i
FACTORS AFFECTING ADHERENCE TO TUBERCULOSIS MEDICATION AMONG
TUBERCULOSIS PATIENTS IN MIATHENE LEVEL IV HOSPITAL,
MERU COUNTY
GROUP MEMBERS:
ERIC JOSEPH KIRAGU KARANJA
-
HS203/101558/19
BETTY KORIR
-
HS203/101435/19
EMANUEL MWENDA KIRIMI
-
HS203/100041/19
WAFULA EMMANUEL JUMA
-
HS203/101531/19
KEVIN KIPROTICH TONUI
-
HS203/101431/19
AUGUST 2023
A RESEARCH PROJECT SUBMITTED IN PARTIAL FULFILLMENT FOR THE
REQUIRMENTS FOR THE AWARD OF THE DEGREE OF BACHELORS OF
CLINICAL MEDICINE AND COMMUNITY HEALTH IN THE SCHOOL OF HEALTH
SCIENCES OF MERU UNIVERSITY OF SCIENCE AND TECHNOLOGY.
ii
DECLARATION
We, hereby declare that this research proposal our original work, and has not been submitted to
any university or institution of higher learning for any academic award.
NAME
REG. NUMBER
SIGN
DATE
WAFULA EMMANUEL JUMA
HS203/101531/19
……………...
…………………
ERIC JK KARANJA
HS203/101558/19
……………...
…………………
BETTY KORIR
HS203/101435/19
……………...
…………………
EMANUEL MWENDA KIRIMI
HS203/100041/19
……………...
…………………
KEVIN KIPROTICH TONUI
HS203/101431/19
……………...
…………………
SUPERVISOR:
NAME
SIGN
DR. DOROTHY KAGENDO
…………….
DATE
…………………………….
Lecturer, Department of Clinical Medicine and Community Health, Meru University of Science
and Technology.
iii
DEDICATION
We dedicate this work to the Almighty God for His provision, protection and guidance throughout
our experience in the University. We also dedicate this research proposal to our loving, comforting
and very supportive parents for their constant support towards our education and moral
uprightness. We also dedicate this research proposal to our lecturers for their continued guidance
and motivation throughout our course work. Lastly, we would like to dedicate this research
proposal to all patients with Tuberculosis throughout their struggle in seeking treatment.
iv
ACKNOWLEDGEMENT
We acknowledge the Dean, School of Health Sciences and the C.O.D of Clinical medicine for
equipping us with skills and potential to propose this research activity.
We also acknowledge and render our heartfelt gratitude to our supervisor, Dr. Dorothy Kagendo
who made this proposal possible. She has been friendly and her guidance and expert advice has
been unmeasurable throughout the undertaking of this proposal.
Much appreciation to group members, they have played a very important role in our academic
journey through their cooperation.
v
Table of contents
Contents
DECLARATION ............................................................................................................................................... ii
DEDICATION ................................................................................................................................................. iii
ACKNOWLEDGEMENT .................................................................................................................................. iv
Table of contents .......................................................................................................................................... v
LIST OF ACHRONYMS .................................................................................................................................. vii
DEFINITIONS OF OPERATIONAL TERMS ..................................................................................................... viii
ABSTRACT..................................................................................................................................................... ix
CHAPTER 1: INTRODUCTION ......................................................................................................................... 1
1.1 Background Information ..................................................................................................................... 1
1.2 Problem Statement ............................................................................................................................. 2
1.3 Justification ......................................................................................................................................... 2
1.4 RESEARCH QUESTIONS........................................................................................................................ 3
1.5 GENERAL OBJECTIVES ......................................................................................................................... 3
1.5.1 SPECIFIC OBJECTIVE ..................................................................................................................... 3
1.6 SIGNIFICANCY OF THE STUDY ............................................................................................................. 4
1.7 LIMITATIONS OF THE STUDY ............................................................................................................... 4
1.8 DELIMINATIONS OF THE STUDY .......................................................................................................... 4
1.9 Conceptual Framework ....................................................................................................................... 5
CHAPTER TWO LITERATURE REVIEW ............................................................................................................ 7
2.1 Introduction ........................................................................................................................................ 7
2.2 TB Treatment adherence .................................................................................................................... 7
2.3 Individual factors and TB treatment adherence ................................................................................. 8
2.4 Behavioral factors affecting TB treatment adherence........................................................................ 8
2.5 Societal factors and TB treatment adherence .................................................................................... 9
2.6 Health facility factors and TB treatment adherence .......................................................................... 9
2.7 Challenges in TB treatment ................................................................................................................. 9
CHAPTER THREE: METHODOLOGY .............................................................................................................. 11
3.1 STUDY AREA ...................................................................................................................................... 11
vi
3.2 STUDY DESIGN................................................................................................................................... 11
3.3 TARGET POPULATION ....................................................................................................................... 11
3.4SAMPLING SIZE DETERMINATION ...................................................................................................... 11
3.5 SAMPLING TECHNIQUES ................................................................................................................... 11
3.5.1SAMPLING METHOD .................................................................................................................. 12
3.6INCLUSION AND EXCLUSION CRITERIA .............................................................................................. 12
3.6.1 INCLUSION CRITERIA ................................................................................................................. 12
3.6.2 EXCLUSION CRITERIA ................................................................................................................. 12
3.7 DATA COLLECTION TECHNIQUE ........................................................................................................ 12
3.8 DATA ANALYSIS AND PRESENTATION ............................................................................................... 12
3.10 STUDY QUALITY CONTROL .............................................................................................................. 12
INSTITUTIONAL CONSENT .................................................................................................................. 13
INFORMED CONSENT AND CONFIDENTIALITY .................................................................................. 13
RISKS ................................................................................................................................................... 13
BENEFITS ............................................................................................................................................. 13
ITEMIZED BUDGET ...................................................................................................................................... 15
References .................................................................................................................................................. 16
APPENDIX .................................................................................................................................................... 17
1.QUESTIONNAIRE .................................................................................................................................. 17
Section A ............................................................................................................................................. 17
vii
ACT
LIST OF ACHRONYMS
Artemisinin combination therapy
ARV
Antiretroviral therapy
DOTS
Directly observed treatment, short course (referring to the internationally approved
tuberculosis treatment strategy)
IEC
Information, education, communication
IRS
Indoor residual spraying
MRD-TB
Multi-drug resistant tuberculosis
RDT
Rapid diagnostic testing
TB
WHO
Tuberculosis
World Health Organization
viii
DEFINITIONS OF OPERATIONAL TERMS
Adherence: an extent to which person’s behavior, taking medication, following diet, and/or
executing lifestyle changes, corresponds with agreed recommendations from health care provider
Average adherence Patients who scored one (1) on Morisky Medication adherence scale during
time of study
Behavioral factors: These are factors that are derived from Health Belief Model (HBM) as
determinants of health behavior that are oriented to personal beliefs or perceptions and beliefs
about a particular disease or event and the way that it will be done to reduce the occurrence. These
are perceptions in the health belief model that influence behavior during treatment
Continuation phase: This is the second phase of TB treatment for 28 weeks with isoniazid and
rifampicin.
Defaulters: Patients who fail to take prescription as prescribed by Health care providers
Full adherence: Patients who scored zero (0) on Morisky Medication adherence scale during time
of study
Individual factors: These are socio-demographic factors and level of knowledge that influences
TB treatment at personal level.
Loss to Follow-up: These are TB patients enrolled in TB care who have missed two consecutive
appointments and are not accounted for.
Poor adherence Patients: who scored two and above (>2) on Morisky Medication adherence
scale during time of study
Societal factors: These are factors that revolve around how people relate with each other and
their beliefs.
Tuberculosis: Tuberculosis is a bacterial infection that mainly affects the lungs. TB is
transmittable between one person and another. TB is preventable and curable with a six-month
regime medication.
ix
ABSTRACT
Tuberculosis (TB) is a global public health problem. This is, despite numerous interventions in
place to reduce its spread and burden among the poor. Mycobacterium Tuberculosis (MTB), being
a treatable, curable and preventable disease, there has been very minimal decline TB incidence in
the past years, with over 4 million cases lying undiagnosed and untreated Worldwide TB is the
13th leading cause of death and second leading infectious killer after COVID 19. A total of 1.6
million died from TB in 2021. OF the total there is 6 million men 3.4 million women and 1.2
children. Multidrug resistant tb remains public health crisis and health security threat. Ending of
epidemic is among health targets of SDGS. In Africa it is the 9th leading cause of death and
infectious after HIV/AIDS with 2.5 million cases. An estimated 417000 people died from tb in
Africa. SINCE 2016. In Kenya approximately 140000 people fell ill with tb in 2020 and only
72943 people were diagnosed and treated. last year Meru ranked as second Kenya tb burden with
3818number of cases. TB has no empirical measure for treatment adherence Meru County has
case notification rate of 189/100000 which are higher than the national standing of 154/100000
Tigania west sub county reported low treatment success rate and cure rate of 68% and 68%
respectively which are way below the national target of 90% cure rate, less than 5% loss to followup (LTFU), <5% TB deaths and 0% patients not accounted for. Further in the recent years there
has been increasing loss to follow up cases of 8% in 2017, to 42% in 2018 as reported by TIBU.
In this study we adopted a descriptive cross-sectional study to determine individual factors,
behavioral factor, societal factors and health facility factors that influence TB patients into
adhering to treatment in Tigania west sub county, Meru County. The data was collected from
structured questionnaire from Morisky adherence scale and focused group discussion and study be
pretested in Meru County Referral Hospital-TB clinic for Validity and reliability.
Sociodemographic factors like living with family and level of knowledge on TB specifically what
causes TB, who can get TB and duration of treatment were associated with TB treatment
adherence. Behavioral factors of perceived severity, perceived susceptibility, Societal factors like
stigma and health facility factors like patients’ satisfaction were factors associated to TB treatment
adherence
1
CHAPTER 1: INTRODUCTION
1.1 Background Information
Tuberculosis (TB) is the leading cause of single infectious agent deaths worldwide, surpassing
malaria and human immunodeficiency virus (HIV/AIDS), with co-infected individuals 20 to 30
times more likely to develop active TB (Boehme, 2022).
Despite the fact that tuberculosis is a treatable, curable, and preventable disease, TB incidence has
decreased by less than 2% in recent years, with over 4 million cases remaining undiagnosed and
untreated Gelmanova, 2022). Adherence to TB drugs has been shown to be a single factor
associated with treatment outcome in the phase III trials of fluoroquinolone (Boehme, 2022).
According to the World Health Organization 2019, poor TB treatment adherence is still a major
barrier to TB eradication. TB treatment adherence is multifaceted and complex, influenced by
individual, family, organizational, and policy factors. Despite the fact that different countries have
adopted standard international guidelines in TB diagnosis, monitoring, and treatment, most
patients are exposed to poorly organized and monitored programs, resulting in insufficient TB care
and the development of drug resistant strains, which hinders effective TB control (Gelmanova,
2022) . Tuberculosis eradication is one of the targets in the recently established Sustainable
Development Goal (SDG) three, which aims to address limitations in TB care by involving the
community at large rather than just focusing on decentralizing TB care in health facilities
Community health volunteers (CHV) were initially used to provide primary care services as well
as promote and preventive health, and patients who use CHVs adhere to treatment better and have
a higher cure rate (Boehme, 2022). If communities are empowered with TB knowledge and fully
implement the community Directly Observed Therapy Short-course (DOTS) strategy, they can
play a critical role in TB care by detecting new TB cases and improving treatment adherence
(Gelmanova, 2022). Kenya's national TB program has a policy in place that encourages health care
workers to use CHVs in the DOTS strategy, though implementation has been limited due to the
policy's unsustainable nature. The provision of incentives to CHVs is critical to the sustainability
and effectiveness of a community program's TB management. In recent years, Sub-Saharan Africa
has seen a decline in volunteerism as people use their time to earn a living.
2
Tuberculosis (TB) is the second leading cause of infectious death in Kenya, responsible for 12.6%
of all such deaths in 2020, according to the WHO. Source: WHO (2021). "Global Health
Observatory (GHO) data: Kenya." https://www.who.int/gho/tb/epidemic/cases_deaths/en/. WHO
2019 estimates that the number of TB cases is much higher than previously reported, with roughly
half of those reported missing each year. The End TB Strategy 2015-2035 aimed to reduce TB
incidence rates to 20% (85/100,000) by 2020 and TB deaths by 35%. The National Tuberculosis
Program in Kenya provides free tuberculosis treatment for six (6) months, divided into two phases:
intensive and continuous.
Despite the fact that TB treatment in Kenya is free, other TB management services, such as chest
X-rays, are not; there is also a need to maintain a balanced diet with vitamin supplementation while
on medication, making TB care expensive (Gelmanova, 2022).
1.2 Problem Statement
Poor adherence to TB treatment is a major impediment to a successful TB fight (Boehme, 2022).
The most common reason for nonadherence is a lack of knowledge about the importance of
treatment, disease transmission, and prevention, despite the fact that most people have a general
understanding of what TB is, which leads to poor health seeking behavior and medication
adherence (Harausz, 2022).
Lost to Follow Up (LTFU) is a common cause of medication non-adherence, resulting in low
treatment success rates, low treatment cure rates, and a high number of LTFU cases. Miathene
subcounty hospital is estimated to have adherence rate of 42%. It is speculated that Miathene
subcounty hospital may have treatment success rate and a treatment cure rate both of which are
significantly lower than the national target. This research purposes to confirm these claims and
estimate levels of increase in LTFU cases in Tigania sub county.
1.3 Justification
According to Kenyan National TB guidelines, TB treatment success is defined as 90% cure rate,
less than 5% loss to follow-up (LTFU), 5% TB deaths, and 0% patients not accounted for in order
to achieve the End TB strategy 2035. TB treatment adherence is complex and multifaceted in and
of itself; however, in order to meet national TB control targets, we must understand the factors that
3
prevent patients from completing their medication as well as those that assist them in completing
their treatment. Despite numerous interventions to improve adherence, the increasing number of
missed appointments and poor treatment outcomes in recent years is concerning. This suggests a
mismatch between current TB interventions and expected outcomes.
The goal of these studies is to identify factors that influence TB treatment adherence and to be able
to suggest better approaches and interventions that address these issues to TB advocates and
policymakers for better TB management.
1.4 RESEARCH QUESTIONS
1. What behavioral traits are linked to TB treatment adherence in Miathene Subcounty
hospital patients receiving anti-TB medications?
2. What personal characteristics affect the adherence of TB patients in Miathene Subcounty
hospital to their anti-TB medications?
3. What social determinants of TB treatment affect adherence among Miathene Subcounty
hospital patients taking anti-TB medications?
4. What are the health facility elements affecting Miathene Subcounty hospital residents who
use anti-TB medications to adhere to their TB treatment regimens?
1.5 GENERAL OBJECTIVES
To determine factors that influence TB treatment adherence among patients taking anti-TB drugs
in Miathene Subcounty hospital Tigania west Subcounty, Kenya.
1.5.1 SPECIFIC OBJECTIVE
1. To identify behavioral factors associated with TB treatment adherence in Miathene
Subcounty hospital patients taking anti-TB drugs.
2. To identify personal characteristics that affect TB patients in Miathene Subcounty hospital
who are using anti-TB medications in regards to treatment adherence
3. To identify the health facility factors influencing the patients in Miathene Subcounty
hospital who are using anti-TB medications to stick to their TB treatment regimens.
4. To identify social elements that affect TB patients in Miathene Subcounty hospital who are
using anti-TB medications in terms of treatment adherence.
4
1.6 SIGNIFICANCY OF THE STUDY
The most crucial element in determining the success rate of TB treatment is treatment adherence.
Improved treatments, strategies, and policies addressing non-adherence to TB medications has
been developed with the help of a greater knowledge of the factors that influence treatment
adherence. This has improved TB medication adherence, raise treatment success rates, and
decrease the incidence of TB and the emergence of MDR-TB. In order to achieve a world free
from TB, the study has been directed at healthcare professionals and TB campaigners.
1.7 LIMITATIONS OF THE STUDY
Self-reported data: Patients may not accurately report their adherence to treatment, leading to
inaccurate data.
Recall bias: Patients may not accurately recall their medication-taking behavior, leading to
inaccurate data.
Selection bias: The study may not be representative of the entire population of TB patients, as the
sample may be biased towards patients who are more likely to adhere to treatment.
1.8 DELIMINATIONS OF THE STUDY
Gender and age: The study could be limited to a specific gender and age group, such as only
women or only patients over the age of 18, to ensure that the results are relevant to that population.
Type of TB: The study could be limited to a specific type of TB, such as pulmonary TB, to ensure
that the results are specific to that type of TB.
5
1.9 Conceptual Framework
The conceptual framework incorporate the Socioecological Model of Urie Bronfenbrenner and the
Health Belief Model of IM Rosenstock (Chakaya, 2022). (Harausz, 2022). Because the tenets of
both models are pertinent to and consistent with the goals of the study, these two theories have
been modified. The six constructs of the Health Belief Model (HBM) are perceived susceptibility,
perceived severity, health motivation, perceived benefits, perceived barriers, and cues for action.
These constructs are important in predicting and explaining behavioral and attitude factors during
TB treatment adherence (Chakaya, 2022). To understand the social determinants affecting TB
treatment adherence, a socioecological model was utilized.
The five hierarchical levels of the socioecological model (SEM) are individual, interpersonal,
community, organization, and policy. These levels affect how patients decide to follow their TB
treatment regimens (Harausz, 2022). Despite intervening elements like policies in existence,
individual characteristics, behavioral factors, societal factors, and health facility factors were
independent variables that affect TB treatment adherence.
6
Independent Variable
Intervening Variable
Dependent
Variable
Individual Factors
Age
Sex
Marital status
Knowledge on TB
Behavioral factors
Perceived severity
Perceived susceptibility
Perceived benefits
Perceived barriers
Cues to action
Self-efficacy
Societal Factors
Patient Referral
Family dots
Stigma
Health facility factors
Time
Cost
Presence of drugs
Facility DOTS CHV
Figure 1: Conceptual Framework.
Policies on TB
management
TB Treatment adherence
-Medication adherence using
Morisky scale
7
CHAPTER TWO LITERATURE REVIEW
2.1 Introduction
According to the END TB strategy 2035, TB treatment adherence is the only element that affects
the outcome and success rate of the treatment. The WHO's end strategy's key tenet is patientcentered, however the majority of TB care and prevention programs are designed top-down rather
than placing them where the real TB patients are. Because of its multifaceted approach, including
the use of laboratories, x-rays, medicine supply, input from HCWs doctors, use of health education,
good follow-up by CHVs, and information systems, TB is a strong test for a functional health
system (WHO,2019).
2.2 TB Treatment adherence
TB treatment adherence ensures treatment success rates of up to 90% cure rate through
interventions such as patient education and counselling, enablers and incentives, psychological
interventions, and reminders. Non-adherence to TB medication contributes to low treatment
success rates and the emergence of MDR-TB (Hasan, 2022). Treatment adherence interventions
such as patient health education, reminders such as DOTs, and VOTs are used to increase TB
treatment adherence (DiNardo, 2022). Many resources have been directed to the Stop TB Strategy
by supporting the DOTS strategy. Although the DOTS strategy has been adopted and implemented
in some countries to improve TB treatment outcomes, some studies show that poorly implemented
DOTS and unmotivated TB focal persons are ineffective in improving treatment adherence
(DiNardo, 2022), (Hasan, 2022). No matter how much money is invested in these strategies, these
services will be insufficient if the patient does not adhere to treatment.
There are several methods for increasing patient adherence to TB treatment. Clinic-based DOT,
which requires the patient to travel daily to a health facility to be given medication, is one approach
used to increase treatment compliance among patients. It has proven to be costly and time
consuming, as well as inconvenient. Other methods include home-based DOT, in which a patient
is assigned an HCW, CHV, or family member to administer medication at home on a daily basis.
Bottle caps for electronics - This method is rapidly being adopted, as is the use of short message
service and/or video observed therapy.
8
2.3 Individual factors and TB treatment adherence
Socioeconomic context, poverty, religious beliefs, and distance to health facilities could be
common factors associated with TB treatment non-adherence and loss to follow-up (WHO, 2019).
Furthermore, (DiNardo, 2022) classified non-adherence factors as social factors, health system
factors, and individual factors. To address health system factors, for example, staffs were trained
on tuberculosis, which improved the quality of TB service delivery, making treatment adherence
one of the complicated health issues requiring a multifaceted approach and a functioning health
care system. This research focuses on finding out if sociodemographic factors such as individual’s
literacy levels, ability to afford food and money to cater for commuting during refills, can affect
TB treatment adherence. Patients who abuse drugs, alcohol, or khat are more likely to receive
default treatment.
TB is classified as either a primary cause of death or a contributing factor to death in the
International Classification of Diseases (ICD-10). The TB mortality rate is under documented
because HIV-positive deaths from TB are classified as HIV deaths. TB is responsible for one out
of every three HIV/AIDS deaths (WHO, 2019). When on TB treatment, being on ART has a
significant impact on reducing TB mortality in clinical settings. ART reduces TB death by 65%;
three-fifths of TB deaths are avoided by starting ARTs early in treatment (DiNardo, 2022). Various
models are used to identify and address TB treatment challenges. This study purposes to find out
if having more than one co-morbidity during the continuation phase of treatment may increase TB
treatment non-adherence (Jindani, 2022).
2.4 Behavioral factors affecting TB treatment adherence
When assessing behavioral compliance to TB medication, the Health Belief Model (HBM) better
defines behavioral factors. HBM influences the behavior of patients taking medication in studies
involving long-term disease therapy such as hypertension, HIV, and diabetes. HBM is influenced
by one's perception of information, the likelihood that one will be obedient to specific actions
based on his/her beliefs, and individuals' perception of disease threat and considering its benefits
(DiNardo, 2022).
Individuals' behavior is influenced by specific attitudes rather than a general attitude toward
something. Furthermore, beliefs, which are one's perception, influence behavior in addition to
attitude. Finally, specific attitudes and beliefs about a behavior cause one to behave in a particular
9
way. By directing positive beliefs, positive health behavior will be formed. Increasing patients'
confidence in medication adherence by increasing perceptions of susceptibility and severity,
perceived benefits and self-efficacy, and decreasing perceptions of barriers. Perceived barriers and
benefits are directly related to non-adherence, cue to action, and psychological distress influence
non-adherence via perceived barriers and benefits (Jindani, 2022).
2.5 Societal factors and TB treatment adherence
Stigma is defined as the process by which an individual is devalued because of a particular
condition. As a result of their condition, this situation marginalizes an individual, excluding them
from most social norms. One of the major factors that may influence patients' ability to adhere to
treatment is stigma, which includes social stigma, fear, patients' beliefs in traditional healing, and
discrimination (El Sahly, 2022).
This research found out that patients with supportive partners can adhere to their treatment more
than those with unsupportive partners or no partners at all, potentially removing additional barriers
(El Sahly, 2022).
2.6 Health facility factors and TB treatment adherence
Health facility factors include the amount of money spent on monthly visits, the time it takes to
receive service, the availability of drugs, the involvement of Facility DOTS and CHV, and patient
satisfaction. Patients who have a poor patient-provider relationship, poor communication between
health care workers, and a long wait for health care services at the health facility are more likely
to default treatment (Jindani, 2022).
Patients are expected to be given health information at each refill during treatment. Knowledge of
tuberculosis and the importance of adherence increases the likelihood of treatment adherence (El
Sahly, 2022). Treatment side effects, loss of income while on medication, and a lack of social
support are all barriers that could prevent TB treatment adherence (El Sahly, 2022), (Jindani,
2022).
2.7 Challenges in TB treatment
TB treatment takes at least six months to complete medication and is considered a long-term
treatment arrangement. If patients do not follow these treatment guidelines or do not understand
10
the importance of finishing treatment even if they feel cured, they will not adhere to treatment
(Kim, 2022).
Missing TB cases can also a significant setback in TB treatment. The TB missed cases are all
significant because they play a critical role in the community's continued TB transmission. Cases
of missing TB patients can be divided into three categories: those who did not seek care, those
who delayed seeking care, and those who sought care but did not receive a diagnostic result or
treatment (Kim, 2022). If there are no severe symptoms, patients may not seek acceptable medical
care; instead, during the early stages of the disease, most patients seek non-medical forms of
treatment such as herbalists and witchdoctors (Lange, 2022). They may postpone treatment due to
financial constraints or barriers to care. Some patients may seek care in a private facility and may
not have received diagnostic results or are not included in the national TB program. Patients
receiving private-sector treatment are more likely to have inappropriate TB testing or treatment,
and those who begin treatment are more likely to have incomplete treatment (WHO, 2019).
For this reason, the study purposes to unveil factors affecting adherence to TB treatment in patient
on anti TB drugs Miathene subcounty hospital
11
CHAPTER THREE: METHODOLOGY
3.1 STUDY AREA
The study was carried out in Miathene level IV Hospital, Meru County. The hospital is the only
hospital serving Miathene Area. It serves as a referral center for the lower health units in the region.
Therefore, the entire population of Miathene receives treatment at the hospital.
3.2 STUDY DESIGN
We used a descriptive cross-sectional study, exploratory in nature, and it employs primarily
qualitative and qualitative methodologies.
3.3 TARGET POPULATION
The study population was be for tuberculosis patients who are currently receiving treatment at
Miathene level IV hospital, Meru County.
3.4SAMPLING SIZE DETERMINATION
The Sample size was determined using Fischer et al (2003) formula when the sample size is less
than 10,000.
n = Z2PQD/d2
Where:
n = minimum sample size
Z = Standard score corresponding to a given confidence level. Confidence Level
or 5% level of significance (= 0.05), Z = 1.96.
P = Prevalence of TB adherence (0.42) q = (1 – p) or percentage of failure which
is (1-0.42)
d = Precision limit or proportion of sampling error which is usually 5% (0.05)
confidence limit.
(1.96*0.42*0.58*1)/(0.05^2) = 191
3.5 SAMPLING TECHNIQUES
The study used both probability and nonprobability sampling technique. Non-probability
technique of purposive sampling technique was be used to select a high number of registered TB
patients. Systemic random sampling was then used to select patients who participated in the study.
Simple random sampling technique was used to ensure all individuals have equal chances to
participate in the study.
12
3.5.1SAMPLING METHOD
The study involved the use of primary and secondary sources of data. We employed simple random
sampling method with all the patients who are currently on TB medication having equal chances
to participate. We had cut pieces of papers equal to the total number of patients on the TB register
and mark them with “yes” for those who was selected to participate and “no” for those who were
not selected participate in the research. These papers was then folded and mixed in a box. We then
followed the names from the register and pick the papers from the box to select the respondents
until all the respondents are obtained. Secondary sources of data,that were used included soft and
hard copies of data that were sorted from the data that were meant for other purposes that might
be found to be related to our area of interest.
3.6INCLUSION AND EXCLUSION CRITERIA
3.6.1 INCLUSION CRITERIA
All TB patients on the register who are currently on medication and receiving treatment at
Miathene level IV Hospital who consented to participate in the study were included.
3.6.2 EXCLUSION CRITERIA
All patients on TB medication at Miathene level IV Hospital that did not consent to participate in
study was excluded.
All TB Patients who were bed ridden and on intensive treatment at Miathene level IV Hospital,
Meru County.
3.7 DATA COLLECTION TECHNIQUE
We used health workers who are already involved in management in the hospital. We trained them
on the use of data collection tools. Interviews was conducted in the local language by interpreting
the questionnaires to the clients. We went go through each data collection tool to saw if filled
correctly and sorted them out.
3.8 DATA ANALYSIS AND PRESENTATION
We analyzed data manually by tallying and using simple electronic calculator to arrive at
the figures. The data presentation to be done in form of graphs, tables and charts.
3.9 DATA MANAGEMENT.
The raw data forms will be securely maintained to guarantee confidentiality and prevent data loss
during the study. Following data collection, a duplicate input of same data will be performed for
13
correctness. Data will be loaded into Microsoft excel and shown as tables pie charts and bar graphs
with frequencies and percentages. The information will be saved on a computer. Missing numbers,
excessive values and discrepancies will be found and fixed as part of data cleaning process. We
analyzed the data.
3.10 ETHICAL CONSIDERATION
INSTITUTIONAL CONSENT
Firstly, we must obtained a letter of introduction from the Head of Department faculty of clinical
medicine and community health of Meru University of Science and Technology. The letter was
then be presented to the office of the Hospital Administrator of Miathene Level IV hospital and
formal permission was granted before data collection started
INFORMED CONSENT AND CONFIDENTIALITY
We explained the purpose of the research to the respondents and formal consent to be obtained.
Confidentiality to be maintained during data collection, processing, analysis, discussion and
dissemination by ensuring that data collected was only be used for research purpose.
RISKS
We explained to the participants that there will be no risks since it was non-invasive and involves
answering questions only.
BENEFITS
We explained the following benefits of the study to the patient; improvement in patients’ care,
reduction on the cases of drug resistance TB, guide TB case detection and follow up, improve
working relationships between health workers, treatment supporters and patients and guide in
policy formulation on TB care.
14
TIME
JANUAR FEBRUA
MARC
APRI
MA
JUN
SEPTEMB
OCTOBE NOVEMB
DECEMB
FRAMEACTIVI
Y
H
L
Y
E
ER
R
ER
RY
TY
DURATION
RESEARCH
PROPOSAL
CONDUCTION
OF
PRETEST,
DATA
COLLECTION
AND
ANALYSIS
REPPRT
WRITING AND
FINDINGS
Figure 3: Work plan
KEY
ACTIVITY AND DURATION
ER
15
ITEMIZED BUDGET
ITEMS
QUANTITY
COST
OF TOTAL
ITEM
Transport
5
@1000
5000
Foolscaps
1 ream
@500
500
Pens
8
@20
160
Eraser
2
@20
40
Printing
30 pages
@20
600
Photocopy
150 pages
@3
450
Binding
2
@100
200
Sanitizer
5
@50
250
Lunch
5
@200
1000
Face Mask
1 carton
@500
500
GRAND
TOTAL
Figure 4: Itemized budget
8700
16
References
World Health Organization. (2019). Ending drug-resistant TB in WHO South-East Asia Region:
eleventh meeting of the regional MDR-TB advisory committee (rGLC SEAR) (No.
SEA/TB/373). World Health Organization. Regional Office for South-East Asia.
Boehme, C., Molnar, J., Peter, J., et al. (2022). Molecular detection of drug-resistant tuberculosis.
New England Journal of Medicine, 387(8), 751-752.
Chakaya, J., Lienhardt, C., Raviglione, M., et al. (2022). New tools for tuberculosis diagnosis,
care, and elimination. The Lancet Infectious Diseases, 22(3), e62-e72.
DiNardo, A., Merle, C., Pavlinac, P., et al. (2022). Clinical trial design considerations for TB
vaccine candidates: Perspectives from the Global TB Vaccine Partnership. Tuberculosis,
134, 102994.
El Sahly, H., Chaisson, R., Ruan, Y., et al. (2022). Population pharmacokinetics and
pharmacodynamics of bedaquiline in multidrug-resistant tuberculosis: an individual
patient data meta-analysis. The Lancet Infectious Diseases, 22(7), 868-878. Gaur, R.,
Singh, R., Bhatnagar, T., et al. (2022). Next-generation sequencing-based identification of novel
drug reistance mutations in drug-resistant tuberculosis. Tuberculosis, 136, 102018.
Gelmanova, I., Atun, R., Benedetti, A., et al. (2022). Sputum bacteriology conversion and
treatment outcomes in multidrug-resistant tuberculosis patients in Russia. The European
Respiratory Journal, 59(2), 2101129.
Harausz, E., Garcia-Prats, A., Hesseling, A., et al. (2022). Research priorities for childhood
tuberculosis: Advances and knowledge gaps. The Lancet Infectious Diseases, 22(6), e154
e166.
Hasan, R., Ahmed, F., Yusuf, M., et al. (2022). Drug-resistant tuberculosis in children: A
systematic review and meta-analysis. PLoS ONE, 17(3), e0260637.
Jindani, A., Nunn, A., Baftijari, M., et al. (2022). High-dose rifapentine with moxifloxacin for
pulmonary tuberculosis. New England Journal of Medicine, 387(11), 1069-1081.
Kim, J., Shin, S., Yim, J., et al. (2022). Prognostic implications of initial radiographic findings in
multidrug-resistant tuberculosis. American Journal of Respiratory and Critical Care
Medicine, 205(2), 231-239.
Lange, C., Nell, A., Keane, J., et al. (2022). Optimizing tuberculosis treatment regimens: A
roadmap to clinical trial design. The Lancet Respiratory Medicine, 10(1), 80-92.
17
APPENDIX
1.QUESTIONNAIRE
We are Clinical medicine students from Meru University carrying out a study on the factors
affecting adherence to tuberculosis medication among tuberculosis patients in Miathene Level IV
hospital, Meru County. The study aims at determining the adherence of tuberculosis medication
and the effect on the quality of life at Miathene level IV.
Your participation in this exercise is voluntary, you are free to join or refuse. Your name will not
be written in the questionnaire for anonymity purposes. This exercise is for academic purposes and
any information given will be treated with confidentiality. Please answer as accurately as possible.
If you agree to participate in this study, put your signature at the space provided.
Participation signature……...
Date………
Section A
Age (years)
a) 0-10 { }
b) 11-20 { }
c) 21-30 { }
d) 31-40 { }
e) 41-50 { }
f) 51 and above { }
Gender
a) Male { }
b) Female { }
3. What is your current marital status?
a. Single { }
b. Married { }
c. Divorced { }
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d. Widow { }
4. Level of education
a. Primary { }
b. Secondary { }
c. Tertiary { }
d. Any other specify { }
5. Please select your employment type
a) Student { }
b) Unemployed { }
c) Salaried { }
d) Business owner { }
e) Others { }
Section B: Factors contributing to non- adherence to TB medication.
1)Have you ever missed TB treatment
a) Yes { }
b) No { }
If yes, how long have missed treatment?
a) Less than 2 months { }
b) More than 2 months { }
2)Are you aware of the drugs you are taking currently?
a) Yes { }
b) No { }
3)For how long are you supposed to take these medicines?
a) Six months { }
b) Eight months { }
4)How long have you been on treatment?
a)1-3 months { }
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b) More than 3 months { }
5)If HIV positive, please mention if you are currently on any other medication
a) Yes { }
b) No { }
6)Mention if you have been treated for TB before
a) Yes { }
b) No { }
7)Do you have a treatment supporter
a) Yes { }
b) No { }
8)Mention if the community health worker is currently involved in your TB treatment
a) Yes { }
b) No { }
9)If, yes, what roles does he/she plays
a) Encourages me to continue taking my drugs and refills for me { }
b) Comes once in a while to see me taking my medicine { }
c)
Others………………………………………………………………………………………………
………………….
10)How often do you meet your community outreach worker?
a) Monthly { }
b) Every two months { }
c) Every 3 months { }
d) As need arise { }
11)What do they talk about in the community (please tick all that apply)
a) The benefits of completing treatment { }
b) The dangers of not completing treatment { }
c) The side effects of medications { }
d) Other issues (specify)……………………………………………………………..
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STUDY AREA
Figure 5: Kenyan Map showing Meru County
21
Figure 6: Meru county Showing Tigania West Sub County.
22
Figure 7: Tigania West subcounty showing Miathene area.