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Background: The prevalence of diseases other than TB detected during chest X-ray (CXR) screening is unknown in sub-Saharan Africa. This represents a missed opportunity for identification and treatment of potentially significant disease. Our aim was to describe and quantify non-TB abnormalities identified by TB-focused CXR screening during the 2016 Kenya National TB Prevalence Survey., Methods: We reviewed a random sample of 1140 adult (≥15 years) CXRs classified as 'abnormal, suggestive of TB' or 'abnormal other' during field interpretation from the TB prevalence survey. Each image was read (blinded to field classification and study radiologist read) by two expert radiologists, with images classified into one of four major anatomical categories and primary radiological findings. A third reader resolved discrepancies. Prevalence and 95% CIs of abnormalities diagnosis were estimated., Findings: Cardiomegaly was the most common non-TB abnormality at 259 out of 1123 (23.1%, 95% CI 20.6% to 25.6%), while cardiomegaly with features of cardiac failure occurred in 17 out of 1123 (1.5%, 95% CI 0.9% to 2.4%). We also identified chronic pulmonary pathology including suspected COPD in 3.2% (95% CI 2.3% to 4.4%) and non-specific patterns in 4.6% (95% CI 3.5% to 6.0%). Prevalence of active-TB and severe post-TB lung changes was 3.6% (95% CI 2.6% to 4.8%) and 1.4% (95% CI 0.8% to 2.3%), respectively., Interpretation: Based on radiological findings, we identified a wide variety of non-TB abnormalities during population-based TB screening. TB prevalence surveys and active case finding activities using mass CXR offer an opportunity to integrate disease screening efforts., Funding: National Institute for Health Research (IMPALA-grant reference 16/136/35)., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)

Background: Empirical treatment of tuberculosis (TB) may be necessary in patients with negative or no Xpert MTB/RIF results. In a context with access to Xpert, we assessed mortality in the 6 months after the initial TB consultation among HIV-positive and HIV-negative patients who received empirical TB treatment or TB treatment based on bacteriological confirmation and we compared it with the mortality among those who did not receive TB treatment., Methods: This prospective cohort study included consecutively adult patients with signs and symptoms of TB attending an outpatient TB clinic in Western Kenya. At the first consultation, patients received a clinical exam and chest X-ray. Sputum was collected for microscopy, Xpert and Mycobacterium tuberculosis complex (MTB) culture. Patients not started on TB treatment were reassessed after 5 days. All patients bacteriologically confirmed (positive Xpert or culture) received TB treatment. Empirical treatment was defined as a decision to start TB treatment without bacteriological confirmation. Patients were reassessed after 6 months., Results: Of 606 patients included, 344/606 (56.8%) were women. Median age was 35 years [Interquartile Range (IQR):27-47] and 398/594 (67.0%) were HIV-positive. In total, 196/606 (32.3%) patients were Xpert- or culture-positive and 331/606 (54.6%) started TB treatment. Overall, 100/398 (25.1%) HIV-positive and 31/196 (15.8%) HIV-negative patients received empirical treatment. Mortality in the 6 months following the first consultation was 1.6 and 0.8/100 patient-months among HIV-positive and HIV-negative patients respectively. In the multivariate analyses, TB treatment - whether empirical or based on bacteriological confirmation- was not associated with increased mortality among HIV-positive patients (aHR:2.51, 95%CI:0.79-7.90 and aHR:1.25, 95%CI:0.37-4.21 respectively). However, HIV-negative patients who received empirical treatment had a higher risk of mortality (aHR:4.85, 95%CI:1.08-21.67) compared to those not started on treatment. HIV-negative patients treated for TB based on bacteriological confirmation did not have a different risk of mortality (aHR:0.77, 95%CI:0.08-7.41)., Conclusions: Our findings suggest that in a context with access to Xpert, clinicians should continue using empirical TB treatment in HIV-positive patients with signs and symptoms of TB and negative Xpert results. However, differential diagnoses other than TB should be actively sought before initiating empirical TB treatment, particularly in HIV-negative patients.

Background: We aimed to determine the prevalence of pulmonary TB amongst the adult population (≥15 years) in 2016 in Kenya., Method: A nationwide cross-sectional survey where participants first underwent TB symptom screening and chest x-ray. Subsequently, participants who reported cough >2weeks and/or had a chest x-ray suggestive of TB, submitted sputum specimen for laboratory examination by smear microscopy, culture and Xpert MTB/RIF., Result: The survey identified 305 prevalent TB cases translating to a prevalence of 558 [95%CI 455-662] per 100,000 adult population. The highest disease burden was reported among people aged 25-34 years (716 [95% CI 526-906]), males (809 [(95% CI 656-962]) and those who live in urban areas (760 [95% CI 539-981]). Compared to the reported TB notification rate for Kenya in 2016, the prevalence to notification ratio was 2.5:1. The gap between the survey prevalence and notification rates was highest among males, age groups 25-34, and the older age group of 65 years and above. Only 48% of the of the survey prevalent cases reported cough >2weeks. In addition, only 59% of the identified cases had the four cardinal symptoms for TB (cough ≥2 weeks, fever, night sweat and weight loss. However, 88.2% had an abnormal chest x-ray suggestive of TB. The use of Xpert MTB/RIF identified 77.7% of the cases compared to smear microscopy's 46%. Twenty-one percent of the survey participants with respiratory symptoms reported to have sought prior health care at private clinics and chemists. Among the survey prevalent cases who reported TB related symptoms, 64.9% had not sought any health care prior to the survey., Conclusion: This survey established that TB prevalence in Kenya is higher than had been estimated, and about half of the those who fall ill with the disease each year are missed., Competing Interests: The authors have declared that no competing interests exist.

Background: Determine-TB LAM assay is a urine point-of-care test useful for TB diagnosis in HIV-positive patients. We assessed the incremental diagnostic yield of adding LAM to algorithms based on clinical signs, sputum smear-microscopy, chest X-ray and Xpert MTB/RIF in HIV-positive patients with symptoms of pulmonary TB (PTB)., Methods: Prospective observational cohort of ambulatory (either severely ill or CD4<200cells/μl or with Body Mass Index<17Kg/m2) and hospitalized symptomatic HIV-positive adults in Kenya. Incremental diagnostic yield of adding LAM was the difference in the proportion of confirmed TB patients (positive Xpert or MTB culture) diagnosed by the algorithm with LAM compared to the algorithm without LAM. The multivariable mortality model was adjusted for age, sex, clinical severity, BMI, CD4, ART initiation, LAM result and TB confirmation., Results: Among 474 patients included, 44.1% were severely ill, 69.6% had CD4<200cells/μl, 59.9% had initiated ART, 23.2% could not produce sputum. LAM, smear-microscopy, Xpert and culture in sputum were positive in 39.0% (185/474), 21.6% (76/352), 29.1% (102/350) and 39.7% (92/232) of the patients tested, respectively. Of 156 patients with confirmed TB, 65.4% were LAM positive. Of those classified as non-TB, 84.0% were LAM negative. Adding LAM increased the diagnostic yield of the algorithms by 36.6%, from 47.4% (95%CI:39.4-55.6) to 84.0% (95%CI:77.3-89.4%), when using clinical signs and X-ray; by 19.9%, from 62.2% (95%CI:54.1-69.8) to 82.1% (95%CI:75.1-87.7), when using clinical signs and microscopy; and by 13.4%, from 74.4% (95%CI:66.8-81.0) to 87.8% (95%CI:81.6-92.5), when using clinical signs and Xpert. LAM positive patients had an increased risk of 2-months mortality (aOR:2.7; 95%CI:1.5-4.9)., Conclusion: LAM should be included in TB diagnostic algorithms in parallel to microscopy or Xpert request for HIV-positive patients either ambulatory (severely ill or CD4<200cells/μl) or hospitalized. LAM allows same day treatment initiation in patients at higher risk of death and in those not able to produce sputum., Competing Interests: The authors have declared that no competing interests exist.

Objective: To determine gender differences in treatment outcomes among 15-49 year olds with smear-positive pulmonary tuberculosis (PTB) and factors associated with poor outcomes in Kenya., Design: Retrospective descriptive cohort., Results: Of 16 056 subjects analysed, 38% were female and 62% male. Females had a higher risk of poor treatment outcome than males (12% vs. 10%, P < 0.001; adjusted OR 1.29, 95%CI 1.16-1.44, P < 0.001). In the first multivariate model, restricting the analysis to human immunodeficiency virus (HIV) positive patients and adjusting for risk factors and clustering, females had a non-significantly lower risk of poor outcome (OR 0.99, 95%CI 0.86-1.13, P = 0.844). In the model restricted to HIV-negative patients, a non-significantly lower risk was found (OR 0.89, 95%CI 0.73-1.09, P = 0.267). In the second model, restricting analysis to patients on antiretroviral therapy (ART) and adjusting for risk factors and clustering, females had a non-significantly lower risk of poor PTB treatment outcomes (OR 0.98, 95%CI 0.84-1.14, P = 0.792). In the model restricted to HIV-positive patients not on ART, a non-significantly higher risk was found (OR 1.15, 95%CI 0.79-1.67, P = 0.461)., Conclusion: Females of reproductive age are likely to have poorer treatment outcomes than males. Among females, not commencing ART during anti-tuberculosis treatment seemed to be associated with poor outcomes.

Background: In 2012, the World Health Organization estimated that there were 120,000 new cases and 9500 deaths due to tuberculosis (TB) in Kenya. Almost a quarter of the cases were not detected, and the treatment of 4% of notified cases ended in default., Objective: To identify the determinants of anti-tuberculosis treatment default., Design: Data from 2012 and 2013 were retrieved from a national case-based electronic data recording system. A comparison was made between new pulmonary TB patients for whom treatment was interrupted vs. those who successfully completed treatment., Results: A total of 106,824 cases were assessed. Human immunodeficiency virus infection was the single most influential risk factor for default (aOR 2.7). More than 94% of patients received family-based directly observed treatment (DOT) and were more likely to default than patients who received DOT from health care workers (aOR 2.0). Caloric nutritional support was associated with lower default rates (aOR 0.89). Males were more likely to default than females (aOR 1.6). Patients cared for in the private sector were less likely to default than those in the public sector (aOR 0.86)., Conclusion: Understanding the factors contributing to default can guide future program improvements and serve as a proxy to understanding the factors that constrain access to care among undetected cases.

Kevin Cain and colleagues reflect on the cross border movement of people from Somalia with MDR-TB and the implications for MDR-TB programs in East Africa.

Setting: In 2007, the World Health Organization recommended introducing rapid Mycobacterium tuberculosis culture into the diagnostic algorithm of smear-negative pulmonary tuberculosis (TB)., Objective: To assess the cost-effectiveness of introducing a rapid non-commercial culture method (thin-layer agar), together with Löwenstein-Jensen culture to diagnose smear-negative TB at a district hospital in Kenya., Design: Outcomes (number of true TB cases treated) were obtained from a prospective study evaluating the effectiveness of a clinical and radiological algorithm (conventional) against the alternative algorithm (conventional plus M. tuberculosis culture) in 380 smear-negative TB suspects. The costs of implementing each algorithm were calculated using a 'micro-costing' or 'ingredient-based' method. We then compared the cost and effectiveness of conventional vs. culture-based algorithms and estimated the incremental cost-effectiveness ratio., Results: The costs of conventional and culture-based algorithms per smear-negative TB suspect were respectively €39.5 and €144. The costs per confirmed and treated TB case were respectively €452 and €913. The culture-based algorithm led to diagnosis and treatment of 27 more cases for an additional cost of €1477 per case., Conclusion: Despite the increase in patients started on treatment thanks to culture, the relatively high cost of a culture-based algorithm will make it difficult for resource-limited countries to afford.

Background: Tuberculosis still remains a major cause of maternal and newborn morbidity and mortality. Integrating tuberculosis screening and detection into postnatal care services ensures prompt and appropriate treatment for affected mothers and their babies. This study therefore examined the feasibility and effect of screening and referral for tuberculosis within postnatal care settings from the perspective of providers., Methods: This operations research study used a pre- and post-intervention design without a comparison group. The study was implemented between March 2009 and August 2010 in five health facilities located in low-income areas of Nairobi, Kenya, which were suspected to have relatively high prevalence of both tuberculosis and HIV. Descriptive statistics and significance tests were employed to determine changes in the indicators of interest between baseline and endline., Results: Among the 12,604 postnatal care clients screened, 14 tuberculosis cases were diagnosed. The proportion of clients screened for at least one cardinal sign of tuberculosis rose from 4% to 66%, and 21% of clients were screened for all six tracer signs and symptoms. A comparison of 10 quality of postnatal care and tuberculosis screening components at baseline and endline showed a highly significant effect on all 10 components., Conclusions: The findings demonstrate that using postnatal care services as a platform for tuberculosis screening and detection is acceptable and feasible. In addition, linking clients identified through screening to further treatment significantly improved. However, the actual number of cases detected was low. A policy debate on whether to link tuberculosis screening with reproductive health services is recommended before full scale-up of this intervention.

Background: The 2007 WHO algorithm for diagnosis of smear-negative pulmonary tuberculosis (PTB) including Mycobacterium tuberculosis (MTB) culture was evaluated in a HIV prevalent area of Kenya., Methods: PTB smear-negative adult suspects were included in a prospective diagnostic study (2009-2011). In addition, program data (2008-2009) were retrospectively analysed. At the first consultation, clinical examination, chest X-ray, and sputum culture (Thin-Layer-Agar and Lowenstein-Jensen) were performed. Patients not started on TB treatment were clinically re-assessed after antibiotic course. The algorithm performance was calculated using culture as reference standard., Results: 380 patients were included prospectively and 406 analyzed retrospectively. Culture was positive for MTB in 17.5% (61/348) and 21.8% (72/330) of cases. Sensitivity of the clinical-radiological algorithm was 55.0% and 31.9% in the prospective study and the program data analysis, respectively. Specificity, positive and negative predictive values were 72.9%, 29.7% and 88.6% in the prospective study and 79.8%, 30.7% and 80.8% in the program data analysis. Performing culture increased the number of confirmed TB patients started on treatment by 43.3% in the prospective study and by 44.4% in the program data analysis. Median time to treatment of confirmed TB patients was 6 days in the prospective study and 27 days in the retrospective study. Inter-reader agreement for X-ray interpretation between the study clinician and a radiologist was low (Kappa coefficient = 0.11, 95%CI: 0.09-0.12). In a multivariate logistic analysis, past TB history, number of symptoms and signs at the clinical exam were independently associated with risk of overtreatment., Conclusion: The clinical-radiological algorithm is suboptimal to diagnose smear-negative PTB. Culture increases significantly the proportion of confirmed TB cases started on treatment. Better access to rapid MTB culture and development of new diagnostic tests is necessary.

Setting: Tuberculosis (TB) treatment center at Coast Provincial General Hospital in Mombasa, Kenya., Objectives: To describe TB management practices in a facility in coastal Kenya and identify factors associated with poor treatment outcomes., Design: Retrospective review of patient treatment records from January 2008 to June 2009. Treatment outcomes of patients were classified as treatment success (cure or treatment completion) or poor treatment outcome (treatment failure, death or default). Relative risk regression was used to determine the association between exposures of interest and poor treatment outcomes., Results: Records were obtained from a total of 183 patients: 142 (78%) had pulmonary TB, 68 (37%) were human immunodeficiency virus (HIV) infected and 81 (44%) had acid-fast bacilli (AFB) positive smear micros- copy. Most treated individuals (86%) achieved a successful treatment outcome as defined by the World Health Organization. Of those with poor treatment outcomes, 64% defaulted, 32% died, and 4% failed treatment. Initial negative AFB smear and HIV co-infection were associated with poor treatment outcomes (RR 3.32, 95%CI 1.22-8.99 and RR 4.61, 95%CI 1.69- 12.59, respectively)., Conclusion: Strategies to accelerate accurate diagnosis of smear-negative TB and increase patient retention during treatment, especially in HIV co-infected individuals, are needed to reduce poor treatment outcomes in Kenya.

Background: The poor face geographical, socio-cultural and health system barriers in accessing tuberculosis care. These may cause delays to timely diagnosis and treatment resulting in more advanced disease and continued transmission of TB. By addressing barriers and reasons for delay, costs incurred by TB patients can be effectively reduced. A Tool to Estimate Patients' Costs has been developed. It can assist TB control programs in assessing such barriers. This study presents the Tool and results of its pilot in Kenya., Methods: The Tool was adapted to the local setting, translated into Kiswahili and pretested. Nine public health facilities in two districts in Eastern Province were purposively sampled. Responses gathered from TB patients above 15 years of age with at least one month of treatment completed and signed informed consent were double entered and analyzed. Follow-up interviews with key informants on district and national level were conducted to assess the impact of the pilot and to explore potential interventions., Results: A total of 208 patients were interviewed in September 2008. TB patients in both districts have a substantial burden of direct (out of pocket; USD 55.8) and indirect (opportunity; USD 294.2) costs due to TB. Inability to work is a major cause of increased poverty. Results confirm a 'medical poverty trap' situation in the two districts: expenditures increased while incomes decreased. Subsequently, TB treatment services were decentralized to fifteen more facilities and other health programs were approached for nutritional support of TB patients and sputum sample transport. On the national level, a TB and poverty sub-committee was convened to develop a comprehensive pro-poor approach., Conclusions: The Tool to Estimate Patients' Costs proved to be a valuable instrument to assess the costs incurred by TB patients, socioeconomic situations, health-seeking behavior patterns, concurrent illnesses such as HIV, and social and gender-related impacts. The Tool helps to identify and tackle bottlenecks in access to TB care, especially for the poor. Reducing delays in diagnosis, decentralization of services, fully integrated TB/HIV care and expansion of health insurance coverage would alleviate patients' economic constraints due to TB.