Browsing by Subject "Prospective Studies"

Now showing 1 - 15 of 15
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    Antenatal depressive symptoms and perinatal complications: a prospective study in rural Ethiopia
    (2017) Bitew, Tesera; Hanlon, Charlotte; Kebede, Eskinder; Honikman, Simone; Fekadu, Abebaw
    Antenatal depressive symptoms affect around 12.3% of women in in low and middle income countries (LMICs) and data are accumulating about associations with adverse outcomes for mother and child. Studies from rural, low-income country community samples are limited. This paper aims to investigate whether antenatal depressive symptoms predict perinatal complications in a rural Ethiopia setting.
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    Avoiding allogenic blood transfusions in endoscopic angiofibroma surgery
    (2016) Wasl, Hisham; McGuire, Jessica; Lubbe, Darlene
    BackgroundSurgical approaches for many tumours are often limited by blood loss, exposure and risk to vital anatomical structures. Therefore, the standard of care for certain skull base tumours has become endoscopic transnasal resection. Other surgical disciplines often use cell salvage techniques, but review of the otolaryngology literature revealed very few case reports. This study investigated the value and safety of salvage-type autologous blood transfusion during the endoscopic resection of juvenile nasopharyngeal angiofibromas (JNA).MethodsJNA is a rare vascular nasal tumour and the study extended over a 3-year period to obtain adequate patient numbers. All patients undergoing endoscopic resection during this period were included in the population sample. Ten patients with JNA were identified and underwent embolization prior to the endoscopic resection. In all cases the intraoperative blood salvage apparatus was used. Close post-operative monitoring was performed.ResultsHomologous blood transfusion could be avoided in all cases. Postoperative monitoring revealed transient bacteraemia in two cases where the leukocyte filter was not used, but no evidence of septicaemia.ConclusionsPerioperative cell saver and autologous blood transfusion in endonasal JNA surgery is safe. Homologous blood transfusion can be avoided by using this technique. The use of cell salvage allows for single stage surgery without the need to abandon surgery due to excessive blood loss and its future use is promising.
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    Changes in self-reported HIV testing during South Africa's 2010/2011 national testing campaign: gains and shortfalls
    (2016) Maughan-Brown, Brendan; Lloyd, Neil; Bor, Jacob; Venkataramani, Atheendar S
    HIV counselling and testing is critical to HIV prevention and treatment efforts. Mass campaigns may be an effective strategy to increase HIV testing in countries with generalized HIV epidemics. We assessed the self-reported uptake of HIV testing among individuals who had never previously tested for HIV, particularly those in high-risk populations, during the period of a national, multisector testing campaign in South Africa (April 2010 and June 2011).
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    Chronic otorrhoea: Spectrum of microorganisms and antibiotic sensitivity in a South African cohort
    (2013) Meyer, E; Whitelaw, A; Edkins, O; Fagan, J J
    BACKGROUND: Chronic otorrhoea is difficult to treat, with treatment in South Africa (SA) being protocol driven and generally initiated at the primary healthcare level. There is a lack of local studies that focus on the bacteriology and antimicrobial sensitivities of chronic otorrhoea, which underpins the management advice offered. AIMS: To determine the microbiological profile and antimicrobial susceptibility of patients with chronic otorrhoea and the validity of the Department of Health's (DoH) current guideline. METHODS: We conducted a prospective study at Groote Schuur Hospital from 2005 to 2009. We included patients with chronic otorrhoea classified as either otitis media or otitis externa, according to our definitions. Pus swabs were taken, from which microorganisms were cultured and tested for antimicrobial susceptibility. RESULTS: Of 79 patients with otorrhoea, 50 had otitis media, 21 had otitis externa and the condition was not determined in 8 patients. The most common organism isolated with otitis media was Proteus mirabilis (18/50; 36%) and with otitis externa, Pseudomonas aeruginosa (7/21; 33%). Otorrhoea had a different microbial spectrum compared with international reports, with methicillin-resistant Staphylococcus aureus infection in a single patient. The organisms isolated were susceptible mainly to fluoroquinolones (96%) and aminoglycosides (81%). CONCLUSION: Amoxicillin is a poor choice of antibiotic due to its low sensitivity, which calls into question the current DoH guideline for otorrhoea. Antimicrobial treatment protocols should be based on local data and be revisited from time to time. This study suggests that, should first-line treatment fail, an antibiotic with Gram-negative cover, e.g. a topical fluoroquinolone, should be considered.
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    Detection of lipoarabinomannan (LAM) in urine is an independent predictor of mortality risk in patients receiving treatment for HIV-associated tuberculosis in sub-Saharan Africa: a systematic review and meta-analysis
    (2016) Gupta-Wright, Ankur; Peters, Jurgens A; Flach, Clare; Lawn, Stephen D
    BackgroundSimple immune capture assays that detect mycobacterial lipoarabinomannan (LAM) antigen in urine are promising new tools for the diagnosis of HIV-associated tuberculosis (HIV-TB). In addition, however, recent prospective cohort studies of patients with HIV-TB have demonstrated associations between LAM in the urine and increased mortality risk during TB treatment, indicating an additional utility of urinary LAM as a prognostic marker. We conducted a systematic review and meta-analysis to summarise the evidence concerning the strength of this relationship in adults with HIV-TB in sub-Saharan Africa, thereby quantifying the assay’s prognostic value.MethodsWe searched MEDLINE and Embase databases using comprehensive search terms for ‘HIV’, ‘TB’, ‘LAM’ and ‘sub-Saharan Africa’. Identified studies were reviewed and selected according to predefined criteria.ResultsWe identified 10 studies eligible for inclusion in this systematic review, reporting on a total of 1172 HIV-TB cases. Of these, 512 patients (44%) tested positive for urinary LAM. After a variable duration of follow-up of between 2 and 6months, overall case fatality rates among HIV-TB cases varied between 7% and 53%. Pooled summary estimates generated by random-effects meta-analysis showed a two-fold increased risk of mortality for urinary LAM-positive HIV-TB cases compared to urinary LAM-negative HIV-TB cases (relative risk 2.3, 95% confidence interval 1.6–3.1). Some heterogeneity was explained by study setting and patient population in sub-group analyses. Five studies also reported multivariable analyses of risk factors for mortality, and pooled summary estimates demonstrated over two-fold increased mortality risk (odds ratio 2.5, 95% confidence interval 1.4–4.5) among urinary LAM-positive HIV-TB cases, even after adjustment for other risk factors for mortality, including CD4 cell count.ConclusionsWe have demonstrated that detectable LAM in urine is associated with increased risk of mortality during TB treatment, and that this relationship remains after adjusting for other risk factors for mortality. This may simply be due to a positive test for urinary LAM serving as a marker of higher mycobacterial load and greater disease dissemination and severity. Alternatively, LAM antigen may directly compromise host immune responses through its known immunomodulatory effects. Detectable LAM in the urine is an independent risk factor for mortality among patients receiving treatment for HIV-TB. Further research is warranted to elucidate the underlying mechanisms and to determine whether this vulnerable patient population may benefit from adjunctive interventions.Electronic supplementary materialThe online version of this article (doi:10.1186/s12916-016-0603-9) contains supplementary material, which is available to authorized users.
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    Diagnostic accuracy, incremental yield and prognostic value of Determine TB-LAM for routine diagnostic testing for tuberculosis in HIV-infected patients requiring acute hospital admission in South Africa: a prospective cohort
    (2017) Lawn, Stephen D; Kerkhoff, Andrew D; Burton, Rosie; Schutz, Charlotte; Boulle, Andrew; Vogt, Monica; Gupta-Wright, Ankur; Nicol, Mark P; Meintjes, Graeme
    Abstract Background We previously reported that one-third of HIV-positive adults requiring medical admission to a South African district hospital had laboratory-confirmed tuberculosis (TB) and that almost two-thirds of cases could be rapidly diagnosed using Xpert MTB/RIF-testing of concentrated urine samples obtained on the first day of admission. Implementation of urine-based, routine, point-of-care TB screening is an attractive intervention that might be facilitated by use of a simple, low-cost diagnostic tool, such as the Determine TB-LAM lateral-flow rapid test for HIV-associated TB. Methods Sputum, urine and blood samples were systematically obtained from unselected HIV-positive adults within 24 hours of admission to a South African township hospital. Additional clinical samples were obtained during hospitalization as clinically indicated. TB was defined by the detection of Mycobacterium tuberculosis in any sample using Xpert MTB/RIF or liquid culture. The diagnostic yield, accuracy and prognostic value of urine-lipoarabinomannan (LAM) testing were determined, but urine-LAM results did not inform treatment decisions. Results Consecutive HIV-positive adult acute medical admissions not already receiving TB treatment (n = 427) were enrolled regardless of clinical presentation or symptoms. TB was diagnosed in 139 patients (TB prevalence 32.6%; median CD4 count 80 cells/μL). In the first 24 hours of admission, sputum (spot and/or induced) samples were obtained from 37.0% of patients and urine samples from 99.5% of patients (P < 0.001). The diagnostic yields from these specimens were 19.4% (n = 27/139) for sputum-microscopy, 26.6% (n = 37/139) for sputum-Xpert, 38.1% (n = 53/139) for urine-LAM and 52.5% (n = 73/139) for sputum-Xpert/urine-LAM combined (P < 0.01). Corresponding yields among patients with CD4 counts <100 cells/μL were 18.9%, 24.3%, 55.4% and 63.5%, respectively (P < 0.01). The diagnostic yield of urine-LAM was unrelated to respiratory symptoms, and LAM assay specificity (using a grade-2 cut-off) was 98.9% (274/277; 95% confidence interval [CI] 96.9–99.8). Among TB cases, positive urine-LAM status was strongly associated with mortality at 90 days (adjusted hazard ratio 4.20; 95% CI 1.50–11.75). Conclusions Routine testing for TB in newly admitted HIV-positive adults using Determine TB-LAM to test urine provides major incremental diagnostic yield with very high specificity when used in combination with sputum testing and has important utility among those without respiratory TB symptoms and/or unable to produce sputum. The assay also rapidly identifies individuals with a poor prognosis.
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    Early morning urine collection to improve urinary lateral flow LAM assay sensitivity in hospitalised patients with HIV-TB co-infection
    (2017) Gina, Phindile; Randall, Philippa J; Muchinga, Tapuwa E; Pooran, Anil; Meldau, Richard; Peter, Jonny G; Sabur, Natasha F
    BACKGROUND: Urine LAM testing has been approved by the WHO for use in hospitalised patients with advanced immunosuppression. However, sensitivity remains suboptimal. We therefore examined the incremental diagnostic sensitivity of early morning urine (EMU) versus random urine sampling using the Determine® lateral flow lipoarabinomannan assay (LF-LAM) in HIV-TB co-infected patients. METHODS: Consenting HIV-infected inpatients, screened as part of a larger prospective randomized controlled trial, that were treated for TB, and could donate matched random and EMU samples were included. Thus paired sample were collected from the same patient, LF-LAM was graded using the pre-January 2014, with grade 1 and 2 manufacturer-designated cut-points (the latter designated grade 1 after January 2014). Single sputum Xpert-MTB/RIF and/or TB culture positivity served as the reference standard (definite TB). Those treated for TB but not meeting this standard were designated probable TB. RESULTS: 123 HIV-infected patients commenced anti-TB treatment and provided matched random and EMU samples. 33% (41/123) and 67% (82/123) had definite and probable TB, respectively. Amongst those with definite TB LF-LAM sensitivity (95%CI), using the grade 2 cut-point, increased from 12% (5-24; 5/43) to 39% (26-54; 16/41) with random versus EMU, respectively (p = 0.005). Similarly, amongst probable TB, LF-LAM sensitivity increased from 10% (5-17; 8/83) to 24% (16-34; 20/82) (p = 0.001). LF-LAM specificity was not determined. CONCLUSION: This proof of concept study indicates that EMU could improve the sensitivity of LF-LAM in hospitalised TB-HIV co-infected patients. These data have implications for clinical practice.
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    Fatal outcomes among patients on maintenance haemodialysis in sub-Saharan Africa: a 10-year audit from the Douala General Hospital in Cameroon
    (2016) Kengne, André Pascal
    Abstract Background End-Stage Renal disease (ESRD) is associated with increased morbidity and mortality. We assessed the occurrence, time-trend and determinants of fatal outcomes of haemodialysis-treated ESRD patients over a 10-year period in a major referral hospital in Cameroon. Methods Medical records of ESRD patients who started chronic haemodialysis at the Douala General Hospital between 2002 and 2012 were reviewed. Baseline characteristics and fatal outcomes on dialysis were recorded. Accelerated-failure time and logistic regression models were used to investigate the determinants of death. Results A total of 661 patients with 436 (66 %) being men were included in the study. Mean age at dialysis initiation was 46.3 ± 14.7 years. The median [25 th –75 th percentiles] duration on dialysis was 187 [34–754] days. A total of 297 (44.9 %) deaths were recorded during follow-up with statistical difference over the years (p < 0.0001 for year by year variation) but not in a linear fashion (p = 0.508 for linear trend), similarly in men and women (p = 0.212 for gender*year interaction). The death rate at 12 months of follow-up was 26.8 % (n = 177), with again similar variations across years (p < 0.0001). In all, 34 % of deaths occurred within the first 120 days. Year of study and background nephropathies were the main determinants of mortality, with the combination of diabetes and hypertension conveying a 127 % (95 % CI: 40–267 %) higher risk of mortality, relative to hypertension alone. Conclusion Mortality in dialysis is excessively high in this setting. Because most of these premature deaths are potentially preventable, additional efforts are needed to offset the risk and maximise the benefits from the ongoing investments of the government to defray the cost of haemodialysis. Potential actions include sensitisation of the population and healthcare practitioners, early detection and referral of individuals with CKD; and additional subsidies to support the cost of managing co-morbidities in patients with CKD in general.
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    Human newborn bacille Calmette–Guérin vaccination and risk of tuberculosis disease: a case-control study
    (2016) Fletcher, Helen A; Filali-Mouhim, Ali; Nemes, Elisa; Hawkridge, Anthony; Keyser, Alana; Njikan, Samuel; Hatherill, Mark; Scriba, Thomas J; Abel, Brian; Kagina, Benjamin M; Veldsman, Ashley; Agudelo, Nancy Marín; Kaplan, Gilla; Hussey, Gregory D; Sekaly, Rafick-Pierre; Hanekom, Willem A
    : An incomplete understanding of the immunological mechanisms underlying protection against tuberculosis (TB) hampers the development of new vaccines against TB. We aimed to define host correlates of prospective risk of TB disease following bacille Calmette-Guérin (BCG) vaccination. : In this study, 5,726 infants vaccinated with BCG at birth were enrolled. Host responses in blood collected at 10 weeks of age were compared between infants who developed pulmonary TB disease during 2 years of follow-up (cases) and those who remained healthy (controls). : Comprehensive gene expression and cellular and soluble marker analysis failed to identify a correlate of risk. We showed that distinct host responses after BCG vaccination may be the reason: two major clusters of gene expression, with different myeloid and lymphoid activation and inflammatory patterns, were evident when all infants were examined together. Cases from each cluster demonstrated distinct patterns of gene expression, which were confirmed by cellular assays. : Distinct patterns of host responses to Mycobacterium bovis BCG suggest that novel TB vaccines may also elicit distinct patterns of host responses. This diversity should be considered in future TB vaccine development.
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    Mortality in Patients with HIV-1 Infection Starting Antiretroviral Therapy in South Africa, Europe, or North America: A Collaborative Analysis of Prospective Studies
    (2014) Boulle, Andrew; Schomaker, Michael; May, Margaret T; Hogg, Robert S; Shepherd, Bryan E; Monge, Susana; Keiser, Olivia; Lampe, Fiona C; Giddy, Janet; Ndirangu, James; Garone, Daniela; Fox, Matthew; Ingle, Suzanne M; Reiss, Peter; Dabis, François; Costagliola, Dominique; Castagna, Antonella; Ehren, Kathrin; Campbell, Colin; Gill, M John; Saag, Michael; Justice, Amy C; Guest, Jodie; Crane, Heidi M; Egger, Matthias; Sterne, Jonathan A C
    High early mortality in patients with HIV-1 starting antiretroviral therapy (ART) in sub-Saharan Africa, compared to Europe and North America, is well documented. Longer-term comparisons between settings have been limited by poor ascertainment of mortality in high burden African settings. This study aimed to compare mortality up to four years on ART between South Africa, Europe, and North America.
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    The effects of a single treatment of an acaricide, Acarosan, and a detergent, Metsan, on Der p 1 allergen levels in the carpets and mattresses of asthmatic children
    (1994) Manjra, A; Berman, D; Toerien, A; Weinberg, E G; Potter, P C
    Baseline levels of the house-dust mite allergen, Der p 1, were measured on the carpets and mattresses of 60 pure-mite-sensitive asthmatic children in the Cape Peninsula, by means of an enzyme-linked immunosorbent assay (ELISA). High levels of mite allergens were recorded (range 2-50 micrograms Der p 1/g dust). In order to investigate the efficacy of the application of acaricides to carpets and bedding, 3 groups of 20 children were studied. Carpets and mattresses in group A were treated with a detergent, Metsan (Snowchem), and in group B with Metsan combined with the acaricide, Acarosan (Noristan). Group C was a control group in which no treatment was applied. The level of airway hyperreactivity (PC20) to histamine was measured at the beginning of the study and again 3 months after acaricide treatment. Significant reductions in carpet Der p 1 levels were achieved in group A (22.83 v. 13.26 micrograms Der p 1/g dust; P = 0.04) and group B (21.76 v. 13.26 micrograms Der p 1/g dust; P = 0.01), but mite levels were not reduced in any of the mattresses treated. There was also no improvement in airway hyperreactivity in any of the groups. This study clearly demonstrates that at present it is not possible to reduce Der p 1 antigen levels in mattresses in the Cape Peninsula with the available acaricides, even when one of these is combined with a detergent solution. Until strategies are developed which will significantly reduce Der p 1 levels in the bedding of sensitive individuals, a reduction in ongoing airway inflammation and airway hyperreactivity cannot be expected.
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    The natural history of latent rheumatic heart disease in a 5 year follow-up study: a prospective observational study
    (2016) ZYhlke, Liesl; Engel, Mark E; Lemmer, Carolina E; van de Wall, Marnie; Nkepu, Simpiwe; Meiring, Alet; Bestawros, Michael; Mayosi, Bongani M
    BackgroundLatent rheumatic heart disease (RHD) occurs in asymptomatic individuals with echocardiographic evidence of RHD and no history of acute rheumatic fever. The natural history of latent RHD is unclear but has important clinical and economic implications about whether these children should receive penicillin prophylaxis or not. We performed a 5-year prospective study of this question.MethodsIn August 2013 through September 2014, we conducted a follow-up study of latent RHD among school pupils using the World Heart Federation (WHF) echocardiographic criteria. Contingency tables were used to assess progression, persistence or regression of latent RHD.ResultsForty two borderline and 13 definite cases of RHD (n 55) were identified, 44 (80%; mean age 13.8 ± 4.0years; 29 (65.9%) female) of whom were available for echocardiographic examination at a median follow-up of 60.8months (interquartile range 51.3-63.5). Over the follow-up period, half the participants (n = 23; 52.3%) improved to normal or better WHF category (regressors), a third (n = 14, 31.8%) remained in the same category (persistors), while seven others (15.9%) progressed from borderline to definite RHD (progressors). In total, 21 subjects (47.7%) reverted to a normal status, nine (20.4%) either improved from definite to borderline or remained in the borderline category, and 14 (31.8%) either remained definite or progressed from borderline to a definite status. Two cases (20%) progressed to symptomatic disease.ConclusionsLatent RHD has a variable natural history that ranges from regression to normal in nearly half of cases, to persistence, progression or development of symptoms in the remainder of subjects.
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    The PTAP sequence duplication in HIV-1 subtype C Gag p6 in drug-naive subjects of India and South Africa
    (2017) Sharma, Shilpee; Aralaguppe, Shambhu G; Abrahams, Melissa-Rose; Williamson, Carolyn; Gray, Clive; Balakrishnan, Pachamuthu; Saravanan, Shanmugam; Murugavel, Kailapuri G; Solomon, Suniti; Ranga, Udaykumar
    Abstract Background HIV-1 subtype C demonstrates several biological properties distinct from other viral subtypes. One such variation is the duplication of PTAP motif in p6 Gag. PTAP motif is a key player in viral budding. Here, we studied the prevalence of PTAP motif duplication in subtype C viral strains in a longitudinal study. Methods In a prospective follow-up study, 65 HIV-1 seropositive drug-naive subjects were monitored in two different clinical cohorts of India for 2 years with repeated sampling at 6-month intervals. The viral RNA was extracted from plasma, the gag segment was amplified and sequenced. From a subset of viral isolates the sequences of pol, env and LTR were sequenced. Using HIV-1 gag amino acid sequences available from public databases and additional sequences derived from the Indian and South-African cohorts, we examined the nature of PTAP motif duplication in subtype C. Results In 16% (8 of 50) of the primary viral strains of India, we identified a sequence duplication of the PTAP motif in Gag p6. The length of the sequence duplication varied from 6 to 14 amino acids in the viral isolates but remained fixed within a subject over a period of 24–36 month follow-up. In the duplicated motif, the core PTAP motif was invariable, but the flanking residues were highly variable. In an acute phase clinical cohort of South Africa, in a subset of 75 subjects, we found the presence of the PTAP duplication at a frequency of 29.3%. An analysis of the gag sequences from the extant databases showed that unlike other subtypes of HIV-1, subtype C has a natural propensity to generate the PTAP motif duplication at a significantly higher frequency and of greater length. Additionally, the global prevalence of PTAP duplication in subtype C appears to be increasing progressively over the past 30 years. Conclusion We showed that in subtype C, the duplication of the PTAP motif in p6 Gag involves sequence stretches of greater length, and at a much higher frequency as compared to other HIV-1 subtypes. Given that subtype C naturally lacks the Alix binding motif, the acquisition of an additional PTAP motif may confer replication advantage on this HIV-1 subtype. Further investigation is warranted to examine the significance of PTAP motif duplication on the replicative fitness of HIV-1.
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    The timing of tuberculosis after isoniazid preventive therapy among gold miners in South Africa: a prospective cohort study
    (2016) Hermans, Sabine M; Grant, Alison D; Chihota, Violet; Lewis, James J; Vynnycky, Emilia; Churchyard, Gavin J; Fielding, Katherine L
    BackgroundThe durability of isoniazid preventive therapy (IPT) in preventing tuberculosis (TB) is limited in high-prevalence settings. The underlying mechanism (reactivation of persistent latent TB or reinfection) is not known. We aimed to investigate the timing of TB incidence during and after IPT and associated risk factors in a very high TB and HIV-prevalence setting, and to compare the observed rate with a modelled estimate of TB incidence rate after IPT due to reinfection.MethodsIn a post-hoc analysis of a cluster-randomized trial of community-wide IPT among South African gold miners, all intervention arm participants that were dispensed IPT for at least one of the intended 9months were included. An incident TB case was defined as any participant with a positive sputum smear or culture, or with a clinical TB diagnosis assigned by a senior study clinician. Crude TB incidence rates were calculated during and after IPT, overall and by follow-up time. HIV status was not available. Multivariable Cox regression was used to analyse risk factors by follow-up time after IPT. Estimates from a published mathematical model of trial data were used to calculate the average reinfection TB incidence in the first year after IPT.ResultsAmong 18,520 participants (96% male, mean age 41years, median follow-up 2.1years), 708 developed TB. The TB incidence rate during the intended IPT period was 1.3/100 person-years (pyrs; 95% confidence interval (CI), 1.0–1.6) and afterwards 2.3/100 pyrs (95% CI, 1.9–2.7). TB incidence increased within 6months followed by a stable rate over time. There was no evidence for changing risk factors for TB disease over time after miners stopped IPT. The average TB incidence rate attributable to reinfection in the first year was estimated at 1.3/100 pyrs, compared to an observed rate of 2.2/100 pyrs (95% CI, 1.8–2.7).ConclusionsThe durability of protection by IPT was lost within 6–12 months in this setting with a high HIV prevalence and a high annual risk of M. tuberculosis infection. The observed rate was higher than the modelled rate, suggesting that reactivation of persistent latent infection played a role in the rapid return to baseline TB incidence.Electronic supplementary materialThe online version of this article (doi:10.1186/s12916-016-0589-3) contains supplementary material, which is available to authorized users.
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    Utility of clinical parameters to identify HIV infection in infants below ten weeks of age in South Africa: a prospective cohort study
    (BioMed Central Ltd, 2011) Jaspan, Heather; Myer, Landon; Madhi, Shabir; Violari, Avy; Gibb, Diana; Stevens, Wendy; Dobbels, Els; Cotton, Mark
    BACKGROUND:As HIV-infected infants have high mortality, the World Health Organization now recommends initiating antiretroviral therapy as early as possible in the first year of life. However, in many settings, laboratory diagnosis of HIV in infants is not readily available. We aimed to develop a clinical algorithm for HIV presumptive diagnosis in infants < 10 weeks old using screening data from the Children with HIV Early Antiretroviral therapy (CHER) study in South Africa.HIV-infected and HIV-uninfected exposed infants < 10 weeks of age were identified through Vertical Transmission Prevention programs. Clinical and laboratory data were systematically recorded, groups were compared using Kruskal-Wallis, analysis of variance (ANOVA), and Fisher's exact tests. Receiver Operating Characteristic (ROC) curves were compiled using combinations of clinical findings. RESULTS: 417 HIV-infected and 125 HIV-exposed, uninfected infants, median age 46 days (IQR 38-55), were included. The median CD4 percentage in HIV-infected infants was 34 (IQR 28-41)%. HIV-infected infants had lower weight-for-age, more lymphadenopathy, oral thrush, and hepatomegaly than exposed uninfected infants (Adjusted Odds Ratio 0.51, 8.8, 5.6 and 23.5 respectively; p < 0.001 for all). Sensitivity of individual signs was low (< 20%) but specificity high (98-100%). If any one of oral thrush, hepatomegaly, splenomegaly, lymphadenopathy, diaper dermatitis, weight < 50th centile are present, sensitivity for HIV infection amongst HIV-exposed infants was 86%. These algorithms performed similarly when used to predict severe immune suppression. CONCLUSIONS: A combination of physical findings is helpful in identifying infants most likely to be HIV-infected. This may inform management algorithms and provide guidance for focused laboratory testing in some settings, and should be further validated in these settings and elsewhere.