scholarly journals A cluster randomized trial of interferon ß-1a for the reduction of transmission of SARS-Cov-2: protocol for the Containing Coronavirus Disease 19 trial (ConCorD-19)

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Carolina Iturriaga ◽  
Nat Eiffler ◽  
Rad Aniba ◽  
Rym Ben-Othman ◽  
Guillermo Perez-Mateluna ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Subcutaneous Administration ◽  
Standard Of Care ◽  
Cluster Randomized Trial ◽  
Viral Clearance ◽  
Post Exposure ◽  
Eligible Household ◽  
Ifn Treatment ◽  
Cluster Randomized ◽  
The Impact

Abstract Background SARS-CoV-2 infection rapidly spreads in populations due to the high rates of community transmission. Interrupting the shedding of SARS-CoV-2 may reduce the incidence of Coronavirus Disease 19 (COVID-19). Herein we provide a protocol for a cluster randomized trial that will examine the effectiveness of treatment with interferon (IFN) ß-1a compared to standard of care in limiting the transmission of SARS-CoV-2. Co-primary objectives are to determine whether IFN therapy reduces (a) the proportion of infected cases shedding SARS-CoV-2 at day 11 post randomization and (b) the incidence of transmission of SARS-CoV-2 infection from index cases to treatment-eligible household post-exposure contacts at day 11 after randomization. Secondary objectives include assessing the impact of IFN treatment on duration of viral clearance, hospitalizations and fatalities, and evaluating the safety of IFN treatment. Methods Three hundred and ten households, each including an index case with a recent COVID-19 diagnosis and at least one asymptomatic treatment-eligible household contact, will be randomized to receive 3 doses of 125 μg IFN ß-1a by subcutaneous administration (days 1, 6, and 11), or standard of care. All participants will be followed until day 29. Discussion The results from this trial will identify whether IFN ß treatment of mild or moderate COVID-19 cases accelerates viral clearance and prevents disease progression and whether IFN ß treatment of post-exposure contacts of COVID-19 cases reduces transmission of infection. Trial Registration: This trial is registered at ClinicalTrials.gov NCT04552379; date of registration September 17, 2020.

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 The impact of providing rapid diagnostic malaria tests on fever management in the private retail sector in Ghana: a cluster randomized trial

BMJ ◽  
2015 ◽  
Vol 350 (mar04 8) ◽  
pp. h1019-h1019 ◽  
Author(s):  
E. K. Ansah ◽  
S. Narh-Bana ◽  
H. Affran-Bonful ◽  
C. Bart-Plange ◽  
B. Cundill ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Cluster Randomized Trial ◽  
Retail Sector ◽  
Cluster Randomized ◽  
The Impact ◽  
Fever Management

scholarly journals Assessing the impact of a school-based latrine cleaning and handwashing program on pupil absence in Nyanza Province, Kenya: a cluster-randomized trial

2014 ◽  
Vol 19 (10) ◽  
pp. 1185-1197 ◽  
Author(s):  
Bethany A. Caruso ◽  
Matthew C. Freeman ◽  
Joshua V. Garn ◽  
Robert Dreibelbis ◽  
Shadi Saboori ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Cluster Randomized Trial ◽  
Nyanza Province ◽  
School Based ◽  
Cluster Randomized ◽  
The Impact

Reducing Physical Aggression in High School Students in KwaZulu-Natal: A Cluster Randomized Trial

2020 ◽  
Vol 35 (6) ◽  
pp. 861-884
Author(s):  
Myra Taylor ◽  
Benn Sartorius ◽  
Saloshni Naidoo ◽  
Hein de Vries
Keyword(s):  
High School Students ◽  
Randomized Trial ◽  
Youth Violence ◽  
Intervention Program ◽  
Physical Violence ◽  
Cluster Randomized Trial ◽  
School Students ◽  
Analytical Technique ◽  
Cluster Randomized ◽  
The Impact

Youth violence is of public health and social concern. A South African cluster randomized trial (434 grade 10 students, 16 schools), used the Integrated Model for Behavior Change conceptual framework to implement a 20 module classroom-based intervention program. The study contributes to the literature and used a strong analytical technique since mixed effects linear regression assessed the impact of the intervention on physical violence endpoints and other socioeconomic confounders/factors. The intervention reduced students' experiencing physical violence compared to controls and social pressure for this, yet no differences were found for hitting others. Our results support findings that school programs against violence can reduce students' experience of physical violence, but translation of these findings to reduce the actual hitting of others may need further approaches and/or more time.

scholarly journals Design and rationale of the Longitudinal Evaluation of Norms and Networks Study (LENNS): A cluster-randomized trial assessing the impact of a norms-centric intervention on exclusive toilet use and maintenance in peri urban communities of Tamil Nadu

2020 ◽  
Author(s):  
Sania Ashraf ◽  
Cristina Bicchieri ◽  
Maryann G. Delea ◽  
Upasak Das ◽  
Kavita Chauhan ◽  
...  
Keyword(s):  
Behavior Change ◽  
Randomized Trial ◽  
Low Income ◽  
Tamil Nadu ◽  
Cluster Randomized Trial ◽  
List Type ◽  
Behavior Change Intervention ◽  
Ex Ante ◽  
Cluster Randomized ◽  
The Impact

AbstractIntroductionInconsistent toilet usage is a continuing challenge in India. Despite the impact of social expectations on toilet usage, few programs and studies have developed theoretically grounded norms-centric behavior change interventions to increase toilet use in low-income settings. This protocol details the rationale and design of an ex-ante, parallel cluster-randomized trial evaluating the impact of a demand-side, norms-centric behavior change intervention on exclusive toilet use and maintenance in peri-urban Tamil Nadu, India.Methods and AnalysisFollowing two years of formative research, we developed an evidence-based norm-centric behavior change intervention called Nam Nalavazhvu (Tamil for “Our wellbeing”). The multi-level intervention aims to shift collective beliefs by shifting empirical expectations or beliefs about other relevant people’s sanitation practices. It also provides action-oriented information to aid individuals to set goals and overcome barriers to build, consistently use and maintain their toilets. This trial includes 76 wards in Pudukkottai and Karur districts, where half were randomly assigned to receive the intervention and the remaining serve as counterfactuals. During baseline and endline (conducted one year after the initiation of intervention) assessments, we collect relevant data and compare results between study arms to determine the impacts of the Nam Nalavazhvu intervention on sanitation-related behavioral, health, wellbeing outcomes and potential moderators. This study is powered to detect differences in the prevalence of exclusive toilet use between study arms. We will also conduct a process evaluation to understand the extent to which the intervention was implemented, as designed.Ethics and DisseminationThe study protocol has been reviewed and approved by the ethics board at the University of Pennsylvania, USA and the Catalyst Foundation, India. Research findings will be disseminated through open access peer reviewed publications and presentations to stakeholders, government officials and conferences.Trial registrationNCT04269824.Strengths and limitations of this studyThis ex-ante, parallel cluster randomized trial assesses the impact of a norm-centric behavior change intervention strategy to improve sanitation practices. These behavior change techniques are novel to the sanitation sector but has been effective in changing a variety of behaviors, such as water use, drinking behavior, and energy consumption.The study outcomes include health, wellbeing outcomes, and a careful assessment of changes in social beliefs, expectations, and social determinants of collective sanitation behaviors.This study is being rolled out during the ongoing COVID-19 pandemic. This can potentially impact the effectiveness of this intervention package that uses community and network-based group activities. However, through a detailed process monitoring and evaluation we will be able to assess the impact on delivery, and subsequent behavior change in this unique setting.

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