I take this occasion to thank God, Almighty for blessing me with his grace and taking my endeavor to a successful culmination. I extend my sincere and heartfelt thanks to my esteemed project supervisor Mr. Onchiri for providing me with the right guidance and advice at the crucial junctures while writing this proposal.

The research was conducted coast general hospital. The study aimed to determine the prevalence of TB among patients and also trying to get the relationship between TB and HIV. It will be done between January and April. The main proposed deliverable is to clearly understand and document the preventive measures to curb the increase in TB infections and also to give a prerequisite in research of one vaccine which can be used by patients suffering from both TB and HIV. This study was a hospital-based descriptive cross-sectional (a type of observational study that analyses cross-sectional data collected from patients).The research was done from a specimen collected from patients which is mainly blood and sputum. It was taken to the laboratory for diagnosis.

LIST OF TABLES AND FIGURES

Table of Contents

Acknowledgment 3

ABSTRACT 4

CHAPTER ONE 8

1.0 INTRODUCTION 8

1.1Background information 8

1.2 Statement of problem 9

1.3Research questions 9

1.4Justification of the study 10

1.5 Objective 10

1.5.1 Broad objective 10

1.5.2 Specific objective 10

CHAPTER TWO 11

2.0 LITERATURE REVIEW 11

2.1 BACKGROUND 11

2.3 Predisposing factors OF tuberculosis 12

2.4 PATHOGENESIS OF TUBERCULOSIS 12

2.4 PREVENTION AND CONTROL OF TUBERCULOSIS 13

2.4.1 Administrative controls 13

2.4.2 Environmental (engineering) controls 13

2.4.3 Personal protection control 13

2.4 DIAGNOSIS OF TUBERCULOSIS 13

2.4.1 Monteux tuberculin skin test ((MTST)/TB skin test 13

2.4.2 Sputum smear microscopy 14

2.4.3 Gene Expert 14

2.5 TREATMENT OF TUBERCULOSIS 14

CHAPTER THREE 15

MATERIALS AND METHODOLOGY 15

3.0 Introduction 15

3.1 Study area 15

3.2 Study design 16

3.3 Study Population. 16

3.3.1 Inclusion criteria 16

3.3.2 Exclusion criteria 17

3.4 Sample size determination 17

3.5 Sample collection, storage and transportation 17

3.6 laboratory diagnosis of tuberculosis 17

3.6.1 Mantoux tuberculin skin test ((MTST) 17

3.6.2 Sputum smear microscopy 18

3.6.3 Gene expert 18

3.7 Benefit and Risks of the study 18

3.7.1 Risks 18

3.7.2 Benefits. 19

3.8 Data analysis and presentation 19

3.9 Ethical Considerations 19

CHAPTER 4 20

4.0 Research Findings 20

4.1 Results 20

CHAPTER FIVE: 28

5.0 DISCUSSION 28

5.1 Introduction 28

5.2 Study findings 28

CHAPTER SIX: 30

6.0 CONCLUSIONS AND RECOMMENDATIONS 30

6.1 Degree of success/Learning experience 30

6.2 Conclusion 30

6.3 Research Contribution 30

6.4 Limitations 31

6.5 Recommendations and future work. 31

REFERENCES 32

APPENDICES 34

APPENDIX 1: WORK PLAN 34

APPENDIX II: BUDGET 35

CHAPTER ONE

Tuberculosis being an infectious disease caused by Mycobacterium tuberculosis is now a major problem globally. In 2006(WHO) estimated that there were 9.2million incidences cases and among this 0.7million cases were HIV-positive. The risk of developing TB is estimated to be between 26-31 times greater in people living with HIV than among those without HIV infection.2014, there were 9.6million new cases of TB of which 12million were among people living with HIV as per world health organization statistics. WHO (world health organization) estimates that one-third of world’s population is infected with m.tuberculosis resulting in an estimated nearly 9million cases of active TB in 2010.worldwide 14.8% of TB patients have HIV co-infection and as many as 50-80% have HIV co-infection in parts of sub-Saharan Africa. The incidence of TB associated with HIV is believed to have peaked at 1.39million in 2005 but now it is decreasing, however, globally TB remains the most common cause of death among patients with AIDS, killing 1of 3patients.TB can develop through the progression of recently acquired infections(primary diseases), reactivation of latent infections or exogenous re-infections. Infection with M.tuberculosis can occur when an individual is exposed to an infectious TB particle (5um in size) containing the tubercle bacilli. Upon reaching pulmonary alveoli they may be ingested by alveolar macrophage and later develop into an m.tuberculae to cause TB. Several studies of HIV infected patient with TB, the median CD4 count was less than 300cells/um. However, in patients with extra-pulmonary involvement or disseminated diseases, a CD4 count may be much lower.

In order for the people to live well and reduce their mortality rates, they should be educated and equipped with knowledge on preventive measures to curb the increase in HIV and TB.

However, TB prevalence is increasing in many countries and being the leading cause of death worldwide. In 2014 1.5million people died of TB, Of these people 0.4million people were HIV positive, TB now annually causes more deaths worldwide than HIV (“GTC-2015″, WHO, Geneva,2015).In 2014 HIV claimed 400000 compared to TB which caused 1.1 million deaths in the same year.

Likewise, infection with HIV increasing has posed as a major predisposing factor to develop TB in people co-infected with M.tuberculosis. In Kenya, HIV, a major predisposing factor for TB is prevalent in all counties with Mombasa county being almost at the top and leading in TB prevalence due to; urbanization, high poverty and low literacy levels among the individuals. These have affected human resource and directly lowered annual economic growth. (CAK- 2013)

If the government will not put in place the preventive measures on time, both HIV and TB will become a pandemic and it will lead to a dearth of more people. This will not only lead to the reduced population but also the workforce will reduce. A lot of revenue set aside for the growth of the economy will be channeled to treating patients. Most of the breadwinners will become liabilities in their homes and thus increased poverty which will in return hider the dream of achieving vision 2030.

1. What are the relationships existing between TB and HIV?
2. What are some of the preventive measure to be put in place to reverse TB burden among people?

A lot of research has been done by different organizations on HIV and TB separately. But they have not done a research to show how HIV and TB are related. The outcome of the research will be aimed to break the big data and come up with a universal way to prevent and also to control the spread of both HIV and TB. This knowledge will be very useful to research institutes who are trying to find the cure for HIV/AIDS. Since the cure of TB is known, the relationship between it and HIV can be used to extend the research on HIV vaccine.

• To determine the rate of Co-infection between Mycobacterium tuberculosis and HIV among patients attending Coast General Hospital.

1. To determine the incidences of TB in Coast General Hospital.
2. To evaluate the relationship existing between TB and HIV
3. To determine the measures to prevent HIV and TB.

TB, the oldest and multisystem diseases with myriad representation and manifestation is the most common cause of infectious disease-related mortality worldwide. WHO has estimated the 2billion people have latent TB. Although the disease is decreasing in the United States, the disease is becoming more common in many parts of the world. Also, the prevalence of drug-resistance TB is also increasing worldwide.Kenya is ranked number 15 out of 22 high TB burden countries in the world and fourth in Africa after South Africa, Nigeria, and Ethiopia ( International Medical Corps, IMC, 2012-2015).

HIV/TB co-infection in Kenya is approximately 48% of new TB patients (IMC-2010). The causative agent is Mycobacterium tuberculosis belonging to a group of organisms including m.microti, m.bovi, m.Africanum. The registered number of new cases of TB worldwide roughly correlates with economics: Highest incidence is seen in the countries of Africa, Asia, and Latin America with the lowest gross national product. WHO estimates that 9million people get TB every year which 95% live in developing countries? An estimated 2-3 million people die from TB every year. A great influence on the rising TB trend is HIV infection. In 2014, 400000 people who had both HIV and TB are estimated to have died, in addition to 1.1million people who died from TB alone (“GTC-2015”, WHO, Geneva, 2015).

Chances are that one out of ten immunocompromised people infected with m. tuberculosis will fall sick in their lifetime with active TB, but among those with HIV, one in ten per year will develop active TB, while one in two or three tuberculin test positive AIDs patients will develop active TB. In developing countries, the impact of HIV infection on the TB situation, especially in the 20-35 years age group is of great and increasing concern. TB is much more increasing in Kenya especially in Mombasa County. Estimated population being about 1,008,485 consisting of 100% of urban population with a population density of 4605 persons per square KM. In 2013 Tb cases were 4726 giving the case notification rate as 469 per 100,000 compared to national average of 261 per 100,000.TB/HIV co-infection rate was 32% in 2013 according to (CHAK-2013-2014)

Among the many predisposing factors to TB HIV is the leading since it suppresses the immunity. Mostly it is a major problem in sub-Saharan countries due to the high incidence of HIV cases. Smoking more than 20 cigarettes per day also increases the risk of TB by two or four times while silicosis increases the risk of 30 fold. Diabetic Mellitus is also an important factor that is growing in importance in developing countries. Other diseases the increase the risk include Hodgkin’s lymphoma, end-stage renal disease, chronic lung disease, malnutrition, and alcoholism. Also, persons, genetic may also be a factor. Overcrowding also plays a major role in TB spread among people. (WHO-2006: Global tuberculosis, control, surveillance, planning, and financing).

Infection with M.tuberculosis results most commonly through exposure of the lungs or mucous membrane to infected aerosols droplets in these aerosols are 1.5um in diameter, person with active pulmonary TB, a single cough can generate 3000 infective droplets of which 10 bacilli are enough to initiate infection upon inhalation , droplet nuclei are deposited within the terminal airspaces of the lungs .The organism grows for 2-12 weeks until it reaches 1000-10,000 sufficient to elicit a cellular immune response. After infection, host either develops primary infection immediately or no initial infection occurs and disease remains latent within the body.Upon inhalation, tuberculosis bacteria travel to the lungs and end up in the alveoli where they are recognized in the immunocompromised host as foreign and attacked by body’s macrophages. Bacteria hare multiplies until they bust macrophages leading to further infection. Infected areas gradually transform into granuloma. This allows the mycobacterium to continue growing and overwhelm the cell it has infected till it dies .centers of these granulomas Necrotize, leading to a mixture of blood and sputum in lungs. This then can heal with time and remain dormant for a long time while one can infect others. After reemergence, tuberculosis infection and symptoms proceed similarly. Host’s immune attempts to contain the growing infected areas by killing off the tissue around them to contain the spread and developing T-cells. This leads to inflammation and some of the other symptoms common to tuberculosis. This tubercle can break off and travel through the bloodstream, leading to extra-pulmonary tuberculosis (development of tuberculosis by holiday D,hailuB Girma M 2003;7 ).

Institutions policies or measures that aim to reduce the time the arrival of people with respiratory TB diseases at a healthcare facility, diagnosis of their condition and placental in an airborne infection isolation room(AIIR).The purpose of these policies is to provide overcharging protection for all HCWs, patients, and visitors to the facility. Administrative control measures include occupational health programs incorporating skin test of HCWs for LTBI after exposure and at regular intervals. (ECDC2005-20016)

This reduces the likelihood of exposure of HCWs other patients and visitors to viable airborne m.tuberculosis. These include mechanical ventilation systems to supply fresh air to patient use of high-efficiency particular air (HEPA) filters. (ECDC2005-20016)

Measures directed to individual HCWs either to prevent infection (such as the use of respirators)or to prevent disease if infected (such as detection and treatment) (ECDC2005-20016)

Used with purified protein derivative(PPD) for active or latent infection (primary method) in vitro blood test based on interferon-gamma release assay (IGRA)with antigens specific for Mycobacterium tuberculosis for latent infection.

It’s a primary method that is always used in TB test in countries with high rate of TB infection. Sputum is stained using fluorescent acid-fast stain and used as a test for TB. It’s a simple and inexpensive method.

This diagnoses TB directing presence of TB bacteria as well as testing for resistance to the drug rifampicin.

1. Recommended treatment of latent TB infection in adults infected with HIV is a daily dose of isoniazid (INH) for 9 months. (Treatment of TB guidelines WHO, Geneva, 2011, 29)

2.Recommended treatment of TB disease in adult infected with HIV (when the disease is caused by an organism that is known or presumed to be susceptible to first-line drugs) is 6-month regimen consisting of.(European respiratory journal, may,1, 2012)

a) The initial phase of (INH) a rifampin and ethambutol (EMB) for first 2 months.

b) Continuation phase of (INH) and rifampin for the last 4 months

3 patients with advanced HIV (CD4 counts <100/um) should be treated with daily or three times weekly therapy both the initial and the continuation phases. Twice weekly therapy may be considered in patients with less advanced immunosuppressed. lamberts-van Weizenbock, C.S (1995),76,455.

4. Treatment of drug-resistant TB in persons with HIV infections is the same as for patients without HIV. However, management of HIV related TB requires expertise in the management of both HIV and HIV.

Note interaction of rifampin (RIF) with certain antiretroviral agents (some protease inhibitors-PIs-) are Non-nucleoside reverse transcriptase inhibitors (NRTI). Rifampin which has fewer problematic drug interactions (British drug resistance journal 1995)

This is the descriptive study with the aim of establishing the major predisposing factor to the widespread of TB in the region.

The research was intended to investigate the role of government, community and other stakeholders in the region management and prevention of TB in the region as well as to verify the prominent contributing factors for the high spread of the disease in Mombasa metropolitan.

The study will be carried out in Coast County referral Hospitals which serves as the tertiary referral center for entire coast region. It is situated along the National bank of the island of Mombasa in Makadara district. The latitude and longitude of Coast County and referral hospital are 4.0435 and 39.6682 respectively. The county has a total population of 939,370 as per census 2009. It has a counseling center, laboratory and treatment units. Patients receive formal pre-treatment adherence, education and counseling sessions.

Data collection methods

1. Interviews.

The patients will have to be asked some questions and their replies will be used as the primary data. This method is the best since it as a personal appeal.

1. Questionnaires.

Patients are expected to fill some questions and the information was used as the primary data.

1. Sampling

Population sampling will be effective and easy since many patients in Mombasa cosmopolitan attends coast general hospital for treatment.

This will be a hospital-based descriptive cross-sectional study.

The study will be carried out at coast county referral hospitals, Mombasa County. The study population will be 334 both inpatients and outpatients. The major economic activity here in Mombasa is fishing, tourism, and local trading. The specimen of choice will be sputum and blood

Any TB and HIV positive client who is attending coast county and referral hospital and is not able and willing to give consent and participate voluntarily.

Sample size will be determined using standard statistical formula (Fishers et al., 1998):

n=Z²pq/d²

Where;

Z²=1.96,

p= 32% based on Mombasa TB prevalence (CHAK 2013),

q=, d²⁼0.05²

n=1.96² X ((0.32) X (1-0.32))/ (0.05)² = 334

Approximately 334 samples

The samples (Sputum) will be collected in sterile TB tubes and blood will be collected in EDTA tube. Samples will be taken immediately to the laboratory to be tested. Sample collected will depend on whether it’s latent or active TB. Patients’ type of specimen, name, and number will be used to record the results of the hospital record book. This will be done at the coast county and referral hospitals.

Used with purified protein derivative(PPD) for active or latent infection (primary method) in vitro blood test based on interferon-gamma release assay(IGRA)with antigens specific for Mycobacterium tuberculosis for latent infection.

Sputum smear stained using fluorescent acid-fast stain and being used for TB.

Procedure

A very thin layer of the sample is placed on a glass slide (smear) series of special stains are then applied to sample, and the stained slide is examined under a microscope for either presence or absence of bacilli.

This diagnoses TB directing presence of TB bacteria as well as testing for resistance to the drug rifampicin.

Principle

Tests which detects the DNA in TB bacteria. It uses a sputum sample and can give results in less than 2hours.Also can detect the genetic mutation associated with resistance to the drug rifampicin.

Advantages

• Most reliable compared to others.
• Speed in giving results.
• Identifies the rifampicin resistance hence the choice of medication is chosen.

Disadvantages

• The shelf life of the cartridge is only 18months
• It’s very stable
• It needs to recalibrated annually
• Test is costly
• Temperature ceiling is critical

During transportation of specimens, there is a risk of infection to the people around and to the person carrying the specimen since Mycobacterium are highly infectious.

The findings of this study will aid the public health implementers in coming up with suitable models that can further prevent and manage TB infection.

Statistical Package for social sciences (SPSS) will be used to analyze the result. Results will be measured using central tendencies such as; mean median and mode and the presented using Tables, figure, bar graph and charts.

Ethical clearance for this study will be sought from the Ethical Review Committee (ERC) of Coast County and referral. Permission to conduct this research will be obtained from MTC Kisii. Before participation, subjects will be required to fill informed consent and assent forms. Sample collection will be done by a qualified laboratory technologist and the proper techniques will follow to reduce any risk.

The samples acquired from the patients will be coded to delink them from the identity of the person.

CHAPTER 4

Table 1

The table above shows the prevalence of positive cases in age groups.

The most affected age group is between 20-50 years.

Generally, the mortality rate was high between the ages of 21-50

This was because most of the infected cases were HIV positive and responded poorly to chemotherapy.

Table 2

The table above shows mortality rate between the age group

This table shows a prevalence rate of infection according to age and sexes of the patients whereby;

Males presented with the highest prevalence rate whereas children and elderly i.e. 1-10, 71-80, and 81-90 had the lowest cases.

Table 3

The table above shows the current drugs used in the management of pulmonary tuberculosis for 3 months in the Hospital.

These drugs were used in combination.

Table 4:

The table above shows the predisposing factors of tuberculosis among the age groups.

In the above table, HIV infection contributed to the highest numbers of infection followed by gender and heavy jobs

Age in years

Graph 1: showing the total number of positives.

According to the bar graph above 21-40 age group has the highest cases while 71-90 had the lowest cases.

Age group

Bar graph 2: showing the common predisposing factors of tuberculosis among the age groups.

Key

1-10 malnutrition & contract with infected cases

11-20 overcrowding

21-30 HIV infection

31-40 male gender and heavy jobs

41-50 diabetes

51-60 poverty

Tb between sexes

Fig 1: showing percentage of TB between sexes

Female 51/150×100 = 34%

51/100×100 =122.4%

Males 99/150×100 =66%

According to the figure above. Males have the highest percentage of infection compared to females.

DRUG USE

Fig 2: shows the current drugs used in the management of tuberculosis in the four months times.

With the data collected and analyzed well, it is clearly seen that HIV and TB are closely related. This data will be useful to the government when making decisions on how to improve health sector. This research can also be extended in future to come up with a vaccine which cures HIV. This will reduce the mortality rate and thus ensure better living and thus increase the productivity of people. High productivity means that the vision 2030 will be achieved.

According to the data presentation and analysis in table 1, pulmonary tuberculosis was found to be more prevalent between the ages 21-40 years.

This was the productive age and most active people in the society. Majority of the patients were employed in firms where they worked and the environment was very dusty.

Other tuberculosis cases occurred as opportunistic infection since most patients were HIV positive.

Those infected between the ages of 1-10 years were children who had close contact with infected cases such as mothers and other caretakers.

The reason was, tuberculosis was transmitted from infected cases to them through aerosol.

The infection between the ages 81-90 years was based on malnutrition and age factor.

Mortality rate was high between the ages 21-50 as it can be seen in table 2.

This was attributed to HIV whereby these characters responded poorly to anti-tubercular drugs. This was because HIV infection weakened their body immunity lowering the body’s ability to fight/protect against diseases hence TB occurred as an opportunistic infection.

Mortality rates between the age 1-10 years and 60-90 years were because most of the patients responded well to chemotherapy and completed the treatment.

Male showed the highest prevalence rate as it can be seen in table3, it was because males were more prone to predisposing factors of tuberculosis such as heavy tasks in the community and more exposed to the outside world where the majority of them suffered from HIV infections.

These factors that contributed to a high prevalence rate of infection in them (male) compared to female patients.

Although tuberculosis is difficult to treat, many anti-tubercular drugs have shown some promises, effectiveness in the treatment and management of tuberculosis.

Those drugs are used in combination (combination therapy) to avoid development of resistance when one drug is used alone (see table 4)

Other reasons for using combination therapy are:

• To broaden the spectrum of the drugs.
• For synergistic purposes.
• For patients compliance i.e. lower the duration of administration.

The most commonly used combination is Rifa four i.e.

• rifampicin
• isoniazid
• ethambutol
• pyrazinamide

Those drugs have shown to be effective in the treatment and management of tuberculosis. Although tuberculosis has been associated with Mycobacterium tuberculosis many factors have led to the high increase of infection (predisposing factors) and fast spread of the same (refer to table 5).

Among the factors, HIV infection has been a threat presenting the highest rate of the predisposition of tuberculosis hence high rate.

Tuberculosis is also associated with the male gender whereby the majority of patients with TB are males due to heavy jobs.

These factors and others have contributed in one way or the other in the rise and spread of tuberculosis in the region and also worldwide.

The research has successively determined the rate of co-infection between Mycobacterium tuberculosis and HIV. This has been clearly seen since most of TB cases among patients attending Coast General Hospital were also diagnosed with HIV virus. Research also recorded accurately the incidences of TB in the Hospital since we used mostly interview and observation which gives primary data and is not prone to biases.

However, since the research was done only in 3 months, it could not extend to relate TB and HIV to come up with a cure for HIV.

According to the research and result, it was concluded that tuberculosis was an infectious disease.

In the region that affected all the age groups and all sexes. It was found to be more prevalent in males and mortality rate was a bit high between the ages of 21-41. This was attributed to HIV/AIDs infection.

The following contributed to high infection rate in the region:-

• Lack of knowledge about the disease among the residence
• Poverty hence no money to buy/get the required prescribed drugs for the needed therapy.
• Ignorance and illiteracy of some people when by the majority of them did not go to the hospital when sick.
• Air pollution due to dust since the region is most of the time dry.
• The high rate of HIV infection whereby tuberculosis occurred as an opportunistic infection.
• Overcrowding in public institutions and villages
• Malnutrition among the old and young children.
• Poor hygiene e.g. spitting anywhere, coughing directly to others etc.

Since the research was done to both TB and HIV, it has shown there is a similarity between the two diseases. From the research, it is seen most of TB cases were recorded among patients who are already infected with HIV. The government can now use this similarity to have a joint fight against HIV and TB. The research can also be extended to come up with a cure for HIV.

I encountered a budget constraint since most of the money was used in commuting, food, and stationaries. Some of the patients also requested some refreshment so as to give the information. At the end of it all, I had to add more budget.

I also experienced a time constraint when trying to complete some of our objectives. Also while covering as much of the scope as possible.

The government should launch a campaign to create awareness to people the dangers of HIV infection and how to prevent its increase. The government should also start improving the standard of living of the citizens to ensure that there is no malnutrition which is the catalyst for TB infection.

I would also encourage the next year students of KMTC Kisii to extend my research. They should take the advantage of this data on HIV/TB coexistence to try and come up with a research on the vaccine which will cure HIV. Sounds crazy? Don’t worry, just give a try. Even the biggest ideas started with a thought. All the best.

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Table 1: The work plan for completion of the study.

The table below shows tasks perfumed during the entire research with the weight given to research writing since it requires a lot of research and typing.

The grant chart below shows how the days were allocated in the entire research period. The longer the cohort, the higher the number of days spent doing a certain task.

The table below shows the total amount of money set aside for the budget and how the money will be used for different tasks during the research.

The pie chart below shows the how the total money of the budget will be allocated to different tasks with transport consuming the highest amount of money.

END

TO GOD BE THE GLORY