Research Proposal

Name Adress Telephone/s E-mail/s

Mutaz Abdallah Abdelhadi MOH- Kassala State-DG Office 0912389974 Sm_mutaz@yahoo.com

Factors associated with default from treatment among adult tuberculosis patients in Kassala State,Sudan 2013

MUTAZ Research Proposal

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 occur in 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 with M. 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 m onths 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\ To identify 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 assess social 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:

The Percentage of Population Type Nomads 8..6 Rural 34.6 Urban 43.2

Family Size

Population Number

3.6

1,881,510

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Rate of Infectious Diseases of Priority The Disease Malaria Tuberculosis Schistosomiasis AIDS The average in Population 2011 52:1000 of Population 120:100,000 of Population 5.2 :100,000 of Population 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 133 cases ( 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 variables
The 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 Chi2 test 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 language will 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 drugresistant 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 1st 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 2nd wk 3rdwk 4thwk

October 1stwk 2ndwk 3rdwk 4thwk

November 1stwk 2ndwk 3rdwk 4thwk

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BUDGET

item Supervisors Data collectors volunteer Training &stationeries Follow-up Total

No 2 12 5

Item cost (SDG) 20 10 10

Days 14 14 40

Total (SDG) 560 1680 2000 230

600 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 Hygiene 2005, 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):97106. 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.

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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 diseases 1998, 2(11):891-897. 11. Collaborative program and integrated control of communicable diseases.(internet communication, January 2007 at http://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.

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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, 8. Nationality 1/ Sudanese 2/other (specify). 5/ separated

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, 4/ primary school, 3/ illiteracy programme, 5/secondary school,

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6/ college student and higher 01. 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

1. 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, 4. Do you have a treatment supporter? 0/ no 1/ yes 2/ 3 to 5 SDG, 3/ more than 5 SDG

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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 01.What is the usual treatment period until full recovery?

1/ yes

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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