertook CBTC treatment intervention are likely to face some certain risks or challenges that 23 University of Ghana http://ugspace.ug.edu.gh might result in poor treatment outcomes leading to increase in TB mortality as linked to FBDOT (Mhimbira et al., 2016). 2.5 Summary The studies reviewed prove CBTC strategy as an effective improvement in providing positive treatment results which have been reported in Tanzania, Zambia, Cambodia, North Province of South Africa and Kenya. In Ghana there has no be a known publication in comparing the difference in treatment outcomes of patients under CBTC or FBDOT but many studies had been done into DOT assessment in treatment outcomes using treatment supporters, factors affecting the implementation of DOT, and effectiveness of DOT intervention strategy. All these studies one way or the other were conducted at specific centers or communities which involved greatly with smaller or other homogenous populations and mostly done at the country's southern areas. Although both treatment strategies have been studied widely and promoted, their effectiveness into TB patient’s treatment outcomes has been inconsistent. To address this gap in knowledge, this study seeks to assess treatment outcomes of TB patients that received their treatment under CBTC or FBDOT and compare the difference in the treatment outcomes against CBTC and FBDOT. 24 University of Ghana http://ugspace.ug.edu.gh CHAPTER THREE METHODS 3.1 Study design A descriptive cross sectional study was adopted, which used available routine data in all the 11 districts in Upper West from 2015 to 2017. It involved a retrospective record review of clients’ treatment cards (TB01) who received tuberculosis treatment across the various districts health facilities. Treatment cards of all clients who received treatment during the period January 2015 to December 2017 were retrieved and data on treatment outcomes, demographic characteristics, type of patient (new, relapse, treatment after failure, return after default and other) were captured, data on disease classification (pulmonary positive, pulmonary negative, extra pulmonary TB and smear not done), weight, BMI, district or place of residence were retrieved from the period specified. 3.2 Study area Upper West Region is situated in the north-western part of Ghana. It lies between longitudes 1 25’’ W and 2 45’’ and latitudes 9 30’’ N and 11 N. It is surrounded by Savannah region to the south, to the north and west by Burkina Faso and to the east by Upper East region. It covers a geographical area of 18.476 sq. km, which forms 12.7% of the total land area of Ghana. The region is further divided into 11 districts, 71 sub- districts, 8 hospitals, 4 polyclinics, 247 CHPS Zones and 1009 communities for effective health services delivery purpose. Each district has at least one DOT center and diagnostic site for TB case detection and management. All health facilities in the region have been covered with the DOT and 25 University of Ghana http://ugspace.ug.edu.gh CBTC intervention strategies. Below is a summary data on some TB which shows a three years trend analysis on TB case notification rate per 100,000 people, forms of TB cases notified, percentage of bacteriologically confirmed cases, childhood cases, TB/HIV activity and treatment results for the period specified. Table 1: Summary of tuberculosis data for Upper West region from 2012 -14 Years Tuberculosis Summary Data 2012 2013 2014 TB Notification Rate (per 100,000 population) 45.0 44.2 40.6 TB Cases Notified (All forms of TB ) 316 328 307 % Bacteriologically Confirmed among Pulmonary 169 (54%) 156 (48%) 164 (53%) Childhood TB Cases Notified (% of total cases) 18 (6%) 18 (5%) 20 (7%) % of TB cases tested for HIV 291 (92%) 317 (97%) 145 (47%) % of TB cases tested HIV + 39 (13%) 53 (17%) 15 (10%) % TB/HIV Enrolled on ART 0 (0%) 0 (0%) 3 (20%) Treatment Success Rate (%) 83 88 87 Cure Rate (%) 68 71 72 Death Rate (%) 12 12 11 Loss to Follow Up (Defaulter) Rate (%) 4 1 2 Source: UWRHD Annual TB Report (2016). 26 University of Ghana http://ugspace.ug.edu.gh 3.3 Study population The study population was made up of TB patients who were registered and treated for TB under CBTC or FBDOT between 2015 and 2017. These are two independent treatment strategies for TB treatment. 3.4 Inclusion criteria The research included TB patients recorded to have received first line anti-TB treatment under CBTC or FBDOT from January 2015 to December 2017. 3.5 Exclusion criteria Recorded TB patients data with incomplete and missing information were excluded. The incomplete and missing information were namely; age, BMI, HIV status, sex, and treatment outcomes etc. 3.6 Variables The independent variables used in the study included demographic characteristics (age, sex, weight, BMI, HIV status and district) of the patients, disease classification, type of patients and treatment interventions. 27 University of Ghana http://ugspace.ug.edu.gh Table 2: Variables and their measurement scale Variables Definition Type of Measurement scale variable Community- TB patients who received TB Independent Binary Based TB Care treatment under CBTC - Yes (CBTC) strategy - No Facility-Based TB patients who received TB Independent Binary DOT (FBDOT) treatment under facility- - Yes based DOT strategy - No TB This is defined as whether a Independent Categorical Classification patient is diagnosed with - Pulmonary pulmonary positive TB, positive TB pulmonary negative TB, - Pulmonary extra- pulmonary TB and negative TB smear not done - Extra- pulmonary TB - Smear not done Type of patient Describes patient’s TB status Independent Categorical before therapy initiation that - New patient is new, replase, treatment - Replase after failure, return after loss - Treatment after 28 University of Ghana http://ugspace.ug.edu.gh Variables Definition Type of Measurement scale variable to follow up, other failure previously treated and other - Return after treatment unknown default - Other Age Age in years of a patient Independent Ordered treated for TB - 0-4 years - 5-14 years - 15-24 years - 25-34 years - 35-44 years - 45-54 years - 55-64 years - 65+ years Sex Biological characteristics of Independent Binary patients - Male - Female 29 University of Ghana http://ugspace.ug.edu.gh Variables Definition Type of Measurement scale variable Weight Initial weight of a patient Independent Continuous treated for TB - 4-7kg - 8-11kg - 12-15kg - 16-24kg - 25-39kg - 40-54kg - >=55 kg HIV Status Results of HIV test done; Independent - Positive Positive, Negative or Not - Negative done - Not done District This is the where the patient Independent - Daffiama stays or lives at the time of Bussie Issa treatment. - Jirapa - Lambussie - Lawra - Nadowli Kaleo - Nandom - Sissala East - Sissala West 30 University of Ghana http://ugspace.ug.edu.gh Variables Definition Type of Measurement scale variable - Wa - Wa East - Wa West 3.7 Indicators The dependent variable of the study was tuberculosis treatment outcomes under CBTC or FBDOT. Treatment outcomes were classified according to WHO standard and Ghana National TB Control Programme guidelines for the evaluation of treatment results. Tuberculosis treatment results were categorized thus, cured, completed, died, failed, default or transferred out. The independent variables were age, sex, HIV status, type of TB patient, TB classification, weight, BMI and district. 31 University of Ghana http://ugspace.ug.edu.gh Table 3: Indicators for TB treatment outcomes Table 3 shows the indicators that were measured; cured, completed, died, failure, loss to follow up and transferred out. Indicator Definition Numerator Denominator Cured Number of pulmonary positive Number of Entire number of patients registered in a specified pulmonary positive pulmonary period that were cured patients registered in positive patients expressed as a proportion over a specified period registered in the the entire number pulmonary that was cured. same period. positive TB patients registered in the same period. Treatment Number of PTB/EPTB patients Number of Entire number of Completed registered in a specified period PTB/EPTB patients PTB/EPTB that completed treatment but registered in a patients registered does not have a negative specified period that in the same sputum smear or culture result completed treatment period. in the last month of treatment but does not have a expressed over the entire negative sputum number of PTB/EPTB patients smear or culture registered in the same period. result in the last month of treatment. 32 University of Ghana http://ugspace.ug.edu.gh Indicator Definition Numerator Denominator Died Number of PTB / EPTB Number of Entire number of patients that died during PTB/EPTB patients PTB/EPTB treatment, regardless of cause that died during patients registered and were recorded in the treatment, regardless in the same specified period expressed as a of cause and were period. proportion over the entire recorded in the number of PTB/EPTB patients specified period. registered in the same period. Treatment Number of PTB patients Number of PTB Entire number of Failure registered in a specified period patients registered in PTB patients whose smear or culture is a specified period registered in the positive at month 5 or later whose smear or same period. during treatment expressed as a culture is positive at proportion over the entire month 5 or later number of PTB patients during treatment. registered in the same period. Loss to Number of PTB/EPTB patients Number of Entire number of Follow Up registered in a specified period PTB/EPTB patients PTB/EPTB whom treatment was registered in a patients registered interrupted for 2 consecutive specified period that in the same months or more expressed as a treatment was period. proportion over the entire interrupted for 2 33 University of Ghana http://ugspace.ug.edu.gh Indicator Definition Numerator Denominator number of PTB/EPTB patients consecutive months registered in the same period. or more. Transferred Number of PTB/EPTB patients Number of Entire number of Out registered in a specified period PTB/EPTB patients PTB/EPTB who has been transferred to registered in a patients registered another facility or district TB specified period who in the same register to continue treatment has been transferred period. and for whom treatment to another facility or outcome is unknown expressed district TB register to as a proportion over the entire continue treatment number of PTB/EPTB patients and for whom registered in the same period. treatment outcome is unknown. Treatment Number of PTB/EPTB patients Number of Entire number of Success registered in a specified period PTB/EPTB patients PTB/EPTB that were cured plus the number registered in a patients registered that completed treatment specified period that in the same expressed as a proportion over were cured plus the period. the entire number of PTB/EPTB number that patients registered in the same completed treatment. period. 34 University of Ghana http://ugspace.ug.edu.gh Indicator Definition Numerator Denominator Adverse Number of PTB/EPB patients Number of Entire number of Outcome registered in a specified period PTB/EPTB patients PTB/ETB patients that defaulter, died, failed and registered in a registered in the transferred out expressed as a specified period that same period. proportion over the entire defaulter, died, failed number of PTB/EPTB patients and transferred out. registered in the specified period. 3.8 Sampling 3.8.1 Sample size determination A census of TB cases who received treatment during the period of January 2015 to December 2017 were selected. 3.8.2 Sampling method All records of tuberculosis patients from 2015 to 2017 were selected. 3.8.3 Data collection techniques/Methods and tools The data used for the study were obtained from patients treatment cards and facility or district tuberculosis registers from 2015 to 2017. The treatment cards of patients who went through treatment during the specified periods were selected. The data captured on 35 University of Ghana http://ugspace.ug.edu.gh the TB01 and TB registers included patients name, age, sex, type of patient, disease category, district or place of residence, weight, BMI, and HIV status etc. A data extraction template in excel was created for the study. This excel extraction template contained all relevant indicators required to address the study objectives. Patients records selected were sorted according to the years stipulated in the study. Then data captured into the excel extraction template were done by variables or indicators of interest. This was done till all the needed information was retrieved. 3.8.4 Quality control The following measures were put in place to ensure that data collected were of good quality: a. Two research assistants were recruited and trained for the data extracted into the excel extraction template. b. The research assistants were trained on how to sort data according the years of interest stated in the study objectives. c. The Principal investigator oriented research assistants on how data was computed according to the study variables and indicators. d. Data selected and retrieved by research assistants were cross-checked by the principal investigator for consistency, completeness and accuracy by verifying from the source records (TB 01 and registers). 36 University of Ghana http://ugspace.ug.edu.gh 3.8.5 Training of field staff A two day training sessions were held for research assistants. The training focused on sorting of patients TB folders and registers, retrieving of data and data entry into excel extraction template. Other data sources explored and documented were included in the training. 3.8.6 Pre-testing of data collection tools Pretesting was undertaken at Lawra Municipal Hospital. Client cards (TB01) of TB patients were provided from 2015 to 2017 and research assistants sorted them according to the years. Relevant variable of the study such as age, sex, HIV status, BMI, weight, treatment outcomes etc. were identified and data entry was done by them. This was repeated for the other years and each research assistant entered 5 folders for each year. 3.8.7 Revision of excel extraction template The classification of the variables and indicators on the excel data extraction template were done to meet the study objectives in order to enhance the right data to be retrieved from the TB 01 and health facility or district TB registers. 3.8.8 Supervision of fieldwork Research assistants were supervised on how data were selected, sorted and retrieved to be capture into the excel extraction template in order to review data challenges, checks for inconsistencies and gaps. 37 University of Ghana http://ugspace.ug.edu.gh 3.9 Data / Statistical Analysis 3.9.1 Background characteristics of TB patients A cross tabulation and descriptive statistics were done to describe the numbers and percentages of patients demographic characteristics of sex, age, HIV status, BMI, weight, type of patient, disease classification and district. 3.9.2 Determination of proportion of TB patients receiving CBTC This proportion was determined by the number of TB patients who received CBTC over the entire number of TB cases recorded within the specified periods in the study. 3.9.3 Determination of proportion of TB patients receiving FBDOT Tuberculosis patients who received FBDOT were determined by the number of patients under this treatment strategy over the total number of TB cases recorded from January 2015 to December 2017. 3.9.4 Determination of treatment outcomes of TB patients receiving CBTC This is TB patients treatment outcomes proportions under CBTC were determined by the number of TB patients registered and were cured, completed, died, failed, defaulted and transferred out over the entire number of TB patients registered. 3.9.5 Determination of treatment outcomes of TB patients receiving FBDOT All patients’ TB treatment outcomes records extracted within the time frame were defined as the denominator. Patient’s treatment strategy under FBDOT were expressed as 38 University of Ghana http://ugspace.ug.edu.gh a proportion of patients cured, completed, died, failed, defaulted and transferred out over the entire number of TB patients registered. 3.9.6 Comparison of treatment outcomes of TB patients In comparing the various proportions of treatment outcomes for TB patients under the two treatment strategies (CBTC or FBDOT). Firstly, calculations were done on the total TB treatment outcomes patients recorded and selected between the periods of January 2015 to December 2017 under CBTC against FBDOT. But the outcomes were also grouped into two major results namely: treatment success and adverse outcomes. A chi square test of association was used to find the significant differences among the two strategies of which a p-value of 0.05 was considered as statistically significant. 4.0 Ethical considerations 4.1 Ethics clearance and approval The study was submitted to the Ghana Health Services Ethics Review Committee of the Ghana Health Service Research and Development Division, Accra (GHS-ERC). It was reviewed and approved before the study commenced and the approval number is GHS- ERC055/05/19. Permission was also sought from the Upper West Regional Health Directorate to undertake the study. 39 University of Ghana http://ugspace.ug.edu.gh 4.2 Privacy and confidentiality Secondary data on TB patients folders were selected, sorted and captured onto the excel extraction template and of which privacy and confidentiality were assured. Whereby personal identifiers such as names and telephone numbers were not recorded. 4.3 Data storage / Security and usage Security for secondary data was password protected and made accessible to only the principal investigator and supervisor of the study. Data extracted was used strictly for the study. 4.4 Compensation For the study conducted, health facilities or districts were not paid or received compensation for the data extracted from the selected TB patient’s folders. 4.5 Potential risk Patients selected for the study had their names coded in the data extraction template instead of writing their names. 4.6 Benefits There were no direct benefits to patients but the research would benefit programme in it scale up for the country. 40 University of Ghana http://ugspace.ug.edu.gh 4.7 Research funding information The Principal Investigator was the sole funder of the study. 4.8 Declaration of conflict of interest There was no conflict of interest in this study. 41 University of Ghana http://ugspace.ug.edu.gh CHAPTER FOUR RESULTS 4.1 General characteristics of TB patients A total of 1,098 TB patients were registered during the period 2015-2017 in the Upper West Region. Out of this, 98.0% (1,076) TB patients’ data were extracted and used in the analysis. A total of 2.0% (22) patients’ records could not be used in the study because some variables were incomplete such as the disease classification, weight, HIV status, treatment outcome etc. were not available. TB patients aged were between 0 to 99 years. The modal age group was 35- 44 years recorded as highest 34.7% in 2015, followed by 25 – 34 years 36.9% in the same year stated above, while 0-4 years constituted the least 38.5% reported in the remaining years respectively (Table 4). Table 4 further shows that, the proportions of males registered as TB patients annually were higher than the females (33.7% and 34.9% respectively) in 2016. Most of the patients’ diagnosed as TB cases about 94.8% (1,020) were new patients with the highest cases recorded in the year 2016 (34.7%). About 37.6% (262) of the patients reported were pulmonary positive in 2015 as the highest followed by 32.3% (225) a decline seen in 2016 and 30.0% (209) in 2017. Of the 1,076 patients HIV status 0.7% was unknown in (8) patients; HIV Negative 90.2% (971) which 2016 made the highest of 34.5% (335) and TB/HIV co-infected, 9.0% (97) of the TB patients were HIV Positive, hence about 41.2% (40) constituted the greater number for the co-infected cases in 2015. Weight was checked for all patients but most patients weight fell between 40-54kg (34.4%) in 2016 followed by (33.9% and 31.6%) in 2017and 2015 respectively. Of the 1,076 patients used in the analysis only 35.0% (377) had their body mass index checked. 42 University of Ghana http://ugspace.ug.edu.gh The most reported BMI reported among patients were underweight 23.8% (84) in 2017 and normal 14.2% (52) in 2016.With regard to district or place of residence during patients’ treatment 2015 recorded the highest of cases 65.2% (113) by Wa Municipal, while Sissala West recorded the lowest 20.0% (4). Wa Municipal was still the only district with the highest number of TB cases registered in 2016 and 2017 (Table 4). Table 4: General patients characteristics Years 2015 2016 2017 Variables Number (%) Number (%) Number (%) Age (Years) 0-4 6 (23.1) 10 (38.5) 10 (38.5) 5-14 11 (28.9) 12 (31.6) 15 (39.5) 15-24 38 ( 31.2) 40 (32.8) 44 ( 36.1) 25-34 71 (36.9) 60 (31.3) 61 (31.8) 35-44 78 (34.7) 77 (34.2) 70 (31.1) 45-54 58 (35.4) 59 (35.9) 47 (28.7) 55-64 41 (31.1) 45 (34.1) 46 (34.9) 65+ 53 (29.9) 64 (36.2) 60 (33.9) Sex Male 242 (33.2) 246 (3 3.7) 242 (3 3.2 ) Female 114 (32.9) 121 (34.9) 111 (32.1) 43 University of Ghana http://ugspace.ug.edu.gh Years 2015 2016 2017 Variables Number (%) Number (%) Number (%) Patient Type New 335 (32.9) 354 (34.7) 331 (32.5) Replase 12 (40.0) 6 (20.0) 12 (40.0) Treatment Failure 6 (50.0) 3 (25.0) 3 (25.0) Return After Default 3 (30.0) 4 (40.0) 3 (30.0) Other − − 4 (100.0) TB Classification Pulmonary Positive 262 (37.6) 225 (3 2.3) 209 ( 30.0) Pulmonary Negative 62 (24.1) 86 (33.4) 109 (42.4) Extra Pulmonary 30 (27.5) 54 (49.5) 25 (22.9) Smear Not Done 2 (14.3) 2 (14.3) 10 (71.4) HIV Status Not Done 4 (50.0) 2 (25.0) 2 (25.0) Positive 40 (41.2) 30 (30.9) 27 ( 27.8 ) Negative 312 (32.1 ) 335 (34.5) 324 (33.4) Weight (kg) 4-7 1 (16.8) 2 (33.3) 3 (50.0) 8-11 4 (28.6) 4 (28.6) 6 (42.9) 12-15 5 (33.3) 6 (40.0) 4 (28.7) 16-24 2 (11.1) 7 (38.9) 9 (50.0) 25-39 40 (38.83) 33 (32.0) 30 (29.1) 44 University of Ghana http://ugspace.ug.edu.gh Years 2015 2016 2017 Variables Number (%) Number (%) Number (%) 40-54 194 (31.6) 210 (34.4) 207 (33.9) >54 110 (35.6) 105 (33.9) 94 (30.4) Body Mass Index Underweight 67 (18.8) 64 (1 7.4) 84 (2 3.8) Normal 51 (14.3) 52 (14.2) 49 (13.9) Overweight 4 (1.1) 1 (0.3) 3 (0.8) Obese 2 (0.6) − − Unavailable data 232 (65.2) 250 (68.1) 217 (61.5) Districts Daffiama Bussie Issa 7 (20.6 ) 10 (2 9.4) 17 (5 0.0) Jirapa 34 (35.4) 40 (41.7) 22 (22.9) Lambussie 26 (68.4) 7 (18.4) 5 (13.2) Lawra 35 (31.5) 51 (45.9) 25 (22.5) Nadowli Kaleo 48 (38.1) 43 (34.1) 35 (27.8 ) Nandom 41 (35.9) 37 (32.5) 36 (31.6) Sissala East 16 (26.2) 32 (52.5) 13 (21.3) Sissala West 4 (20.0) 6 (30.0) 10 (50.0) Wa 113 (65.2) 107 (71.4) 102 (63.4) Wa East 9 (14.3) 16 (25.4 ) 38 (60.3) Wa West 23 (25.3) 18 (19.8) 50 (54.9) Total 356 (33.1) 367 (34.1) 353 (32.8) 45 University of Ghana http://ugspace.ug.edu.gh 4.2 Demographic characteristics of TB patients with their treatment strategies Table 5 shows the demographic characteristics of the 1,076 TB patients ’data extracted. Of which about 83.6% (899) patients were under Community-Based TB Care and 18.5% (177) under Facility-Based Directly Observed Therapy. The patients were between 0 to 99 years. The modal age group was between 35 - 44 years (20.2. %), followed by 25 - 34 years (18.0%) was seen in CBTC while Facility-Based DOT constituted the lowest of (24.3% and 16.9% respectively). Overall, the proportions of males (68.6%) registered under CBTC were greater than the females (31.4%) and this observation was also perceived same under FBDOT but had the least of TB patients. Tuberculosis patients with newly diagnosed TB (94.6%) and patients with smear-positive pulmonary TB (69.2 %) were most likely to be under CBTC. Most patients tested and counselled for HIV was higher in CBTC especially with the number of patients tested HIV Negative 90.8% followed by HIV Positive 8.3%.Weight was checked for all patients but most patients’ weight fell between 40-54kg (56.8%) under CBTC as compared to (56.5%) also under facility-based DOT. Of the 1,076 patients used in the analysis only 35.0% (377) had their body mass index checked. As shown in (Table 5), out of the 1,076 patient’s data extracted about 84.2% (149) patients under FBDOT and 25.4% (228) under CBTC had their body mass index checked. Body mass index results reported most among patients whom were checked was underweight 13.7% (123) and 52.0% (92) under the respective treatment strategies. With respect to districts were patients received their anti-TB medications, Community-Based TB Care had the highest cases registered especially by Wa Municipality 17.8% followed by Nadowli-Kaleo 14.0% and Nandom 46 University of Ghana http://ugspace.ug.edu.gh 12.7% while under Facility-Based TB DOT Wa and Lawra were the only districts which had patients that opted for that particular treatment strategy. Further shown in Table 5 the 177 TB patients that were registered under the Facility-Based DOT, Wa Municipal constituted the highest of about 91.5%. Table 5: Patients demographic characteristics with their treatment strategies (2015 – 17) FBDOT CBTC Variables Number (%) Number (%) Age (Years) 0-4 7 (3.9) 19 (2.1) 5-14 5 (2.8) 33 (3.7) 15-24 19 (10.7) 103 (11.5) 25-34 30 (16.9) 162 (18.0) 35-44 43 (24.3) 182 (20.2) 45-54 22 (12.4) 142 (15.8) 55-64 20 (11.3) 112 (12.5) 65+ 31 (17.5) 146 (16.2) Sex Male 113 (63.8) 617 (68.6) Female 64 (36.2) 282 (31.4) 47 University of Ghana http://ugspace.ug.edu.gh Patient Type New 170 (96.1) 850 (94.6) Replase 4 (2.3) 26 (2.9) Treatment Failure − 12 (1.3) Return After Default 2 (1.1) 8 (0.9) Other 1 (0.6) 3 (0.4) TB Classification Smear Positive 74 (41.8) 622 (69.2) Smear Negative 68 (38.4) 189 (21.0) Extra Pulmonary 28 (15.8) 81(9.0) Smear Not Done 7 (3.9) 7 (0.8) HIV Status Not Done 1 (0.6) 7 (0.8) Positive 22 (12.4) 75 (8.3) Negative 154 (87.0) 817 (90.9) Weight (kg) 4-7 1 (0.6 ) 5 (0 .6 ) 8-11 5 (2.8 ) 9 (1.0) 12-15 1 (0.6) 14 (1.6) 16-24 4 ( 2.3) 14 (1.6) 25-39 10 ( 5.7 ) 93 (10.4) 40-54 100 ( 56.5) 511 (56.8) >54 56 (31.6 ) 253 (28.1) 48 University of Ghana http://ugspace.ug.edu.gh Body Mass Index Underweight 92 (52.0) 123 (1 3.7) Normal 54 (30.5) 98 (10.9) Overweight 3 ( 1.7) 5 ( 0.6) Obese − 2 (0.2) Unavailable data 28 (15.8) 671 (74.6) Districts DBI − 34 (3.8) Jirapa − 96 (10.7) Lambussie − 38 (4.2) Lawra 15 (8.5) 96 (10.7) Nadowli Kaleo − 126 (14.0) Nandom − 114 (12.7) Sissala East − 61 (6.8) Sissala West − 20 (2.2) Wa 162 (91.5) 160 (17.8) Wa East − 63 (7.0) Wa West − 91 (10.1) Total 177 (16.5) 899 (83.6) 49 University of Ghana http://ugspace.ug.edu.gh 4.3 Proportion of TB patients receiving CBTC and FBDOT Table 6 shows that most of the TB cases (34.1%) were registered in 2016 and the least (33.1%) in 2015. The proportions of TB patients that received their anti-TB treatment under CBTC were 83.6% (899) and 16.5% (177) for Facility-Based DOT. Most patients registered under Community-Based TB Care in 2015 (36.9%) as compared to 2017 with also the highest of cases registered under the Facility-Based DOT (46.9%). Table 6: Proportion of TB patients receiving CBTC and FBDOT Variable FBDOT CBTC Year Number (%) Number (%) Total (%) 2015 24 (13.6) 332 (36.9) 356 (33.1) 2016 70 (39.6) 297 (33.0) 367 (34.1) 2017 83(46.9) 270 (30.0) 353 (32.8) Total 177 (100.0) 899 (100.0) 1,076 (100.0) 4.4 Tuberculosis patients treatment outcomes under Facility-Based DOT (2015 -17) Figure 2 provides the treatment outcomes for 2015, 2016 and 2017. In 2015, of the 24 registered patients’ data used in the analysis, 33.3% (8) died and 29.2% (7) were both cured and treatment completed. However, 4.2% (1) of the patients failed treatment and defaulted respectively. In 2016, 60% (42) of TB patients’ treatment outcomes data analyzed for the year were treatment completed. Patients cured were 27.1%; 8.6% died during the course of the 50 University of Ghana http://ugspace.ug.edu.gh treatment and 4.3% were lost to follow up. However, there were no treatment failure and transferred out of cases. In 2017, as shown in figure 2 that 56.7% treatment completed was most the treatment outcomes recorded among the TB patients followed by cured 33.7% and 6.0% were lost to follow up. Patients reported dead during treatment were 2.4% and those with unsuccessful treatment were also 1.2%. Figure 2: Treatment outcomes of patients who received TB treatment under FBDOT Figure 3: Treatment outcomes of patients who received TB treatment under CBTC 51 University of Ghana http://ugspace.ug.edu.gh 4.5 Tuberculosis patients treatment outcomes under CBTC (2015 -17) Figure 3 provides the treatment outcomes for 2015, 2016 and 2017. In 2015, about 45.0% of TB patients treatment outcomes were cured. Patients whom completed treatment were 37.7%; 12.3% died during the course of the treatment and 2.4% were lost to follow up. However, 2.1% and 1.0% were patients that failed their treatment and transferred out respectively. In 2016, as shown in Figure 3, treatment outcomes analysis done for the year illustrates that cure rate (39.7%) among patients registered were higher, followed by treatment completed (26.1%) and (7.7%) reported dead during their treatment. Patients due to lost to follow up were (3.4%), those whom also failed the treatment were (2.7%) and (0.3%) was transferred out. In 2017, of the 270 patients registered for the year, 44.8% (121) completed treatment and 38.9% (105) were cured. About 12.0% (32) of the patients died, 3.3% (9) defaulted and less than 2.0% (3) failed the treatment. 4. 6 Tuberculosis patients treatment outcomes and treatment strategies As show in Table 7, TB treatment success rates were respectively 84.3% (145) and 15.7% (27) in patients under CBTC vs. FBDOT. But adverse outcome rates were relatively higher among patients who received their TB treatment under CBTC than patients under FBDOT. Treatment outcomes did not differ significantly between TB patients who opted Community TB Care and those on Facility-Based DOT (p = 0.08). 52 University of Ghana http://ugspace.ug.edu.gh Table 7: Tuberculosis patients treatment outcomes and treatment strategies (2015 - 17) Treatment Outcomes (1,076) Adverse Treatment Pearson chi2 1 2 Indicators Outcome Rate Success Rate (p-value) Treatment Strategies Number (%) Number (%) 0.08 Facility-Based TB DOT 27 (15.7) 150 (16.6) Community-Based TB Care 145 (84.3) 754 (83.4) 1 Adverse Outcome = Died + Failure + Defaulted + Transferred out 2 Treatment Success = Cured + Treatment complete 53 University of Ghana http://ugspace.ug.edu.gh CHAPTER FIVE DISCUSSIONS The study was cross-sectional which involved the review of TB patients records who received tuberculosis treatment from 2015 to 2017 in the Upper West region that compared treatment outcomes of CBTC with FBTDOT. Of the 1,076 TB patients records reviewed, showed that CBTC was associated with higher 83.4% (754) treatment success than FBTDOT 16.6% (150). However, CBTC for adverse outcomes compared to FBTDOT was also seen higher (84.3% and 15.7% respectively) but there was no significant difference between treatment outcomes of patients that received their TB treatment under CBTC and those on FBTDOT (p = 0.08). According to NTP and WHO, 2016 global target of 90% for TB treatment success which functions as a yard stick for performance assessment to the Tuberculosis Control Programme. In this study, the overall treatment success which is the total proportion of patients that were cured plus those who completed treatment was lower 84.0% as compared to success rate for Ghana 85% and adverse outcome rate of 15.9% higher than WHO recommendation of less than 10% (NTP, 2016).This findings on success rate could be as a result of the high death rate (10.4%) and low cure rate (39.5%) recorded especially among new patients 38.8% (1,020) in the study. Hence, the study recommends that there should be much attention on patients follow up investigations, enforcement of patients treatment monitoring and adherence to improved successful outcomes in the coming years. A greater number of 98.0% (1,076) of patients data extracted were completed specifically on treatment strategies and outcomes but had result of lapses of poor documentation on 54 University of Ghana http://ugspace.ug.edu.gh patients BMI, MAUC and BCG scar taken for children. This observation points to an urgent need to improve TB programme documentations by health personnel responsible for TB care in the hospital. The study found that some patients characteristics such as sex, age, patient type, and TB classification were the risk factors to tuberculosis treatment outcomes. This results agrees with the study were causes associated with treatment adherence and loss to follow up according to Gelmanova et al., (2007) that health facility distance to patients, complete or incomplete relapse of symptoms during the intensive phase of treatment, side effects, the male gender, age, use of toxic substances, detainment of clients during treatment, pre-existing pulmonary disease, previous default, TB/HIV co- infection, alcohol consumption, tobacco smoking, absence of treatment supervision and poor quality of patient care at the health facility. The study also found that TB/HIV co- infection among TB/HIV patients was higher (21.7%) resulting as a risk factor for TB mortality. This is in line with previous finding by WHO (2019) showed that TB is the leading cause of death in PLWH thus; 1 in 3 PLWH die from TB worldwide. Community-Based TB Care in the study, saw an increase steady of about 84% TB patients for the three (3) years period stipulated. This outcome was similar to Baris, Hadeley and Maher, (2000) findings which revealed that an increase accessibility to effective TB treatment rely on decentralization of TB control activities away from health facilities. Findings in the study showed that the proportion of patients that received their anti-TB medication were about 17% as compared to patients that were registered under CBTC. In view to the above findings, a study by Ogden et al., (1999) pointed clearly that TB patients often choose not to use health facilities available for their treatment because of 55 University of Ghana http://ugspace.ug.edu.gh dissatisfaction, long waiting hours, shortage of medicines and poor interrelationship between providers and patients. Facility-based DOT recorded 30.5% cure rate. This result is contrary to the findings by Deun and Rieder, (2012) in Tanzania which showed improvement of cure rates from 60% to 80% in DOT implementation. Cured rate associated with CBTC strategy in the study was 41.3% which was in contrast to Wilkinson (1997) study conducted in Hlabisa district of South Africa that reported 90.0% cure rate on CBTC. Mortality rate of TB in CBTC vs FBDOT was high 10.7% among patients registered and which could be attributed to certain risks or challenges that might has resulted in the poor treatment outcomes leading to the increase of TB mortality as compared to FBDOT as reveled similarly in Mhimbira et al., (2016) study. Therefore the high death rate in this study suggests that there is the need for drastic measures that must be put in place by the Upper West region in order to improve treatment adherence, early case detection and treatment monitoring since much done is not enough for the control of TB interventions. The default rate for CBTC was 3.0% but it was 5.1% for patients that received their treatment under FBDOT which was higher than World Health Organization default rate of less than 5%. The study findings was compatible with the Chesney, (2001); Porter and Medicine, (2002) that majority 96 to 100% of the patients fell within treatment adherence rate category of which then was reported as default rate of 51.4%. In line with other studies reported by Cuneo et. al, (1989) and Tesfahuneygn et. al, (2015) showed that about half of TB patients do not complete their treatment due to lack of social support, side effects, non-compliance, loss to follow up, missing appointment dates, lack of transportation fare, poor communication between patients and health providers and 56 University of Ghana http://ugspace.ug.edu.gh medicines stock out are the main reasons contributing to relapse, drug resistance, long infectiousness and death. Therefore, the presence of CBTC is key in ensuring that patients adhere to their treatment regimen and monitoring strategies such as contact tracing of index cases can also reduce the default rate. Our main findings confirmed that TB treatment outcomes were extremely higher or equal in CBTC compared to the FBDOT strategy. This is similar to Mhimbira et al., (2016) study which indicated that, TB patients under CBTC are similar or better to have treatment results as compared to FBDOT which could be attributed to treatment adherence, medicines storage and absence of supervision contributing to main factors leading to poor TB treatment outcomes at the facility. Another study revealed that if institutional DOTS and CBDOTS are combined it would results into better or similar reporting of cured rate following patients TB treatment (Thim et al., 2004). 5.1 Limitation of the study This study like other studies had some limits. Foremost, this was a retrospective study that used routine data available on TB patients treatment cards. However, the data analyzed was on TB patients notified to the Upper West region over three years. Secondly, data was not a representative of the general population because of some clients who received treatments were incomplete and unavailable during data extraction. Thirdly, quality data on some information extracted from client’s cards were inaccurate and inappropriate. Also the lack of data authenticity thus; some parts of the data extracted were missing because of the years chosen for the study. Finally, variables that were 57 University of Ghana http://ugspace.ug.edu.gh defined or categorized differently than what the researcher had chosen for the study variables of interest. 5.2 Strengths Despite with the limitations stated above, the study analysis had high quality data for the results obtained which conferred rigor inferences that are valid and relevant. 58 University of Ghana http://ugspace.ug.edu.gh CHAPTER SIX CONCLUSION AND RECOMMENDATIONS 6.1 Conclusion This study assessed TB treatment outcomes between CBTC and FBDOT of TB patients in the Upper West region. CBTC seems to have had higher treatment success compared to FBDOT but not significant so this requires further studies. 6.2 Recommendations However, based on the study results, the following recommendations were made to improve TB treatment outcomes of TB patients in the Upper West region: 1. Improved supervision and treatment monitoring of TB patients on treatment especially pulmonary positives cases and ensuring proper documentation is done into clients cards. 2. Intensified counselling and support, defaulter tracing and advocating the use of treatment supporters to enable treatment adherence and successful outcomes. 3. Future studies on assessment of factors that influences TB patients treatment outcomes under CBTC especially in resource-constrained settings where it can informed programme design and monitoring and evaluation. 59 University of Ghana http://ugspace.ug.edu.gh REFERENCE Amo-Adjei, J., & Awusabo-Asare, K. (2013).Reflections on tuberculosis diagnosis and treatment outcomes in Ghana. Archives of Public Health =Archives Belges d Santé Publique, 71(1), 22. doi.org/10.1186/2049-3258-71-22. Balt, E., & Edington, M., Lotter, J.D., Preller, A., & Uys, M., (1998). Tuberculosis: A Training Manual for Health Workers Government Printer, Pretoria. Cameron, C. (1996). Patient compliance: recognition of factors involved and suggestions for promoting compliance with therapeutic regimens. Journal of Advanced Nursing, 24, 244-250. Centers for Disease Control, (2013). Core Curriculum on Tuberculosis: What the Clinician Should Know. (6th ed.), 1–320. http://doi.org/10.1128/IAI.00057-06. Centers for Disease Control, (2018). Fact Sheets | General | Tuberculosis: General Information | TB | CDC. Retrieved November 6, 2018, from https://www.cdc.gov/tb/publications/factsheets/general/tb.htm Chaulk, C.P., & Grady M. (2000). Evaluating tuberculosis control programmes; strategies, tools and models. The International Journal of Tuberculosis & Lung Disease, 4 (2), S55-S60. Chesney, M.A., (2001). Advancing Adherence: A Clinician–Patient Collaboration. The Art of HIV Management Series. Abbott Laboratories, San Francisco. Cuneo, W. D., & Snider, D. E. (1989). Enhancing patient compliance with tuberculosis therapy. Clinics in Chest Medicine, 10(3), 375–380. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/2673646 Dick J, & Schoeman JH. (1996). Tuberculosis in the community: The perceptions of members of a tuberculosis health team towards a voluntary health work Degraaf, B. R. (2012). COMMUNITY BASED TREATMENT OF TUBERCULOSIS IN RURAL MOZAMBIQUE. Retrieved from http://d- scholarship.pitt.edu/11901/1/DeGraaf_Thesis_ETD_2012.pdf Edington, M.E., (1991). Tuberculosis patient care decentralised to district clinics with community-based directly observed treatment in a rural district of South Africa. The International Journal of Tuberculosis and Lung Disease, 3 (5), 445-450. Enarson, D.A., Rieder, H.L., Arnadottir, & Trébucq, T. A. (2000). Management of Tuberculosis: A Guide for Low Income Countries (5th ed.), International Union Against Tuberculosis and Lung Disease. Evidence for action World Health Organization 2003. (2003). Retrieved from http://www.who.int/chp/knowledge/publications/adherence_full_report.pdf Glatthaar, E., & Barends, L.J.A., (1995). The community and TB control: a success story CHASA: Journal of the Community Health Association of South Africa, 6 (4),179-186. Ghana Health Service NTP. (2013). National Tuberculosis Control Programe 2013 Prevalence Survey Report Ghana. Ghana Health Service NTP. (2016). National Tuberculosis Control Programe 2016 Annual TB Report Ghana. Ghana Health Service NTP. (2018). National Tuberculosis Control Programe 2018 Annual TB Report Ghana. Gelmanova, I., Keshavjee, S., Golubchikova, V., Berezina, V., Strelis, A., Yanova, G., … Murray, M. (2007). Barriers to successful tuberculosis treatment in Tomsk, Russian 60 University of Ghana http://ugspace.ug.edu.gh Federation: non-adherence, default and the acquisition of multidrug resistance. Bulletin of the World Health Organization, 85, 703–711. https://doi.org/10.1590/S0042-96862007000900016 Mhimbira, F., Hella, J., Maroa, T., Kisandu, S., Chiryamkubi, M., Said, K., … Fenner, L. (2016). Home-based and facility-based directly observed therapy of tuberculosis treatment under programmatic conditions in urban Tanzania. PLoS ONE, 11(8), 1– 13. https://doi.org/10.1371/journal.pone.0161171 Huvila, I. (2018). Taking Excavation to a Virtual World : Importing Archaeological Spatial Data to Second Life and Opensim, 1–8. https://doi.org/10.1017/CBO9781107415324.004 Kathe, W., Barsch, F., & Honnef, S. (2003). Trade in Devil’s Claw (Harpagophytum procumbens) in Germany – status, trends and certification, 1–40. Kotokey, R., Bhattacharya, D., Das, P., Azad, A., & De, A. (2007). Study of efficacy of DOTS in pulmonary tuberculosis patients with associated diabetes. Lung India, 24(2), 58. https://doi.org/10.4103/0970-2113.44212 Knight, L., (2000). Tuberculosis & sustainable development. The Stop TB Initiative: Report. World Health Organization: Geneva. (WHO/CDS/STB/.4). Lwilla F, Schellenberg D, Masanja H, Acosta C, Galindo C, & Aponte J, et al. (2003). Evaluation of efficacy of community-based vs. institutional-based direct observed short-course treatment for the control of tuberculosis in Kilombero district, Tanzania. Trop Med Int Health. 8, 204–210. Lisha, P., James P., &Ravindran, C., (2012). Morbidity and mortality at five years after initiating category 1 treatment among patients with new sputum smear positive pulmonary tuberculosis. Indian J. Tuberc., 59 (2): 83-91.Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/22838205 Maher D. (2003). The role of the community in the control of tuberculosis. Tuberculosis. 83, 177–182. Maher D, Floyd K, Sharma BV, Jaramillo E, Nkhoma W, & Nyarko E, et al. (2003). Community contribution to TB care: practice and policy review of experience of community contribution to TB care and recommendations to national TB programs. Geneva, Switzerland: World Health Organization. Munro, S. A., Lewin, S. A., Smith, H. J., Engel, M. E., Fretheim, A., & Volmink, J. (2007). Patient adherence to tuberculosis treatment: a systematic review of qualitative research. PLoS Medicine, 4(7), e238. https://doi.org/10.1371/journal.pmed.0040238. National Tuberculosis Control Programme, Ghana (2012).Training Manual, unpublished document. National TB and Leprosy Programme Ministry of Health and Social Welfare (2013). th Manual for the management of tuberculosis and leprosy. 6 ed. Dar es Salaam. Ogden, J.S., Rangan, M., Uplekar, J., Porter, R., Brugha, A., Zwi, & Nyheim, D., (1991). Shifting the paradigm in tuberculosis control: illustrations from India. The International Journal of Tuberculosis and Lung Disease, 4 (3), 855-861. Pablos-Méndez, A., Knirsch, C. A., Barr, R. G., Lerner, B. H., & Frieden, T. R. (1997). Nonadherence in tuberculosis treatment: predictors and consequences in New York City. The American Journal of Medicine, 102(2), 164–170. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/9217566 61 University of Ghana http://ugspace.ug.edu.gh Pawlowski, A., Jansson, M., Sköld, M., Rottenberg, M. E., & Källenius, G. (2012). Tuberculosis and HIV Co-Infection. PLoS Pathogens, 8(2), e1002464. https://doi.org/10.1371/journal.ppat.1002464 Porter, J., Medicine, J. O.-S. S. and, & 2002, undefined. (n.d.). Commentary on" The Resurgence of Disease: Social and Historical Perspectives on the" New" Tuberculosis". Popline.Org. Retrieved from https://www.popline.org/node/242360 Prado, T. N. do, Wada, N., Guidoni, L. M., Golub, J. E., Dietze, R., & Maciel, E. L. N. (2011). Cost-effectiveness of community health worker versus home-based guardians for directly observed treatment of tuberculosis in Vitória, Espírito Santo State, Brazil. Cadernos de Saude Publica, 27(5), 944–952. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/21655845 Sheik-Mohamed, A., & Velema, J. P. (1999). Where health care has no access: the nomadic populations of sub-Saharan Africa. Tropical Medicine and International Health, 4(10), 695–707. https://doi.org/10.1046/j.1365-3156.1999.00473.x Stanhope, M., & Lancaster, J., (2000). Community and Public Health Nursing. (5th ed.), CV Mosby, St. Louis. Tessema, B., Muche, A., Bekele, A., Reissig, D., Emmrich, F., & Sack, U. (2009). Treatment outcome of tuberculosis patients at Gondar University Teaching Hospital, Northwest Ethiopia. A five-year retrospective study. BMC Public Health, 9(1), 371. Tesfahuneygn, G., Medhin, G., & Legesse, M. (2015). Adherence to Anti-tuberculosis treatment and treatment outcomes among tuberculosis patients in Alamata District, northeast Ethiopia. BMC Research Notes, 8(1), 503. https://doi.org/10.1186/s13104- 015-1452-x THE STOP TB STRATEGY Building on and enhancing DOTS to meet the TB-related Millennium Development Goals. (2006). Retrieved from http://apps.who.int/iris/bitstream/handle/10665/69241/WHO_HTM_STB_2006.368 _eng.pdf;jsessionid=C22CC32B0A0838E971C1A1EE75042953?sequence=1 Thim, S., Sath, S., Sina, M., Tsai, E. Y., Delgado, J. C., Shapiro, A. E., … Goldfeld, A. E. (2004). A Community-Based Tuberculosis Program in Cambodia. JAMA: The Journal of the American Medical Association, 292(5), 566–568. https://doi.org/10.1001/jama.292.5.566-c UWRHD. (2013). TB Annual Report 2013 - Upper West Region, Ghana. UWRHD. (2016). TB Annual Report 2016 - Upper West Region, Ghana. UWRHD. (2017). TB Annual Report 2017 - Upper West Region, Ghana. UWRHD. (2018). TB Annual Report 2018 - Upper West Region, Ghana Van Deun A, & Rieder HL. ( 2012). DOT, S, or DOTS? Editorial. Public Health Action. 2012. Wandwalo E, Makundi E, Hasler T, & Morkve O. (2006). Acceptability of community and health facility-based directly observed treatment of tuberculosis in Tanzanian urban setting. Health Policy, 78, 284–294. World Health Organization. (1974). Expert Committee on Tuberculosis, author. Ninth Report. Technical Series 552. Geneva. World Health Organization, (1997). Treatment of Tuberculosis: Guidelines for National Programmes, 2nd edition. Geneva (WHO/TB/97.220). World Health Organization, (2005). Gender in Tuberculosis Research. Gender and Health 62 University of Ghana http://ugspace.ug.edu.gh Research Series, Geneva. World Health Organization. (2006). DOTS Expansion Working Group Strategic Plan 2006-2015, 91. https://doi.org/(WHO/HTM/TB/2006.370). World Health Organization (2010). Policy Framework for Implementing New Tuberculosis Diagnostics Table of Contents, (March). World Health Organization (2011). Global Plan to Stop TB 2011–2015. Geneva, Switzerland. th World Health Organization (2013). Global Tuberculosis Report 2013. Retrieved on 9 January, 2019 from www.who.int/iris/bitstream/10665/91355/1/9789241564656_eng.pdf. World Health Organization (2015). The End TB th strategy. http://www.who.int/tb/post2015_strategy/en/. Accessed 9 January, 2019. World Health Organization. (2015). Global Plan Stop to End TB. The Paradigm shift. https://doi.org/10 January, 2019. World Health Organization (2006-2015). The Stop TB th Strategy http://www.who.int/tb/strategy/stop_tb_strategy/en/. Accessed 29 January, 2019. World Health Organization. (2015). Global Tuberculosis Report 2015. World Health Organization. (2016). Global Tuberculosis Report 2016. WHO. (2018). Tuberculosis. Retrieved November 6, 2018, from http://www.who.int/en/news-room/fact-sheets/detail/tuberculosis WHO | Disease burden and mortality estimates. (2019). WHO. Retrieved from https://www.who.int/healthinfo/global_burden_disease/estimates/en/index1.html Wilkinson, D., (1997). Managing tuberculosis case-loads in African countries. Lancet, 349 (9055), 882. Zeka, A. N., Tasbakan, S., & Cavusoglu, C. (2011). Evaluation of the GeneXpert MTB/RIF Assay for Rapid Diagnosis of Tuberculosis and Detection of Rifampin Resistance in Pulmonary and Extrapulmonary Specimens. Journal of Clinical Microbiology, 49(12), 4138–4141. https://doi.org/10.1128/JCM.05434-11 Zwarenstein, M., Schoeman, J.H., Vundule, C., Lombard, C.J., & Tatley, M., (2000). Tuberculosis in Swaziland: a health needs assessment in preparation for a community-based programme. The International Journal of Tuberculosis and Lung Disease, 5 (6), 650-654. 63 University of Ghana http://ugspace.ug.edu.gh APPENDICE Appendix 1: Excel extraction template form District Year Id Type TB Sex Age Weight BMI MUAC HIV BCG District Treatment Treatment of Classification (kg) (kg/m2) (Children Status scar Strategic outcome Patient only) (Children only) 64 University of Ghana http://ugspace.ug.edu.gh University of Ghana http://ugspace.ug.edu.gh Appendix 2: Ethics clearance and approval letter 64 University of Ghana http://ugspace.ug.edu.gh University of Ghana http://ugspace.ug.edu.gh 64