|Year : 2017 | Volume
| Issue : 2 | Page : 116-122
Tuberculosis and the determinants of treatment outcome in Zaria, North Western Nigeria – A nine-year (2007–2015) epidemiological review
Adegboyega Oyefabi1, Eyitayo Adetiba2, Emmanuel Leeshak2, Olufemi Adesigbin2
1 Kaduna State University, Tafawa Balewa Way, Kaduna, Nigeria
2 National Tuberculosis and Leprosy Training Centre, Saye, Zaria, Nigeria
|Date of Web Publication||15-Nov-2017|
Kaduna State University, Tafawa Balewa Way, PMB 2339, Kaduna
Source of Support: None, Conflict of Interest: None
Introduction: Tuberculosis (TB) kills, worldwide, about 1.5 million people infected by the disease per year according to the 2015 World Health Organization (WHO) Global TB report. In sub-Saharan Africa, Nigeria accounts for the highest absolute number of TB morbidity and the 4th among the six high-TB burden countries, which account for about 60% of all TB cases globally.
Materials and Methods: This study is a retrospective, descriptive cross-sectional review of the facility TB registers of 4054 patients who accessed TB healthcare services at the 25 directly observed treatment short course (DOTS) Primary Health Care facilities in Zaria, Northwestern Nigeria, between January 1, 2007 and December 31, 2015.
Results: Majority of the patients were males (2601; 64.2%), belonging to the age group <40 years (2837; 70%) The patients presented mainly with pulmonary TB (3591; 88.6%). Only half the number of patients (50.3%) had smear-positive results before the commencement of short-course chemotherapy with either 2RHZE/6EH or 2SRHZE/IRHZE/5RHE (1, 2 = 1 or 2 months intensive phase, 5 = 5 months continuation phase, R = rifampicin, H = isoniazid, Z= pyrazinamide, E = ethambutol, S = streptomycin). Human immunodeficiency virus (HIV) coinfection was reported in 774 (19.1%) patients. The treatment success rate was 80.2% (3253 patients); 278 (6.9%) of the patients were lost to follow-up, 176 (4.3%) were transferred out, and 235 (5.8%) died. The determinants of the unsuccessful treatment outcome were being a male, aged >40 years, TB and HIV coinfection, a greater degree of sputum smear positivity before treatment, located at far distances from DOTS centers, and being on retreatment or second-line regimen.
Conclusion: The treatment success rate falls below the recommended 85% by the WHO.
Recommendations: There is a need for the Nigeria government in collaboration with international agencies to intensify effort at TB surveillance, monitoring, and control activities in Nigeria. Effort should be directed at promoting TB/HIV awareness, the early recognition and diagnosis of TB, and strategies to expand and improve DOTS service at community level.
Keywords: DOTS, patients, smear positivity, success rate, tuberculosis, World Health Organization
|How to cite this article:|
Oyefabi A, Adetiba E, Leeshak E, Adesigbin O. Tuberculosis and the determinants of treatment outcome in Zaria, North Western Nigeria – A nine-year (2007–2015) epidemiological review. J Med Trop 2017;19:116-22
|How to cite this URL:|
Oyefabi A, Adetiba E, Leeshak E, Adesigbin O. Tuberculosis and the determinants of treatment outcome in Zaria, North Western Nigeria – A nine-year (2007–2015) epidemiological review. J Med Trop [serial online] 2017 [cited 2020 Jul 11];19:116-22. Available from: http://www.jmedtropics.org/text.asp?2017/19/2/116/218402
| Introduction|| |
Tuberculosis (TB) is the most common causes of infectious disease-related morbidity and mortality worldwide. The global TB prevalence is second only to the human immunodeficiency syndrome [human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS)]. Nigeria is regarded as a major target in the global control of the disease, being the 4th highest TB-burden country in the world, and number one in Africa. The increasing global burden of HIV has affected the prevalence and transmission of TB dramatically. Worldwide, TB is a disease that is predominant among the poor and the less privileged people, especially in Africa, Southeast Asia, Brazil, India, and Latin America. The risk factors for the prevalence of TB among these population groups include large family size, overcrowding with resultant high population density, ignorance regarding the mode of presentation and the management of the disease, extreme poverty, and HIV. These and other related factors influence the exposure and the manifestation of TB differently in different communities in Nigeria. There is also a projection that at the current rate of transmission and the development of TB, over four million TB cases are expected to occur in the country between 2015 and 2020.,
TB is a chronic infection caused by bacteria belonging to the Mycobacterium tuberculosis complex, usually characterized pathologically by the formation of granulomas. The most common site of TB infection is the lung parenchyma [pulmonary TB (PTB)], but other organs may be involved in extrapulmonary TB.
Any cough lasting two or more weeks with or without weight loss, night sweats, or fever is a presumptive TB case. The issue of the treatment outcome for TB has, therefore, become very important due to increasing TB prevalence, the relationship between HIV and TB infection, its close association with poverty, and the growing prevalence of drug-resistant TB (DR-TB), which mirrors the functional state and the efficiency of the community TB control program. Closely related with the treatment outcome are also the TB case detection and the TB cure rates.
Developing nations such as Nigeria have challenges with case detection due to the poor laboratory support in their directly observed treatment short course (DOTS) services. TB detection is largely performed by sputum Acid Fast Bacilli (AFB) microscopy test in Nigeria. The isolation of the TB pathogen by culture only exists at regional and national reference laboratories, although the molecular diagnosis gene Xpert tests are now available in some tertiary and reference centers in the country.
In the absence of readily available culture facilities in high-burden countries, most cases of extrapulmonary TB are diagnosed based on clinical presentations, radiological findings, and other laboratory-based indicators. The few patients who overcome the challenge of not getting laboratory confirmation may still face other challenges such as inappropriate drug prescriptions, anti-TB drugs of uncertain quality, irregular drug supply, and poor adherence to treatment., These factors may have varied effects on the treatment outcome for the patients with TB.
The determinants of TB treatment outcome have not been published previously for Zaria metropolis. The purpose of this study, therefore, is to determine the factors contributing to the TB treatment outcomes in Zaria, Northwestern Nigeria, using the TB registers of the 25 TB DOTS facilities in the metropolis.
| Materials and methods|| |
Background of the study area
The study was conducted in Zaria, an historic Hausa metropolis in Northwestern Nigeria. The metropolis consists of Zaria and Sabon Gari local government areas, with an estimated population of 495,943 and 322,876, respectively, as well as 25 DOTS facilities including the National Tuberculosis and Leprosy Training Centre, Saye, Zaria. Each of the two Local Government Areas has a local government tuberculosis and leprosy supervisor (LGTBLS) who is responsible for coordinating TB and leprosy control activities in the local government of their jurisdiction.
Study design and study population
A 9-year retrospective, descriptive cross-sectional review was conducted of the local government TB central registers of 4054 patients who accessed TB healthcare services at the 25 DOTS facilities in Zaria between January 1, 2007 and December 31, 2015. All the patients with complete register records were included in the survey.
The information obtained from the central TB registers includes sociodemographic and clinical data such as age, sex, the site of infection, drug regimen, sputum smear results, the type of the patients, HIV status, the name of facility, the dates of initiation, and the completion of treatment. The records were scrutinized by the researcher, error entries were corrected where possible, and incomplete records were removed to ensure the consistency and accuracy of entries. The researcher was assisted by two research assistants who were trained on data extraction from the TB registers and data entry.
The data were collated and entered into the computer using IBM SPSS Statistics for Windows, Version 20.0. Armonk, NY: IBM Corp, while the StataCorp STATA/SE 12 (StataCorp., 2011; Stata Statistical Software: Release 12, College Station, TX; StataCorp LP) was used for both descriptive and inferential analyses. We computed the frequencies and the percentages of the sociodemographic and clinical profiles of the patients; chi-square and P values were determined for the treatment outcomes [[Table 1] and [Table 2]]. The level of statistical significance was set at P ≤ 0.05. The treatment outcomes were also stratified by the treatment regimen, and the associations were determined with the chi-square analysis and adjusted odd ratios [Table 3]. The multivariate logistic regression analysis was used to determine the factors independently associated with treatment outcomes among the patients [Table 4]. The primary outcome variable was the TB treatment outcome with the following two label values: successful and unsuccessful treatment outcomes. The successful treatment outcome was the summation of the cured and completed treatment variables, whereas the unsuccessful treatment outcome was the summation of the treatment failure, loss to follow up, and transferred and dead patients. The predictor variables identified from the patients’ records were age, sex, residential address, the type of facility, HIV status, and initial sputum test positivity. The dependent variable (treatment outcome) was regressed against these sets of independent (predictors) variables to determine the significant factors associated with the TB treatment outcome [Table 4].
|Table 1: Demographic and clinical profiles of the tuberculosis patients at DOTS facilities in Zaria in 2007–2015 (n = 4054)|
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|Table 2: Treatment outcome stratified by the age of the tuberculosis patients at DOTS facilities in Zaria in 2007–2015 (n = 4054)|
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|Table 3: Treatment outcome stratified by the treatment regimen among tuberculosis patients at DOTS facilities in Zaria (2007–2015) (n = 3884)|
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|Table 4: Multivariable logistic regression analysis of factors associated with treatment outcomes among pulmonary tuberculosis patients in Zaria, Nigeria in 2007–2015 (n = 3881)|
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Ethical clearance for the study was obtained from the Kaduna State Ministry of Health. The authors were permitted to use the TB registers by the LGTBLSs after explaining the purpose of the study and agreement to anonymize the data.
| Results|| |
There were 4054 respondents. Males were 2601 (64.2%) in number, whereas females were 1453 (35.8%) in number. Four-fifths (80%) of the patients lived within the Zaria metropolis, whereas the other one-fifth were residents of remote rural communities, at least 30 km from Zaria. Patients new to treatment were 3663 (90.4%) in number, whereas patients undergoing retreatment as well as those who had treatment failure, loss to follow-up, were transferred, and died due to TB constituted the rest of the cases, which were 391 (9.6%.) in number. Majority of the patients had PTB (3591; 88.6%) [Table 1].
Only half of the number of patients (2041; 50.3%) had smear-positive results at baseline, whereas 1229 (34.5%) patients had smear-negative results. The sputum test results were unknown for 784 (19.3%) patients with suspected PTB before the commencement of the therapy. The sputum AFB microscopy results of respondents who were smear positive were as follows: 642 (15.8%) 1+, 643 (15.9%) 2+, 756 (18.6%) 3+ smear positive before the treatment. They presented with PTB (88.6%) and extrapulmonary TB (11.4%). Patients with TB and HIV coinfection were 774 (19.1%) in number [Table 1].
Post-treatment, 1128 (27.8%) patients were confirmed cured based on bacteriological evidence, while 2125 (52.4%) patients completed treatment but had no bacteriological evidence to confirm cure. A total of 278 (6.9%) patients were lost to follow-up, 176 (4.3%) patients were transferred out, and 235 (5.8%) patients died. There was a statistically significant association between the ages of the patients and TB cure, because more number of patients aged <40 years were cured and completed treatment (P ≤ 0.004) [Table 2].
[Table 3] reveals that those who were on first-line treatment regimen significantly achieved better cure [X2 = 698, adjusted odd ratio (AOR) = 78.8, 95% confidence interval (CI) = 50–124] and completed treatment [X2 = 344, AOR = 0.42, 95% CI = 0.33–0.51] better than those in the retreatment group. They were also less likely to fail treatment when compared to those in the retreatment group [odd ratio (OR) = 0.19, 95% CI = 0.08–0.46]. There was no significant difference between those who died, defaulted, or transferred out and the treatment regimen (OR < 1, P > 0.05). The logistic regression analysis results in [Table 4] shows that the odds of experiencing unsuccessful treatment outcome was 20% higher for patients who were on retreatment regimen (OR = 1.2, 95% CI = 0.99–1.6) than the patients who were new for treatment. [Table 4] also reveals that females were less likely to have unsuccessful treatment outcome in comparison to the males (OR = 0.74, 95% CI = 0.61–0.90). Older patients were also more likely to experience unsuccessful treatment outcome than the younger patients (OR = 1.33, 95% CI = 1.1–1.61). Patients who were HIV negative (OR = 0.73, 95% CI = 0.57–0.91) and patients with unknown retroviral status (OR = 0.74, 95% CI = 0.58–0.95) had better treatment outcome than the patients coinfected with TB and HIV. The odds for unsuccessful treatment also significantly increased for patients from distant locations outside Zaria metropolis than for those within Zaria (OR = 1.5, 95% CI = 1.2–1.86).
Patients with 1+ (OR = 1) sputum test result at the commencement of therapy also significantly had better treatment outcome than those patients with 2+ (OR = 1.20, 95% CI = 0.78–1.44), 3+ (OR = 1.06, 95% CI = 0.78–1.44), and smear-negative PTB (OR = 1.46, 95% CI = 1.12–1.99).
| Discussion|| |
Majority of the 4054 patients were new (90.4%) cases presenting with PTB (88.6%). Only half the number of patients had a smear-positive result, while the sputum test was not performed for 784 (19.3%) patients with suspected PTB before the commencement of the therapy. Only approximately one-third of the patients were confirmed cured based on bacteriological evidence, while more than half the number of patients completed treatment with no bacteriological evidence to confirm cure. Overall, 278 (6.9%) patients were lost to follow-up, 176 (4.3%) patients transferred out, and 235 (5.8%) patients died. The logistic regression analysis revealed that treatment outcome was significantly associated with the patients’ sex, age, HIV status, treatment regimen, and the pretreatment sputum test results.
Although males constituted the majority of the patients, females achieved higher cure rates in this study. Previous studies have highlighted a higher prevalence of PTB among men than women, and this preponderance may be attributed to increased male activities that increase the risk of contacts with the infected persons in the work place, during visits to overcrowded recreation centers, and involvement in higher risky sexual behaviors with consequent HIV infection, which is a strong risk factor for developing TB disease. A total of 450 (11%) males and 323 (8%) females had HIV and TB coinfection in this study. We also found that the patients aged <40 years had better treatment outcomes than older patients. A previous study attributed this to the higher loss to follow-up and more death rates and worsened TB morbidity in the elderly.
The TB DOTS facilities are disproportionately located in Zaria, an urban metropolis, than in the rural communities. This explains why some patients had to travel more than 30 km away from their homes in the rural communities to Zaria to access TB services. This means that those who could not afford the transport fare or who found it difficult to get a means of transportation to the DOTS centers may default on treatment. Although the treatment of TB is free, the payment of transport fare and other hidden out-of-pocket costs are borne by the patients. This may worsen the vicious cycle of TB and poverty., The outcome of treatment at both the public and private facilities was the same in this study. This may be because of continuous engagement and collaboration between the private health centers and TB control program., Quality-assured sputum smear bacteriology is a cardinal component of the strategy to control TB. However, in the current study, only half of the number of participants had access to sputum AFB microscopy test before the commencement of the anti-TB therapy. This might be because the sputum smear microscopy test could not be performed due to inadequate laboratory back up facilities or due to situations where the demand for the laboratory services outweighs the available resources.
It should be noted that the treatment of drug-susceptible TB was in two categories. Category 1 was for new cases, whereas category 2 was for retreatment cases such as relapse (R), treatment after failure, or treatment after loss to follow-up (formerly RAD). We observed in this study that the patients’ outcomes were better for those on the CAT 1 therapy (2RHZE/6EH, 2RHZE/4RH) than those on CAT 2 therapy (2SRHZE/IRHZE/5RHE). This shows the need to emphasize early diagnosis and the initiation of appropriate treatment for TB with the first-line drugs (which are the most effective and least toxic anti-TB drugs) before complications that may lead to multidrug-resistant TB (MDR-TB) set in. The World Health Organization (WHO) has recently directed that for patients who require TB retreatment, the category II regimen should no longer be prescribed empirically, and drug-susceptibility testing should be conducted to inform the choice of treatment regimen. One in five of the patients (19%) had HIV coinfection [Table 1]. This result is similar to the 19% coinfection rate reported from Maiduguri and the national median HIV–TB coinfection rate of 17%. However, this result is lower than the HIV–TB coinfection prevalence rates of 33.2, 43.6, and 57.1% reported from Chad, Tanzania, and Ethiopia, respectively.The percentage of patients who were cured and were confirmed regarding the same by the sputum AFB microscopy test, which was performed on the 6th or 7th month of therapy, was 27.79%. The percentage of those who completed treatment but did not have the confirmatory tests performed or reported was 52.4% [Table 2]. The treatment success rate is, therefore, only 80.2%, which is still lower than the recommended 85% by the WHO. The case detection rate was very low at 50.3% compared with the WHO’s recommendation of 70%. Both, the low TB case detection and cure rates, are serious challenges militating against the control of TB in Nigeria.
The study has some limitations. As a facility-based retrospective study, we were limited to the information available in the patient’s records. Patient selection and issues with data quality may introduce bias. In addition, no drug susceptibility tests were conducted, and, therefore, we are unable to estimate the impact of DR-TB on outcomes.
| Conclusion|| |
In this study, individuals aged ≥40 years, males, patients with concomitant HIV infection and those with 2+ and 3+ degree of smear positivity, TB with smear-negative result, distant location to the DOTS center, and being on retreatment regimen significantly contributed to poor treatment outcomes (P < 0.05). The case detection and cure rates in this study were lower than the WHO’s recommendations. Those who were on first-line treatment regimen significantly achieved better cure than those in the retreatment group, which emphasizes the need for early diagnosis and treatment of TB to prevent the incidence of MDR-TB.
There is a need to locate more functional DOTS facilities in rural communities to improve access to TB diagnosis and management. At the community level, there is a need to involve community volunteers and leaders in the trainings conducted on TB for early presumptive diagnosis in the community and quick referral to the nearest DOTS centers. The public–private mix needs to be strengthened by the government and other TB stakeholders by initiating programs to subsidize TB management at private health facilities. All patients presumed with having TB should also have access to HIV treatment and counseling, because good treatment outcomes can only be achieved when patients coinfected with TB–HIV receive appropriate and timely services.
The authors wish to thank Dr. Lawrence Alalade of the Ladiya Clinic, Zaria, for assisting the authors in obtaining the TB registers from the Tuberculosis and Leprosy Supervisors in Zaria and Sabon Gari LGAs of Kaduna state.
Financial support and sponsorship
The abstract presentation of this paper at the 4th International Conference on Epidemiology and Public Health on October 3–5, 2016, London, United Kingdom was supported by the Nigeria Tertiary Education Trust Fund (TETFUND).
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4]