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INTRODUCTION
Tuberculosis (TB) is second killer worldwide due to a single infectious agent. In 2011, 8.7
million people fell ill with TB and 1.4 million died from TB
(1)
. Over 95% of TB deaths occurin low- and middle-income countries, and it is among the top three causes of death for
women aged 15 to 44(2). In 2010, there were about 10 million orphan children as a result of
TB deaths among parents (2). In Sub-Saharan Africa an estimated 17 million people were
infected withM. tuberculosis. , the incidence of TB has been driven upward, as reflected in
estimates derived from population-based surveys and from routine TB surveillance data(3).
Sudan shoulder 8% of TB burden in the (EMRO) region (4). Tuberculosis is a major cause of
morbidity and mortality in Eastern Sudan. According to National Tuberculosis Program
(NTP), Kassala is classified as one of the most suffering states in Sudan from the burden of
tuberculosis infection. The TB epidemic is an outgrowth of the longstanding wars
(Ethiopian/Eretria, Eastern front conflict), which has gravitated poverty, malnutrition, and
increased number of displaced populations and refugees in the state. This resulting in poor
health infrastructure with lack of microscopic services and health personnel has also
contributed to the epidemic. In Kassala State, annual risk of TB infection is 120 cases per 100
000 populations(4)
.
Successful treatment of tuberculosis (TB) involve taking anti-tuberculosis drugs for at least
six months. Several countries surpassed the global target for treatment success of 85% in
2005, and in the year 2010 the target for success has been raised to 90% (5). In Sudan the
treatment success rate remained static at a rate of 80% to 82%. The main barrier for achieving
the desired success rate is the high default rate; which has increased from 10% in the 2008 to
11.9 in 2010(4). Combined with transfer-out it equals 16.1% (1246 out of 7729 patients
registered). This figure is relatively high in comparison to the other countries in the region
(which have default rates of 1%-13% that include transfers).WHO and the Sudanese TB
treatment protocol defined defaulting as a treatment interruption of two consecutive months
or more(4). Defaulting is frequently used as part of the term adherence which is defined as
the extent to which a persons behavior taking medication, following a diet, and/or
executing lifestyle changes, corresponds with agreed recommendations from a health care
provider . While, WHO defined transfer out as apatient who has been transferred to another
recording and reporting unit and whose treatment outcome is unknown.NTP aims at
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achieving a 4% default rate from the current rate of 11.9%. Knowing that default rate in
Kassala State is 11% with adding the transfers will be 16% (4).
Causes of non-adherence to anti-TB drugs have been studied worldwide; a review of many
studies (mostly from low and middle income countries) reflected the complex nature of the
adherence to treatment, and how it is influenced by the interaction of several factors. The
factors that influence adherence were categorized into structural factors (including poverty,
especially costs , financial burden and gender discrimination ), personal factors (including
knowledge, beliefs and attitudes towards treatment, interpretation of illness and wellness),
social context (incorporating support from the family and the community and stigma), health
services factors (incorporating organization of care and treatment, disease progress and side
effects)(6)
.Few studies conducted in Sudan to investigate reasons behind high default rate, one of them
were carried out in Khartoum state and one in Sinnar State. Plock C (2008) found that, in her
study in Jabal-Awlia locality in Khartoum state, most of the default happened during the
continuation phase and the possible explanation for this was the patients feeling of
improvement(7). Also not receiving information about TB treatment was found to have a
significant association with the default; the later factor could have been influenced by a
deficient health care organization (short consultation time, lack of fixed clinic hours and lack
of privacy during consultation)(7). Ibrahim H (2009) conducted study to figure out the reasons
behind high Tuberculosis default rate in Sinnar state which was reaching up to 20% of total
reported treatment outcome. The study found that there was clear discordance between
reported defaulting to Sudan National tuberculosis program and recorded at the TBMUS
register book. Also it found that there were more than 7% were death cases and considered as
default in register book (8). The study showed that the patient awareness concerning TB
duration was topped the reasons of high default rate, and it followed by socio-economic
factors and geographical factor(9).
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Problem statement
Tuberculosis is an infectious disease that due to its severity, social stigma, as well as financial
and economic burden, is of high public health importance.
Default rate in Kassala State is 11% with adding the transfers will be 16%, while NTP aims at
achieving a 4% default rate. In addition to that, defaulter rates are increasing in Kassala state.
So far no operational research on defaulting had been carried in Kassala state, to investigate
the risk factors and reasons for abandoning TB treatment, and thus this remains unaddressed.
Justification
The aim of this study was to see what the reasons behind high default rate in Kassala state
which reached to 16% in year 2011.
The importance of this study came out because it was the first study to see the actual reasons
behind high default rate in Kassala State.
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Objectives
Research question/hypothesis:
What are the factors that associated with default from treatment among adult TB patients in
Kassala State?
General objective:
To determine factors associated with defaulting from treatment among adult TB in
Kassala State during 2012.
Specific objectives:
1\ Toidentify structural factors (including poverty, financial burden and gender
discrimination)associated with defaulting from treatment of tuberculosis
2\ To estimate personal factors (including knowledge, beliefs and attitudes towards
treatment, interpretation of illness and wellness) related to defaulting from treatment of
tuberculosis
3\ To assesssocial context (incorporating support from the family and the community and
stigma),associated with defaulting from treatment of tuberculosis
4\ To measure health services factors (incorporating organization of care and treatment,
disease progress and side effects) associated with defaulting from treatment of tuberculosis
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MATERIALS AND METHODS
Study design Case control study design
Study area/setting Kassala State- East Sudan
Kassala State is the one of the eastern Sudan states encompassing 11 locality .Kassala is
bordered by Eritrea and Ethiopia to the east . Red sea state to the north; Khartoum River Nile
states to the west and Gadarif state to south west (see the map in the Annex 1) Kassala state
land space is 42.282 km (Sq). In the northern part of the state the climate is the red sea
climate, while in the other parts the environment is a desert, semi desert and valley and
savanna climate with large fruit farms inside Kassala locality. The average rainfall is 350 to
400 ml. and the temperature 33 C. to 47C. Degrees
Population and Demographic Indicators:
Kassala State is the ninth between the States in terms of population
Population:
Population
NumberFamily SizeThe Percentage of Population TypeUrbanRuralNomads
1,881,5103.643.234.8.
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Rate of Infectious Diseases of Priority
The Disease The average in Population 2011
Malaria 52:1000 of Population
Tuberculosis 120:100,000 of PopulationSchistosomiasis 5.2 :100,000 of Population
AIDS 0.67:1000 of Population
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Study population/subjects The cases are pulmonary TB cases defaulted from treatment and the controls are cases
of pulmonary TB continuing their treatment.
Inclusion criteria for selection of cases (Defaulters ):-1- Pulmonary TB patients who default from the treatment for 2 consecutive months (
according to WHO definition)
2- Both sexes from 15 years and above
Exclusion criteria:1-TB patient less than 15 years.
2- Severely ill TB patients.
3- Other type of TB
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Sample size The total sample size will be 133cases ( all defaulter in KS during 2012) + 266
control
Total Sample = 399 participants
Sampling technique:- Total coverage sample technique for cases.
- Simple random sample technique for selection of unmatched controls
- 1 Case : 2 Control- 133 Cases : 266 Control
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Study variablesThe Dependent Variable: default from treatment
The Independent Variable:
Structural factors:- Poverty, Financial burden and gender discrimination Personal factors:- Age , Sex, Marital status- Knowledge, beliefs and attitudes towards treatment, interpretation of illness and
wellness
- Residence (rural, urban and IDPs),- Language , Educational level , Occupation, Social contest- (incorporating support from the family and the community and stigma), Health services factors- Distance from TB center,- Availability of TB drugs ,-
Availability of Health Cadre
- Waiting time in TB Center- Receiving information about TB
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Data collection
It is home-based study, where a trained data collector will contact defaulters and
controls in their homes and he/she will fill the questionnaire.
Structured questionnaire will be filled for cases and controls by trained personnel
Address of defaulters will be taken from health register (TB treatment register)
Control will be randomly selected (unmatched) for each case from health register and
their questionnaires, consent will be carried by the same health worker.
Data analysis plan
-
The data will be processed; double entered and checked using Epi Info
software.
- The results will be tabulated to display the baseline and socio-demographic
characteristics between cases and controls. Independent T-test for continuous
variables and Chi2test for categorical variables will be used to estimate the p.value
so as to test for statistical significance. Significance level will be considered at
p.value 0.05.
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ETHICAL CONSIDERATIONS
Written informed consent in Arabic and verbal translation in local languagewill be obtained before enrolment in the study. The health worker who
conducts the questionnaire will provide the consent.
Both cases and controls should have the consent. Approval from the local ethical committee or from the state ministry of health
will be considered.
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IMPLICATION OF THE STUDY
Defaulting TB treatment poses serious limitations to the success of TB control programme in
many countries in the world and is one of the contributing factors to the development of drug-
resistant forms of TB.Defaulter rates are increasing in Kassala state So far no operational
research on defaulting had been carried in Kassala state, to investigate the risk factors and
reasons for abandoning TB treatment, and thus this remains unaddressed.This study served as
the first one of its kind and thus can contribute to develop a methodology on which similar
subsequent investigations in other states of Sudan can be based. This study can provide
information about reasons of defaulting, thus will guide intervention of stakeholder and
policy makers to address these reasons.
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Time frame &budget:
Time Frame
Planned activity Time frame 2013
September October November
1st
wk
2nd
wk
3rd
wk 4th
wk 1st
wk 2nd
wk 3rd
wk 4th
wk 1st
wk 2nd
wk 3rd
wk 4th
wk
Contacting with local authorities to
get approval
Identification of the Data Collection
team,
Meeting with assessment team to
discuss assessment and share
responsibilities.
Preparation & distribution of data
collection tools
Training of the Data Collection Team
Data collection.
Data entry and analysis.
1rst report draft
Final Research report
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BUDGET
item No Item cost (SDG) Days Total (SDG)
Supervisors 2 20 14 560
Data collectors 12 10 14 1680
volunteer 5 10 40 2000
Training
&stationeries
230
Follow-up 600
Total Five thousand and one hundred and sixty SDG 5160
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REFERANCES
1. Muture B, Keraka M, Kimuu P, Kabiru E, Ombeka V and Oguya F. Factors
associated with default from treatment among tuberculosis patients in nairobi
province, Kenya: A case control study. BMJ Public Health Volume 11, retrieved from
http://www.biomedcentral.com/1471-2458/11/696
2. DodorEA, AfenyanduGY: Factors associated with tuberculosis treatment default
and completion at Effia-Nkwanta Regional Hospital in Ghana. Trans R Soc Trop Med
Hygiene2005, 99(11):827-832.
3. Demissie M, Kabede D: Defaulting from tuberculosis treatment at the Addis Ababa
TB Centre and factors associated with it. Ethiopian Medical Journal 1994, 32(2):97-
106.
4. Federal Ministry of Health -National Tuberculosis Control Program.Annual
progress report. 2011
5. Daniel OJ, Oladapo OT, Alausa OK: Default from treatment programme in Sagamu,
Nigeria. Nigeria Journal of Medicine 2006, 15(1):63-7.
6. Kaona FAD, Tuba M, Siziya S, Sikaona S: An assessment of factors contributing to
treatment adherence and Knowledge of TB transmission among patients on TB
treatment. BMC Public Health 2004, 4:68.
7.Plock C. Risk factors and reasons for defaulting TB treatment in JebelAwlia Locality,
Khartoum State, Republic of Sudan,2008.
http://www.biomedcentral.com/1471-2458/11/696http://www.biomedcentral.com/1471-2458/11/696http://www.biomedcentral.com/1471-2458/11/6968/13/2019 Final Proposal July 2013
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8. Ibrahim E. The reasons behind high TB default rate in Sinnar State,Republic of
Sudan, 2009.
9. Wasonga J: Factors contributing to tuberculosis treatment defaulting among slum
dwellers in Nairobi, Kenya, International congress on drug therapy in HIV. The
Gardiner-Caldwell Group Ltd; 2006:310.
10. Comolet TM, Rakotomalala R, Rajaonarioa H: Factors determining compliance
with tuberculosis treatment in urban environment, Tamatave, Madagascar.
International Journal of Tuberculosis and Lung diseases1998, 2(11):891-897.
11. Collaborative program and integrated control of communicable
diseases.(internet communication, January 2007 athttp://who.int/)
12. SNTP.Annual statistical report 2005, Statistics and Information unit, SNTP Federal
Ministry of Health.
13. TB.Annual statistical report 2005, Statistics and Information unit, Federal
Ministry of Health.
http://who.int/http://who.int/http://who.int/http://who.int/8/13/2019 Final Proposal July 2013
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Annex 1:
Kassala State Map
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Annex 2: Questionnaire
Question
1. Date of the Interview..
2. Health Area.
3. Name of Health Facility..
GENERAL INFORMATION
5. Age..
6. Sex 1/ Male 2/Female
7. Marital Status
1/ Single, 2/ married, 3/ divorced, 4/ widowed, 5/ separated
8. Nationality
1/ Sudanese 2/other (specify).
9. If Sudanese, specify tribe
01. Occupation
1/ regular employment, 2/ unemployed, 3/ daily laborer, 4/ retired, 5/ student
00. Education
1/Illiterate 2/khalwa, 3/ illiteracy programme,
4/ primary school, 5/secondary school,
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6/ college student and higher
0. Number of household member (persons that live under one roof)
1/ 1 to 3, 2/ 4 to 6, 3/ 7 to 9, 4/ 10 and more,
INFORMATION ON TREATMENT
0. Did you change TBMU since initiating treatment?
0/ no 1/ yes
. If yes, did you miss treatment during change?
0/ no 1/ yes
2. Distance to treatment centre
1/ within 30 minutes, 2/ 30 minutes to 1 hour,
3/ more than 1 hour
3. Are there any costs involved in travelling to the TBMU (both ways)?
0/ no, 1/ less than 2 SDG, 2/ 3 to 5 SDG, 3/ more than 5 SDG
4. Do you have a treatment supporter?
0/ no 1/ yes
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5. How frequently did you go to the TBMU to get your drugs after the first 2 months?
1/ weekly, 2/ every second week, 3/ monthly, 4/ irregularly, 5/ defaulted
6. If answer is different from monthly, why?
1/ no available transport, 2/centre is far from residence, 3/ high cost of
treatment, 4/ feels embarrassed to come to the centre, 5/ family is not
supportive, 6/ no drugs are available, 7/other (specify)
7.Do you feel that receiving treatment makes you feel?
1/ better, 2/ as before, no changes, 3/ feel ashamed,4/ bad, 5/ realizes that it is important
to stop the spread, 6/ other (specify)
8.How do you feel about having TB?
1/ Normal. No problem for me as I know it can be cured,
2/ I feel embarrassed and I dont want anyone to know,
3/ I am afraid I might infect others or I might die,
4/ I dont care if I can be cured or not
01.How did you perceive the treatment at the TBMU? (multiple answers possible)
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1/ normal. Not good, not bad.
2/ Good and supportive.
3/ unfriendly
4/ staff does not have time to explain things well.
5/ treatment with derision.
00.Did you receive any information on the disease and its treatment? 0/ no 1/ yes
0.What is the usual treatment period until full recovery?
1/ 1 month, 2/ 2 to 4 months, 3/ 5 to 7 months, 4/ 8 months, 5/ dont know, 6/ others
(specify)
02.For defaulters only: what was the reason for you defaulting TB treatment?
03.Do you own anything of the following?
1/ Radio, 2/ TV, 3/ daily newspaper
Data collectors name:
Supervisors name:
Remarks:
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