scholarly journals Community Intervention for Child Tuberculosis Active Contact Investigation and Management: study protocol for a parallel cluster randomized controlled trial

2021 ◽  
Author(s):  
Anca Vasiliu ◽  
Sabrina Eymard-Duvernay ◽  
Boris Tchounga ◽  
Daniel Atwine ◽  
Elisabete de Carvalho ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Standard Of Care ◽  
Preventive Therapy ◽  
Community Based ◽  
Randomized Controlled ◽  
Eligible Child ◽  
Contact Investigation ◽  
Cluster Randomized ◽  
The Impact ◽  
Index Cases

Abstract Background: There are major gaps in the management of pediatric tuberculosis (TB) contact investigation for rapid identification of active tuberculosis and initiation of preventive therapy. This study aims to evaluate the impact of a community-based intervention as compared to facility-based model for the management of children in contact with bacteriologically confirmed pulmonary TB adults in low-resource high-burden settings.Methods/design: This multicenter parallel open label cluster-randomized controlled trial is composed of three phases: I, baseline phase in which retrospective data are collected, quality of data recording in facility registers is checked and expected acceptability and feasibility of the intervention is assessed; II, intervention phase with enrolment of index cases and contact cases in either facility- or community based models; and III, explanatory phase including endpoint data analysis, cost effectiveness analysis and post-intervention acceptability assessment by heath care providers and beneficiaries. The study uses both quantitative and qualitative analysis methods. The community-based intervention includes identification and screening of all household contacts, referral of contact with TB-suggestive symptoms to the facility for investigation, and household initiation of preventive therapy with follow-up of eligible child contacts by community healthcare workers, i.e. all young (<5 years) child contacts or older (5-14 years) child contacts living with HIV, and with no evidence of TB disease. Twenty clusters representing TB diagnostic and treatment facilities with their catchment areas are randomized in a 1:1 ratio to either the community-based intervention arm or the facility-based standard of care arm in Cameroon and Uganda. Randomization was stratified by country and constrained on the number of index cases per cluster. The primary endpoint is the proportion of eligible child contacts who initiate and complete the preventive therapy. The sample size is of 1500 child contacts to identify a 10% difference between the arms with the assumption that 60% of children will complete the preventive therapy in the standard of care arm.Discussion: This study will provide evidence of the impact of a community-based intervention on household child contact screening, and management of TB preventive therapy in order to improve care and prevention of childhood TB in high low resource high-burden settings.

scholarly journals Community intervention for child tuberculosis active contact investigation and management: study protocol for a parallel cluster randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Anca Vasiliu ◽  
Sabrina Eymard-Duvernay ◽  
Boris Tchounga ◽  
Daniel Atwine ◽  
Elisabete de Carvalho ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Standard Of Care ◽  
Preventive Therapy ◽  
Community Based ◽  
Randomized Controlled ◽  
Eligible Child ◽  
Contact Investigation ◽  
Cluster Randomized ◽  
The Impact ◽  
Index Cases

Abstract Background There are major gaps in the management of pediatric tuberculosis (TB) contact investigation for rapid identification of active tuberculosis and initiation of preventive therapy. This study aims to evaluate the impact of a community-based intervention as compared to facility-based model for the management of children in contact with bacteriologically confirmed pulmonary TB adults in low-resource high-burden settings. Methods/design This multicenter parallel open-label cluster randomized controlled trial is composed of three phases: I, baseline phase in which retrospective data are collected, quality of data recording in facility registers is checked, and expected acceptability and feasibility of the intervention is assessed; II, intervention phase with enrolment of index cases and contact cases in either facility- or community-based models; and III, explanatory phase including endpoint data analysis, cost-effectiveness analysis, and post-intervention acceptability assessment by healthcare providers and beneficiaries. The study uses both quantitative and qualitative analysis methods. The community-based intervention includes identification and screening of all household contacts, referral of contacts with TB-suggestive symptoms to the facility for investigation, and household initiation of preventive therapy with follow-up of eligible child contacts by community healthcare workers, i.e., all young (< 5 years) child contacts or older (5–14 years) child contacts living with HIV, and with no evidence of TB disease. Twenty clusters representing TB diagnostic and treatment facilities with their catchment areas are randomized in a 1:1 ratio to either the community-based intervention arm or the facility-based standard of care arm in Cameroon and Uganda. Randomization was stratified by country and constrained on the number of index cases per cluster. The primary endpoint is the proportion of eligible child contacts who initiate and complete the preventive therapy. The sample size is of 1500 child contacts to identify a 10% difference between the arms with the assumption that 60% of children will complete the preventive therapy in the standard of care arm. Discussion This study will provide evidence of the impact of a community-based intervention on household child contact screening and management of TB preventive therapy in order to improve care and prevention of childhood TB in low-resource high-burden settings. Trial registration ClinicalTrials.gov NCT03832023. Registered on 6 February 2019

scholarly journals Community Intervention for Child Tuberculosis Active Contact Investigation and Management: Study Protocol for A Cluster Randomized Trial

2020 ◽  
Author(s):  
Anca Vasiliu ◽  
Sabrina Eymard-Duvernay ◽  
Boris Tchounga ◽  
Daniel Atwine ◽  
Elisabete de Carvalho ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Standard Of Care ◽  
Cluster Randomized Trial ◽  
Preventive Therapy ◽  
Community Based ◽  
High Burden ◽  
Eligible Child ◽  
Contact Investigation ◽  
Cluster Randomized ◽  
The Impact

Abstract Background: There are major gaps in the management of pediatric tuberculosis (TB) contact investigation for rapid identification of active tuberculosis and initiation of preventive therapy. This study aims to evaluate the impact of a community-based intervention as compared to facility-based model for the management of children in contact with bacteriologically confirmed pulmonary TB adults in low-resource high-burden settings.Methods/design: This multicenter cluster-randomized trial is composed of three phases: I, baseline phase in which retrospective data are collected, quality of data recording in facility registers is checked and expected acceptability and feasibility of the intervention is assessed; II, intervention phase with enrolment of index cases and contact cases in either facility- or community based models; and III, explanatory phase including endpoint data analysis, cost effectiveness analysis and post-intervention acceptability assessment by heath care providers and beneficiaries. The study uses both quantitative and qualitative analysis methods. The community-based intervention includes identification and screening of all household contacts, referral of contact with TB-suggestive symptoms to the facility for investigation, and household initiation of preventive therapy with follow-up of eligible child contacts by community healthcare workers, i.e. all young (<5 years) child contacts or older (5-14 years) child contacts living with HIV, and with no evidence of TB disease. Twenty clusters representing TB diagnostic and treatment facilities with their catchment areas are randomized in a 1:1 ratio to either the community-based intervention arm or the facility-based standard of care arm in Cameroon and Uganda. The primary endpoint is the proportion of eligible child contacts who initiate and complete the preventive therapy. The sample size is of 1500 child contacts to identify a 10% difference between the arms with the assumption that 60% of children will complete the preventive therapy in the standard of care arm.Discussion: This study will provide evidence of the impact of a community-based intervention on household child contact screening, and management of TB preventive therapy in order to improve care and prevention of childhood TB in high low resource high-burden settings.Trial registration: the study has been registered on the 6th of February 2019 on ClinicalTrials.gov with the number NCT03832023 (https://clinicaltrials.gov/ct2/show/NCT03832023?term=CONTACT&cond=Tuberculosis&cntry=UG&draw=2&rank=1 )

scholarly journals Reduced exposure to malaria vectors following indoor residual spraying of pirimiphos-methyl in a high-burden district of rural Mozambique with high ownership of long-lasting insecticidal nets: entomological surveillance results from a cluster-randomized trial

2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Joseph M. Wagman ◽  
Kenyssony Varela ◽  
Rose Zulliger ◽  
Abuchahama Saifodine ◽  
Rodaly Muthoni ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Indoor Residual Spraying ◽  
Malaria Vectors ◽  
Light Traps ◽  
High Burden ◽  
Randomized Controlled ◽  
Pirimiphos Methyl ◽  
Cluster Randomized ◽  
The Impact ◽  
Long Lasting Insecticidal Nets

Abstract Background The need to develop new products and novel approaches for malaria vector control is recognized as a global health priority. One approach to meeting this need has been the development of new products for indoor residual spraying (IRS) with novel active ingredients for public health. While initial results showing the impact of several of these next-generation IRS products have been encouraging, questions remain about how to best deploy them for maximum impact. To help address these questions, a 2-year cluster-randomized controlled trial to measure the impact of IRS with a microencapsulated formulation of pirimiphos-methyl (PM) in an area with high ownership of long-lasting insecticidal nets (LLINs) was conducted in a high-transmission district of central Mozambique with pyrethroid resistant vectors. Presented here are the results of the vector surveillance component of the trial. Methods The 2 year, two-armed trial was conducted in Mopeia District, Zambezia Province, Mozambique. In ten sentinel villages, five that received IRS with PM in October–November 2016 and again in October–November 2017 and five that received no IRS, indoor light trap collections and paired indoor-outdoor human landing collections catches (HLCs) were conducted monthly from September 2016 through October 2018. A universal coverage campaign in June 2017, just prior to the second spray round, distributed 131,540 standard alpha-cypermethrin LLINs across all study villages and increased overall net usage rates in children under 5 years old to over 90%. Results The primary malaria vector during the trial was Anopheles funestus sensu lato (s.l.), and standard World Health Organization (WHO) tube tests with this population indicated variable but increasing resistance to pyrethroids (including alpha-cypermethrin, from > 85% mortality in 2017 to 7% mortality in 2018) and uniform susceptibility to PM (100% mortality in both years). Over the entire duration of the study, IRS reduced An. funestus s.l. densities by 48% (CI95 33–59%; p < 0.001) in indoor light traps and by 74% (CI95 38–90%; p = 0.010) during indoor and outdoor HLC, though in each study year reductions in vector density were consistently greatest in those months immediately following the IRS campaigns and waned over time. Overall there was no strong preference for An. funestus to feed indoors or outdoors, and these biting behaviours did not differ significantly across study arms: observed indoor-outdoor biting ratios were 1.10 (CI95 1.00–1.21) in no-IRS villages and 0.88 (CI95 0.67–1.15) in IRS villages. The impact of IRS was consistent in reducing HLC exposures both indoors (75% reduction: CI95 47–88%; p = 0. < 0.001) and outdoors (68% reduction: CI95 22–87%; p = 0.012). While substantially fewer Anopheles gambiae s.l. were collected during the study, trends show a similar impact of IRS on this key vector group as well, with a 33% (CI95 7–53%; p = 0.019) reduction in mosquitoes collected in light traps and a non-statistically significant 39% reduction (p = 0.249) in HLC landing rates. Conclusion IRS with PM used in addition to pyrethroid-only LLINs substantially reduced human exposures to malaria vectors during both years of the cluster-randomized controlled trial in Mopeia—a high-burden district where the primary vector, An. funestus s.l., was equally likely to feed indoors or outdoors and demonstrated increasing resistance to pyrethroids. Findings suggest that IRS with PM can provide effective vector control, including in some settings where pyrethroid-only ITNs are widely used. Trial registrationclinicaltrials.gov, NCT02910934. Registered 22 September 2016, https://www.clinicaltrials.gov/ct2/show/NCT02910934.

scholarly journals Effectiveness of Yoga Lifestyle on Lipid Metabolism in a Vulnerable Population—A Community Based Multicenter Randomized Controlled Trial

Medicines ◽  
2021 ◽  
Vol 8 (7) ◽  
pp. 37
Author(s):  
Raghuram Nagarathna ◽  
Saurabh Kumar ◽  
Akshay Anand ◽  
Ishwara N. Acharya ◽  
Amit Kumar Singh ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
High Risk ◽  
Controlled Trial ◽  
Density Lipoprotein ◽  
Lipid Profiles ◽  
Community Based ◽  
Randomized Controlled ◽  
Rural And Urban ◽  
Yoga Group ◽  
The Impact

Background: Dyslipidemia poses a high risk for cardiovascular disease and stroke in Type 2 diabetes (T2DM). There are no studies on the impact of a validated integrated yoga lifestyle protocol on lipid profiles in a high-risk diabetes population. Methods: Here, we report the results of lipid profile values of 11,254 (yoga 5932 and control 5322) adults (20–70 years) of both genders with high risk (≥60 on Indian diabetes risk score) for diabetes from a nationwide rural and urban community-based two group (yoga and conventional management) cluster randomized controlled trial. The yoga group practiced a validated integrated yoga lifestyle protocol (DYP) in nine day camps followed by daily one-hour practice. Biochemical profiling included glycated hemoglobin and lipid profiles before and after three months. Results: There was a significant difference between groups (p < 0.001 ANCOVA) with improved serum total cholesterol, triglycerides, low-density lipoprotein, and high-density lipoprotein in the yoga group compared to the control group. Further, the regulatory effect of yoga was noted with a significant decrease or increase in those with high or low values of lipids, respectively, with marginal or no change in those within the normal range. Conclusion: Yoga lifestyle improves and regulates (lowered if high, increased if low) the blood lipid levels in both genders of prediabetic and diabetic individuals in both rural and urban Indian communities.

scholarly journals Frequency of repositioning for preventing pressure ulcers in patients hospitalized in ICU: protocol of a cluster randomized controlled trial

BMC Nursing ◽  
2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Olga L. Cortés ◽  
Mauricio Herrera-Galindo ◽  
Juan Carlos Villar ◽  
Yudi A. Rojas ◽  
María del Pilar Paipa ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Critical Care ◽  
Pressure Ulcers ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Link Type ◽  
Cluster Randomized ◽  
The Impact

Abstract Background Despite being considered preventable, ulcers due to pressure affect between 30 and 50% of patients at high and very high risk and susceptibility, especially those hospitalized under critical care. Despite a lack of evidence over the efficacy in prevention against ulcers due to pressure, hourly repositioning in critical care as an intervention is used with more or less frequency to alleviate pressure on patients’ tissues. This brings up the objective of our study, which is to evaluate the efficacy in prevention of ulcers due to pressure acquired during hospitalization, specifically regarding two frequency levels of repositioning or manual posture switching in adults hospitalized in different intensive care units in different Colombian hospitals. Methods A nurse-applied cluster randomized controlled trial of parallel groups (two branches), in which 22 eligible ICUs (each consisting of 150 patients), will be randomized to a high-frequency level repositioning intervention or to a conventional care (control group). Patients will be followed until their exit from each cluster. The primary result of this study is originated by regarding pressure ulcers using clusters (number of first ulcers per patient, at the early stage of progression, first one acquired after admission for 1000 days). The secondary results include evaluating the risk index on the patients’ level (Hazard ratio, 95% IC) and a description of repositioning complications. Two interim analyses will be performed through the course of this study. A statistical difference between the groups < 0.05 in the main outcome, the progression of ulcers due to pressure (best or worst outcome in the experimental group), will determine whether the study should be put to a halt/determine the termination of the study. Conclusion This study is innovative in its use of clusters to advance knowledge of the impact of repositioning as a prevention strategy against the appearance of ulcers caused by pressure in critical care patients. The resulting recommendations of this study can be used for future clinical practice guidelines in prevention and safety for patients at risk. Trial registration PENFUP phase-2 was Registered in Clinicaltrials.gov (NCT04604665) in October 2020.

scholarly journals UTILIZING NUTRITION SERVICES PROVIDERS TO PREVENT LATE-LIFE SUICIDE: IMPLEMENTING A RANDOMIZED, CONTROLLED TRIAL

2019 ◽  
Vol 3 (Supplement_1) ◽  
pp. S824-S825
Author(s):  
Matthew C Fullen ◽  
Mary Chase Mize ◽  
Laura R Shannonhouse
Keyword(s):  
Randomized Controlled Trial ◽  
Suicide Prevention ◽  
Controlled Trial ◽  
Late Life ◽  
Warning Signs ◽  
Community Based ◽  
Randomized Controlled ◽  
Nutrition Services ◽  
Suicide Prevention Training ◽  
The Impact

Abstract A challenge in preventing late-life suicide is identifying and responding to persons-at-risk prior to a suicide attempt. Distressed older adults are less likely to turn to a mental health professional, meaning that community-based prevention strategies are vitally important to comprehensive prevention frameworks. Due to their “natural helper” role, nutrition services (NS) volunteers may be well-positioned to identify suicide warning signs and respond accordingly. Unfortunately, there is a lack of systematic, empirically-tested evaluations of the effectiveness of community-based strategies to prevent older adult suicide, including the use of NS volunteers. To remedy this, the authors partnered with several home- and community-based service organizations to measure the impact of training nutrition services volunteers in suicide prevention skills. The authors will present preliminary findings from this federally-funded randomized, controlled trial of suicide prevention training (i.e., ASIST; safeTALK) on late-life suicidality and its correlates.

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