scholarly journals Post-exposure prophylaxis against SARS-CoV-2 in close contacts of confirmed COVID-19 cases (CORIPREV): study protocol for a cluster-randomized trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Darrell H. S. Tan ◽  
Adrienne K. Chan ◽  
Peter Jüni ◽  
George Tomlinson ◽  
Nick Daneman ◽  
...  
Keyword(s):  
High Risk ◽  
Randomized Trial ◽  
Sample Size ◽  
Cluster Randomized Trial ◽  
Risk Exposure ◽  
Post Exposure Prophylaxis ◽  
Primary Analysis ◽  
Cluster Randomized ◽  
Exposure Prophylaxis ◽  
The Impact

Abstract Background Post-exposure prophylaxis (PEP) is a well-established strategy for the prevention of infectious diseases, in which recently exposed people take a short course of medication to prevent infection. The primary objective of the COVID-19 Ring-based Prevention Trial with lopinavir/ritonavir (CORIPREV-LR) is to evaluate the efficacy of a 14-day course of oral lopinavir/ritonavir as PEP against COVID-19 among individuals with a high-risk exposure to a confirmed case. Methods This is an open-label, multicenter, 1:1 cluster-randomized trial of LPV/r 800/200 mg twice daily for 14 days (intervention arm) versus no intervention (control arm), using an adaptive approach to sample size calculation. Participants will be individuals aged > 6 months with a high-risk exposure to a confirmed COVID-19 case within the past 7 days. A combination of remote and in-person study visits at days 1, 7, 14, 35, and 90 includes comprehensive epidemiological, clinical, microbiologic, and serologic sampling. The primary outcome is microbiologically confirmed COVID-19 infection within 14 days after exposure, defined as a positive respiratory tract specimen for SARS-CoV-2 by polymerase chain reaction. Secondary outcomes include safety, symptomatic COVID-19, seropositivity, hospitalization, respiratory failure requiring ventilator support, mortality, psychological impact, and health-related quality of life. Additional analyses will examine the impact of LPV/r on these outcomes in the subset of participants who test positive for SARS-CoV-2 at baseline. To detect a relative risk reduction of 40% with 80% power at α = 0.05, assuming the secondary attack rate in ring members (p0) = 15%, 5 contacts per case and intra-class correlation coefficient (ICC) = 0.05, we require 110 clusters per arm, or 220 clusters overall and approximately 1220 enrollees after accounting for 10% loss-to-follow-up. We will modify the sample size target after 60 clusters, based on preliminary estimates of p0, ICC, and cluster size and consider switching to an alternative drug after interim analyses and as new data emerges. The primary analysis will be a generalized linear mixed model with logit link to estimate the effect of LPV/r on the probability of infection. Participants who test positive at baseline will be excluded from the primary analysis but will be maintained for additional analyses to examine the impact of LPV/r on early treatment. Discussion Harnessing safe, existing drugs such as LPV/r as PEP could provide an important tool for control of the COVID-19 pandemic. Novel aspects of our design include the ring-based prevention approach, and the incorporation of remote strategies for conducting study visits and biospecimen collection. Trial registration This trial was registered at www.ClinicalTrials.gov (NCT04321174) on March 25, 2020.

scholarly journals Post-exposure Prophylaxis Against SARS-CoV-2 in Close Contacts of Confirmed COVID-19 Cases (CORIPREV): Study Protocol for a Cluster-randomised Trial

2020 ◽  
Author(s):  
Darrell Tan ◽  
Adrienne K. Chan ◽  
Peter Jüni ◽  
George Tomlinson ◽  
Nick Daneman ◽  
...  
Keyword(s):  
High Risk ◽  
Sample Size ◽  
Randomised Trial ◽  
Sample Size Calculation ◽  
Risk Exposure ◽  
Cluster Randomised Trial ◽  
Post Exposure Prophylaxis ◽  
Post Exposure ◽  
Exposure Prophylaxis ◽  
The Impact

Abstract Background: Post-exposure prophylaxis (PEP) is a well-established strategy for the prevention of infectious diseases, in which recently exposed people take a short course of medication to prevent infection. The primary objective of the COVID-19 Ring-based Prevention Trial with lopinavir/ritonavir (CORIPREV-LR) is to evaluate the efficacy of a 14-day course of oral lopinavir/ritonavir as PEP against COVID-19 among individuals with a high-risk exposure to a confirmed case.Methods: This is an open-label, multicenter, 1:1 cluster-randomized trial of LPV/r versus no intervention, using an adaptive approach to sample size calculation. Participants will be individuals aged >6 months with a high-risk exposure to a confirmed COVID-19 case within the past 7 days. A combination of remote and in-person study visits at days 1, 7, 14, 35 and 90 include comprehensive epidemiological, clinical, microbiologic and serologic sampling. The primary outcome is microbiologically confirmed COVID-19 infection within 14 days after exposure, defined as a positive respiratory tract specimen for SARS-CoV-2 by polymerase chain reaction. Secondary outcomes include safety, symptomatic COVID-19, seropositivity, hospitalization, respiratory failure requiring ventilator support, mortality, psychological impact, and health-related quality of life. Additional analyses will examine the impact of LPV/r on these outcomes in the subset of participants who test positive for SARS-CoV-2 at baseline. To detect a relative risk reduction of 40% with 80% power at α=0.05, assuming p0=15%, 5 contacts per case and intra-class correlation coefficient (ICC)=0.05, we require 110 clusters per arm, or 220 clusters overall and approximately 1220 enrollees after accounting for 10% loss-to-follow-up. We will modify the sample size target after 60 clusters, based on preliminary estimates of p0, ICC and cluster size and consider switching to an alternative drug after interim analyses and as new data emerges. The primary analysis will be a generalized linear mixed model with logit link to estimate the effect of LPV/r on the probability of infection. Discussion: Harnessing safe, existing drugs such as LPV/r as PEP could provide an important tool for control of the COVID-19 pandemic. Novel aspects of our design include the ring-based prevention approach, and the incorporation of remote strategies for conducting study visits and biospecimen collection.Trial registration: This trial was registered at www.clinicaltrials.gov (NCT04321174) on March 25, 2020. https://clinicaltrials.gov/ct2/show/NCT04321174

scholarly journals Protocol, rationale and design of PEOPLE (Post ExpOsure Prophylaxis for LEprosy in the Comoros and Madagascar): a cluster randomized trial on effectiveness of different modalities of implementation of post-exposure prophylaxis of leprosy contacts

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Nimer Ortuno-Gutierrez ◽  
Assoumani Younoussa ◽  
Andriamira Randrianantoandro ◽  
Sofie Braet ◽  
Bertrand Cauchoix ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Cluster Randomized Trial ◽  
Post Exposure Prophylaxis ◽  
Post Exposure ◽  
Link Type ◽  
High Incidence ◽  
Leprosy Patients ◽  
Household Members ◽  
Cluster Randomized ◽  
Exposure Prophylaxis

Abstract Background Leprosy is an ancient infectious disease with a global annual incidence that has plateaued above 200,000 new cases since over a decade. New strategies are required to overcome this stalemate. Post-exposure prophylaxis (PEP) with a single dose of Rifampicin (SDR) has conditionally been recommended by the World Health Organization (WHO), based on a randomized-controlled-trial in Bangladesh. More evidence is required. The Post ExpOsure Prophylaxis for Leprosy (PEOPLE) trial will assess effectiveness of different modalities of PEP on the Comoros and Madagascar. Methods PEOPLE is a cluster-randomized trial with villages selected on previous leprosy-incidence and randomly allocated to four arms. Four annual door-to-door surveys will be performed in all arms. All consenting permanent residents will be screened for leprosy. Leprosy patients will be treated according to international guidelines and eligible contacts will be provided with SDR-PEP. Arm-1 is the comparator in which no PEP will be provided. In arms 2, 3 and 4, SDR-PEP will be provided at double the regular dose (20 mg/kg) to eligible contacts aged two years and above. In arm 2 all household-members of incident leprosy patients are eligible. In arm 3 not only household-members but also neighbourhood contacts living within 100-m of an incident case are eligible. In arm 4 such neighbourhood contacts are only eligible if they test positive to anti-PGL-I, a serological marker. Incidence rate ratios calculated between the comparator arm 1 and each of the intervention arms will constitute the primary outcome. Discussion Different trials on PEP have yielded varying results. The pivotal COLEP trial in Bangladesh showed a 57% reduction in incidence over a two-year period post-intervention without any rebound in the following years. A study in a high-incidence setting in Indonesia showed no effect of PEP provided to close contacts but a major effect of PEP provided as a blanket measure to an entire island population. High background incidence could be the reason of the lack of effect of PEP provided to individual contacts. The PEOPLE trial will assess effectiveness of PEP in a high incidence setting and will compare three different approaches, to identify who benefits most from PEP. Trial registration Clinicaltrials.Gov. NCT03662022. Initial Protocol Version 1.2, 27-Aug-2018.

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.

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