scholarly journals Screening for Tuberculosis With Xpert MTB/RIF Assay Versus Fluorescent Microscopy Among Adults Newly Diagnosed With Human Immunodeficiency Virus in Rural Malawi: A Cluster Randomized Trial (Chepetsa)

2018 ◽  
Vol 68 (7) ◽  
pp. 1176-1183 ◽  
Author(s):  
Lucky G Ngwira ◽  
Elizabeth L Corbett ◽  
McEwen Khundi ◽  
Grace L Barnes ◽  
Austin Nkhoma ◽  
...  
Keyword(s):  
Human Immunodeficiency Virus ◽  
Randomized Trial ◽  
Point Of Care ◽  
Cluster Randomized Trial ◽  
World Health ◽  
Newly Diagnosed ◽  
Hiv Diagnosis ◽  
Immunodeficiency Virus ◽  
All Cause Mortality ◽  
Cluster Randomized

Abstract Background Tuberculosis (TB) remains the leading cause of death among human immunodeficiency virus (HIV)–infected individuals globally. Screening for TB at the point of HIV diagnosis with a high-sensitivity assay presents an opportunity to reduce mortality. Methods We performed a cluster randomized trial of TB screening among adults newly diagnosed with HIV in 12 primary health clinics in rural Thyolo, Malawi. Clinics were allocated in a 1:1 ratio to perform either point-of-care Xpert MTB/RIF assay (Xpert) or point-of-care light-emitting diode fluorescence microscopy (LED-FM) for individuals screening positive for TB symptoms. Asymptomatic participants were offered isoniazid preventive therapy in both arms. Investigators, but not clinic staff or participants, were masked to allocation. Our primary outcome was the incidence rate ratio (RR) of all-cause mortality within 12 months of HIV diagnosis. Results Prevalent TB was diagnosed in 24 of 1001 (2.4%) individuals enrolled in clinics randomized to Xpert, compared with 10 of 841 (1.2%) in clinics randomized to LED-FM. All-cause mortality was 22% lower in the Xpert arm than in the LED-FM arm (6.7 vs 8.6 per 100 person-years; RR, 0.78 [95% confidence interval {CI}, .58–1.06]). A planned subgroup analysis suggested that participants with more advanced HIV (World Health Organization clinical stage 3 or 4) disease had lower mortality in clinics randomized to Xpert than to LED-FM (RR, 0.43 [95% CI, .22–.87]). Conclusions In rural Malawi, using point-of-care Xpert MTB/RIF to test symptomatic patients for TB at the time of HIV diagnosis reduced all-cause 12-month mortality among individuals with advanced HIV. Clinical Trials Registration NCT01450085.

scholarly journals Impact of Point-of-Care Xpert MTB/RIF on Tuberculosis Treatment Initiation. A Cluster-randomized Trial

2017 ◽  
Vol 196 (7) ◽  
pp. 901-910 ◽  
Author(s):  
Richard J. Lessells ◽  
Graham S. Cooke ◽  
Nuala McGrath ◽  
Mark P. Nicol ◽  
Marie-Louise Newell ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Treatment Initiation ◽  
Point Of Care ◽  
Cluster Randomized Trial ◽  
Tuberculosis Treatment ◽  
Cluster Randomized

scholarly journals Clinic-Based Urinary Lipoarabinomannan as a Biomarker of Clinical Disease Severity and Mortality Among Antiretroviral Therapy-Naive Human Immunodeficiency Virus-Infected Adults in South Africa

2017 ◽  
Vol 4 (3) ◽  
Author(s):  
Paul K. Drain ◽  
Elena Losina ◽  
Sharon M Coleman ◽  
Janet Giddy ◽  
Douglas Ross ◽  
...  
Keyword(s):  
Human Immunodeficiency Virus ◽  
Antiretroviral Therapy ◽  
Disease Severity ◽  
Clinical Signs ◽  
Signs And Symptoms ◽  
Fold Increase ◽  
Clinical Disease ◽  
Hiv Diagnosis ◽  
Immunodeficiency Virus ◽  
All Cause Mortality

Abstract Background Urinary lipoarabinomannan (LAM) has limited sensitivity for diagnosing active human immunodeficiency virus (HIV)-associated tuberculosis (TB) disease, but LAM screening at HIV diagnosis might identify adults with more severe clinical disease or greater risk of mortality. Methods We enrolled antiretroviral therapy-naive HIV-infected adults from 4 clinics in Durban. Nurses performed urine LAM testing using a rapid assay (Determine TB LAM) graded from low (1+) to high (≥3+) intensity. Urine LAM results were not used to guide anti-TB therapy. We assessed TB-related symptoms and obtained sputum for mycobacterial smear and culture. Participants were observed for 12 months, and we used multivariable Cox proportional hazard models to determine hazard ratios for all-cause mortality. Results Among 726 HIV-infected adults with median CD4 of 205 cells/mm3 (interquartile range, 79–350 cells/mm3), 93 (13%) were LAM positive and 89 (12%) participants died during the follow-up period. In multivariable analyses, urine LAM-positive participants had a mortality hazard ratio (MHR) of 3.58 (95% confidence interval [CI], 2.20–5.81) for all-cause mortality. Among participants with mycobacterial-confirmed TB, urine LAM-positivity had a 2.91 (95% CI, 1.26–6.73) MHR for all participants and a 4.55 (95% CI, 1.71–12.1) MHR for participants with CD4 ≤100 cell/mm3. Participants with LAM-positive TB had significantly more clinical signs and symptoms of disease, compared with participants with LAM-negative TB disease. Conclusions Among HIV-infected adults, urinary LAM-positive patients had more clinical disease severity and a 3-fold increase in 12-month mortality compared with those who were LAM negative.

scholarly journals Reduction in Short-term Outpatient Consultations After a Campaign With Measles Vaccine in Children Aged 9–59 Months: Substudy Within a Cluster-Randomized Trial

2020 ◽  
Vol 9 (5) ◽  
pp. 535-543
Author(s):  
Anshu Varma ◽  
Peter Aaby ◽  
Sanne Marie Thysen ◽  
Aksel Karl Georg Jensen ◽  
Ane Bærent Fisker
Keyword(s):  
Randomized Trial ◽  
Vaccination Campaign ◽  
Cluster Randomized Trial ◽  
Haemophilus Influenzae Type ◽  
Type B ◽  
Short Term ◽  
All Cause Mortality ◽  
Measles Vaccination ◽  
Cluster Randomized ◽  
Binomial Models

Abstract Background We assessed a measles vaccination campaign’s potential short-term adverse events. Methods In a cluster-randomized trial assessing a measles vaccination campaign’s effect on all-cause mortality and hospital admission among children aged 9–59 months in Guinea-Bissau, children received a measles vaccination (intervention) or a health check-up (control). One month to 2 months later, we visited a subgroup of children to ask mothers/guardians about outpatient consultations since enrollment. In log-binomial models, we estimated the relative risk (RR) of nonaccidental outpatient consultations. Results Among 8319 children (4437 intervention/3882 control), 652 nonaccidental outpatient consultations occurred (322 intervention/330 control). The measles vaccination campaign tended to reduce nonaccidental outpatient consultations by 16% (RR, 0.84 [95% confidence interval {CI}, .65–1.11]), especially if caused by respiratory symptoms (RR, 0.68 [95% CI, .42–1.11]). The reduction tended to be larger in children who prior to trial enrollment had a pentavalent vaccination (diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae type b) as the most recent vaccination (RR, 0.61 [95% CI, .42–.89]) than in children who prior to trial enrollment had a routine measles vaccination as the most recent vaccination (RR, 0.93 [95% CI, .68–1.26]) (P = .04 for interaction). Conclusions In the short term, a measles vaccination campaign seems not to increase nonaccidental outpatient consultations but may reduce them. Clinical Trials Registration NCT03460002.

Simplifying the World Health Organization Protocol: 3 Steps Versus 6 Steps for Performance of Hand Hygiene in a Cluster-randomized Trial

2018 ◽  
Vol 69 (4) ◽  
pp. 614-620 ◽  
Author(s):  
Sarah Tschudin-Sutter ◽  
Daniel Sepulcri ◽  
Marc Dangel ◽  
Anja Ulrich ◽  
Reno Frei ◽  
...  
Keyword(s):  
Hand Hygiene ◽  
Randomized Trial ◽  
World Health Organization ◽  
Cluster Randomized Trial ◽  
Interquartile Range ◽  
World Health ◽  
Bacterial Colony ◽  
Bacterial Counts ◽  
Cluster Randomized ◽  
Health Organization

Abstract Background In an experimental setting, a simplified, 3-step hand hygiene technique for applying alcohol-based hand rub was non inferior in terms of reduction of bacterial counts, as compared to the conventional World Health Organization 6-step technique. We therefore compared compliance and microbiological efficacy between both hand hygiene techniques in routine clinical practice. Methods We performed a cluster-randomized trial from October–November 2015 at the University Hospital Basel, Switzerland: a tertiary, academic care center (ISRCTN45923734). We randomly assigned 12 wards to either the 3-step technique or the conventional 6-step technique of hand rubbing. The primary endpoints were compliance with the assigned technique and reduction of bacterial counts on the hands of health-care workers. Results Overall, 2923 hand hygiene indications were observed, and compliance was 70.7% (2066/2923). Compliance with technique and indications was 51.7% (595/1151) and 75.9% (1151/1516) on wards assigned to the 3-step technique, respectively, as compared to 12.7% (116/915) and 65.0% (915/1407) on wards assigned to the 6-step technique (P < .001). The reduction factor (RF) of bacterial colony counts did not differ between techniques (median RF 0.97 log10 colony-forming units [CFU] [interquartile range 0.39–1.59] for the 3-step technique vs median RF 1.04 log10 CFU [interquartile range 0.49–1.52] for the 6-step technique; P = .629). Conclusions In a clinical setting, the simpler hand hygiene technique, consisting of 3 steps, resulted in higher compliance with both hand hygiene indications and technique, as compared to the 6 steps. As the results of the microbiological analyses exclude inferiority, the conventional 6 steps could be safely replaced by a simpler hand hygiene technique. Clinical Trials Registration ISRCTN45923734.

scholarly journals Point-of-Care Cluster Randomized Trial in Stroke Secondary Prevention Using Electronic Health Records

Stroke ◽  
2014 ◽  
Vol 45 (7) ◽  
pp. 2066-2071 ◽  
Author(s):  
Alex Dregan ◽  
Tjeerd P. van Staa ◽  
Lisa McDermott ◽  
Gerard McCann ◽  
Mark Ashworth ◽  
...  
Keyword(s):  
Electronic Health Records ◽  
Secondary Prevention ◽  
Randomized Trial ◽  
Point Of Care ◽  
Cluster Randomized Trial ◽  
Health Records ◽  
Electronic Health ◽  
Cluster Randomized

scholarly journals Improving Tuberculosis Preventive Therapy Uptake: A Cluster-randomized Trial of Symptom-based Versus Tuberculin Skin Test–based Screening of Household Tuberculosis Contacts Less Than 5 Years of Age

2019 ◽  
Vol 70 (8) ◽  
pp. 1725-1732
Author(s):  
Nicole Salazar-Austin ◽  
Silvia Cohn ◽  
Grace Link Barnes ◽  
Molefi Tladi ◽  
Katlego Motlhaoleng ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Skin Testing ◽  
Cluster Randomized Trial ◽  
Preventive Therapy ◽  
World Health ◽  
Contact Tracing ◽  
Tuberculin Skin Testing ◽  
Symptom Screening ◽  
Significant Difference ◽  
Cluster Randomized

Abstract Background Tuberculosis preventive therapy (TPT) is highly effective at preventing tuberculosis disease in household child contacts (&lt;5 years), but is poorly implemented worldwide. In 2006, the World Health Organization recommended symptom-based screening as a replacement for tuberculin skin testing (TST) to simplify contact evaluation and improve implementation. We aimed to determine the effectiveness of this recommendation. Methods We conducted a pragmatic, cluster-randomized trial to determine whether contact evaluation using symptom screening improved the proportion of identified child contacts who initiated TPT, compared to TST-based screening, in Matlosana, South Africa. We randomized 16 clinics to either symptom-based or TST-based contact evaluations. Outcome data were abstracted from customized child contact management files. Results Contact tracing identified 550 and 467 child contacts in the symptom and TST arms, respectively (0.39 vs 0.32 per case, respectively; P = .27). There was no significant difference by arm in the adjusted proportion of identified child contacts who were screened (52% in symptom arm vs 60% in TST arm; P = .39). The adjusted proportion of identified child contacts who initiated TPT or tuberculosis treatment was 51.5% in the symptom clinics and 57.1% in the TST clinics (difference −5.6%, 95% confidence interval −23.7 to 12.6; P = .52). Based on the district’s historic average of 0.7 child contacts per index case, 14% and 15% of child contacts completed 6 months of TPT in the symptom and TST arms, respectively (P = .89). Conclusions Symptom-based screening did not improve the proportion of identified child contacts evaluated or initiated on TPT, compared to TST-based screening. Further research is needed to identify bottlenecks and evaluate interventions to ensure all child contacts receive TPT. Clinical Trials Registration NCT03074799.

scholarly journals Age-based targeting of biannual azithromycin distribution for child survival in Niger: an adaptive cluster-randomized trial protocol (AVENIR)

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Kieran S. O’Brien ◽  
◽  
Ahmed M. Arzika ◽  
Abdou Amza ◽  
Ramatou Maliki ◽  
...  
Keyword(s):  
Antimicrobial Resistance ◽  
Randomized Trial ◽  
Child Survival ◽  
Cluster Randomized Trial ◽  
Macrolide Resistance ◽  
World Health ◽  
First Year ◽  
Genetic Determinants ◽  
Cluster Randomized ◽  
The Impact

Abstract Background Biannual distribution of azithromycin to children 1–59 months old reduced mortality by 14% in a cluster-randomized trial. The World Health Organization has proposed targeting this intervention to the subgroup of children 1–11 months old to reduce selection for antimicrobial resistance. Here, we describe a trial designed to determine the impact of age-based targeting of biannual azithromycin on mortality and antimicrobial resistance. Methods AVENIR is a cluster-randomized, placebo-controlled, double-masked, response-adaptive large simple trial in Niger. During the 2.5-year study period, 3350 communities are targeted for enrollment. In the first year, communities in the Dosso region will be randomized 1:1:1 to 1) azithromycin 1–11: biannual azithromycin to children 1–11 months old with placebo to children 12–59 months old, 2) azithromycin 1–59: biannual azithromycin to children 1–59 months old, or 3) placebo: biannual placebo to children 1–59 months old. Regions enrolled after the first year will be randomized with an updated allocation based on the probability of mortality in children 1–59 months in each arm during the preceding study period. A biannual door-to-door census will be conducted to enumerate the population, distribute azithromycin and placebo, and monitor vital status. Primary mortality outcomes are defined as all-cause mortality rate (deaths per 1000 person-years) after 2.5 years from the first enrollment in 1) children 1–59 months old comparing the azithromycin 1–59 and placebo arms, 2) children 1–11 months old comparing the azithromycin 1–11 and placebo arm, and 3) children 12–59 months in the azithromycin 1–11 and azithromycin 1–59 arms. In the Dosso region, 50 communities from each arm will be followed to monitor antimicrobial resistance. Primary resistance outcomes will be assessed after 2 years of distributions and include 1) prevalence of genetic determinants of macrolide resistance in nasopharyngeal samples from children 1–59 months old, and 2) load of genetic determinants of macrolide resistance in rectal samples from children 1–59 months old. Discussion As high-mortality settings consider this intervention, the results of this trial will provide evidence to support programmatic and policy decision-making on age-based strategies for azithromycin distribution to promote child survival. Trial registration This trial was registered on January 13, 2020 (clinicaltrials.gov: NCT04224987).

scholarly journals Human Immunodeficiency Virus Infection Newly Diagnosed at Autopsy in New York City, 2008–2012

2015 ◽  
Vol 2 (4) ◽  
Author(s):  
Chitra Ramaswamy ◽  
Tanya M. Ellman ◽  
Julie Myers ◽  
Ann Madsen ◽  
Kent Sepkowitz ◽  
...  
Keyword(s):  
New York ◽  
Human Immunodeficiency Virus ◽  
New York City ◽  
Hiv Testing ◽  
York City ◽  
Population Based ◽  
Medical Examiner ◽  
Newly Diagnosed ◽  
Hiv Diagnosis ◽  
Immunodeficiency Virus

Abstract Background.  Studying the most extreme example of late diagnosis, new HIV diagnoses after death, may be instructive to HIV testing efforts. Using the results of routine HIV testing of autopsies performed by the Office of Chief Medical Examiner (OCME), we identified new HIV diagnoses after death in New York City (NYC) from 2008 to 2012. Methods.  Population-based registries for HIV and deaths were linked to identify decedents not known to be HIV-infected before death. Multivariable logistic regression models were constructed to determine correlates of a new HIV diagnosis after death among all persons newly diagnosed with HIV and among all HIV-infected decedents receiving an OCME autopsy. Results.  Of 264 893 deaths, 24 426 (9.2%) were autopsied by the NYC OCME. Of these, 1623 (6.6%) were infected with HIV, including 142 (8.8%) with a new HIV diagnosis at autopsy. This represents 0.8% (142 of 18 542) of all new HIV diagnoses during the 5-year period. Decedents newly diagnosed with HIV at OCME autopsy were predominantly male (73.9%), aged 13–64 years (85.9%), non-white (85.2%), unmarried (81.7%), less than college educated (83.8%), and residents of an impoverished neighborhood (62.0%). Of all HIV-infected OCME decedents aged ≥65 years (n = 71), 22.0% were diagnosed at autopsy. The strongest independent correlate of new HIV diagnosis at autopsy in both multivariable models was age ≥65 years. Conclusions.  Human immunodeficiency virus diagnoses first made after death are rare, but, when observed, these diagnoses are more commonly found among persons ≥65 years, suggesting that despite highly visible efforts to promote HIV testing community-wide, timely diagnosis among older adults living in impoverished, high-prevalence neighborhoods may require additional strategies.

scholarly journals Integrated management of atrial fibrillation in primary care: results of the ALL-IN cluster randomized trial

2020 ◽  
Vol 41 (30) ◽  
pp. 2836-2844 ◽  
Author(s):  
Carline J van den Dries ◽  
Sander van Doorn ◽  
Frans H Rutten ◽  
Ruud Oudega ◽  
Sjef J C M van de Leur ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Primary Care ◽  
Usual Care ◽  
Randomized Trial ◽  
Integrated Care ◽  
Cluster Randomized Trial ◽  
Easy Access ◽  
Care Intervention ◽  
All Cause Mortality ◽  
Cluster Randomized

Abstract Aims To evaluate whether integrated care for atrial fibrillation (AF) can be safely orchestrated in primary care. Methods and results The ALL-IN trial was a cluster randomized, open-label, pragmatic non-inferiority trial performed in primary care practices in the Netherlands. We randomized 26 practices: 15 to the integrated care intervention and 11 to usual care. The integrated care intervention consisted of (i) quarterly AF check-ups by trained nurses in primary care, also focusing on possibly interfering comorbidities, (ii) monitoring of anticoagulation therapy in primary care, and finally (iii) easy-access availability of consultations from cardiologists and anticoagulation clinics. The primary endpoint was all-cause mortality during 2 years of follow-up. In the intervention arm, 527 out of 941 eligible AF patients aged ≥65 years provided informed consent to undergo the intervention. These 527 patients were compared with 713 AF patients in the control arm receiving usual care. Median age was 77 (interquartile range 72–83) years. The all-cause mortality rate was 3.5 per 100 patient-years in the intervention arm vs. 6.7 per 100 patient-years in the control arm [adjusted hazard ratio (HR) 0.55; 95% confidence interval (CI) 0.37–0.82]. For non-cardiovascular mortality, the adjusted HR was 0.47 (95% CI 0.27–0.82). For other adverse events, no statistically significant differences were observed. Conclusion In this cluster randomized trial, integrated care for elderly AF patients in primary care showed a 45% reduction in all-cause mortality when compared with usual care.

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