scholarly journals Effect of interventions to reduce malaria incidence among military personnel on active duty: study protocol for a cluster randomised controlled trial of the impact of etofenprox-treated uniforms, permethrin-treated uniforms and DEET insect repellent

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Daniel Msellemu ◽  
Amanda Ross ◽  
Lucky Temu ◽  
Irene Moshi ◽  
Lorenz Hofer ◽  
...  
Keyword(s):  
Military Personnel ◽  
Malaria Infection ◽  
Malaria Incidence ◽  
Controlled Trial ◽  
Active Duty ◽  
Insect Repellent ◽  
Insect Repellents ◽  
Link Type ◽  
Cluster Randomised ◽  
The Impact

Abstract Background While there is strong evidence that bite protection methods such as permethrin-treated clothing and topical insect repellents are protective against insect bites, there are few studies assessing the impact on malaria infection. This study will estimate the protective efficacy of treated uniforms and DEET insect repellent on the incidence of malaria infection among military personnel in an operational setting. Permethrin-treated uniforms used with DEET lotion will be compared to etofenprox-treated uniforms with DEET lotion. The effect of DEET lotion will be estimated by comparing permethrin-treated uniforms with DEET or placebo lotion. Method A cluster randomised double-blind placebo-controlled trial is planned to evaluate the effectiveness of the interventions on preventing malaria infections in soldiers on active duty at Mgambo National Service Camp in Tanga, Tanzania. The arms are (1) permethrin-treated uniform with 30% DEET liposome formula; (2) permethrin-treated uniform with placebo lotion; (3) candidate insect repellent system, i.e. etofenprox-treated uniform with 30% DEET liposome formula; and (4) placebo, i.e. untreated uniforms with placebo lotion. The primary outcome is the incidence of Plasmodium falciparum malaria infection detected by polymerase chain reaction (PCR) by active case detection using surveys every 2 weeks for 12 months. Rapid diagnostic tests will be used for the diagnosis of participants with symptoms. The unit of randomisation will be combania: companies formed by recruits aged 18 to 25 years; combania do activities together and sleep in the same dormitory. Unequal randomisation will be used to optimise statistical power for the primary comparison between permethrin-treated uniforms with DEET and etofenprox-treated uniforms with DEET. Discussion This trial will provide the estimate of the effects of permethrin with DEET compared to those of the new fabric treatment etofenprox with DEET and any additional effect of using DEET. The results will inform strategies to protect military personnel and civilians who have more outdoor or occupational malaria exposure than the general public. Trial registration ClinicalTrials.govNCT02938975.

scholarly journals Effect of Interventions to Reduce Malaria Incidence Among Military Personnel on Active Duty: Study Protocol for a Cluster Randomised Controlled Trial of the Impact of Etofenprox-treated Uniforms, Permethrin-treated Uniforms and DEET Insect Repellent

2021 ◽  
Author(s):  
Daniel Msellemu ◽  
Amanda Ross ◽  
Lucky Temu ◽  
Irene Moshi ◽  
Lorenz Hofer ◽  
...  
Keyword(s):  
Military Personnel ◽  
Malaria Infection ◽  
Malaria Incidence ◽  
Protective Efficacy ◽  
Controlled Trial ◽  
Active Duty ◽  
Insect Repellent ◽  
Insect Repellents ◽  
Cluster Randomised ◽  
The Impact

Abstract Background: While there is strong evidence that permethrin-treated clothing and topical insect repellents are protective against insect bites, there are few studies assessing the impact on malaria infection. This study will evaluate the impact of the protective efficacy of bite prevention methods on the incidence of malaria infection among military personnel in an operational setting. Permethrin-treated uniforms will be compared to etofenprox-treated uniforms, with both clothing treatments used in conjunction with DEET insect repellent. An additional study arm will test permethrin uniforms with placebo lotion to determine if there is any additional protective effect of using DEET with insecticide-treated clothing. Method: A cluster randomised double-blind placebo-controlled trial is planned to evaluate the effectiveness of the interventions on preventing malaria infections in soldiers on active duty at Mgambo National Service Camp in Tanga, Tanzania. The arms are (1) permethrin-treated uniform with 30% DEET liposome formula; (2) permethrin-treated uniform with placebo lotion; (3) candidate insect repellent system, i.e., etofenprox-treated uniform with 30% DEET liposome formula; and (4) placebo, i.e., untreated uniforms with placebo lotion. The primary outcome is the incidence of Plasmodium falciparum malaria infection detected by polymerase chain reaction (PCR) by active case detection using surveys every 2 weeks for 12 months. Rapid diagnostic tests will be used for diagnosis of participants with symptoms. The unit of randomisation will be combania: companies formed by recruits aged 18 to 25 years; combania do activities together and sleep in the same dormitory. Unequal randomisation will be used to optimise statistical power for the primary comparison between permethrin-treated uniforms with DEET and etofenprox-treated uniforms with DEET. Discussion: This trial will estimate the effects of permethrin with DEET compared to those of the new fabric treatment etofenprox with DEET and any additional effect of using DEET. The results will inform strategies to protect military personnel and civilians who have more outdoor or occupational malaria exposure than the general public. Trial registration: clinicaltrials.gov Registration number NCT02938975.

scholarly journals An external pilot cluster randomised controlled trial of a theory-based intervention to improve appropriate polypharmacy in older people in primary care (PolyPrime): study protocol

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Audrey Rankin ◽  
◽  
Cathal A. Cadogan ◽  
Heather E. Barry ◽  
Evie Gardner ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomised Controlled Trial ◽  
Older People ◽  
Usual Care ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Online Video ◽  
Link Type ◽  
Cluster Randomised ◽  
Randomised Controlled

Abstract Background The use of multiple medications (polypharmacy) is a concern in older people (≥65 years) and is associated with negative health outcomes. For older populations with multimorbidity, polypharmacy is the reality and the key challenge is ensuring appropriate polypharmacy (as opposed to inappropriate polypharmacy). This external pilot cluster randomised controlled trial (cRCT) aims to further test a theory-based intervention to improve appropriate polypharmacy in older people in primary care in two jurisdictions, Northern Ireland (NI) and the Republic of Ireland (ROI). Methods Twelve GP practices across NI (n=6) and the six counties in the ROI that border NI will be randomised to either the intervention or usual care group. Members of the research team have developed an intervention to improve appropriate polypharmacy in older people in primary care using the Theoretical Domains Framework of behaviour change. The intervention consists of two components: (1) an online video which demonstrates how a GP may prescribe appropriate polypharmacy during a consultation with an older patient and (2) a patient recall process, whereby patients are invited to scheduled medication review consultations with GPs. Ten older patients receiving polypharmacy (≥4 medications) will be recruited per GP practice (n=120). GP practices allocated to the intervention arm will be asked to watch the online video and schedule medication reviews with patients on two occasions; an initial and a 6-month follow-up appointment. GP practices allocated to the control arm will continue to provide usual care to patients. The study will assess the feasibility of recruitment, retention and study procedures including collecting data on medication appropriateness (from GP records), quality of life and health service use (i.e. hospitalisations). An embedded process evaluation will assess intervention fidelity (i.e. was the intervention delivered as intended), acceptability of the intervention and potential mechanisms of action. Discussion This pilot cRCT will provide evidence of the feasibility of a range of study parameters such as recruitment and retention, data collection procedures and the acceptability of the intervention. Pre-specified progression criteria will also be used to determine whether or not to proceed to a definitive cRCT. Trial registration ISRCTN, ISRCTN41009897. Registered 19 November 2019. ClinicalTrials.gov, NCT04181879. Registered 02 December 2019.

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 Achieving equitable uptake of handwashing and sanitation by addressing both supply and demand-based constraints: findings from a randomized controlled trial in rural Bangladesh

2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Sarker Masud Parvez ◽  
Musarrat Jabeen Rahman ◽  
Rashidul Azad ◽  
Mahbubur Rahman ◽  
Leanne Unicomb ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Supply And Demand ◽  
Efficacy Trial ◽  
Experimental Conditions ◽  
Randomized Controlled ◽  
Link Type ◽  
Education Levels ◽  
Change Promotion ◽  
And Control ◽  
The Impact

Abstract Background Supply driven programs that are not closely connected to community demand and demand-driven programs that fail to ensure supply both risk worsening inequity. Understanding patterns of uptake of behaviors among the poorest under ideal experimental conditions, such as those of an efficacy trial, can help identify strategies that could be strengthened in routine programmatic conditions for more equitable uptake. WASH Benefits Bangladesh was a randomized controlled efficacy trial that provided free-of cost WASH hardware along with behavior change promotion. The current paper aimed to determine the impact of the removal of supply and demand constraints on the uptake of handwashing and sanitation behaviors across wealth and education levels. Methods The current analysis selected 4 indicators from the WASH Benefits trial— presence of water and soap in household handwashing stations, observed mother’s hand cleanliness, observed visible feces on latrine slab or floor and reported last child defecation in potty or toilet. A baseline assessment was conducted immediately after enrolment and endline assessment was conducted approximately 2 years later. We compared change in uptake of these indicators including wealth quintiles (Q) between intervention and control groups from baseline to endline. Results For hand cleanliness, the poorest mothers improved more [Q1 difference in difference, DID: 16% (7, 25%)] than the wealthiest mothers [Q5 DID: 7% (− 4, 17%)]. The poorest households had largest improvements for observed presence of water and soap in handwashing station [Q1 DID: 82% (75, 90%)] compared to the wealthiest households [Q5 DID: 39% (30, 50%)]. Similarly, poorer household demonstrated greater reductions in visible feces on latrine slab or floor [Q1DID, − 25% (− 35, − 15) Q2: − 34% (− 44, − 23%)] than the wealthiest household [Q5 DID: − 1% (− 11, 8%). For reported last child defecation in potty or toilet, the poorest mothers showed greater improvement [Q1–4 DID: 50–54% (44, 60%)] than the wealthier mothers [Q5 DID: 39% (31, 46%). Conclusion By simultaneously addressing supply and demand-constraints among the poorest, we observed substantial overall improvements in equity. Within scaled-up programs, a separate targeted strategy that relaxes constraints for the poorest can improve the equity of a program. Trial registration WASH Benefits Bangladesh: ClinicalTrials.gov, identifier: NCT01590095. Date of registration: April 30, 2012 ‘Retrospectively registered’.

scholarly journals Protocol for the mWellcare trial: a multicentre, cluster randomised, 12-month, controlled trial to compare the effectiveness of mWellcare, an mHealth system for an integrated management of patients with hypertension and diabetes, versus enhanced usual care in India

BMJ Open ◽  
2017 ◽  
Vol 7 (8) ◽  
pp. e014851 ◽  
Author(s):  
Dilip Jha ◽  
Priti Gupta ◽  
Vamadevan S Ajay ◽  
Devraj Jindal ◽  
Pablo Perel ◽  
...  
Keyword(s):  
Public Health ◽  
Cost Effectiveness ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
London School ◽  
Clinical Trial Registry ◽  
Link Type ◽  
Adherence To Medication ◽  
Cluster Randomised ◽  
Registration Number

IntroductionRising burden of cardiovascular disease (CVD) and diabetes is a major challenge to the health system in India. Innovative approaches such as mobile phone technology (mHealth) for electronic decision support in delivering evidence-based and integrated care for hypertension, diabetes and comorbid depression have potential to transform the primary healthcare system.Methods and analysismWellcare trial is a multicentre, cluster randomised controlled trial evaluating the clinical and cost-effectiveness of a mHealth system and nurse managed care for people with hypertension and diabetes in rural India. mWellcare system is an Android-based mobile application designed to generate algorithm-based clinical management prompts for treating hypertension and diabetes and also capable of storing health records, sending alerts and reminders for follow-up and adherence to medication. We recruited a total of 3702 participants from 40 Community Health Centres (CHCs), with ≥90 at each of the CHCs in the intervention and control (enhanced care) arms. The primary outcome is the difference in mean change (from baseline to 1 year) in systolic blood pressure and glycated haemoglobin (HbA1c) between the two treatment arms. The secondary outcomes are difference in mean change from baseline to 1 year in fasting plasma glucose, total cholesterol, predicted 10-year risk of CVD, depression, smoking behaviour, body mass index and alcohol use between the two treatment arms and cost-effectiveness.Ethics and disseminationThe study has been approved by the institutional Ethics Committees at Public Health Foundation of India and the London School of Hygiene and Tropical Medicine. Findings will be disseminated widely through peer-reviewed publications, conference presentations and other mechanisms.Trial registrationmWellcare trial is registered with Clinicaltrial.gov (Registration numberNCT02480062; Pre-results) and Clinical Trial Registry of India (Registration number CTRI/2016/02/006641). The current version of the protocol is Version 2 dated 19 October 2015 and the study sponsor is Public Health Foundation of India, Gurgaon, India (www.phfi.org).

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