Assessing the effect of decentralisation of laboratory diagnosis for drug-resistant tuberculosis in Kenya.

SETTING: Drug susceptibility testing (DST) is recommended in Kenya to identify multidrug-resistant tuberculosis (MDR-TB) in persons registered for tuberculosis (TB) retreatment. DST is performed at a central laboratory with a two-step growth-based process and a regional laboratory with a simultaneous molecular- and growth-based process. OBJECTIVE: To compare proportions of retreatment cases who underwent DST and turnaround times for hospitals referring to the central vs. regional laboratory. DESIGN: Cases were persons registered for TB retreatment from 1 January 2012 to 31 December 2013. Records of 11 hospitals and 7 hospitals referring patients to the regional and central laboratories, respectively, were reviewed. RESULTS: Respectively 238/432 (55%) and 88/355 (25%) cases from hospitals referring to the regional and central laboratories underwent DST. The mean time from case registration to receipt of DST results and initiation of MDR-TB treatment was quicker in hospitals referring to the regional laboratory. The time required for the transportation of specimens, specimen testing and receipt of DST results at hospitals was shorter for the regional laboratory (P < 0.05). CONCLUSION: Testing was faster and more complete at hospitals referring to the regional laboratory. A comprehensive review of MDR-TB detection in Kenya is required to increase the proportion of cases receiving DST.

Gender differences in treatment outcomes among 15-49 year olds with smear-positive pulmonary tuberculosis in Kenya.

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.

Correlates of default from anti-tuberculosis treatment: a case study using Kenya's electronic data system.

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.

Is introducing rapid culture into the diagnostic algorithm of smear-negative tuberculosis cost-effective?

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.

Outcomes of isoniazid prophylaxis among HIV-infected children attending routine HIV care in Kenya.

SETTING: Three human immunodeficiency virus (HIV) care clinics in Eastern Province, Kenya. OBJECTIVES: To establish rates of treatment completion, loss to follow-up, adverse drug reactions, tuberculosis (TB) disease and mortality among 606 HIV-infected children during 6 months of isoniazid preventive therapy (IPT). DESIGN: Retrospective record review. RESULTS: Of 606 HIV-infected children started on IPT, 556 (91.7%) successfully completed treatment, while 20 (3.3%) completed with interruptions. Cumulatively, 30 children (4.9%) did not complete IPT: 4 (0.7%) were lost to follow-up, 4 (0.7%) discontinued because of treatment interruptions, 2 (0.3%) developed adverse drug reactions, 1 developed a chronic cough, 1 was transferred to a non-IPT facility and 18 (3%) developed TB, including 2 who eventually died. TB disease was diagnosed in a median of 3 weeks (interquartile range [IQR] 2-16) post-IPT initiation. The median CD4 cell count for those aged 1-4 years who developed TB disease was 1023 cells/mm(3) (IQR 375-1432), while for those aged 5-14 years it was 149 cells/mm(3) (IQR 16-332). Isoniazid resistance was not detected in the four culture-confirmed TB cases. CONCLUSION: The high treatment completion, low loss to follow-up rate and few adverse drug reactions affirm the feasibility of IPT provision to children in HIV care clinics.

Screening for tuberculosis in pregnancy: do we need more than a symptom screen? Experience from western Kenya.

OBJECTIVES: 1) To explore the utility of tuberculosis (TB) symptom screening for symptoms of ≥2 weeks' duration in a routine setting, and 2) to compare differences in TB diagnosis between human immunodeficiency virus (HIV) infected and non-HIV-infected pregnant women in western Kenya. DESIGN: Comparative cross-sectional study among pregnant women with known HIV status screened for TB from 2010 to 2012, in Eldoret, western Kenya. RESULTS: Of 2983 participants, respectively 34 (1%), 1488 (50.5%) and 1461 (49.5%) had unknown, positive and negative HIV status. The median age was respectively 30 years (interquartile range [IQR] 26-35) and 26 years (IQR 24-31) in HIV-infected and non-infected participants. A positive symptom screen was found in respectively 8% (119/1488) and 5% (67/1461) of the HIV-infected and non-infected women. The median CD4 count at enrolment was 377 cells/µl (IQR 244-530) for HIV-infected women. One non-HIV-infected patient was sputum-positive. For HIV-infected women, TB was presumptively treated in 1% (16/1488) based on clinical symptoms and chest X-ray. Cumulatively, anti-tuberculosis treatment was offered to 0.6% (17/2949) of the participants. CONCLUSION: This study does not seem to demonstrate the utility of TB symptom screening questionnaires in a routine setting among pregnant women, either HIV-infected or non-infected, in western Kenya.

Community-based multi-disease prevention campaigns for controlling human immunodeficiency virus-associated tuberculosis.

Human immunodeficiency virus (HIV) infection increases the risk of tuberculosis (TB) 21-34 fold, and has fuelled the resurgence of TB in sub-Saharan Africa. The World Health Organization (WHO) recommends the Three I's for HIV/TB (infection control, intensified case finding [ICF] and isoniazid preventive therapy) and earlier initiation of antiretroviral therapy for preventing TB in persons with HIV. Current service delivery frameworks do not identify people early enough to maximally harness the preventive benefits of these interventions. Community-based campaigns were essential components of global efforts to control major public health threats such as polio, measles, guinea worm disease and smallpox. They were also successful in helping to control TB in resource-rich settings. There have been recent community-based efforts to identify persons who have TB and/or HIV. Multi-disease community-based frameworks have been rare. Based on findings from a WHO meta-analysis and a Cochrane review, integrating ICF into the recent multi-disease prevention campaign in Kenya may have had implications in controlling TB. Community-based multi-disease prevention campaigns represent a potentially powerful strategy to deliver prevention interventions, identify people with HIV and/or TB, and link those eligible to care and treatment.

Community-based treatment of multidrug-resistant tuberculosis: early experience and results from Western Kenya.

BACKGROUND: In the light of the 2010 World Health Organization estimation of 650 000 cases of multidrug-resistant tuberculosis (MDR-TB) globally, the need to develop, implement and scale up MDR-TB treatment programs is clear. The need is greatest and urgent in resource-poor countries, such as Kenya, with a high TB burden and an anticipated rise in reported cases of MDR-TB with increasing access to drug susceptibility testing. OBJECTIVES: To describe the set-up of a community-based program, early clinical outcomes, challenges and possible solutions. SETTING: The Moi Teaching and Referral Hospital (Moi Hospital) catchment areas: Western and North Rift Provinces, Kenya. DESIGN: Program description and retrospective chart review. RESULTS: An MDR-TB team established a community-based program with either home-based DOT or local facility-based DOT. Following referral, the team instituted a home visit, identified and hired a DOT worker, trained family and local health care professionals in MDR-TB care and initiated community-based MDR-TB treatment. In the first 24 months, 14 patients were referred, 5 died prior to initiation of treatment and one had extensively drug-resistant TB. Among eight patients who initiated community-based DOT, 87% underwent culture conversion by 6 months, and 75% were cured with no relapse after a median follow-up of 15.5 months. Multiple challenges were experienced, including system delays, stigma and limited funding. CONCLUSION: Despite multiple challenges, our model of an MDR-TB team that establishes a community-based treatment system encircling diagnosed cases of MDR-TB is feasible, with acceptable treatment outcomes.

Impact of smear microscopy results and observed therapy on tuberculosis treatment in Mombasa, Kenya.

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.

Antiretroviral treatment uptake and attrition among HIV-positive patients with tuberculosis in Kibera, Kenya.

Using data of human immunodeficiency virus-positive patients with tuberculosis from three primary care clinics in Kibera slums, Nairobi, Kenya, we report on the proportion that started antiretroviral treatment (ART) and attrition (deaths, lost to follow-up and stopped treatment) before and while on ART. Of 427 ART eligible patients, enrolled between January 2004 and December 2008, 70% started ART, 19% were lost to attrition and 11% had not initiated ART. Of those who started ART, 14% were lost to attrition, making a cumulative pre-ART and ART attrition of 33%. ART uptake among patients with TB was relatively good, but programme attrition was high and needs urgent addressing.

Piloting the use of personal digital assistants for tuberculosis and human immunodeficiency virus surveillance, Kenya, 2007.

SETTING: Improved documentation of human immunodeficiency virus (HIV) testing and care among tuberculosis (TB) patients is needed to strengthen TB-HIV programs. In 2007, Kenya piloted the use of personal digital assistants (PDAs) instead of paper registers to collect TB-HIV surveillance data from TB clinics. OBJECTIVE: To evaluate the acceptability, data quality and usefulness of PDAs. DESIGN: We interviewed four of 31 district coordinators who collected data in PDAs for patients initiating TB treatment from April to June 2007. In 10 of 93 clinics, we randomly selected patient records for comparison with corresponding records in paper registers or PDAs. Using Cochran-Mantel-Haenszel tests, we compared missing data proportions in paper registers with PDAs. We evaluated PDA usefulness by analyzing PDA data from all 93 clinics. RESULTS: PDAs were well accepted. Patient records were more frequently missing (28/97 vs. 1/112, P < 0.001) and data fields more frequently incomplete (148/1449 vs. 167/2331, P = 0.03) in PDAs compared with paper registers. PDAs, however, facilitated clinic-level analyses: 48/93 (52%) clinics were not reaching the targets of testing >or=80% of TB patients for HIV, and 8 (9%) clinics were providing <80% of TB-HIV co-infected patients with cotrimoxazole (CTX). CONCLUSION: PDAs had high rates of missing data but helped identify clinics that were undertesting for HIV or underprescribing CTX.

Tuberculosis transmission in Kenya: results of the third National Tuberculin Survey.

SETTING: Kenya, a country with a high burden of tuberculosis (TB) and human immunodeficiency virus (HIV) infection. OBJECTIVES: To assess the prevalence of TB infection, bacille Calmette-Guérin (BCG) coverage and the annual risk of tuberculosis infection (ARTI), and to compare estimates with previous findings. METHODS: A sample of primary school children aged 6-14 years from the same study districts sampled in previous surveys were tuberculin skin tested using the Mantoux method from September 2004 to July 2007. The prevalence of TB infection was estimated by the mirror method, with the mode at 17 mm. RESULTS: Of the 94 771 registered children, 76 676 (80.9%) completed the survey investigations, 12 107 (15.8%) of whom had no BCG scar. The prevalence of TB infection was estimated at 10.2%, with a corresponding ARTI of 1.1%. The ARTI obtained from the current survey is comparable to that of the 1994-1996 survey and higher than that of the 1986-1990 survey. The BCG coverage was comparable with the 1994-1996 survey and higher than in the 1986-1990 survey. CONCLUSION: TB transmission in Kenya has remained the same over the last decade, which suggests that activities undertaken by the TB control programme have been sufficient to hold TB transmission steady, but insufficient to reduce it.

Task shifting in HIV clinics, Western Kenya.

BACKGROUND: United states Agency for International development-Academic Model for Providing Accesses to Healthcare (USAID-AMPATH) cares for over 80,000 HIV-infected patients. Express care (EC) model addresses challenges of: clinically stable patient's adherent to combined-antiretroviral-therapy with minimal need for clinician intervention and high risk patients newly initiated on cART with CD4 counts < or = 100 cells/mm3 with frequent need for clinician intervention. OBJECTIVE: To improve patient outcomes without increasing clinic resources. DESIGN: A descriptive study of a clinician supervised shared nurse model. SETTING: USAID-AMPATH clinics, Western Kenya. RESULTS: Four thousand eight hundred and twenty four patients were seen during the pilot period, 90.4% were eligible for EC of whom 34.6% were enrolled. Nurses performed all traditional roles and attended to two thirds and three quarters of stable and high risk patient visits respectively. Clinicians attended to one third and one quarter of stable and high risk patient visits respectively and all visits ineligible for express care. CONCLUSION: The EC model is feasible. Task shifting allowed stable patients to receive visits with nurses, while clinicians had more time to concentrate on patients that were new as well as more acutely ill patients.

Public-private mix for control of tuberculosis and TB-HIV in Nairobi, Kenya: outcomes, opportunities and obstacles.

SETTING: Nairobi, the capital of Kenya. OBJECTIVE: To promote standardised tuberculosis (TB) care by private health providers and links with the public sector. DESIGN AND METHODS: A description of the results of interventions aimed at engaging private health providers in TB care and control in Nairobi. Participating providers are supported to provide TB care that conforms to national guidelines. The standard surveillance tools are used for programme monitoring and evaluation. RESULTS: By the end of 2006, 26 of 46 (57%) private hospitals and nursing homes were engaged. TB cases reported by private providers increased from 469 in 2002 to 1740 in 2006. The treatment success rate for smear-positive pulmonary TB treated by private providers ranged from 76% to 85% between 2002 and 2005. Of the 1740 TB patients notified by the private sector in 2006, 732 (42%) were tested for human immunodeficiency virus (HIV), of whom 372 (51%) were positive. Of the 372 HIV-positive TB patients, 227 (61%) were provided with cotrimoxazole preventive treatment (CPT) and 136 (37%) with antiretroviral treatment (ART). CONCLUSION: Private providers can be engaged to provide TB-HIV care conforming to national norms. The challenges include providing diagnostics, CPT and ART and the capacity to train and supervise these providers.

National scale-up of HIV testing and provision of HIV care to tuberculosis patients in Kenya.

SETTING: Kenya, one of the 22 tuberculosis (TB) high-burden countries, whose TB burden is fuelled by the human immunodeficiency virus (HIV). OBJECTIVE: To monitor and evaluate the implementation of HIV testing and provision of HIV care to TB patients in Kenya through the establishment of a routine TB-HIV integrated surveillance system. DESIGN: A descriptive report of the status of implementation of HIV testing and provision of HIV interventions to TB patients one year after the introduction of the revised TB case recording and reporting system. RESULTS: From July 2005 to June 2006, 88% of 112835 TB patients were reported to the National Leprosy and TB Control Programme, 98773 (87.9%) of whom were reported using a revised recording and reporting system that included TB-HIV indicators. HIV testing of TB patients increased from 31.5% at the beginning of this period to 59% at the end. Of the 46428 patients tested for HIV, 25558 (55%) were found to be HIV-positive, 85% of whom were provided with cotrimoxazole preventive treatment and 28% with antiretroviral treatment. CONCLUSION: A country-wide integrated TB-HIV surveillance system in TB patients can be implemented and provides essential data to monitor and evaluate TB-HIV related interventions.

Knowledge, attitudes, and practices of private medical practitioners on tuberculosis among HIV/AIDS patients in Eldoret, Kenya.

BACKGROUND: Tuberculosis (TB) is one of the major communicable diseases afflicting mankind today. Its prevalence is increasing with increase in HIV infection. It is important that doctors be able to correctly diagnose and institute proper management of patients with TB. OBJECTIVES: To determine the knowledge, attitudes, and practices (KAP) of private medical practitioners in Eldoret on the management of TB. DESIGN: Cross-sectional descriptive qualitative study. SETTING: Private medical practitioners' clinics and the outpatient departments of private hospitals in Eldoret town, western, Kenya. Eldoret is a cosmopolitan town 350-km north west of Nairobi. It is the main town in the north Rift Valley with such infrastructure as roads, international airport, and banks. SUBJECTS: Private medical practitioners in Eldoret. RESULTS: Fifty three out of 70 private doctors were interviewed. Of these 84.9% were male. Only 5.7% knew that sputum for AAFBs is collected on spot, early morning, and spot, whereas 69.8% and 13.2% said it should be collected on three and six consecutive early mornings respectively. Sputum and chest X-ray were the most common investigations used to diagnose TB. Few doctors knew that the clinical features considered as suspicious for TB in children were failure to thrive (FTT) (20.6%), contact with open TB case (12.8%), and cough for more than two or more weeks (7.8%). Others wrongly considered cough for four or more weeks (9.2%). Features correctly considered of diagnostic value by a few of the private doctors in paediatric TB were: chest X-ray (19.8%), FTT (8.7%), positive sputum for AAFBs (8.7%), and history of contact with TB case (8.7%). A small number of doctors based their diagnosis on chest X-ray (38%), AAFBs (19%), and Keith-Jones criteria (6.3%). There were 16 regimes mentioned and used for the treatment of TB. The NLTP recommended regimes such as 2RHZ/4RH, 2RHZE/6HE, 2RHZ/6HE and 2SHRZE/1RHZE/5HRE, were used by 9(19.6%), 2(4.3%), 0% and 0% of the doctors respectively. The rest used unrecommended regimes and no doctor used the re-treatment regime of 2SHRZE/1RHZE/5RHE. Similar regimes were used for the HIV as for the non-HIV-infected patients. None of the interviewees had appropriate knowledge on all the areas of diagnosis, treatment, case recording, and follow up. CONCLUSION: Most doctors were not aware of the correct diagnosis and treatment of TB and many used unrecommended treatment regimes. They were generally unfamiliar with the recording system of TB cases. Most doctors did not know the definitions of the various re-treatment cases. Continuing medical education on clinical management of TB patients is needed for doctors in private practice.

Monoclonal antibody binding to a surface-exposed epitope on Cowdria ruminantium that is conserved among eight strains.

Monoclonal antibodies (MAb) binding to Cowdria ruminantium elementary bodies (EB) were identified by enzyme-linked immunosorbent assay, and surface binding of one MAb (446.15) to intact EB was determined by immunofluorescence, immunogold labeling, and transmission electron microscopy. MAb 446.15 bound an antigen of approximately 43 kDa in immunoblots of eight geographically distinct strains. The MAb did not react with Ehrlichia canis antigens or uninfected bovine endothelial cell lysate and may be useful in diagnostic assays and vaccine development.