Background: Infants are a target population for new tuberculosis (TB) vaccines. TB incidence estimates are needed to guide the design of trials. To determine the TB incidence and cohort retention among young children using comprehensive diagnostic methods in a high burden area. Methods: Infants 0–42 days were enrolled. Through 4 monthly follow-up and unscheduled (sick) visits up to the age of 2 years, infants with presumptive TB based on a history of contact, TB symptoms or pre-determined hospitalization criteria were admitted to a case verification ward. Two induced sputa and gastric aspirates were collected for culture and GeneXpert. Mantoux and HIV tests were done. Clinical management was based on the Keith Edwards score. Cases were classified into microbiologically confirmed or radiologic, diagnosed by blinded expert assessment. Cox regression was used to identify risk factors for incident TB and study retention. Results: Of 2900 infants enrolled, 927 (32%) developed presumptive TB, 737/927 (80%) were investigated. Sixty-nine TB cases were diagnosed (bacteriologic and radiologic). All TB incidence was 2/100 person-years of observation (pyo) (95% CI: 1.65–2.65). Nine were bacteriologic cases, incidence 0.3/100 pyo. The radiologic TB incidence was 1.82/100 pyo. Bacteriologic TB was associated with infant HIV infection, higher Keith Edwards scores. Completeness of 4-month vaccinations and HIV infection were positively associated with retention. Conclusions: TB incidence was high. An all TB endpoint would require a sample size of a few thousand children, but tens of thousands, when limited to bacteriologic TB.

Objective To compare the prevalence of tuberculosis infection and disease in household contacts of patients with bacteriologically confirmed tuberculosis disease and contacts of non-bacteriologically confirmed disease in western Kenya. Methods We enrolled newly diagnosed index patients and their household contacts from March 2014 to June 2016. All contacts were evaluated with a symptom questionnaire, tuberculin skin test (TST) and HIV test. Clinical evaluation and sputum testing were performed for those with symptoms, positive TST result or HIV infection. Results We enrolled 1155 contacts of 330 index patients with bacteriologically confirmed tuberculosis and 192 contacts of 55 index patients with non-bacteriologically confirmed tuberculosis. 3.5% of contacts of patients with bacteriologically confirmed tuberculosis were diagnosed with tuberculosis, whereas no contacts of index patients with non-bacteriologically confirmed tuberculosis were. Of those diagnosed with tuberculosis disease, 58.5% reported symptoms, 34.1% reported no symptoms but had positive TST results, and 7.3% had neither symptoms nor positive TST but were HIV-positive. Among 872 contacts with a TST result, 50.9% of contacts of index patients with bacteriologically confirmed tuberculosis and 41.0% of contacts of index patients with non-bacteriologically confirmed tuberculosis had a positive result (prevalence ratio = 1.16, 95% confidence interval 0.92-1.48). Conclusion In a high-burden setting, tuberculosis disease was more prevalent among contacts of patients with bacteriologically confirmed tuberculosis than contacts of patients with non-bacteriologically confirmed disease. TST was feasible to perform and helped to detect cases that would have been missed had only symptomatic contacts been evaluated.

Abstract Setting Siaya District, Western Kenya, with the highest TB notification rates in Kenya (400/100,000) Objective To determine the prevalence and annual risk of infection with M. tuberculosis (ARTI) among adolescents aged 12-18 years Design Adolescents aged 12-18 years were enrolled in an area under continuous health and demographic surveillance in 2008-2009. At enrolment, clinical and demographic data were collected and study participants screened for tuberculosis (TB) and for tuberculous infection using tuberculin skin tests (TST). Results Of 5004 adolescents enrolled, 4808 (96%) returned for TST readings. Of these 2327(48.4%) were female, 861 (17.9%) had no BCG scar, and 23 (0.5%) were HIV positive. The baseline prevalence of tuberculous infection was 32% (95% CI 29-35%) with a corresponding ARTI of 2.6% (95% CI 2.2-3.1%). Male gender (OR 1.3, 95%CI 1.2,1.5), having a BCG scar (OR 1.4,95%CI 1.3,1.7) and not being enrolled in school (OR 1.8, 95%CI 1.4,2.3) were independent predictors of a positive tuberculin skin test at baseline. Conclusion We found a high ARTI indicating very high TB transmission rates, suggesting that in this population prevention studies including TB vaccine trials would be both highly relevant and efficient.

Background: Adolescents are a prime target group for tuberculosis (TB) vaccine trials that include prevention of infection (POI). The BCG vaccine is given at birth and does not prevent TB infection. TB infection, a critical endpoint for POI vaccine trials would need to be documented to estimate sample sizes in target populations. Methods: Adolescents aged 12-18 years of age were enrolled in an area under continuous demographic surveillance. A tuberculin skin test (TST) survey was conducted as part of a study on TB prevalence and incidence. All adolescents got TSTs at enrolment and returned after 72 hours for reading. A TST of ≥10mm if HIV negative or ≥ 5mm if HIV positive, was considered positive. Results: Of 4808 adolescents returning for TST readings (96% of those enrolled), mean age was 14.4 (SD 1.9), 4518(94%) were enrolled in school and 21(0.4%) gave a previous history of tuberculosis. Among adolescents with TST reactivity, the mean TST induration was 13.2 mm (SD 5.4). The overall prevalence of latent TB infection was 1544/4808 (32.1%, 95% CI 29.2-35.1) with a corresponding annual risk of TB infection (ARTI) of 2.6% (95% CI 2.2-3.1). Risk factors for a positive TST included being male (OR 1.3, 95%CI 1.2,1.5), history of having a household TB contact (OR 1.5, 95%CI 1.2,1.8), having a BCG scar (OR 1.5,95%CI 1.2,1.8), living in a rural area (OR 1.4, 95%CI 1.1,1.9), and being out of school (OR 1.8, 95%CI 1.4,2.3). Conclusion: We conclude that the high TB transmission rates we found in this study, suggest that adolescents in this region may be an appropriate target group for TB vaccine trials including TB vaccine trials aiming to prevent infection.

Background. Data on pneumococcal conjugate vaccine (PCV) indirect effects in low-income countries with high human immunodeficiency virus (HIV) burden are limited. We examined adult pneumococcal pneumonia incidence before and after PCV introduction in Kenya in 2011. Methods. From 1 January 2008 to 31 December 2016, we conducted surveillance for acute respiratory infection (ARI) among similar to 12 000 adults (>= 18 years) in western Kenya, where HIV prevalence is similar to 17%. ARI cases (cough or difficulty breathing or chest pain, plus temperature >= 38.0 degrees C or oxygen saturation <90%) presenting to a clinic underwent blood culture and pneumococcal urine antigen testing (UAT). We calculated ARI incidence and adjusted for healthcare seeking. The proportion of ARI cases with pneumococcus detected among those with complete testing (blood culture and UAT) was multiplied by adjusted ARI incidence to estimate pneumococcal pneumonia incidence. Results. Pre-PCV (2008-2010) crude and adjusted ARI incidences were 3.14 and 5.30/100 person-years-observation (pyo), respectively. Among ARI cases, 39.0% (340/872) had both blood culture and UAT; 21.2% (72/340) had pneumococcus detected, yielding a baseline pneumococcal pneumonia incidence of 1.12/100 pyo (95% confidence interval [CI]: 1.0-1.3). In each post-PCV year (2012-2016), the incidence was significantly lower than baseline; with incidence rate ratios (IRRs) of 0.53 (95% CI: 0.31-0.61) in 2012 and 0.13 (95% CI: 0.09-0.17) in 2016. Similar declines were observed in HIV-infected (IRR: 0.13; 95% CI: 0.08-0.22) and HIV-uninfected (IRR: 0.10; 95% CI: 0.05-0.20) adults. Conclusions. Adult pneumococcal pneumonia declined in western Kenya following PCV introduction, likely reflecting vaccine indirect effects. Evidence of herd protection is critical for guiding PCV policy decisions in resource-constrained areas.

Objective: HIV-associated mortality rates in Africa decreased by 10-20% annually in 2003-2011, after the introduction of antiretroviral therapy (ART). We sought to document HIV-associated mortality rates in the general population in Kenya after 2011 in an era of expanded access to ART. Design: We obtained data on mortality rates and migration from a health and demographic surveillance system (HDSS) in Gem, western Kenya, and data for HDSS residents aged 15-64 years from home-based HIV counseling and testing (HBCT) rounds in 2011, 2012, 2013, and 2016. Methods: Mortality trends were determined among a closed cohort of residents who participated in at least the 2011 round of HBCT. Results: Of 32 467 eligible HDSS residents, 22 688 (70%) participated in the 2011 round and comprised the study cohort. All-cause mortality rates declined from 10.0 [95% confidence interval (CI) 8.4-11.7] per 1000 in 2011 to 7.4 (95% CI 5 center dot 7-9 center dot 0) in 2016, whereas the mortality rate was stable among HIV-uninfected residents, at 5.7 per 1000 person-years. Among HIV-infected residents, mortality rates declined from 30.5 per 1000 in 2011 to 15.9 per 1000 in 2016 (average decline 6% per year). The HIV-infected group receiving ART had higher mortality rates than the HIV-uninfected group [adjusted rate ratio (aRR) 2.8, 95% CI 2.2-3.4], as did the HIV-infected group who did not receive ART (aRR 5.3, 95% CI 4.5-6.2). Conclusions: Mortality rates among HIV-infected individuals declined substantially during ART expansion between 2011 and 2016, though less than during early ART introduction. Mortality trends among HIV-infected populations are critical to understanding epidemic dynamics.

OBJECTIVE To evaluate the utility of a broad and non-specific symptom screen for identifying people with undiagnosed HIV infection. DESIGN Secondary analysis of operational data collected during implementation of a cluster-randomized trial for tuberculosis case detection. METHODS As part of the trial, adults reporting cough, fever, night sweats, weight loss, or difficulty breathing of any duration in the past month were identified in health facilities and community-based mobile screening units in western Kenya. Adults reporting any symptom were offered HIV testing. We analysed the HIV testing data from this study, using modified Poisson regression to identify predictors of new HIV diagnoses among adults with symptoms and initially unknown HIV status. RESULTS We identified 3,818 symptomatic adults, referred 1424 (37%) for testing, of whom 1065 (75%) accepted, and 107 (10%) were newly diagnosed with HIV. The prevalence of new HIV diagnoses was 21% (95% CI: 17-25%) among those tested in health facilities and 5% (95% CI 4-7%) among those tested in mobile units. More men were diagnosed with HIV than women despite fewer men being screened. People who reported 4-5 symptoms were over twice as likely to be diagnosed with HIV compared to those reporting 1-3 symptoms (adjusted prevalence ratio [aPR] in health facilities = 2.58, 95% CI, 1.65-4.05; aPR in mobile units = 2.63, 95% CI, 1.37-5.03). CONCLUSION We observed a high yield of new HIV diagnoses among adults identified by active application of a broad symptom screen. Integrated tuberculosis and HIV screening using could help close the detection gap for both conditions.

SETTING:Although Kenya has a high burden of tuberculosis (TB), only 46% of cases were diagnosed in 2016.OBJECTIVE:To identify strategies for increasing attendance at community-based mobile screening units.DESIGN:We analysed operational data from a cluster-randomised trial, which included community-based mobile screening implemented during February 2015-April 2016. Community health volunteers (CHVs) recruited individuals with symptoms from the community, who were offered testing for human immunodeficiency virus (HIV) and sputum collection for Xpert® MTB/RIF testing. We compared attendance across different mobile unit sites using Wilcoxon rank-sum test.RESULTS:A total of 1424 adults with symptoms were screened at 25 mobile unit sites. The median total attendance among sites was 54 (range 6-134, interquartile range [IQR] 24-84). The median yields of TB diagnoses and new HIV diagnoses were respectively 2.4% (range 0.0-16.7, IQR 0.0-5.3) and 2.5% (range 0.0-33.3, IQR 1.2-4.2). Attendance at urban sites was variable; attendance at rural sites where CHVs were paid a daily minimum wage was significantly higher than at rural sites where CHVs were paid a nominal monthly stipend (P < 0.001).CONCLUSION:Mobile units were most effective and efficient when implemented as a single event with community health workers who are paid a daily wage.

SETTING: Efficient tuberculosis (TB) active case-finding strategies are important in settings with high TB burdens and limited resources, such as those in western Kenya.OBJECTIVE: To guide efforts to optimize screening efficiency, we identified the predictors of TB among people screened in health facilities and communities.DESIGN: During February 2015-June 2016, adults aged ≥15 years reporting any TB symptom were identified in health facilities and community mobile screening units, and evaluated for TB. We assessed the predictors of TB using a modified Poisson regression with generalized estimating equations to account for clustering according to screening site.RESULTS: TB was diagnosed in 484 (20.3%) of 2394 symptomatic adults in health facilities and 39 (3.4%) of 1424 in communities. In health facilities, >10% of symptomatic adults in all demographic groups had TB, and no predictors were associated with a ≥2-fold increased risk. In communities, the independent predictors of TB were male sex (adjusted prevalence ratio [aPR] = 4.26, 95%CI 2.43-7.45), HIV infection (aPR 2.37, 95%CI 1.18-4.77), and household TB contact in the last 2 years (aPR 2.84, 95%CI 1.62-4.96).CONCLUSION: Our findings support the notion of general TB screening in health facilities and evaluation of the adult household contacts of TB patients.

Setting: Siaya County, with the highest tuberculosis notification rates in Kenya. Objectives: To determine the incidence of active tuberculosis and 1-year cohort retention in 12-18-year-old adolescents, in preparation for phase III tuberculosis vaccine trials. Methods: Adolescents were enrolled and followed up for 1-2 years to determine tuberculosis incidence. Adolescents with a positive tuberculin skin test, history of cohabitation with a tuberculosis case or at least 1 tuberculosis symptom received clinical and sputum examination and a chest radiograph. Definite tuberculosis cases were bacteriologically confirmed and clinical cases diagnosed by a clinician based on a suggestive chest radiograph and having clinical symptoms. Risk factors were explored using Poisson regression. Results: Among 4934 adolescents without tuberculosis at baseline, 26 tuberculosis cases were identified during follow-up with a corresponding incidence density of 4.4 [95% confidence interval (CI): 3.0-6.4] events per 1000 person-years of observation, 12 definite tuberculosis cases; incidence density of 2.0 (95% CI: 0.9-3.1). Having previous tuberculosis (rate ratio: 12.5; CI: 1.8-100) and presence of tuberculin skin test conversion (rate ratio: 3.4; CI: 1.5-7.7) were significantly associated with higher risk of tuberculosis. Overall (4086/4925), 83.0% of adolescents were retained in the study after 1 year of follow-up. Being female, older, out of school and being orphaned were significant risk factors for loss to follow-up. Conclusion: The tuberculosis incidence in adolescents will help inform future tuberculosis vaccine trial sample size calculations for this setting. The predictive factors for tuberculosis and retention can be further explored in future trials.

Background In Kenya, coverage of antiretroviral therapy (ART) among people with HIV infection has increased from 7% in 2006, to 57% in 2016; and, in western Kenya, coverage of voluntary medical male circumcision (VMMC) increased from 45% in 2008, to 72% in 2014. We investigated trends in HIV prevalence and incidence in a high burden area in western Kenya in 2011-16. Methods In 2011, 2012, and 2016, population-based surveys were done via a health and demographic surveillance system and home-based counselling and testing in Gem, Siaya County, Kenya, including 28 688, 17 021, and 16 772 individuals aged 15-64 years. Data on demographic variables, self-reported HIV status, and risk factors were collected. Rapid HIV testing was offered to survey participants. Participants were tracked between surveys by use of health and demographic surveillance system identification numbers. HIV prevalence was calculated as a proportion, and HIV incidence was expressed as number of new infections per 1000 person-years of follow-up. Findings HIV prevalence was stable in participants aged 15-64 years: 15% (4300/28 532) in 2011, 12% (2051/16 875) in 2012, and 15% (2312/15 626) in 2016. Crude prevalences in participants aged 15-34 years were 11% (1893/17 197) in 2011, 10% (1015/10 118) in 2012, and 9% (848/9125) in 2016; adjusted for age and sex these prevalences were 11%, 9%, and 8%. 12 606 (41%) of the 30 520 non-HIV-infected individuals enrolled were seen again in at least one more survey round, and were included in the analysis of HIV incidence. HIV incidence was 11.1 (95% CI 9.1-13.1) per 1000 person-years from 2011 to 2012, and 5.7 (4.6-6.9) per 1000 person-years from 2012 to 2016. Interpretation With increasing coverage of ART and VMMC, HIV incidence declined substantially in Siaya County between 2011 and 2016. VMMC, but not ART, was suggested to have a direct protective effect, presumably because ART tended to be given to individuals with advanced HIV infection. HIV incidence is still high and not close to the elimination target of one per 1000 person-years. The effect of further scale-up of ART and VMMC needs to be monitored. Copyright (C) 2018 Elsevier Ltd. All rights reserved.

Introduction to determine the predictors of mortality in infants in Siaya, western Kenya, ahead of novel tuberculosis (TB) vaccine trials in the same population. Methods in a study to determine tuberculosis incidence, 2900 infants aged 0-45 days, weighing ≥ 1700g were enrolled. Four monthly follow up visits were conducted for at least 12 months. HIV testing was done at six weeks of age. Free ancillary care was provided. Deaths were reported by parents, study staff and community workers. Cox proportional Hazard analysis was used to identify risk factors. The period of analysis commenced at six weeks old and was censored at 12 months of age. Results included in the analysis were 2528 infants with 2020 person years of follow up (pyo). There were 117 deaths (4.6 %). The post-neonatal mortality rate was 58 (95% CI: 48, 69) per 1000 pyo. In multivariate analysis, health facility births were protective against mortality (Hazard Ratio (HR) 0.54; 95% CI: 0.34, 0.84) and infant HIV infection at baseline was associated with increased mortality (HR 10.3; 95% CI: 6.40, 16.7). HIV uninfected infants born to HIV infected mothers had increased hazards of mortality (HR 1.73; 95% CI: 1.03, 2.90). Gender, weight at six weeks, maternal education and occupation were not significant predictors of mortality. Conclusion infant mortality was high and was associated with being born outside a health facility, maternal HIV infection and HIV infection of the infant. Measures to decrease mother to child transmission and other HIV control measures need to be strengthened further to see incremental reductions in infant mortality.

Objectives To describe the epidemiology of childhood tuberculosis (TB) in Kenya, assess the magnitude of TB/human immunodeficiency virus (HIV) co-infection and identify risk factors for mortality during TB treatment. Study design We conducted a retrospective analysis of the Kenyan national TB program data for patients enrolled from 2013 through 2015. A total of 23 753 children aged less than 15 years were included in the analysis. Survival analysis was performed with censorship at 9 months and mortality was the main outcome. We used Cox proportional hazards regression for assessing risk factors for mortality. Results Childhood TB accounted for 9% (n = 24 216) of all patients with TB; 98% of the notified children (n = 23 753) were included in the analysis. TB/HIV co-infection was 28% (n = 6112). Most TB cases (71 %; n = 16 969) were detected through self-referral. Treatment was successful in 90% (n = 19 088) and 4% (n =1058) died. Independent risk factors for mortality included being HIV infected but not on antiretroviral therapy (adjusted hazard ratio [aHR], 4.84; 95% CI, 3.59-6.51). being HIV infected and on antiretroviral therapy (aHR, 3.69; 95% CI, 3.14-4.35), children aged less than 5 years (aHR. 1.25: 95% CI, 1.08-1.44), and being diagnosed with smear negative pulmonary disease (aHR, 1.68; 95% CI, 1.27-2.24). Conclusions Most childhood TB cases in Kenya were detected through passive case finding. TB/HIV co-infection is high among children on treatment for TB, and HIV is associated with an increased risk of death. There is a need to intensify active case finding among children. TB prevention interventions among HIV-infected children. early diagnosis of HIV, and early antiretroviral therapy initiation among children on TB treatment should be strengthened.

Background: The World Health Organization (WHO) and the Global Burden of Disease (GBD) study at the Institute for Health Metrics and Evaluation (IHME) periodically provide global estimates of tuberculosis (TB) mortality. We compared the 2015 WHO and GBD TB mortality estimates and explored which factors might drive the differences. Methods: We extracted the number of estimated TB-attributable deaths, disaggregated by age, HIV status, sex and country from publicly available WHO and GBD datasets for the year 2015. We 'standardized' differences between sources by adjusting each country's difference in absolute number of deaths by the average number of deaths estimated by both sources. Results: For 195 countries with estimates from both institutions, WHO estimated 1 768 482 deaths attributable to TB, whereas GBD estimated 1 322 916 deaths, a difference of 445 566 deaths or 29% of the average of the two estimates. The countries with the largest absolute differences in deaths were Nigeria (216 621), Bangladesh (49 863) and Tanzania (38 272). The standardized difference was not associated with HIV prevalence, prevalence of multidrug resistance or global region, but did show correlation with the case detection rate as estimated by WHO [r = -0.37, 95% confidence interval (CI): -049; -0.24] or, inversely, with case detection rate based on GBD data (r = 0.44, 95% CI: 0.31; 0.54). Countries with a recent national prevalence survey had higher standardized differences (higher estimates by WHO) than those without (P = 0.006). After exclusion of countries with recent prevalence surveys, the overall correlation between both estimates was r = 0.991. Conclusions: A few countries account for the large global discrepancy in TB mortality estimates. The differences are due to the methodological approaches used by WHO and GBD. The use and interpretation of prevalence survey data and case detection rates seem to play a role in the observed differences.

HIV is a major driver of the tuberculosis epidemic in sub-Saharan Africa. The population-level impact of antiretroviral therapy (ART) scale-up on tuberculosis rates in this region has not been well studied. We conducted a descriptive analysis to examine evidence of population-level effect of ART on tuberculosis by comparing trends in estimated tuberculosis notification rates, by HIV status, for countries in sub-Saharan Africa.

Tuberculosis (TB) case finding is an important component of TB control because it can reduce transmission of Mycobacterium tuberculosis (MTB) through prompt detection and treatment of infectious patients.

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Abstract Measuring tuberculosis transmission is exceedingly difficult, given the remarkable variability in the timing of clinical disease after Mycobacterium tuberculosis infection; incident disease can result from either a recent (ie, weeks to months) or a remote (ie, several years to decades) infection event. Although we cannot identify with certainty the timing and location of tuberculosis transmission for individuals, approaches for estimating the individual probability of recent transmission and for estimating the fraction of tuberculosis cases due to recent transmission in populations have been developed. Data used to estimate the probable burden of recent transmission include tuberculosis case notifications in young children and trends in tuberculin skin test and interferon γ–release assays. More recently, M. tuberculosis whole-genome sequencing has been used to estimate population levels of recent transmission, identify the distribution of specific strains within communities, and decipher chains of transmission among culture-positive tuberculosis cases. The factors that drive the transmission of tuberculosis in communities depend on the burden of prevalent tuberculosis; the ways in which individuals live, work, and interact (eg, congregate settings); and the capacity of healthcare and public health systems to identify and effectively treat individuals with infectious forms of tuberculosis. Here we provide an overview of these factors, describe tools for measurement of ongoing transmission, and highlight knowledge gaps that must be addressed.

Background Mortality from TB continues to be a global public health challenge. TB ranks alongside Human Immunodeficiency Virus (HIV) as the leading infectious causes of death globally. HIV is a major driver of TB related morbidity and mortality while TB is the leading cause of mortality among people living with HIV/AIDS. We sought to determine excess mortality associated with HIV and the effect of antiretroviral therapy on reducing mortality among tuberculosis patients in Kenya. Methods We conducted a retrospective analysis of Kenya national tuberculosis program data of patients enrolled from 2013 through 2014. We used direct standardization to obtain standardized mortality ratios for tuberculosis patients compared with the general population. We calculated the population attributable fraction of tuberculosis deaths due to HIV based on the standardized mortality ratio for deaths among TB patients with HIV compared to TB patients without HIV. We used Cox proportional hazards regression for assessing risk factors for mortality. Results Of 162,014 patients included in the analysis, 6% died. Mortality was 10.6 (95% CI: 10.4-10.8) times higher among TB patients than the general population; 42% of deaths were attributable to HIV infection. Patients with HIV who were not receiving ART had an over four-fold risk of death compared to patients without HIV (aHR = 4.2, 95% CI 3.9-4.6). In contrast, patients with HIV who were receiving ART had only 2.6 times the risk of death (aHR = 2.6, 95% CI 2.5-2.7). Conclusion HIV was a significant contributor to TB-associated deaths in Kenya. Mortality among HIV-infected individuals was higher among those not on ART than those on ART. Early initiation of ART among HIV infected people (a "test and treat" approach) should further reduce TB-associated deaths.