CHAPTER 1: BACKGROUND OF THE STUDY

1.1 INTRODUCTION

This chapter we focused on background, problem statements, general objective, specific objective,
research questions, significance of the study, scope of the study, definition of key terms,
conceptual frame work.

1.2 BACKGROUND

Tuberculosis (TB) is a communicable illness caused by the bacillus Mycobacterium tuberculosis

that can be spread through droplet nuclei when coughing, sneezing, screaming, or singing
(Castelnuovo B, 2010; Okethwangu et al., 2019). Tuberculosis infection has a detrimental impact
on the productive sector of the economy, resulting in a decrease in national productivity (WHO,
1999; WHO Africa, 2023). Reduced production, yet excessive resource consumption during
individual or community disease, could result in national anarchy. To prevent new infections, the
World Health Organization recommends early case detection, correct diagnosis, and standardized
treatment (Meseret Tadele et al., 2022; WHO, 2023).

TB is still a serious global health issue. When TB was deemed a worldwide emergency in 1993,
the World Health Organization (WHO) started advocating for a patient support and management
approach called Directly Observed Treatment Short-Course (DOTS) (Chebet et al., 2022). Anti-
TB drugs are taken by patients utilizing DOTS while being watched after by a healthcare
professional. DOTS guarantees that the appropriate drugs are administered at the appropriate times
and dosages.(Prasetyo et al., 2015) In 2005, DOTS was being used in 187 countries, and 4.9 million
TB cases were treated with this approach. According to the year's reports, the worldwide
effectiveness of DOTS deployment in halting-the spread of tuberculosis was suggested
(Okethwangu et al., 2019; Serapelwane et al., 2016).

Under DOTS, the percentage of smear-positive patients who are cured (have a negative sputum-
smear test at the conclusion of treatment) plus the percentage who finish treatment is known as
treatment success. These patients are registered in an annual cohort (Dye et al., 2005). Therefore,
one of the most important factors in disease control is treatment adherence since noncompliance

1
with treatment can lead to long-term infectiousness and greater rates of ineffective therapy, which
can result in high transmission, drug resistance, and death (Hussein et al., 2021).

In addition to concentrating on decentralizing TB care in medical facilities, the Sustainable

Development Goal (SDG) three aims to eradicate tuberculosis and the population at large. SDG
three was recently established to address the shortcomings in TB care (Chebet et al., 2022).

Treatment under direct observation: At least five days a week, the trial participants got daily
treatment under direct observation. In programming contexts, this might not be feasible. Given the
pill burden and the absence of a fixed dose combination formulation, directly observed treatment.
may be crucial as a preventative step against the possible amplification of drug resistance. Overall,
even though this 4-month regimen is shorter than the current standard of care, patient support is
still a crucial component of TB therapy. Current WHO recommendations promote the use of
directly observed treatment as well as other forms of patient support (WHO, 2022).

1.2.1 Globally

TB is a disease that may be prevented and is typically cured. However, in 2022, tuberculosis (TB)
was about twice as common as HIV/AIDS and the second most common infectious agent-related
cause of mortality worldwide, after coronavirus disease (COVID-19). Over 10 million individuals
still contract tuberculosis annually. The United Nations (UN) and World Health Organization have
adopted the aim of ending the worldwide tuberculosis epidemic by 2030, and urgent effort is
needed to achieve this goal (WHO, 2023). In the 1990s, the Directly Observed Treatment, Short
Course (DOTS) strategy was expanded globally, entails improving the provision of high-quality
TB treatment through nationally coordinated TB programs, and has resulted in significant
mortality reductions through better treatment outcomes and reporting (Idoko & Adeyemi, 2022a).
The incidence of tuberculosis has been gradually decreasing over the past ten years at a rate of
only 1% to 2% per year, notwithstanding these efforts. The End TB strategy, which was introduced
in 2015 and calls for a 90% in TB incidence and a 95% reduction by 2035, is one example of the
reinvigorated worldwide objectives in recent years to accelerate these drops in the TB bund (Vesga
et al., 2019).

2
Despite the fact that the causal organism was identified over a century ago and that there have been
decades of extremely efficient medications and vaccines that make tuberculosis (TB) preventive
and curable, the illness is still a global public health concern. An estimated 8.70 million TB
incident cases occurred worldwide in 2011, with 2.20 million of those cases thought to have
occurred in India, according to the WHO Global TB Report 2012 (Das et al., 2015).

This demonstrates how widespread poverty, poor treatment adherence, decreased immunity, and
significant disparities in access to high-quality diagnostic and treatment services still exist in these
nations. Because the majority of TB cases occur in low- and middle-income countries, and because
approximately 75% of TB patients are in the youngest and most economically productive age
groups (15 54 years), this is especially important for the developing world (Gebreweld et al.,
2018). In order to prevent the spread of the disease, cure it, and prevent drug resistance, recurrence,
and mortality, adherence to TB treatment is essential. In addition to being one of the biggest
challenges to TB control worldwide, non-adherence to TB therapy is also a key contributor to
treatment failure (Chen et al., 2020a).

1.2.2 Africa

The high TB burden in African nations has been attributed to a number of factors, including
inadequate prevention efforts, poverty-limited healthcare systems, and the introduction and quick
spread of HIV and multidrug-resistant TB (MDR-TB) (Kassim et al., 2021). An estimated 2.5
million people fell ill with TB in the African region in 2021, and around 500,000 people died of
the disease in the same year. The heavy burden of HIV in the region is reflected in the 20% of
new TB cases that are reported among people living with HIV and AIDS (WHO Africa, 2023).

According to the Ethiopian DOTS trial, inadequate patient treatment compliance and inadequate
patient monitoring throughout treatment were linked to a low TB cure rate (Serapelwane et al.,
2016). According to this study, it is essential to investigate and document the experiences of TB
patients using DOTS since the data may help identify issues with DOTS use (Serapelwane et al.,
2016). As a result of the HIV epidemic, the number of TB cases in Sub-Saharan Africa has
significantly increased (Castelnuovo B, 2010).

3
A 90% reduction in TB deaths from 2015 and an 80% reduction in TB incidence rate from 2015
are among the ambitious but attainable targets set by the global strategy and regional framework
for reducing the TB burden in the African Region by 2030. The ultimate goal is to ensure that no
family affected by TB faces catastrophic costs. to improve compliance with DOTS centers in order
to accomplish this goal (WHO Africa, 2023).

Furthermore, the Direct Observed Treatment Short-course program, which was launched in 1997,
has been used for years to identify TB cases early, diagnose them, and treat them in accordance
with the guidelines. Ethiopia is still one of the nations with the highest rates of TB, TB/HIV, and
DR-TB from 2015 to 2020, despite a 42% decline in yearly TB incidence from 369 cases per
100,000 people in 1990 to 177 cases per 100,000 people in 2019 (Meseret Tadele et al., 2022).

1.2.3 Somalia

According to the World Health Organization, tuberculosis (TB) is the primary cause of sickness
and mortality among Somali adults. It also significantly reduces work productivity and raises his
household expenses to assist the affected household member during the lengthy TB treatment. By
lessening the impact of TB on the populace, the Global Fund TB program in Somalia was deemed
to have made a substantial contribution to the overall improvement of the population's health state
(Hussein et al., 2021).

In 1995, the directly observed treatment short course (DOTS) approach was implemented by the
(SNTBCP) Somalia National TB Control Program. At least one TB Centre was established in each
of Somalia's 18 regions as a result of the implementation of this approach. Compared to
Somaliland, this area is said to have much greater risks of MDR-TB and lower DOTS coverage
(Kassim et al., 2021).

In unstable states like Somalia, tuberculosis continues to pose a serious health threat despite
worldwide advancements in its control. Numerous factors contribute to this, including the high
proportion of infectious TB patients who go undetected and, consequently, untreated, perpetuating
the community's cycle of TB transmission (Sheikh et al., 2021). Therefore, Somalia has been
designated as a high-burden nation for multidrug-resistant tuberculosis (MDR-TB) by the World

4
Health Organization (WHO). Somalia reported 43,000 (27,000 62,000) TB cases in 2021, which
translates to a rate of 250 (158 362) cases per 100,000 people (Mohamed et al., 2023).

1.3 PROBLEM STATEMENT DOTS

Tuberculosis (TB) is a communicable illness caused by the bacillus Mycobacterium tuberculosis

(Castelnuovo B, 2010; Okethwangu et al., 2019). In 2022, tuberculosis (TB) was about the second
most common infectious agent-related cause of mortality worldwide, after coronavirus disease
(COVID-19). Over 10 million individuals still contract tuberculosis annually, as reported by
WHO. Therefore, one of the most important factors in disease control is treatment adherence since
noncompliance with treatment can lead to long-term infectiousness and greater rates of ineffective
therapy, which can result in high transmission, drug resistance, and death. Therefore, we know
that Somalia is counted among the countries with the most MDR in Africa and the world (WHO
Africa, 2023). In 1995, the directly observed treatment short course (DOTS) approach was
implemented by the Somalia National TB Control Program. At least one TB Centre was
established in each of Somalia's 18 regions as a result of the implementation of this approach
(Kassim et al., 2021).

However, patient adherence to DOTS in Mogadishu remains inconsistent, reducing the

effectiveness of the strategy. Since this type of research has not yet been conducted in Somalia,
ence to DOTS in
Mogadishu TB Centre.

This study aims to identify and analyze the specific factors affecting patient adherence to DOTS
in Mogadishu to provide insights that could improve treatment outcomes, decrease TB
transmission, reduce MDR-TB prevalence, and inform policy-making for better healthcare
delivery.

1.4 OBJECTIVES OF THE STUDY

1.4.1 General objective

The general objective of this study is to determine the factors affecting patient adherence to DOTs
in patients who attended selected hospitals in Mogadishu, Somalia

5
1.4.2 Specific objectives

1. To identify the relationship between DOTS adherence level and sociodemographic factors
affecting patient adherence to DOTs who attended selected hospitals in Mogadishu-Somalia,
between December 2024 and February2025.
2. To assess the
service in selected hospitals in Mogadishu-Somalia, between December 2024 and
February2025.
3. To determine the relationship between DOTS adherence level and behavior and cultural factors
affecting patient adherence to DOTs in patients who attended selected hospitals in Mogadishu-
Somalia, between December 2024 and February2025.
4. To identify the correlation between DOTS adherence level and accessibility and availability
factors affecting patient adherence to DOTs in patients who attended selected hospitals in
Mogadishu-Somalia, between December 2024 and February2025.

1.5 RESEARCH QUESTIONS

1. What is the relationship between DOTS adherence level and sociodemographic factors
affecting patient adherence to DOTs in patients who attended selected hospitals in Mogadishu,
Somalia?
2. What is the relationship
service in selected hospitals in Mogadishu, Somalia?
3. How are behavior and cultural factors affecting patient adherence to DOTs in patients who
attended selected hospitals in Mogadishu, Somalia?
4. What is the relationship between DOTS adherence level and availability & accessibility factors
affecting patient adherence to DOTs in patients who attended selected hospitals in Mogadishu,
Somalia?

1.6 PURPOSE OF THE STUDY

The purpose of the study is to identify and understand the various barriers and facilitators that
influence the reasons behind low adherence rates, address obstacles and inform the design of
policies or programs to support better patient outcomes and reduce TB incidence.

6
1.7 SIGNIFICANCE OF THE STUDY

Studying these factors is significant because it helps healthcare providers and policymakers to
Ensure healthcare systems are equipped with resources and accessible DOTS centers, strengthen
healthcare provider- also important to our local
authorities or government to add their policy for reducing non-adherences. It also helps other
researchers by providing a guideline that they can use in future research on the same topic

1.8 SCOPE OF THE STUDY

The scope of this research consists of three main categories which are:

1.8.1 Content scope of the study

The study will concentrate on factors affecting patient adherence to DOTS TB who attended
selected hospitals in Mogadishu, Somalia. It contains the background of the study which
demonstrate the topic of the study in depth.

1.8.2 Geographic scope of the study

This study will be carrying out in Mogadishu, Somalia.

1.8.3 Time scope of the study.

The study will be conducting at time period between September 2024 up to March 2025.

1.9 DEFINITION OF TERMS

TB: is a contagious bacterial disease caused by Mycobacterium tuberculosis, an infectious disease

that primarily affects adults in their most productive years

DS-TB is a type of tuberculosis that can be treated with the first line anti-

resistance to rifampicin and isoniazid.

7
MDR-TB is a form of tuberculosis disease coursed by a strain of mycobacterium tuberculosis
complex that resistance to at least one or two of the most powerful first line anti- TB drugs
rifampicin and isoniazid.

Intensive phase is the first two month of treatment in drug susceptible patients, which contains
RHZE.

Continuation phase is the remaining months of the treatment completion either 4 or 7 depend on
duration of treatment.

DOT: is program that involves a healthcare professional observing a tuberculosis (TB) patient
take their medication, is essential at least during the intensive phase of treatment (the first two
months).

Adherence: respondents with scores more than five was rigorized as high DOTs adherence level.

Non adherence: respondents with scores less than five was identified as low DOTs adherence
level.

Poor knowledge those respondents who got less than 2 score are categorized as poor.

Average Knowledge those respondents who got more than 2 and less than five.

Good knowledge: are respondents who had score more than five score.

Successful treatment: means that a patient has completed their treatment without bacteriological
evidence of failure.

Treatment success under DOTS is defined as the percentage of smear positive patients
registered who are cured (negative sputum-smear result at the end of treatment) plus the
percentage who complete treatment.

8
1.10 CONCEPTUAL FRAME WORK

IV

Behavior and
of TB Cultural factors;
Cause of TB. Addict
mode of substances,
Sociodemographic transmissions Availability &
Feelings of
factors; way to treat, stigma. Accessibility
Age, duration of Family factors
sex, treatment. Members & Availability
occupation, Symptoms of Community of dots.
marital status, TB support. Education.
& Accesses of
educational transportati
level on and
F. TB history information

Adherence to DOTS

9
CHAPTER 2: LITERETURE REVIEW

2.1 INTRODUCTION

In this chapter of the literature, we will focus on views of factors that affect patient adherence to
DOTS services among people who have been diagnosed with TB. Before discussing the factors,
we will emphasize an overview of DOTS in general. the literature outlines what is known or works
done by others in the different research areas.

2.2 OVERVIEW

Term DOTS was originally an acronym referring to directly observed treatment (DOT) and short-
course chemotherapy, but it has now become the word used to designate a broader public health
strategy with five main components (Dye et al., 2005). Government commitment to ongoing
tuberculosis control activities. Case detection using sputum smear microscopy among
symptomatic patients who self-report to health providers. A six- to eight-month treatment schedule
is recommended for all confirmed sputum smear-positive cases, with directly observed treatment
(DOT) for at least the first two months. A consistent, ongoing supply of all needed anti-TB
medications. A standardized recording and reporting system that enables the evaluation of
treatment outcomes for individual patients as well as the overall tuberculosis control program
(WHO, 1999).

The best method currently available for reducing the TB epidemic is Directly Observed Treatment,
Short-course(WHO, 1999). DOT; a mechanism to guarantee consistent drug supply; and a standard
method for documenting and reporting, which Short-course assessment of treatment results. More
than 90% of new, drug-susceptible TB patients can be cured with standard short-course regimens,
and good cure rates are necessary before case detection can be expanded (Dye et al., 2005).
According to the World Health Organization (WHO), non-adherence should be at least 5%. Due
to the rising global TB burden, the World Health Organization declared a global TB emergency in
1993. The Direct Observed Treatment Short Course (DOTS) was introduced. The primary goal of
the plan, which was created to control tuberculosis globally, was to attain 85% treatment rates and
70% case detection by 2005. treatment for MDR-TB still commonly lasts about 2 years, with a

10
55 67% cure rate; in comparison, a routine 6-month treatment regimen can yield a 95% cure rate
for drug-susceptible TB cases (Okethwangu et al., 2019). DOTS thus guarantees adherence to TB
therapy. A supervisor sees the patient drink the drug at each dose of the treatment plan (Hussein
et al., 2021). DOTS extensions are urgently needed for two unique issues. These include MDR-
TB, particularly in the former Soviet Union, and tuberculosis associated with HIV, particularly in
Africa (Bleed et al., 2000).

In TB control, the DOTS (Directly Observed Treatment, Short-course) approach has significantly
raised the standard of diagnostic and treatment results worldwide. DOTS has been used in India
since 1993 to manage TB therapy effectively. Giving each dose under close supervision is the most
crucial aspect of DOTS in order to guarantee patient adherence to therapy. Insufficient knowledge
about tuberculosis, including its treatment, may complicate treatment compliance. One of the
biggest obstacles to TB therapy is non-adherence to treatment (Gopi et al., 2007). The frequency
of TB-related deaths has already decreased since DOTS was introduced, and good treatment
success has been linked to the use of Directly Observed Treatment Short-Course (DOTS) in the
public sector. Ensuring that patients take their medications as prescribed remains a significant
difficulty in the treatment of tuberculosis. Still, 5,000 7,000 people lose their lives each year
(Nepal et al., 2012).

The World Health Organization defines medication adherence as "the extent to which an
individual's behavior aligns with the established guidelines from a healthcare provider." Long-
term infectiousness, drug resistance, relapse, and death are all consequences of the lengthy course
of TB treatment, which increases the chance of treatment stoppage or default (C et al., 2022).

Due to adherence problems and the emergence of multi-drug-resistant strains of Mycobacterium

tuberculosis, the cure rate for smear-positive pulmonary tuberculosis in Africa is lower than the
global cure rate (54% 74%) compared to 84% globally (Castelnuovo B, 2010). Multi-drug-
resistant mycobacteria are on the rise throughout the continent as a result of patients not adhering
to their anti-TB treatment and poor compliance. Although national programs may have different
definitions of defaulters, the WHO defines default as a treatment interruption of two consecutive
months or more following at least one month of treatment (Castelnuovo B, 2010).

11
The incidence of TB patient follow-up losses in sub-Saharan Africa is significant, ranging from
11.3 to 29.6%. Numerous interrelated factors impact TB patients' adherence to therapy, according
to research. Some of the factors that have been empirically shown to affect drug adherence include
lack of knowledge about TB in general and treatment regimen and length in particular; loss of
employment or opportunity to work and resulting financial difficulties issues and lack of access to
health services; social stigma and discrimination; side effects of medications; long treatment
(Mukasa et al., 2020)
(Gebreweld et al., 2018). east-northwest region. demonstrates that 86% of all cases
enrolled in the DOTS program received successful treatment in the East Gojjam zone.
Additionally, factors that significantly impacted the success of TB treatment outcomes in the study
area included sex, place of residence, educational status, smear results obtained at the time of
DOTS program entry, and HIV test results (Meseret Tadele et al., 2022).

The Somali populace is well-versed in the symptoms and indicators of tuberculosis. Nonetheless,
there are differing opinions about how diseases are spread and treated, including traditional beliefs
and Western biomedicine. Smear-positive and smear-negative patients are segregated in inpatient
wards as part of the project's infection control measures. Additionally, other infection control
measures like cough triage, separating coughing patients, or per cent suspected or confirmed TB
cases to wear surgical machi-squaring areas are not used because of the high levels of stigma.
Nonetheless, all medical institutions have outdoor waiting areas, and health education includes
infection control instructions regarding cough hygiene. It has been difficult to make sure that
employees wear high-filtration masks when responding to suspected or confirmed TB cases
(Liddle et al., 2013).

The new cases were substantially more regimen-compliant than retreatment cases, and the majority
of the complying patients (83.87%) were receiving Category 1 treatment. In addition, the study
demonstrated that treatment adherence was considerably improved when there were no issues with
medicine consumption (Gopi et al., 2007).

12
2.3

availability and accessibility factors.

2.3.1 Sociodemographic factors

The sociodemographic characteristics of the patients, their age, gender, religion, community,
education, occupation, and income, were taken into consideration in this study in order to
determine how treatment adherence was affected. Males made up 91.18 per cent of the non-
adherent patients in the study, and a chi-square test with Yates correction indicated a strong
correlation between participants' gender and treatment adherence (Gopi et al., 2007).

According to a previous study on the sociodemographic and economic characteristics of patients

in India who were part of the DOTS program, 71% of the patients were men, 39% were over 45,
39% were illiterate, and 35% were unemployed. The patients' lifestyle markers included being a
smoker (41%) and an alcoholic (31%). (Gopi et al., 2007). However, compared to older age groups,
the younger (15 45) age group had a noticeably better rate of adherence/compliance. This study
was conducted in Nepal's Palpa District. (Nepal et al., 2012). Alcohol use was habitual for 41.18
per cent of the non-compliant patients, and it was considerably higher in the non-adherent group.
However, there was no correlation between treatment adherence and tobacco use (Gopi et al.,
2007).

In Ethiopia, the odds of successful TB treatment outcomes were 1.95 times higher for male DOTS
program participants from urban areas than for those from rural areas. The odds of successful TB
treatment outcomes were 3.92 times higher for male DOTS program participants with non-reactive
HIV test findings than for those with reactive HIV test results. The odds of successful TB treatment
outcomes were also 6.09 times higher for male TB patients who were enrolled in the DOTS
program and had positive pulmonary TB results than for those who had extrapulmonary TB
(Meseret Tadele et al., 2022). However Ethiopian female TB patients with the ability to read and
write in their educational background during enrollment in the DOTS program were 1.81 times
more likely to have successful TB treatment outcomes compared to those female patients without

13
the ability to read and write in their educational background during enrollment in DOTS program
(Shargie & Lindtjørn, 2005).

Patients with greater family incomes showed a higher percentage of DOTS compliance, according
to family income levels. According to that study, there is a substantial correlation between patient
compliance and family income in Palpa District, Nepal (Nepal et al., 2012). The majority of
patients in Asmara, Eritrea, reported that one of their biggest issues throughout treatment was
losing their job or the chance to work. After receiving their diagnosis, many said they lost their
jobs, were too sick to work, or couldn't obtain regular employment due to the lengthy treatment
plans (Gebreweld et al., 2018).

Compared to males in Uganda, men in Somalia are more likely to become drug defaulters for
tuberculosis because Somalian men do not take the illness seriously, and once they feel better, they
will stop using the drugs because of how long they must take them. Additionally, a study conducted
in Kenya revealed that the Somali community has lower levels of education than Kenyans,
indicating that illiteracy is a significant factor in the failure to take TB medicine (Hussein et al.,
2021). Furthermore, prior research in Somalia and other countries has found a link between poor
TB outcomes and low socioeconomic features, such as household income and medical expenses.
Recent research has also shown a greater probability of unsuccessful TB in relation to lifestyle.
Males made up about 78% of the study participants. 73% were unemployed, and nearly one-third
(36.5%) lived in a household with nine or more people (Sheikh et al., 2021). According to Somali
staff during informal interviews, the primary reasons for defaulting were: patients from nomadic
groups; the stress of being separated from family (e.g., the husband asking the wife to return);
socioeconomic factors like the cost of the trip or the necessity of returning to grazing land for
farming and cattle raising; feeling better; or not believing in the treatment (Liddle et al., 2013).

The WHO End TB Strategy target of zero is far from being met by the approximately 50% of TB
patients and their households who experience catastrophic total costs (direct medical expenses,
non-medical expenses, and indirect costs like income losses) that exceed 20% of yearly family
income. This demonstrates that there are significant financial and economic obstacles to receiving
and finishing TB treatment, which must be removed by accelerating the transition to universal
health coverage and improving social protection (WHO, 2023).

14
2.3.2

Treatment adherence was unaffected by knowledge of the disease's etiology and mechanism of
transmission. In the West Tripura District of India, the majority of complying patients (58.10%)
were statistically significant in their understanding of disease transmission prevention. (Gopi et
al., 2007). Nevertheless, more than 50% of the patients had misconceptions about how TB spreads,
how to avoid it, and the effects of irregular and insufficient therapy. Few of them knew about the
adverse effects of the medications (Nepal et al., 2012). Once more, 53.23 per cent of patients who
were adherent knew the right amount of time for therapy. Additionally, patients who believed
incorrectly that the disease was cured when symptoms subsided were more likely to follow the
regimen, and patients who were aware of monitored therapy were far more likely to do so (Gopi
et al., 2007).

Patients' Awareness of the Mode of TB Transmission and the Significance of TB Treatment in

Mogadishu, Somalia with a 95.1% awareness rate, the majority of individuals understand the
significance of TB treatment, whereas just 4.9% of people are unaware of this fact (Hussein et al.,
2021). Compared to their counterparts, patients with inadequate awareness of TB symptoms were
3.16 times more likely to experience a delay throughout a 50-day period. Additionally, a patient
delay of more than 120 days was predicted by a lack of knowledge about the symptoms of
tuberculosis, a failure to make one's own decisions regarding TB treatment, and a lack of awareness
that biomedical treatment, rather than traditional treatment, is an option for treating tuberculosis.
conducted in Mogadishu's dot centers (Sheikh et al., 2021).

The responders in Eretria lacked a general understanding of tuberculosis. The majority of patients
were either unaware of the etiology of the disease, its route of transmission, or the duration of
treatment. Respondents and key informants most frequently cited the patient's "feeling cured" as
the reason for stopping therapy (Gebreweld et al., 2018).

Lack of awareness of the adverse effects of the anti-TB medication regimen of pyrazinamide (Z),
ethambutol (E), rifampicin (R), and isoniazid (H) for patients with drug-susceptible TB (WHO,
2023). It resulted in the delayed reporting of side effects; an anti-TB medication is a combination
medication used to treat tuberculosis, and because of its metallic taste, it can trigger nausea and
vomiting. This patient was obviously unaware that the issues she was experiencing were caused

15
by the adverse effects of the anti-TB medication. This indicates that a high treatment defaulter rate
and a low cure rate were caused by a lack of awareness of the adverse effects of TB medications
(Serapelwane et al., 2016).

The percentage of DOTS compliance was higher among TB patients with a high understanding of
TB and its treatment than among those with moderate and poor knowledge. Accordingly, patient
compliance was significantly correlated with the degree of patients' knowledge about tuberculosis
and its treatment (Nepal et al., 2012). Patients who believed that the disease was cured when
symptoms subsided were more likely to follow their treatment plan, and those who were aware of
supervised treatment were significantly more likely to do so (Gopi et al., 2007). Addressing the
comparatively high risk of treatment failure noted in our study requires close monitoring of TB
patients and health education to increase understanding. MDR-TB has a tendency to rise if such a
high treatment failure rate for TB is not reduced (Kassim et al., 2021).

2.3.3 Available factors

For the purpose of marketing and implementing DOTS, the Program created the technical
guidelines and training materials that were required. With a focus on the major nations with the
highest TB burdens, GTB simultaneously started providing more extensive technical assistance to
more than 60 countries. In 1990, there were just ten countries utilizing DOTS; by 1997, there were
102. Less than 1% of patients were treated via DOTS in 1990, although that number rose. (WHO,
1999).

Despite the availability of free TB treatment, financial issues (such as transportation fees) may still
have an impact on treatment adherence. In order to motivate patients to adhere to therapy, the
WHO-TB treatment guideline suggests that they be given incentives (Gebreweld et al., 2018).
Approximately 73% of patients who saw their treatment supervisor at each appointment complied
with their treatment, compared to 47.8% of patients who did not. Therefore, there was a strong
correlation between patients' compliance and the availability of their treatment supervisor, with
noncompliance being higher (52.2%) among those who did not meet their supervisor at every visit
(Gebreweld et al., 2018). The rise in patients' adherence to treatment was explained by the health
education provided by the treatment supervisor at each session., (Meseret Tadele et al., 2022).
When it came to therapy supervision, statistical analysis revealed that patients whose treatment

16
was supervised during the intensive and continuation phases of treatment had a noticeably higher
adherence rate (Das et al., 2015).

2.3.4 Accessibility factors

Patients were found to be walking great distances to the health Centre during the interviews. These
observations support Govender and Mash's (2009) findings that the distance to and from the
hospital was a major predictor of treatment default. The results of this study unequivocally
demonstrate that patients with tuberculosis in rural areas lacked access to health treatments.
(Serapelwane et al., 2016).

In Asmara, for transportation the majority of participants stated that being able to follow their
treatment plan was made easier by the clinic's distance. But few patients from the Asmara-area
communities cited transport as a problem. Rather than that, several patients said that the daily costs
for six months are difficult, especially with the availability of car services (Gebreweld et al., 2018).
the study found a substantial correlation between improved compliance and trip duration. Patients
with tuberculosis who travelled for treatment in less time (74.2%) had a higher percentage of
patient compliance than those who travelled for more time (more than 30 minutes). (Nepal et al.,
2012).

Social support: Because they nearly entirely make up for lost income, family and community
support are crucial during treatment. Many of the patients received financial assistance for
transportation, and others received physical assistance for walking to the clinic. One of the biggest
obstacles to TB treatment adherence was discovered to be a lack of social support. Approximately
50% of the patients in this study had no family or community support, either financially or
socially.(Gebreweld et al., 2018).

17
CHAPTER 3: RESEARCH METHODOLOGY

3.1 INTRODUCTION

This chapter describes systematically introduction, study design, study area, Study population,
Sample technique, Sample size, Research instrument, Data collection, Data analysis, Ethical
consideration, and Questionnaire.

3.2 STUDY DESIGN

This study applied a quantitative method, a questionnaire-guided cross-sectional survey among

DS-TB patients registered under DeMartini hospital, Forlanini hospital and Gulled specialist
hospital in Mogadishu, Somalia. Because a cross-sectional study is a research design in which data
is collected from various individuals at a single point in time. it is used to study multiple entities
in depth in order to gain insight into the larger case and to describe and explain rather than predict
a phenomenon.

3.3 STUDY AREA

In Mogadishu, there are more than 17 TB Centers, three of them were selected. Among the
hospitals we had conducted the study were DeMartini hospital, Forlanini hospital and Gulled
specialist hospital in Mogadishu, Somalia.

DeMartini hospital located Hamar-Wayne district in Banadir region. It established in 1992 by

Italian colonialists, it's main public hospital into comprehensive healthcare provider, renowned for
its critical care, chronic illness management and disability support under the ministry of health
Somalia. Despite the extensive damage during the civil war, the hospital was reconstructed and
reopened in December 2016.

Forlanini/Lazaretto hospital is a government hospital under the ministry of health, it was built by
Italian government in February 1924. It is located in Banadir region of Abdul-Aziz district. The
hospital contains three partially functional parts that require renovation, as well as one newly

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repaired emergency department, Mental health department, TB MDR treatment, COVID-19
section.

Gulled specialist hospital was founded 2002 as an outpatient clinic by Ahmed Y. Gulled. At that
time there was a wide spread misuse of medications specially TB treatment that was detrimental
to the health of the people and drug resistance.

3.4 STUDY POPULATION

DS-TB outpatients (> 18 years), who started treatment at one of the three selected hospitals, with
at least three consecutive weeks took the drug. with DS-TB, both pulmonary and extra-pulmonary,
and who were registered with the TB-DOT clinic of the hospitals.

3.4.1 Inclusion criteria

The inclusion criteria included the following: (1) newly diagnosed DS-TB outpatients, whether in
the intensive or continuation phase. (2) Men and women of both sexes who are older than or equal
to 18 (3) individuals without a mental illness who have started using anti-TB medications, (4)
patients who are able to converse effectively and comprehend the questionnaire's contents, and (5)
patients who voluntarily agree to take part in this study and are able to communicate their true
opinions on the issue.

3.4.2 Exclusion criteria

exclusion criteria included the following: (1) MDR-TB patients, as well as pregnant mothers
whose health may require a modification of the usual TB medication schedule. (2) TB patients
who were critical condition at the time of the study, (3) patients greater than 70 yrs who were
physically weak and uncooperative towards the study, (4) patients with disability conditions, and
(5) those who declined to participate in the study were excluded.

3.5 SAMPLING TECHINUQUE

As mentioned in study population, the target population of this study was the population of TB
patients at selected hospitals in Mogadishu, Somalia. The study used probability; we took simple

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random sampling to select the respondents of the research. because they give equal chance of
representation to every subject. TB patients were chosen from each institution according to a
proportionate representation of all TB patient records at each hospital before data collection. Thus,
(80 for Forlanini hospital, 70 for gulled specialist hospital, 46 for DeMartini hospital) TB patients
were randomly selected from Forlanini/lazaretto, Gulled and DeMartini hospital, respectively.

3.6 SAMPLE SIZE DETERMINATION

To calculate the minimum required sample size for the study, we took estimated proportion of 85%
which has confidence level of 95% and absolute precision of 5%, by using the Denial Formula for
proportions, which is a simplified way to calculate the sample size for surveys or studies:

Were

n = required sample size, Z= z-score of confidence level (1.96 for 95%), p = estimated proportion
(0.85 for 85%), d = is absolute precision (0.5 for 5%).

So, the minimum required sample size is approximately 196 patients.

3.7 RESEARCH INSTRUMENT

Data collection was carried out with observation along the areas of study, sitting questionnaire that
were valid and had reliable for requiring population questionnaire checked from any error and then
finally disturbed.

3.7.1 Validity

Quality of instrument was assessed on content validity before being implemented for the data
collection. The content validity was assessed by experts included Supervisor, co-advisor thesis
Research Expert. Pre-testing was carried out to find the mistakes and deceptive questions after the
target sample size was established. Following the pre-testing, all of the errors were eliminated.
Then, structured questionnaires covering a wide range of demographic variables were used to

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collect the data. Ten percentage for TB patients in the same research locations pre-tested our
questionnaire.

The questionnaire translates into local language Somalia to ease understanding. The privacy of
respondents was strictly be maintained. The data was checked frequently after completing the
interview

3.7.2 Reliability

Reliability of respondents through the instruments of the questionnaire was established. Prior to
actual use, a standard test and retest were conducted to guarantee the data's reliability. Some
modifications, including rewording the questions, might be made. Respondent confidentiality is
guaranteed in the questionnaire and by the researcher to prevent subject or participant bias, which
is one of the risks to reliability.

3.8 DETA COLLECTION

Structural questionnaires were used to collect primary data. The questionnaire was designed after
we reviewed a lot of the literature. Close ended questions were used to identify the Factors
affecting patient adherence to DOTS in Mogadishu Somalia. The questionnaire has six sections
including; Section A; socio-demographic characteristics such as age, sex, educational
qualification, occupation and marital status, and residence. Section B; contained questions that
uggested preventive measures, as well as TB
medications and other adjuncts being taking by the patients. Section C; focused on behavioral &
cultural factors, like family support, advice of health care providers, stigma of the surrounding
community. Section D; focused on accessibility of DOTs centers, in way of; transportation type,
time it takes to reach. While Section E; focused largely to explore the availability of DOTS service,
in term of available health education, and difficulties faced to get DOTS service. Finally, Section
F; we used MMAS 8 items which contains 8 questions. Each question has to choose or
o all 1, and 0 for negative responds, except the
last question which is inverse. (See questionnaires).

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So, scores more than five was identified as high adherence while less than five was rigorized as
low adherence.(Xu et al., 2017). In our study the patient who completed the drug signed as
adherences to DOTs program and others as non-adherent to DOTs program.

3.9 DATA ANALYSIS

When the questionnaires were collected by using google form, we checked the completeness of
questionnaires and eliminated illogical data. After ensuring that the questionnaire was complete
and correct, all data were entered an excel database and SPSS version 26.0 software was used for
statistical analysis. Descriptive statistics include frequency and percentage, and Chi-square tests
were used to evaluate the relationship between differences in the categorical data between different
groups, with P-Values of 0.05 showing statistical significance by used multiple logistic regression.
Data were presented with tables.

3.10 ETHICAL CONSIDERATION

We obtained approval the Somali National University research manual Board and administrations
of the hospitals, in order to ensure compliance with the codes of conduct in this research. The
participants are free to opt in or out of the research, experiment or study at any given stage. The
participants are made aware of the purpose, benefits, risks and funding before agreeing or declining
to join. We also made oral consent from participants to proof their willing to cooperate, and that
they are coursed in any way.

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