Prevalence and factors associated with tuberculosis treatment outcome among hazardous or harmful alcohol users in public primary health care in South Africa.

BACKGROUND
Tuberculosis (TB) remains a chronic infectious disease with high morbidity and mortality.


OBJECTIVE
The aim of this study was to assess the prevalence and associated factors of tuberculosis treatment failure, death and default among hazardous or harmful alcohol users.


METHOD
We conducted a prospective study with TB patients in 40 public health clinics in three districts in South Africa. All consecutively new tuberculosis and retreatment patients presenting at the 40 primary health care facilities with hazardous or harmful alcohol use were included in this study. Logistic regression was used to assess determinants of TB treatment failure, death and default.


RESULTS
The findings of our study showed that 70% of TB patients were either cured or had completed their TB treatment by the end of 6 months. In multivariate analysis participants living in a shack or traditional housing (Odds Ratio=OR: 0.63, Confidence Interval=CI: 0.45-0.89), being a TB retreatment patient (OR: 1.61, CI: 1.15-2.26) and residing in the eThekwini district (OR: 1.82, CI: 1.27-2.58) were significant predictors of treatment failure, death and default.


CONCLUSION
A high rate of treatment failure, death and default were found in the TB patients. Several factors were identified that can guide interventions for the prevention of treatment failure, death and default.


Background
Although there are numerous global efforts to control tuberculosis (TB), it remains a chronic infectious disease with high morbidity and mortality in several parts of the world. 1,2,3As the world's most frequent contagious disease, TB causes about 2 million deaths a year, with more than 8 million people contractingthe disease every year. 4,5According to the WHO, 6 an estimated 1.7 million people died from TB in 2009, with the highest number of TB related deaths being in the African region.
While modern TB treatment regimens are generally associated with a good prognosis, 7 factors such as bacterium characteristics, heterogeneity of patients' clinical characteristics, patient behaviour, quality of health care, HIV co-infection and multi-drug resistant tuberculosis (MDRTB) are known to influence TB treatment outcomes. 2,8,9,10A number of factors including age, male gender, delays in diagnosis and treatment, drug resistance, and co-morbid conditions including HIV co-infection, diabetes 1 , alcoholism, smoking, lower educational and income levels, unemployment, treatment for other concomitant diseases, and side effects of anti-TB drugs 11 have been associated with increased risk of death in patients with active tuberculosis.3][14] These studies show the pathogenic impact of alcohol on the immune system causing susceptibility to TB among drinkers. 13ople that drink heavily show higher relapse rates, a Prevalence and factors associated with tuberculosis treatment outcome among hazardous or harmful alcohol users in public primary health care in South Africa higher probability of an unfavourable clinical course and a higher probability of experiencing the most destructive forms of TB. 12,14 TB patients with an unsuccessful treatment outcome, especially due to treatment failure and default, are a public health concern as they are at risk for clinical deterioration and complications, can continue to be infectious to others, and are at risk of premature death from TB. 9,12 TB treatment default, defined by the World Health Organization (WHO) as a treatment interruption of two consecutive months or more after at least one month on treatment, 13 is among the factors that has been linked to TB related mortality, 45% in Vietnam, 27% in Mexico, 28% in South Africa and 54% in the USA. 14[17][18] There seems to be strong evidence that the risk of death and default increases among HIV positive patients.previous default, and the male sex. 12,20,22Alcohol abuse has also been associated with forgetting to take treatment (in 7.5% cases) and consequently defaulting. 20 2007, the African continent had the lowest tuberculosis (TB) cure rate (54%-74%) compared to the global cure rate (84%), primarily due to the lack of treatment adherence. 23A low cure rate and a high treatment default rate provide opportunities for maintaining transmission, relapse or treatment failure, mortality and the development of resistant TB. 22,24 Some studies have indicated that in sub-Saharan Africa poor public transport contributes to high treatment default. 20,25e aim of this study was to assess the prevalence and associated risk factors of tuberculosis treatment failure, death and default among hazardous or harmful alcohol users in selected health districts in South Africa.The Department of Health in South Africa has also provided approval for this study.

Measures
The outcome was the successful TB response, classified by WHO as cured or treatment completed (versus treatment failure, defaulted, died or transferred out to another health facility. 13This was assessed by inspection of medical records.Further, patients who previously had not completed their TB treatment were asked as to why they had stopped TB treatment.

Chronic conditions:
Two questions were asked to determine whether participants had chronic conditions and taking medications for their chronic conditions.The questions asked were "Has a doctor or nurse or health worker at a clinic or hospital ever told you that you have or have had any of the following conditions?"They were given a list of chronic conditions to choose from. 26,27sponse options were "yes" or "no".
The 10-item Kessler Psychological Distress Scale (K-10): was used to measure global psychological distress, including significant pathology which does not meet formal criteria for a psychiatric illness. 28,29The frequency with which each of the items was experienced was recorded using a five-point Likert scale ranging from ''none of the time'' to ''all the time''.This score was then summed with increasing scores reflecting an increasing degree of psychological distress.We examined the K-10 scale used as a binary variable, comparing scores of 10-15 versus 16 or more.The internal reliability coefficient for the K-10 in this study was alpha = 0.92.

Sample characteristics
We identified 1196 TB patients across 40 primary care clinics.These patients were screened for alcohol and tested positive for the AUDIT.The participants were followed up at 6 months and assessed for TB treatment outcomes.1049 (88%) were followed-up and 12% could not be followed up due to various reasons including misplaced fieldworkers codebooks, the incorrect recording of names, names that could not be matched with the clinic register and misplaced clinic registers.
The   Qualitative responses as to why patients defaulted on their treatment In total 106 patients responded with reasons as to why they had previously stopped TB medication,which

Discussion
The findings of our study showed that the majority of new tuberculosis and retreatment patients (70%) were either cured or had completed their TB treatment by the end of 6 months.Of concern though is the notable finding that 30% of TB patients had treatment failure, had died or defaulted on their treatment.High default rates have been reported to be the main cause of the growing number of treatment failure and increased drug resistance in retreatment cases. 32r study results support previous reports of better success in treatment rate for females compared to males.Although this difference between males and females was not statistically significant, similar findings were reported in previous studies where men seemed to have more default rate compared to women. 1,3,11,20is study indicates that compared to patients residing in permanent housing, patients living in a shack or a traditional dwelling were found to be at greater risk for treatment failure, death and default.There has been an abundance of literature on poverty as a risk factor for TB adherence. 3,4,6,33 Alo, patients classified among the poorest and most socially marginalized struggle to afford transport to get to clinics for their TB treatment.It is expected that transport in the inner cities was generally easily accessible compared to rural areas but this may not be the case.Previous study findings in a systematic review assessing TB treatment compliance and the factors predictive for poor adherence among TB patients in sub-Saharan Africa have also reported the poor public transport as a problem that can result in high treatment default. 20,25An unexpected finding was that patients who had a formal salary (30.8%) experienced more treatment default, and death outcomes compared to those who either relied on family contributions (28.9%) or social grants (28.4%).It would have been expected that patients with a formal salary would be able to complete their treatment as they were expected to afford to get to the clinic as previous studies have also indicated a strong association between treatment default and low income. 11,12milar to previous studies, 12,[19][20][21] we also found that retreatment was strongly associated with treatment default.With the Department of Health having introduced a programme of tracing TB treatment defaulters, it would help to determine the detailed reasons for were mainly significant health improvement, structural and psychosocial including alcohol problems (Table 3).We found psychological distress was associated with treatment default, although in multivariate analysis this was not significant.This may be important to note as this sample being a vulnerable group, may require special attention in the control of TB. 34 A study in India among new smear positive TB patients treated under DOTS found alcoholism as a predictor of noncompliance and poor patient provider interaction as a barrier to enhanced treatment compliance, 35 the problem of alcohol use was also mentioned by self-report as a reason to default in this study.Contrary to the findings of previous studies where comorbid conditions resulted in treatment failure, 36 it was encouraging that in the current study fewer participants (26.4%) with three or more chronic conditions experienced treatment failure, default and death compared to those who had less or no other chronic conditions.

Study limitations
Caution should be taken when interpreting the results of this study because of certain limitations.One of the limitations was that most variables were assessed by self-report and desirable responses may have been given.Generalisability of our findings is limited to TB patients on treatment in public primary care facilities.
Another limitation is the loss to follow-up (12%) due to incorrect recording of names.The missing codebooks of fieldworkers and names not found in clinic registers may have resulted in the study findings being biased because those interviewed might differ from those not found, and it is possible that more non-traceable defaulters had died.Furthermore, the study only assessed TB patients in the urban and peri-urban health facilities.

Conclusion
We assessed the prevalence and associated factors of

and 7
or more for women on the AUDIT questionnaire after the screening were included in this study.Research assistants conducted follow-up interviews at 6 months following baseline assessment at scheduled clinic visits.The research assistants were all individuals with a matric or Grade 12 qualification living in the communities where the study clinics were located and who spoke the predominant languages, namely English, Afrikaans, i-Zulu, i-Xhosa and Tswana, in the respective areas.They all attended a 3-day training in questionnaire administration, research procedures and ethics upon which they received a certificate for successful completion.In addition, medical file information was collected for HIV and TB treatment status and outcome.Nonattenders were followed up by telephone and home visits arranged as necessary.Ethical approval was obtained from the Human Sciences Research Council Research Ethics Committee (Protocol REC No.1/16/02/11).
tuberculosis treatment failure, death and default among hazardous or harmful alcohol users in public health clinics.A high rate of treatment failure, death and default were found in the assessed TB patients.Several factors were identified including sociodemographic and being a retreatment patient that can guide interventions for the prevention of treatment failure, death and default.

TABLE 1
Associations with TB treatment failure, death and default for all TB patients (new and retreatment)

TABLE 2 Table 2 :
Regression model with TB treatment failure, death and default for all TB patients (new and retreatment)

Table 3 :
Qualitative responses as to why patients defaulted on their TB treatment (N=106)