Integrating digital solutions into national health data systems through public-private collaboration: An early experience of the SPICE platform in Kenya.

Public-private collaborative efforts to address healthcare challenges in low- and middle-income countries have been the focus of digital initiatives to improve both access and quality of health services. We report the early feasibility, experience, and learnings of migrating healthcare data generated from a proprietary, privately owned cloud-based environment into an on-premises National Health Data Center (NHDC) in compliance with Kenya's data management legislation. In 2018, Medtronic LABS entered into a partnership with the Kenya Ministry of Health and other stakeholders to improve access to quality services and data availability for non-communicable diseases (diabetes and hypertension), anchored on the SPICE digital health platform. Data migration from SPICE to the NHDC necessitated the establishment of multi-stakeholder coordination structures, alignment on system configuration requirements, provisioning of on-premises servers, data replication and monitoring. The data replication process showed consistency in format and content with no evidence of data loss. The monitoring of the server uptime and availability, however, exposed overall downtime of 15% of the total time tracked between April and December 2022 caused by Internet Protocol address configuration issues, power outages, firewall rule changes, and unscheduled system maintenance. Monthly tracked downtime however reduced from a high of 28% in April 2022 to 5% in December 2022. Our early experience shows that data migration from proprietary host environments to public "one-stop-shop" national data warehouses are feasible provided investments are made in the requisite infrastructure, software and human resource capacity to ensure long-term sustainability, maintenance, and scale to match cloud-based data hosting. Further, digital health solutions developed in collaboration with non-state actors can be integrated into national data systems, saving Governments the cost and efforts of building similar tools while leveraging private sector capacity.

Unmet need for COVID-19 vaccination coverage in Kenya.

COVID-19 has impacted the health and livelihoods of billions of people since it emerged in 2019. Vaccination for COVID-19 is a critical intervention that is being rolled out globally to end the pandemic. Understanding the spatial inequalities in vaccination coverage and access to vaccination centres is important for planning this intervention nationally. Here, COVID-19 vaccination data, representing the number of people given at least one dose of vaccine, a list of the approved vaccination sites, population data and ancillary GIS data were used to assess vaccination coverage, using Kenya as an example. Firstly, physical access was modelled using travel time to estimate the proportion of population within 1 hour of a vaccination site. Secondly, a Bayesian conditional autoregressive (CAR) model was used to estimate the COVID-19 vaccination coverage and the same framework used to forecast coverage rates for the first quarter of 2022. Nationally, the average travel time to a designated COVID-19 vaccination site (n = 622) was 75.5 min (Range: 62.9 - 94.5 min) and over 87% of the population >18 years reside within 1 hour to a vaccination site. The COVID-19 vaccination coverage in December 2021 was 16.70% (95% CI: 16.66 - 16.74) - 4.4 million people and was forecasted to be 30.75% (95% CI: 25.04 - 36.96) - 8.1 million people by the end of March 2022. Approximately 21 million adults were still unvaccinated in December 2021 and, in the absence of accelerated vaccine uptake, over 17.2 million adults may not be vaccinated by end March 2022 nationally. Our results highlight geographic inequalities at sub-national level and are important in targeting and improving vaccination coverage in hard-to-reach populations. Similar mapping efforts could help other countries identify and increase vaccination coverage for such populations.

Accuracy of computer-aided chest X-ray in community-based tuberculosis screening: Lessons from the 2016 Kenya National Tuberculosis Prevalence Survey.

Community-based screening for tuberculosis (TB) could improve detection but is resource intensive. We set out to evaluate the accuracy of computer-aided TB screening using digital chest X-ray (CXR) to determine if this approach met target product profiles (TPP) for community-based screening. CXR images from participants in the 2016 Kenya National TB Prevalence Survey were evaluated using CAD4TBv6 (Delft Imaging), giving a probabilistic score for pulmonary TB ranging from 0 (low probability) to 99 (high probability). We constructed a Bayesian latent class model to estimate the accuracy of CAD4TBv6 screening compared to bacteriologically-confirmed TB across CAD4TBv6 threshold cut-offs, incorporating data on Clinical Officer CXR interpretation, participant demographics (age, sex, TB symptoms, previous TB history), and sputum results. We compared model-estimated sensitivity and specificity of CAD4TBv6 to optimum and minimum TPPs. Of 63,050 prevalence survey participants, 61,848 (98%) had analysable CXR images, and 8,966 (14.5%) underwent sputum bacteriological testing; 298 had bacteriologically-confirmed pulmonary TB. Median CAD4TBv6 scores for participants with bacteriologically-confirmed TB were significantly higher (72, IQR: 58-82.75) compared to participants with bacteriologically-negative sputum results (49, IQR: 44-57, p<0.0001). CAD4TBv6 met the optimum TPP; with the threshold set to achieve a mean sensitivity of 95% (optimum TPP), specificity was 83.3%, (95% credible interval [CrI]: 83.0%-83.7%, CAD4TBv6 threshold: 55). There was considerable variation in accuracy by participant characteristics, with older individuals and those with previous TB having lowest specificity. CAD4TBv6 met the optimal TPP for TB community screening. To optimise screening accuracy and efficiency of confirmatory sputum testing, we recommend that an adaptive approach to threshold setting is adopted based on participant characteristics.

'If not TB, what could it be?' Chest X-ray findings from the 2016 Kenya Tuberculosis Prevalence Survey.

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).

Cost-effectiveness of diagnostic algorithms including lateral-flow urine lipoarabinomannan for HIV-positive patients with symptoms of tuberculosis.

BACKGROUND: Tuberculosis (TB) is the leading cause of death among HIV-positive patients. We assessed the cost-effectiveness of including lateral-flow urine lipoarabinomannan (LF-LAM) in TB diagnostic algorithms for severely ill or immunosuppressed HIV-positive patients with symptoms of TB in Kenya. METHODS: From a decision-analysis tree, ten diagnostic algorithms were elaborated and compared. All algorithms included clinical exam. The costs of each algorithm were calculated using a 'micro-costing' method. The efficacy was estimated through a prospective study that included severely ill or immunosuppressed (CD4<200cells/µL) HIV-positive adults with symptoms of TB. The cost-effectiveness analysis was performed using the disability-adjusted life year (DALY) averted as effectiveness outcome. A 4% discount rate was applied. RESULTS: The algorithm that added LF-LAM alone to the clinical exam lead to the least average cost per TB case detected (€47) and was the most cost-effective with a cost/DALY averted of €4.6. The algorithms including LF-LAM, microscopy and X-ray, and LF-LAM and Xpert in sputum, detected a high number of TB cases with a cost/DALY averted of €6.1 for each of them. In the comparisons of the algorithms two by two, using LF-LAM instead of microscopy (clinic&LAM vs clinicµscopy) and using LF-LAM along with GeneXpert in sputum instead of GeneXpert in urine along with GeneXpert in sputum, (clinic&LAM&Xpert_sputum vs clinic&Xpert_sputum&Xpert_urine) led to the highest increase in the cost-effectiveness ratios (ICERs): €-7.2 and €-12.6 respectively. In these two comparisons, using LF-LAM increased the number of TB patients detected while reducing costs. Adding LF-LAM to smear microscopy alone or to smear microscopy and Xray led to the highest increase in the additional number of TB cases detected (31 and 25 respectively) with an incremental efficiency estimated at 134 and 344 DALYs respectively. The ICERs were €22.0 and €8.6 respectively. CONCLUSION: Including LF-LAM in TB diagnostic algorithms is cost-effective for severely ill or immunosuppressed HIV-positive patients.

The spatial epidemiology of leprosy in Kenya: A retrospective study.

BACKGROUND: Leprosy elimination defined as a registered prevalence rate of less than 1 case per 10,000 persons was achieved in Kenya at the national level in 1989. However, there are still pockets of leprosy in some counties where late diagnosis and consequent physical disability persist. The epidemiology of leprosy in Kenya for the period 2012 through to 2015 was defined using spatial methods. METHODS: This was a retrospective ecological correlational study that utilized leprosy case based data extracted from the National Leprosy Control Program database. Geographic information system and demographic data were obtained from Kenya National Bureau of Statistics (KNBS). Chi square tests were carried out to check for association between sociodemographic factors and disease indicators. Two Spatial Poisson Conditional Autoregressive (CAR) models were fitted in WinBUGS 1.4 software. The first model included all leprosy cases (new, retreatment, transfers from another health facility) and the second one included only new leprosy cases. These models were used to estimate leprosy relative risks per county as compared to the whole country i.e. the risk of presenting with leprosy given the geographical location. PRINCIPAL FINDINGS: Children aged less than 15 years accounted for 7.5% of all leprosy cases indicating active leprosy transmission in Kenya. The risk of leprosy notification increased by about 5% for every 1 year increase in age, whereas a 1% increase in the proportion of MB cases increased the chances of new leprosy case notification by 4%. When compared to the whole country, counties with the highest risk of leprosy include Kwale (relative risk of 15), Kilifi (RR;8.9) and Homabay (RR;4.1), whereas Turkana had the lowest relative risk of 0.005. CONCLUSION: Leprosy incidence exhibits geographical variation and there is need to institute tailored local control measures in these areas to reduce the burden of disability.

Mortality in the first six months among HIV-positive and HIV-negative patients empirically treated for tuberculosis.

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.

Kenya tuberculosis prevalence survey 2016: Challenges and opportunities of ending TB in Kenya.

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.

Incremental Yield of Including Determine-TB LAM Assay in Diagnostic Algorithms for Hospitalized and Ambulatory HIV-Positive Patients in Kenya.

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.

Using Survival Analysis to Identify Risk Factors for Treatment Interruption among New and Retreatment Tuberculosis Patients in Kenya.

Despite high tuberculosis (TB) treatment success rate, treatment adherence is one of the major obstacles to tuberculosis control in Kenya. Our objective was to identify patient-related factors that were associated with time to TB treatment interruption and the geographic distribution of the risk of treatment interruption by county. Data of new and retreatment patients registered in TIBU, a Kenyan national case-based electronic data recording system, between 2013 and 2014 was obtained. Kaplan-Meier curves and log rank tests were used to assess the adherence patterns. Mixed-effects Cox proportional hazards modeling was used for multivariate analysis. Records from 90,170 patients were included in the study. The cumulative incidence of treatment interruption was 4.5% for new patients, and 8.5% for retreatment patients. The risk of treatment interruption was highest during the intensive phase of treatment. Having previously been lost to follow-up was the greatest independent risk factor for treatment interruption (HR: 4.79 [3.99, 5.75]), followed by being HIV-positive not on ART (HR: 1.96 [1.70, 2.26]) and TB relapse (HR: 1.70 [1.44, 2.00]). Male and underweight patients had high risks of treatment interruption (HR: 1.46 [1.35, 1.58]; 1.11 [1.03, 1.20], respectively). High rates of treatment interruption were observed in counties in the central part of Kenya while counties in the northeast had the lowest risk of treatment interruption. A better understanding of treatment interruption risk factors is necessary to improve adherence to treatment. Interventions should focus on patients during the intensive phase, patients who have previously been lost to follow-up, and promotion of integrated TB and HIV services among public and private facilities.

A review of data quality of an electronic tuberculosis surveillance system for case-based reporting in Kenya.

BACKGROUND: Kenya recently transitioned from a paper to an electronic system for recording and reporting of tuberculosis (TB) data. METHODS: During September-October 2013, the data quality of the new system was evaluated through an audit of data in paper source documents and in the national electronic system, and an analysis of all 99 281 cases reported in 2012. RESULTS: While the new electronic system overall is robust, this assessment demonstrated limitations in the concordance and completeness of data reaching the national level. CONCLUSIONS: Additional oversight and training in data entry are needed to strengthen TB surveillance data quality in Kenya.

The movement of multidrug-resistant tuberculosis across borders in East Africa needs a regional and global solution.

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.

Feasibility and effect of integrating tuberculosis screening and detection in postnatal care services: an operations research study.

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.

PEPFAR support for the scaling up of collaborative TB/HIV activities.

The US President's Emergency Plan for AIDS Relief (PEPFAR) has supported a comprehensive package of care in which interventions to address HIV-related tuberculosis (TB) have received increased funding and support in recent years. PEPFAR's TB/HIV programming is based on the World Health Organization's 12-point policy for collaborative TB/HIV activities, which are integrated into PEPFAR annual guidance. PEPFAR implementing partners have provided crucial support to TB/HIV collaboration, and as a result, PEPFAR-supported countries in sub-Saharan Africa have made significant gains in HIV testing and counseling of TB patients and linkages to HIV care and treatment, intensified TB case finding, and TB infection control. PEPFAR's support of TB/HIV integration has also included significant investment in health systems, including improved laboratory services and educating and enlarging the workforce. The scale-up of antiretroviral therapy along with support of programs to increase HIV counseling and testing and improve linkage and retention in HIV care may have considerable impact on TB morbidity and mortality, if used synergistically with isoniazid preventive therapy, intensified case finding, and infection control. Issues to be addressed by future programming include accelerating implementation of isoniazid preventive therapy, increasing access and ensuring appropriate use of new TB diagnostics, supporting early initiation of antiretroviral therapy for HIV-infected TB patients, and strengthening systems to monitor and evaluate program implementation.

Adherence to self-administered tuberculosis treatment in a high HIV-prevalence setting: a cross-sectional survey in Homa Bay, Kenya.

BACKGROUND: Good adherence to treatment is crucial to control tuberculosis (TB). Efficiency and feasibility of directly observed therapy (DOT) under routine program conditions have been questioned. As an alternative, Médecins sans Frontières introduced self-administered therapy (SAT) in several TB programs. We aimed to measure adherence to TB treatment among patients receiving TB chemotherapy with fixed dose combination (FDC) under SAT at the Homa Bay district hospital (Kenya). A second objective was to compare the adherence agreement between different assessment tools. METHODS: We conducted a cross-sectional survey amongst a series of new TB patients receiving 6 months of standard TB chemotherapy with FDC under SAT. Adherence was assessed at home with urine testing for Isoniazid (INH), pill count, interviewer-administered questionnaire and visual analogue scale (VAS). RESULTS: In November 2008 and in June 2009, 212 of 279 eligible patients were assessed for adherence. Overall, 95.2% [95%CI: 91.3-97.7] of the patients reported not having missed a tablet in the last 4 days. On the VAS, complete adherence was estimated at 92.5% [95%CI: 88.0-95.6]. INH urine test was positive for 97.6% [95%CI: 94.6-99.2] of the patients. Pill count could be assessed among only 70% of the interviewed patients. Among them, it was complete for 82.3% [95%CI: 75.1-88.1]. Among the 212 surveyed patients, 193 (91.0%) were successfully treated (cured or treatment completed). The data suggest a fair agreement between the questionnaire and the INH urine test (k = 0.43) and between the questionnaire and the VAS (k = 0.40). Agreement was poor between the other adherence tools. CONCLUSION: These results suggest that SAT, together with the FDC, allows achieving appropriate adherence to antituberculosis treatment in a high TB and HIV burden area. The use of a combination of a VAS and a questionnaire can be an adequate approach to monitor adherence to TB treatment in routine program conditions.

Performance of the 2007 WHO algorithm to diagnose smear-negative pulmonary tuberculosis in a HIV prevalent setting.

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.

Assessing access barriers to tuberculosis care with the tool to Estimate Patients' Costs: pilot results from two districts 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.

New methods for estimating the tuberculosis case detection rate in high-HIV prevalence countries: the example of Kenya.

OBJECTIVE: To develop new methods for estimating the sputum smear-positive tuberculosis case detection rate (CDR) in a country where infection with HIV is prevalent. METHODS: We estimated the smear-positive tuberculosis CDR in HIV-negative and HIV-positive adults, and in all adults in Kenya. Data on time trends in tuberculosis case notification rates and on HIV infection prevalence in adults and in tuberculosis patients were used, along with data on tuberculosis control programme performance. FINDINGS: In 2006, the estimated smear-positive tuberculosis CDR in HIV-negative adults was 79% (95% confidence interval, CI: 64-94) and in HIV-positive adults, 57% (95% CI: 26-88), giving a weighted mean of 68% (95% CI: 49-87). The separate estimate for all smear-positive tuberculosis cases was 72% (95% CI: 53-91), giving an overall average for the three estimates of 70% (95% CI: 58-82). As the tuberculosis CDR in 1996 was 57% (95% CI: 47-67), the estimated increase by 2006 was 13 percentage points (95% CI: 6-20), or 23%. This increase was accompanied by a more than doubling of the resources devoted to tuberculosis control in Kenya, including facilities and staff. CONCLUSION: Using three approaches to estimate the tuberculosis CDR in a country where HIV infection is prevalent, we showed that expansion of the tuberculosis control programme in Kenya led to an increase of 23% in the CDR between 1996 and 2006. While the methods developed here can be applied in other countries with a high prevalence of HIV infection, they rely on precise data on trends in such prevalence in the general population and among tuberculosis patients.