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GREAT LAKE UNIVERSITY OF KISUMU (GLUK)
TROPICAL INSTITUTE OF COMMUNITY HEALTH AND DEVELOPMENT (TICH).
P.O BOX 2224 (40100) KISUMU
ASIGNMENT: (CHD 600) Basic Research proposal
NAME: Godfrey Masai Neuno
REGISTRATION NUMBER: B16/J-01/15
LECTURER: Dr Jane Mumma.
SUBMISSION DATE: 27th July 2016.
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TABLE OF CONTENT
ContentsRESEARCH TOPIC:...................................................................................................................................4
ACCRONYMS:.......................................................................................................................................5
1.0 ABSTRACT:.....................................................................................................................................6
2.0 INTRODUCTION:............................................................................................................................6
2.1 Background:..................................................................................................................................6
2.2 Problem statement:........................................................................................................................8
2.3 Research questions:.......................................................................................................................8
2.4 Research objectives:......................................................................................................................9
2.5 Justification:..................................................................................................................................9
2.6 Significance;..................................................................................................................................9
3.0 LITERATURE REVIEW:...............................................................................................................10
3.1.0 Introduction;.............................................................................................................................10
3.2.0 Definition and historic back ground to TB;...............................................................................10
3.2.1 Incidence and risk factors of pulmonary tuberculosis;..............................................................13
3.2.2 Signs and symptoms of pulmonary tuberculosis;......................................................................15
3.2.3 Treatment for pulmonary tuberculosis patients;........................................................................15
3.3.0 DOTS program as a treatment of TB patients;..........................................................................16
3.4.0 Concept of family support;.......................................................................................................18
4.0 METHODS:.....................................................................................................................................19
4.1 Paradigm;.....................................................................................................................................19
4.2 Study design;...............................................................................................................................20
4.3 Population and sample;................................................................................................................20
4.4 Investigative techniques and tools;..............................................................................................20
4.5 Data Analysis;.............................................................................................................................20
4.6 Data collection time table;...........................................................................................................21
5.0 ETHICAL CONSIDERATIONS:....................................................................................................21
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6.0 ASSUMPTIONS:............................................................................................................................22
7.0 LIMITATIONS:..............................................................................................................................22
8.0 BUDGET:........................................................................................................................................22
9.0 REFERENCES:...............................................................................................................................24
10.0 APPENDICES:..............................................................................................................................26
a) Questionnaire;...............................................................................................................................26
b) NIH certificate;..............................................................................................................................33
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RESEARCH TOPIC: Tuberculosis treatment default in Bungoma County.
A submission being a requirement in partial fulfillment for the award of bachelors of Science
degree in health promotion (BHP) at Great Lakes University of Kisumu (GLUK).
4
ACCRONYMS:
WHO……………. World Health Organization.
HIV/AIDS……… Human Immuno Deficiency Virus/ Acquired Immuno Deficiency Syndrome.
TB………………. Tuberculosis.
USAIDS………… United States Aids.
DOT.…………… Direct Observation of Treatment.
MDR-TB………... Multi Drug Resistant Tuberculosis
HAART………......Highly Active Anti-Retroviral Treatment
DLTLD…………...Division of Lung Tuberculosis and Lung Diseases
NASCOP………... National Aids & Sexually transmitted disease Control Program.
TIBU……………. Electronic data capturing system.
NIH……………… National Institutes of Health
AFB……………… Acid Fast Bacilli
OI………………… Opportunistic Infection.
NTP………………. National TB Program.
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1.0 ABSTRACT:
Default from treatment is among major hindrances to the achievement of the global target of
successfully treating 90% of detected TB cases (Brudney&Dobkin 1991) and remains a major
challenge to its sustenance. Poor adherence to treatment means patients remain infectious for
longer, are more likely to relapse or succumb to tuberculosis and could result in treatment failure
as well as fostering emergence of MDR and may increase the cost of treatment.
Bungoma county recorded 7% default rate in 2015 (DLTLD report 2016) and the purpose of this
study is to determine why patients on TB treatment default in the County and I intend to apply a
retrospective cohort study basing on the DLTLD TIBU reporting system on patients who were
put on treatment between January 2014 to March 2015 and the findings will be used to address
the identified gaps which in turn will go a long way in improving case holding.
2.0 INTRODUCTION:The following will be covered in this chapter;
2.1 Background
2.2 Problem statement
2.3 Research questions
2.4 Research objectives
2.5 Justification and
2.6 Significance
2.1 Background:
TB is a major contributor to the global burden of disease particularly in low and middle income
countries due to its association with HIV/AIDS (Corbett et al. 2006). In 2009 WHO estimated
that globally there were 9.4 million incidence of TB cases, and nearly 380 000 TB deaths among
HIV-positive people (World Health Organization 2010). In 2008, Kenya was ranked 13th among
the twenty-two countries with high TB burden globally while South Africa and Uganda ranked
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9th and 16th respectively (USAID 2009). Cases of tuberculosis in Kenya increased nine-fold from
11,625 cases in 1990 to 116,723 in 2007. Up to year 2006, treatment success rates stagnated at
around 80% in spite of the government's policy of free tuberculosis treatment in public health
facilities but it has since improved to 89% though short of the 90% WHO target for the 2013
cohort as per the 2014 WHO Global TB Report.
Successful treatment of tuberculosis involves taking anti-tuberculosis drugs for at least six
months. Kenya subscribes to the internationally accepted WHO strategy for TB control which
includes recommended tuberculosis treatment regimes. Although treatment duration for new TB
patients in Kenya was previously 8 months in total, a shorter 6-months regime was started in
2007 in Nairobi province and later expanded to cover the whole country by 2009. Consequently,
duration of treatment within the study period will either be six or eight months. The first two
months of treatment is called intensive phase while the remaining six months (for the 8 months’
regime) or 4 months (for the 6-month regime) is called continuation phase. During the intensive
phase of treatment, patients collect drugs from facilities weekly while fortnightly collections are
done during the continuation phase. The treatment regime for retreatment patients was 8 months
and included Streptomycin (S) in the first 2 months. Emphasis is made on DOT by a health
worker or other responsible persons, including household members or others with whom the
patient has a close relationship, at least during the intensive phase of treatment.
Some patients fail to adhere to treatment and eventually default before completing the course.
Patients whose treatment is interrupted for 2 consecutive months or more as defined by WHO,
are reported as 'Out of Control' at the end of treatment period. Poor adherence to treatment means
that patients remain infectious for longer and are more likely to relapse or succumb to
tuberculosis. In addition, erratic or selective compliance to treatment and default could result in
treatment failure, foster emergence of drug resistant tuberculosis and may increase the cost of
treatment. Due to serious consequences of default, some National TB Programs offer incentives
and social support to ensure treatment compliance and completion to maximize the likelihood of
cure, hence avoid adverse treatment outcomes and minimize the chances of developing drug
resistance.
7
Bungoma County has an estimated 1.5 million people which is about 3.8% of the country's
population and an urban population of 22% but contributes about 2% of the national annual TB
burden. Of the 89,759 TB cases detected nationwide in 2013, 1,779 were registered in the
County. It had a Case Notification Rate (CNR) of 117/100,000 population among the TB control
regions and recorded a default rate of (Out of Control) 7% for all cases compared to 9% recorded
nationally. Defaulter tracing mechanisms are generally weak in Kenya, and Bungoma County is
not an exception (DLTLD annual report 2013).
2.2 Problem statement:TB is an infectious disease and the aims of treatment include, preventing death from TB,
decrease its transmission, cure the patient, reduce relapse/recurrence and prevent drug resistance.
Default from treatment therefore greatly compromises the achievement of these aims
consequently meaning there is more mortality, increase in TB cases who remain infectious in the
community and patients are likely to reoccur with incidences of MDR being more
(Brudney&Dobkin 1991).
MDR TB is a growing concern worldwide with an estimated burden of 424,203 of which 10,449
are found in Africa (Zigol, 2006). TB in Kenya is primarily driven by HIV and poverty with the
urban slum population making the greatest contribution (DLTLD, 2010). To treat one case of
MDR in Kenya, it costs about 1.5m Kenya shillings therefore if these cases are prevented from
occurring, a lot of funds can be saved to fund other activities in the health sector.
It is against this backdrop that I belief focusing on the 7% of the patients who went out of control
in the County and addressing the findings as to why they defaulted from the study, will go a long
way in not only unlocking the gaps but achieving the desired outcomes and reducing
considerably the incidences of MDR TB in the county.
2.3 Research questions: Broad question;
Why do Tuberculosis patients default treatment?
Specific questions;
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Why do patients with Tuberculosis default from treatment and what are the contributing
factors?
Do patients who are put on Tuberculosis treatment understand what the disease is?
2.4 Research objectives:Broad objective:
To determine why Tuberculosis patients default from treatment.
Specific objectives:
To establish why patients with tuberculosis default from treatment and to identify factors
associated with default.
To find out if Tuberculosis patients on treatment understand what the disease is.
2.5 Justification:The study seeks to establish why TB patients default from treatment. Default from treatment is among
the major hindrances to the achievement of the global target of successfully treating 90% of
detected TB cases and remains a major challenge to its sustenance. Poor adherence to treatment
means patients remain infectious for longer, are more likely to relapse or succumb to
tuberculosis and could result in treatment failure as well as fostering emergence of MDR and
may increase the cost of treatment.
2.6 Significance;The study to be undertaken aims at establishing the reasons and factors which contribute to
patients on TB treatment defaulting and using them to mitigate on ways of curbing this
undesirable outcome.
Several similar studies have been done before and findings here will also complement findings
from such studies. Subsequently the findings of the study will also contribute to additional
knowledge on the reasons of TB treatment default and this will make it easier for policy
formulation regarding TB treatment default in the county and other TB control zones. It will
also stimulate a desire for further research into the dynamics that explain the institutional
challenges into controlling TB treatment default.
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3.0 LITERATURE REVIEW:
3.1.0 Introduction;In this chapter, several relevant aspects to the study are explored and reviewed. Information from
this reviews are grouped and presented as follows:
3.2.0 Definition and historic back ground to TB;
3.2.1 Incidence and risk factors of pulmonary tuberculosis;
3.2.2 Signs and symptoms of pulmonary tuberculosis;
3.2.3 Treatment for pulmonary tuberculosis patients;
3.3.0 DOTS program as a treatment of TB patients and
3.4.0 Concept of family support;
3.2.0 Definition and historic back ground to TB; Tuberculosis is a chronically infectious and notifiable disease produced by a tubercle bacillus,
mycobacterium tuberculosis (Crofton et al, 1999). It occurs most often in crowded, inner city,
economically disadvantaged environments and among people with other medical risk factors
(Monahan & Neighbors, 1998).
TB is spread from person to person through airborne transmission by droplet nuclei. When
people with pulmonary or laryngeal tuberculosis cough, sneeze, speak, laugh or sing, they can
send droplet nuclei into the air and other people who inhale the infectious airborne droplet nuclei
can become infected (Taylor & Littlewood, 2000).
Ferrara and Meacci (2005), lungs are primarily involved but the infection can spread to other
organs. Close contacts (people with prolonged, frequent, or intense contact) are at the highest
risk of becoming infected (typically 22% infection rate but studies have reported even up to
100%). A person with untreated TB can infect an estimated twenty other people annually. Others
at risk include, people born in areas where TB is common, immune-compromised people,
residents and employees of high-risk congregate settings, health care workers who serve high-
risk clients, medically underserved, low-income populations, high-risk racial or ethnic minority
populations and children exposed to adults in high-risk categories.
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Nettina (2006), transmission can only occur from people with active TB disease and not latent
TB infection. The probability of transmission depends on infectiousness of the person with TB
(quantity expelled), environment of exposure, duration of exposure, and virulence of the
organism.
In 1998 Pio and Chaulet, classified TB based on the site of the diseases and bacteriological status
which includes;
Pulmonary tuberculosis sputum smear- positive (PTB+): This refers to a patient with at
least two sputum specimens for acid-fast bacilli (AFB) by Microscopy or a patient with
only one sputum specimen positive for AFB by microscopy plus radiographic chest
abnormalities consistent with active pulmonary TB, or a patient with only one sputum
specimen positive for AFB by microscopy and a culture positive for Mycobacterium
tuberculosis.
Pulmonary tuberculosis, sputum smear negative (PTB-): This refers to a patient with
symptoms suggestive of TB with at least two sputum specimen negative for AFB by
microscopy and with radiographic chest abnormalities consistent with active pulmonary
TB, or patient with at least two sputum specimens negative for AFB by microscopy and
culture positive for Mycobacterium tuberculosis, or a patient with two sets of at least two
sputum specimens taken at least two weeks apart negative for AFB by microscopy and
radiographic abnormalities consistent with pulmonary TB, and lack of clinical response
to one week of broad- spectrum antibiotic and decision is made by a clinician to treat
with full course of anti-tuberculosis chemotherapy.
Extra pulmonary tuberculosis: This refers to a patient with tuberculosis of organs other
than lungs: pleura, lymph nodes, abdomen, genito-urinary tract, skin, joints and bones,
and meninges. Diagnosis should be based on one culture positive specimen or
histological evidence or strong clinical evidence consistent with active extra pulmonary
tuberculosis, followed by a decision by a clinician to treat with a full course of anti-
tuberculosis chemotherapy.
At the time of diagnosis every tuberculosis patient is registered under one of the following
categories (Fujiwara & Colleagues, 2005)
New case: a patient who has never had treatment for tuberculosis or who has taken anti-
tuberculosis drug for less than four weeks
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Relapse case: a patient who has been declared cured of any form of tuberculosis in the
past by a clinician, after one full course of chemotherapy, and has become sputum
smear-positive
Failure case: a patient who, while on treatment, remained or became again smear
positive five months or later during the course of Treatment.
Treatment after default: a patient who interrupts treatment for two months or more, and
returns to treatment with smear positive sputum.
Transfer in: a patient who has been transferred from another control jurisdiction
tuberculosis register to continue treatment and
Other: all cases which do not fit the above definitions, for example a patient treated more
than 4 weeks by a private agency, and patient diagnosed with TB and relapsed with
negative sputum smear.
WHO (2004) describes TB into 7 types
New case: a patient, who has never taken anti tuberculosis treatment or has taken it for
less than one month,
Relapsed case: a patient declared cured of TB by a physician but who reports back to the
health service and is found to be bacteriologically positive,
Transferred in case: a patient who has been received into a tuberculosis unit/district
hospital after starting treatment in another unit where he has been recorded,
Default case: a patient who has received anti-tuberculosis treatment for one month from
any source and who has interrupted treatment for more than two months,
Failure case: an initial smear positive patient who remains smear positive at five months
or more after starting treatment or an initial smear negative patient who becomes smear
positive during the course of treatment,
Chronic case: a patient who remains smear positive after completing a re-treatment
regimen, and
Other: a patient who does not fit into any of the above categories, e.g. a relapse patient
may be smear negative or an extra-pulmonary TB patient who has not responded to
treatment. Such patients are categorized as others and receive category II treatment.
WHO (2004) also described the tuberculosis based on the severity of illness:
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Seriously ill / not seriously ill smear negative pulmonary TB: Smear negative pulmonary
TB cases should be clinically ascertained for the severity of illness and
Seriously ill / not seriously ill extra-pulmonary TB: Seriously ill extra-pulmonary TB
includes meningitis, disseminated TB, tuberculosis pericarditis, peritonitis, bilateral or
extensive pleurisy, spinal disease with neurological complications, intestinal and
genitourinary TB. In this study all of the participants are patients in category I, because
the most common and infectious category for TB diseases is pulmonary TB.
Depending on the classification of TB, type of TB, severity of illness, history of treatment in the
past, history of interruptions in the treatment, the patient will receive specific treatment for that
category. The drugs are to be taken on alternate days under direct observation (DOTS-Directly
Observed Treatment, Short- course).
In summary, pulmonary tuberculosis is an infectious disease caused by Mycobacterium
tuberculosis and may affect almost any tissue or organ of the body and diagnosis can be done
radiologically, by a tuberculin skin test, a serological test, microbiological smears and cultures.
Transmission can only occur from people with active TB via airborne spread and transmission
can be stopped by isolating patients with active disease and starting them on effective anti-
tuberculosis therapy.
3.2.1 Incidence and risk factors of pulmonary tuberculosis;
The emergence and dissemination of human immunodeficiency virus (HIV) in the 1980s
promoted increased tuberculosis (TB) incidence around the world, even though in developed
countries it had been considered under control.
TB is one of the most common causes of morbidity and mortality among HIV patients living in
low-income countries10. Some estimates have shown that 30 to 60% of HIV patients are carriers
of Mycobacterium tuberculosis with an 8 to 10% likelihood per year of developing the disease,
whereas among immunocompetent individuals, the lifetime risk of TB reaches 10%. HIV
increases the risk of progression from latent Mycobacterium tuberculosis infection, early
infection or reinfection to active disease. Previous studies have demonstrated that patients living
with HIV/AIDS have a poor prognosis when they have TB.
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The introduction of HAART has markedly changed the natural history of HIV infection in both
developed and developing countries, with a notable reduction in the risk of contracting
opportunistic infections (OI) such as TB, Pneumocystis jirovecii pneumonia, Mycobacterium
avium complex infection and cytomegalovirus retinitis among others. In Brazil, access to
HAART has been available since 1996 and these drugs have promoted a significant reduction in
overall OI, prolonged patient survival and improved quality of life for the patients. In addition,
HAART has produced changes in the clinical characteristics and prognosis among HIV/TB co-
infected patients to their advantage.
By the year 2002, with a population of 217 million people, Indonesia was the fourth largest
country in population in the world and ranked third of countries with the highest (10 %) TB
burden following India (30 %) and China (15 %). The WHO global surveillance and monitoring
project in 1999, estimated the incidence in Indonesia to be around 583,000 cases and 262,000
new smear positive cases per year.
The prevalence of smear positive cases is estimated to be 715,000, with 140,000 patients dying
yearly of TB (Ministry of Health, Republic Indonesia, 2004).
Risk factors of pulmonary TB Tuberculosis can develop after inhaling droplets sprayed into the
air from a cough or sneeze by someone infected with Mycobacterium tuberculosis. The disease is
characterized by the development of granulomas (granular tumors) in the infected tissues. The
usual site of the disease is the lungs, but other organs may be involved.
Primary pulmonary TB develops in the minority of people whose immune systems do not
successfully contain the primary infection while in people with good immune system, the disease
may occur within weeks after the primary infection or lie dormant for years and reappear when
the immune system is weak after the initial infection is contained (Ferrara & Meacci, 2005).
The risk of contracting TB increases with the frequency of contact with people who have the
disease, with crowded or unsanitary living conditions and with poor nutrition. Recently, there has
been an increase in cases of TB. Factors that may contribute to the increase in tuberculosis
infection in a population are: an increase in the number of homeless individuals (poor
environment and poor nutrition), the appearance of drug-resistant strains of TB, incomplete
treatment of TB infectious (such as failure to take medications for the prescribed length of time)
14
which can contribute to the emergence of drug resistant strains of bacteria. Individuals with
immune systems damaged by AIDS have a higher risk of developing active tuberculosis, either
from new exposure to TB or reactivation of dormant mycobacteria. In addition, without the aid
of an active immune system, treatment is more difficult and the disease is more resistant to
therapy (Ferrara & Meacci, 2005).
3.2.2 Signs and symptoms of pulmonary tuberculosis; According to Crofton, Horne and Miller (1999), the signs and symptoms of pulmonary TB are
limited to minor cough and mild fever, apparent fatigue, unintentional weight loss, coughing up
blood, fever and night sweats, phlegm-producing cough, wheezing, excessive sweating,
especially at night, chest pain, breathing difficulty.
Furthermore, Nettina (2006), described signs and symptoms of pulmonary TB into two types,
1) constitutional symptoms which include; fatigue, anorexia, weight loss, low-grade fever,
night sweat, indigestion, acute febrile illness, chills, flu like symptom, and
2) pulmonary signs and symptoms which include; cough progressing infrequency and
producing mucoid or mucopurulent sputum, hemoptysis, chest pain, dyspnea.
3.2.3 Treatment for pulmonary tuberculosis patients; Treatment regimens are divided into the initial or intensive phase and the continuation phase.
There is a standard code for TB treatment which uses an abbreviation for each anti-TB drugs.
Intensive /initial phase: during the intensive/initial phase, a combination of four drugs
are used which have the bactericidal effect leading to a rapid bacteriological sputum
conversion and improvement of clinical symptoms, the pulmonary TB patient must take
the medicines every day for 2-3 months (Pio & Chaulet, 1998).
Continuation phase: during the continuation phase, the patient takes the medicines for 4
months, the sterilizing effect of the therapy eliminates remaining bacilli and prevents
relapse (Pio & Chaulet, 1998).
There are five essential anti-TB drugs used for treating TB: Isoniazid (H), Rifampicin (R),
Pyrazinamide (Z), Streptomycin (S), and Ethambutol (E), and there are three main properties of
anti-TB drugs: bactericidal ability, sterilizing ability and the ability to prevent resistance.
Isoniazid and Rifampicin are the most powerful bactericidal drugs, active against all types of TB
bacilli. Pyrazinamide and Streptomycin are also bactericidal effective against only certain types
15
of TB bacilli. Pyrazinamide is active in an acid environment against TB bacilli inside
macrophages while Streptomycin is active against rapidly multiplying TB bacilli (WHO, 2006).
Complying with the drug regimen is critical for success. Directly observed therapy (DOT) is
cost-effective for patients at high-risk for non-adherence, and should be used in all cases,
chemotherapy can be successful only within an appropriate health system infrastructure which
addresses both the clinical and social management of patients and their contacts (Christopher et
al., 2003).
Ethambutol is a bacteriostatic drug used in association with more powerful bactericidal drugs to
prevent the emergence of resistant bacilli (WHO, 2003). The major principles for TB treatment
are;
Drug treatment is an individual and a public health measure,
Regimens must contain multiple drugs to which organisms are susceptible and
Drugs must be given for a sufficient period of time, (Nettina, 2006).
Some pulmonary TB patients do not complete taking the anti TB medications because they feel
better while others cannot tolerate the side effects of the medications.
3.3.0 DOTS program as a treatment of TB patients;Directly observed treatment or therapy (DOT) is an integral and essential component of DOTS
for tuberculosis, the global strategy for effective TB control (WHO, 1999).
Directly Observe Treatment (DOT), defined as observation of the patient by a health care
personal or other responsible person as the patient ingests anti-tuberculosis medications.
Directly Observed Treatment has been recommended as the standard of care as it improves
patient compliance to the TB treatment. DOT also reduced relapse rates, drug resistance rates
and leads to high rates of treatment compliance (American Thoracic Society, 1994).
Directly observed treatment, short course (DOTS) the internationally recommended approach to
TB control, which forms the core of the stop TB strategy. DOTS has five elements which
includes;
Government’s commitment to ensuring sustained, comprehensive tuberculosis control
activity
Case detection by sputum smear microscopy among symptomatic suspects.
A standardized treatment regimen of 6-8 months including directly observed treatment
(DOT)
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A regular uninterrupted supply of all essential anti TB drugs, and
A standardized recording and reporting system that allows assessment of case detection
and treatment results for each patient and of the tuberculosis control programmed overall
performance (WHO,1999).
Directly observed treatment, short course (DOTS) means that a supervisor watches the client
swallowing the medication for all doses over the course of treatment. The purpose of DOTS is to
ensure that a TB patient takes correct drugs, the correct dose, and at the correct times (WHO,
1999).
DOTS have been shown to be effective in curing pulmonary TB in many studies already
completed. In China, (tuberculosis control collaboration, 1996) between 1991 and 1994, DOT
was used as a strategy with short-course drug therapy to treat 112,842 patients. The results of
treatment showed a cure rate of 89.7% among 55,213 new cases with smear-positive tuberculosis
and 81.1% among 57,629 previously treated patients. The failure rate dropped from 17.6% to
6.2%. This study represents a success for DOT, as previously only 50% of patients with TB were
cured (Moore et al., 1996).
Mac et al., (1999) studied about evaluation of the effectiveness of DOTS Program in Vietnamese
tuberculosis patients and they found that completion of therapy rate was higher in the DOTS
group than in the non-DOTS group, the relapse rate was lower in the DOTS group than in the
non-DOTS group, and sputum conversion occurred more rapidly in the DOTS group than in the
non-DOTS group. That means to treat TB is more effective with DOTS than non DOTS.
In Thailand, Kamolratanakul et al., (as cited in Tengtrisorn, 2001) conducted a randomized
controlled trial of DOTS at 8 district hospitals, 3 provincial hospitals and 4 zonal TB centers of
the government health system. And the results showed that treatment outcomes were improved
compared to pre study conditions.
DOTS strategy is very important to TB patients because having TB is not only a physical
problem but also social, therefore TB patients need their families to strengthen them and to
motivate them to follow the treatment regimen by directly observing them in taking the
medications.
17
3.4.0 Concept of family support; Fleischnacker (2002) described factors influencing compliance related to the patient, such as the
patients’ environment, including social activities, social relationships, and health care
professionals.
The American Thoracic Society (2003) described factors that interfere with compliance to TB
treatment regimen including cultural and linguistic barriers to cooperation, lifestyle differences,
homelessness, substance abuse, and a large number of other conditions and circumstances that,
for the patient are priorities that compete with taking treatment for tuberculosis.
Abel and Painter (2003), found that patients who perceived themselves as being actively engaged
in their care with their provider reported greater adherence to treatment and provider advice.
Perception of engagement was conceptualized as access to the health care provider, information
sharing, involvement of patient in the decision making related to self-care activities, and respect
and support by the provider of patient's choices. They have also linked psychological wellbeing
to engagement of activities, such as adherence to treatment, appointments, and provider advice.
Quality provider patient relationships have been found to promote treatment adherence. Race,
marital status, current substance abuse, low literacy, poor understanding of the need for
treatment, insufficient confidence in the clinician or medication, psychological problems, low
motivation to change behavior, and low socioeconomic status are prominent patient factors that
have a negative impact on adherence.
Dodor and Afentadu (2005) in their study found that noncompliance to the treatment was
significantly associated with income per month, ability to afford supplementary drugs,
availability of family support and problems relating with others while on treatment. A cordial
relationship between patients and health staff was the main motivating factor for completion of
treatment, whilst financial difficulty was the main reason for noncompliance to the treatment.
Hadjis et al., in 2002, studied the role of family social support in first-stroke recovery process,
and found that higher levels of family support, both instrumental and emotional was associated
with progressive improvement of functional status, mainly in severely impaired patients. Family
support is a factor for pulmonary TB Patients in complying with the DOTS program, because the
length of the treatment process and the side effects of the TB drugs can lower pulmonary TB
motivation to comply with the treatment regimen.
18
In summary, the immediate environment and family factors so to say have an indelible mark in
treatment compliance and should be focused when instituting treatment mechanisms as a key
stakeholder.
4.0 METHODS:
It will mainly be quantitative study focusing on a retrospective cohort study of TB patients
enrolled between January 2014 and December 2015 who did not complete their treatment as per
recommended guidelines due to one reason or another excluding those who died or transferred to
other jurisdictions.
4.1 Paradigm;Paradigm is defined as the underlying assumptions and intellectual structure upon which research
and development in a field of inquiry is based (Thomas Kuln, 1962).
Several theoretical frameworks exist which attempts to explain why people default from
treatment. Some of them include,
Ogden, J et al 1999 on shifting the paradigm in tuberculosis control: Illustration from India.
Which suggest a paradigm shift from a patient- centered approach towards enabling the entire
health system in the community. In its attempt to answer the question, ‘who is to blame for
treatment failure in TB’? some key lessons emerge which include, that TB control cannot be seen
in isolation from the usual way of life, there is need to enable patients obtain care and need to
bring all actors e.g. non-governmental organizations and policy makers in our social life in play.
Joseph, C, Okeibunor et al 2015 in a study on Barriers to Care Seeking in Directly Observed
Therapy Short-Course (DOTS) Clinics and Tuberculosis Control in Southern Nigeria: A
Qualitative Analysis, recommended that the attitude of health workers must be addressed if
community members will use the DOTS clinics.
The problem with default is generally health system-based. In order to address these barriers, it is
recommended that the NTP adopts a more holistic approach to deal with them. Joshua Amo-
Adjei in a research done on Views of health service providers on obstacles to tuberculosis
control in Ghana in 2013.
19
4.2 Study design;
A case control study where Secondary data for the study population (cases, N = 125) will be
extracted from TB treatment registers in selected treatment facilities using a facility
questionnaire. These will include demographic data (age, gender, residence, marital status) and
medical and treatment data (treatment observer, patient and TB types, HIV status, treatment
regimen, sputum smear microscopy results, the date treatment was started, date treatment was
defaulted and the reasons for defaulting treatment).
4.3 Population and sample;
The study population will comprise the cohort of patients registered during the period January
2014 to March 2015 in all TB treatment facilities (total number of treatment centers was about
174) distributed across all 9 sub-counties of Bungoma County. Cases will be patients whose
treatment was interrupted for 2 consecutive months or more (as defined by WHO), and reported
as 'Out of Control' (N = 125) as an outcome.
4.4 Investigative techniques and tools;
Data will be collected using an interviewer-administered questionnaire. The questionnaire will
constitute of socio-demographic characteristics, patient related therapy or drug related
information, social and health system /health provider related variables and will be pre-tested
before the actual data collection. Data will be collected after verbal informed consent is obtained.
HCWs will be trained for this purpose of data collection and will not be from the health facilities
where TB patients will be interviewed.
4.5 Data Analysis;
Descriptive statistics such as frequencies and cross tabulation will be made for most selected
variables and multivariable logistic regression analyses will be performed to determine risk
factors associated with treatment default.
20
4.6 Data collection time table;The process of data collection will start in harness in July 2016 with presentation of the proposal
and finally the dissemination of the findings after my defense in the month of May 2017 as
postulated in the table below;
TIME FRAME.
ACTIVITY
July August Sept Oct Nov Dec Jan Feb May
Presentation of the
research proposal
×
Literature review × × × × ×
Tool development ×
Training of research
assistants
×
Pretesting the data
collection tool
×
Data collection ×
Data analysis × ×
Defense ×
Dissemination ×
5.0 ETHICAL CONSIDERATIONS:
I will seek the approval of the county government of Bungoma through the department of health
and the central government through the DLTLD and obtain an official permission letter to
conduct the study.
All patients will be provided with a written informed consent and receive a copy of the form and
to ensure confidentiality, names will be avoided in the questionnaire and reporting the results of
21
the study. In addition, the collected information will be locked with a key (hard copies) and by
passwords (soft copies). The data will therefore be managed securely and anonymously.
6.0 ASSUMPTIONS:During this study, my assumption is that;
Participants' gender will not significantly affect their perceptions.
All respondents will answer all survey questions honestly and to the best of their
abilities.
Permission to conduct the study in the identified areas will be granted by the relevant
authorities.
7.0 LIMITATIONS:The study will mainly focus on those patients who were initiated on the standard treatment
regimen and have an outcome of out of control. This excludes those who may have defaulted
while on treatment and traced back to treatment. Therefore, the findings may not be
representative of all cases.
8.0 BUDGET:
REQUIRED ITEMS UNIT OF
MEASURE
QTY COST
PER
UNIT
KSHS CTS
STATIONARY;
A4 papers
Pencils
Erasers
Waterproof folders
Felt pens
Stapler
Staples
Biro pens
Ream
No
No
No
No
No
Pkt.
No
10
20
20
20
6
2
1
20
250
25
15
60
120
450
50
20
2500
500
300
1200
720
900
50
400
00
00
00
00
00
00
00
00
22
Ruler
Calculator
No
No
20
4
45
1050
900
4200
00
00
Sub total 11,670 00
PHOTOCOPIES/PRINTING
SERVICES;
Questionnaire
Flash drives
Typing and printing services
Binding
Dissemination of results
No
No
No
No
No
200
2
120
4
5
1250
35
450
25,000
1000
2500
4200
1800
2500
00
00
00
00
00
Sub total12,000 00
ALLOWANCES;
Training of assistants
Transport @ lunch for assistants during
training
Transport @ lunch during pretest
Transport @ lunch during data
collection
Days
Days
Days
Days
3
20
20
20
2000
1500
1500
1500
6000
30000
30000
30000
00
00
00
00
Sub total 96,000 00
CORDINATION;
Airtime PI and supervisors Days 3 5000 15000 00
Lunches & transport for 4 supervisors
during pretest and actual data collectionDay2 3 2500 30000 00
Sub total 45,000 00
TOTAL 164,670 00
Contingencies 10% OF TOTAL 16,467 00
GRAND TOTAL 181,137 00
23
9.0 REFERENCES:1. Marlucia da Silva Garrido, et al. (2012); Factors Associated with Tuberculosis Treatment
Default in an Endemic Area of the Brazilian Amazon: A Case Control-Study
2. Determinants of Treatment Adherence among Smear-Positive Pulmonary Tuberculosis
Patients in Southern Ethiopia. EstifanosBiruShargie, et al (2007).
3. Sophia Vijay, et al (2012); Risk Factors Associated with Default among New Smear Positive
TB Patients Treated under DOTS in India.
4. ImadCherkaoui, et al. (2014); Treatment Default amongst Patients with Tuberculosis in Urban
Morocco: Predicting and Explaining Default and Post-Default Sputum Smear and Drug
Susceptibility Results.
5. Bernard N Muture, et al. (2011); Factors associated with default from treatment among
tuberculosis patients in Nairobi province, Kenya: A case control study.
6. Brian Lackey, et al (2015); Patient Characteristics Associated with Tuberculosis Treatment
Default: A Cohort Study in a High-Incidence Area of Lima, Peru
7. Natasha Chida, et al. (2015); Determinants of Default from Tuberculosis Treatment among
Patients with Drug-Susceptible Tuberculosis in Karachi, Pakistan: A Mixed Methods Study.
8. Akilew Awoke Adane , et al (2013); Non-Adherence to Anti-Tuberculosis Treatment and
Determinant Factors among Patients with Tuberculosis in Northwest Ethiopia.
9. Alyssa Finlay,et al (2012); Patient- and provider-level risk factors associated with default from
tuberculosis treatment, South Africa, 2002: a case-control study.
10. Maeve K. Lalor, et al (2013); Risk Factors Associated with Default from Multi- and
Extensively Drug-Resistant Tuberculosis Treatment, Uzbekistan: A Retrospective Cohort
Analysis
11. Ministry of Health Kenya DLTLD report 2010, 2007, 2016.
24
12. WHO global surveillance and monitoring project 1999
13. WHO global report 2010, 2007, 1994, 2003
14. Brudney&Dobkin 1991; Linguistic and Cultural Aspects of Tuberculosis Screening and
Management for Refugees and Immigrants; Seattle Washington.
15. Corbett et al. 2006; Tuberculosis disease and mortality in sub Saharan Africa; a case study of
Malawi
15. USAID 2007 report
16. Zigol, 2006; Global burden of MDR TB. Kenya’s case.
17. Crofton et al, 1999. The economic burden and the cost-effectiveness of treatment
18. Monahan & Neighbors, 1998; Foundations of clinical practice- Frances
19. Taylor & Littlewood, 2000; Causes and costs of hospitalization of Tuberculosis patients.
20. Ferrara and Meacci 2005; Advances in diagnosis and treatment of Tuberculosis.
21. Nettina (2006); Creative solutions to enhance nursing quality.
22. 1998 Pio and Chaulet; A study on the knowledge, practices and beliefs on causes, diagnosis
and treatment of TB.
23. Fujiwara & Colleagues, 2005; Exogenous Reinfection as a Cause of Recurrent Tuberculosis
after Curative Treatment.
24. Fleischnacker, 2002; Indonesia health care system and management of pulmonary TB patient;
an observed treatment behavior and treatment standards.
25. Tonsing, 2006; Improving Tuberculosis control through public-private mix.
26. Lee et al., 2002; Impact of diabetes and smoking on mortality in Tuberculosis.
27. Moore et al., 1996; Directly Observed Therapy (DOT) for Tuberculosis. The success story of
the United States.
25
28. The American Thoracic Society (2003)
29. Abel and Painter (2003); Treatment of tuberculosis. American Journal of. Respiratory and
Critical Care Medicine .167, ... qualitative study International Journal of Nursing Studies
30. Kamolratanakul et al., as cited in Tengtrisorn, 2001; cost of TB on diagnosis in different
settings in Asia and Africa.
31. Dodor and Afentadu (2005); Noncompliance among tuberculosis patients in Wardha district,
India
32. Hadjis et al., in 2002; Relationship between family support and health behavior.
33. Thomas kuln, 1962; Structure of scientific revolution.
34. Ogden, J et al 1999, shifting the paradigm in tuberculosis control: Illustration from India.
35. Joseph, C, Okeibunor et al 2015; Barriers to Care Seeking in Directly Observed Therapy
Short-Course (DOTS) Clinics and Tuberculosis Control in Southern Nigeria:
36. Joshua Amo-Adjei; Views of health service providers on obstacles to tuberculosis control
Ghana (2013).
10.0 APPENDICES:
a) Questionnaire;
QUESTIONNAIRE:
Individual patient’s questionnaire number
Date of interview ………………………………………………….
Instructions
ENTER THE OPTION IN THE BOX for all the questions using figures except for Qn.1 and
Qn.35 for which you should enter text in the space provided.
26
SECTION A: DEMOGRAPHIC INFORMATION
Qn1; Sub-county…………………………………village………………………………
Qn 2; Age in Years: 1. (1≤ 14) 2. (15-25) 3. (26-35) 4. (36-45) 5. (46-55)6.
(56-65) 7. (≥66).
Qn3; Religion: 1. Christian 2. Islam 3. Other
Qn4; Gender 1. Male 2. Female
Qn5; Marital Status 1. Married 2. Separated 4. Cohabiting
5. Widowed 6. Single
Qn6 ; Language 1. English 2. Kiswahili 3. other
Qn7 ; How much formal education did you get?1.None
2. Primary 3. Secondary 4. Tertiary
SECTION B: PATIENT RELATED FACTORS
Qn8; Have you smoked cigarettes in the last 6 months?
1.Yes 2. No 3. Cannot remember
27
Qn9; Did you drink alcohol in the last 6 months?
1. Yes 2. No 3. Cannot remember
Qn10; Do you have a Treatment Supporter?
1.Yes 2. No
SECTION C: SOCIOECONOMIC VARIABLES
Qn11; Employment Status ;1. Employed 2. Unemployed
3. Self-employed
Qn12; What is your income (KSHS per month)? 1.Low (<1000)
2. Medium (1000-10,000) 3. High (>10,000)
Qn13 ; During the time you were taking TB medicines, what would
you say was your situation in terms of food availability?
1. Always available to take with medicines
2. Not always available 3. Available most of the time 4. Never available
SECTION D: HEALTH-CARE SYSTEM RELATED
Qn14; What would be the most convenient TB clinic opening times
for you?
1.[ <8am-5pm] 3. [8am->5pm]
2. [8am-5pm] 4. [ <8am->5pm]
Qn15; How much time do you usually wait at the TB clinic
before being attended?
28
1. [<1hr] 2. [ 1-2 hrs.] 3. [ >2hrs]
Qn16; Where do you normally collect your TB medicines?
1.GOK facility 2. FBO facility 3. Private facility
4. Others
Qn17; How much distance do you travel to collect your TB
Medicines (Km?)
1. [<5] 2. [5-10] 3. [11-15] 4. [16-20] 5. [ >20]
Qn18; How much does it cost you to get to the health facility (KSHS)
1.Nothing (walking distance) 2. [<50]
3.[ 50-150] 4. [ >150]
Qn19; Who supervised you when you were taking your TB
medicine? (DOT Status)
1. None. 2. Health Worker at the facility.
3. Family member 4. Community member
Qn20; How would you rate the attitude of staff who attended you
at the health facility?
1. Very friendly 2. Friendly 3. Indifferent
4. Unfriendly 5. Very unfriendly
Qn21; When you went to pick your medicines at the TB clinic,
what would you say about the availability of medicines?
29
1. Always available 2. Sometimes not available
Qn22; I just want to take some time to find out what you know
about TB. The following is/ are symptoms of TB
a) Coughing [1. Yes2. No]
b) Night sweats [1. Yes2. No]
c) Loss of Weight [1. Yes 2. No]
d) Chest Pains [1. Yes 2. No]
Qn23; TB treatment should be taken until [Yes or No]
a) 6 months [1. Yes 2. No]
b) One feels better then stop on your own [1. Yes
2.No]
c) 6 months completed and health worker tells you to
stop [1. Yes 2. No]
SECTION E: DEFAULT FACTORS
Qn24; Who do you live with? 1.Family 2. Friends
3. Alone 4. Other
Qn25; How many other people live with you? 1.(0) 2. (1-3)
3.(4-6) 4. (>7)
Qn26; How big is your dwelling/ house (number of rooms)?
30
1. (1-2) 2. (3-4) 3. (>5)
Qn27; How long have you stayed in your current dwelling/ house?
1. (<3 months) 2. (3-12 months) 3. (>12 months)
SECTION F: STIGMA and DESCRIMINATION
Qn28 a; Did you inform your family of friends that you were on
TB treatment?
1. Yes 2. No
Qn 28 b; If no, why?
1. Fear of being isolated by friends or relatives
2. No one to trust 3. Other
SECTION G: DISEASE AND MEDICINE RELATED
Qn29 a; Did you experience any side effects when you were
taking TB treatment?
1.Yes 2. No
Qn 29 b; If Yes to above question, which side effects did
you experience?
1.Diarrhoea & Vomiting 2. Headaches and
dizziness 3. Skin rashes 4. Numb feet or hands
5. Yellow eyes 6. Painful limbs 7. Other
31
Qn30; From the day you started taking your TB medicines,
how long did it take you before you felt better? (months)
1.[<2] 2. [ 2-4] 3. [ 5-6] 4. [ Did not feel better]
Qn31 a; Did you complete your TB treatment?
1.Yes 2. No
Qn31 b; If the response to the above question is No, what
Were the reasons for you to stop treatment? 1.Side effects
2.Feeling well 3. Too many tablets 4. Stigma
5.Distance 6. Cost of travel 7. Lack of family support
8.No food 9. Inadequate supply of medicines
10. Medicine not working 11. Not feel better on medicines
12.No reason l3. Other
Qn32; Disease Classification (Tick appropriately according
To the treatment card or TB register)
1.PTB-SM+ 2. PTB-SM- 3. EPTB
4. PTB and EPTB 5. Not Indicated
Qn33; HIV Status (as indicated on TB treatment card or TB register)
1.Positive 2. Negative 3. Not Known/indicated
Qn34a; Was the patient taking other medicines besides
TB treatment
32
1.Yes 2. No
Qn34 b; If yes to the above question, which medicines was
the patient taking?
1.HAART 2. Anti-hypertensives 3. Psychiatric
(antipsychotic, antidepressants) 4. Other
Qn35 In your opinion, what could make patients complete their TB treatments?
……………………………………………………………………………………………………
…… THANK YOU VERY MUCH FOR YOUR TIME AND COOPERATION……….
b) NIH certificate;
Certificate of Completion
The National Institutes of Health (NIH) Office of Extramural Research certifies that Godfrey Neuno successfully completed the NIH Web-based training course "Protecting Human Research Participants".
Date of completion: 07/22/2016.
Certification Number: 2112986.
33
