scholarly journals Efficacy of a spatial repellent for control of malaria in Indonesia: a cluster-randomized controlled trial

2019 ◽  
Author(s):  
Din Syafruddin ◽  
Puji BS Asih ◽  
Ismail Ekoprayitno Rozi ◽  
Dendi Hadi Permana ◽  
Anggi Puspa Nur Hidayati ◽  
...  
Keyword(s):  
Protective Effect ◽  
Protective Efficacy ◽  
Controlled Trial ◽  
Effective Means ◽  
Placebo Control ◽  
Radical Cure ◽  
Significance Level ◽  
Spatial Repellent ◽  
Cluster Randomized ◽  
First Time

AbstractA cluster randomized, double-blinded, placebo-controlled trial was conducted to estimate protective efficacy of a spatial repellent against malaria infection at Sumba, Indonesia. Following radical cure in 1,341 children aged ≥ 6 months - ≤5 years in 24 clusters, households were given transfluthrin or placebo passive emanators (devices designed to release vaporized chemical). Monthly blood screening and biweekly human-landing mosquito catches were performed during 10-months baseline (June 2015 to March 2016) and a 24-month intervention period (April 2016 to April 2018). Screening detected 164 first-time infections and an accumulative total of 459 infections in 667 subjects in placebo-control households; and 134 first-time and 253 accumulative total infections among 665 subjects in active intervention households. The 24-cluster protective effect of 27.7% and 31.3%, for time to first-event and overall (total new) infections, respectively, was not statistically significant. Purportedly, this was due in part to zero to low incidence in some clusters, undermining the ability to detect a protective effect. Subgroup analysis of 19 clusters where at least one infection occurred during baseline showed 33.3% (p-value = 0.083) and 40.9% (p-value = 0.0236, statistically significant at the 1-sided 5% significance level) protective effect to first-infection and overall infections, respectively. Among 12 moderate-to high-risk clusters, a statistically significant decrease on infection by intervention was detected (60% protective efficacy). Primary entomological analysis of impact was inconclusive. While this study suggests spatial repellents prevent malaria, additional evidence is required to demonstrate the product class provides an operationally feasible and effective means of reducing malaria transmission.

scholarly journals Impact of a Spatial Repellent (SR) product on Anopheles and non-Anopheles mosquitoes in Sumba, Indonesia

2021 ◽  
Author(s):  
Dendi Hadi Permana ◽  
Siti Zubaidah ◽  
Lepa Syahrani ◽  
Puji Budi Setia Asih ◽  
Din Syafruddin ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Statistical Significance ◽  
Intervention Strategy ◽  
Placebo Control ◽  
Vector Borne Diseases ◽  
Anopheles Mosquitoes ◽  
Spatial Repellent ◽  
Cluster Randomized ◽  
Double Blinded ◽  
The Impact

Abstract Background East Nusa Tenggara province, Indonesia, contributed to 5% of malaria cases nationally in 2020, with other mosquito-borne diseases such as dengue and filariasis also being endemic. Monitoring of spatial and temporal vector species compositions and bionomic traits is an efficient method for generating evidence towards intervention strategy optimization and meeting disease elimination goals. MethodsThe impact of a spatial repellent (SR) on human biting mosquitoes was evaluated as part of a parent cluster-randomized, double-blinded, placebo-controlled trial, in Sumba, East Nusa Tenggara. A ten-month (June 2015–March 2016) baseline study was followed by a 24-month intervention period (April 2016 to April 2018) - where half the clusters were randomly assigned either a passive transfluthrin emanator or a placebo control. ResultsHuman-landing mosquito catches documented a reduction in landing rates related to the SR. Overall, there was a 16.4% reduction (21% indoors, and 11.3% outdoors) in human biting rates (HBR) for Anopheles. For Aedes, there was a 44.3% HBR reduction indoors and a 35.6% reduction outdoors. This reduction was 38.3% indoors and 39.1% outdoors for Armigeres, and 36.0% indoors and 32.3% outdoors for Culex species. Intervention impacts on the HBRs were not significant and are attributed to large inter-household and inter cluster variation. Anopheles flavirostris, An. balabacensis and An. maculatus individually impacted the overall malaria infections hazard rate with statistically significance. Though there was SR-based protection against malaria for all Anopheles species (except An. sundaicus s.l.), only five (An. aconitus, An. kochi, An. maculatus, An. tessellatus and An. sundaicus s.l.) demonstrated statistical significance. The SR numerically reduced Anopheles parity rates indoors and outdoors when compared to the placebo. ConclusionEvidence demonstrating that Anopheles vectors bite both indoors and outdoors indicates that currently implemented indoor-based vector control tools may not be sufficient to eliminate malaria. The documented impact of the SR intervention on Aedes, Armigeres and Culex species points to its importance in combatting other vector borne diseases. Studies to determine the impact of spatial repellents on other mosquito-borne diseases is recommended.

A double blind, randomised placebo controlled trial evaluating the effect of a pholyphenolic rich plant based nail bed balm on the severity of chemotherapy-induced onycholysis.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 10103-10103
Author(s):  
Robert J. Thomas ◽  
Madeleine M A Williams ◽  
Masoom Mutilib ◽  
Saul Berkovitz ◽  
Fawzi Attia ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Life Quality ◽  
Placebo Control ◽  
Severity Scale ◽  
Double Blind ◽  
Significance Level ◽  
Nail Bed ◽  
Published Evidence ◽  
Related Quality ◽  
Future Evaluation

10103 Background: Nail damage is common amongst patients receiving chemotherapy, especially taxanes, causing pain, distress, disfigurement, infection and restricted daily activities. Cooling the nail beds helps but there has been no published evidence for the effectiveness of nail balms, despite their popular use. We investigated whether a topical nail bed balm containing bioactive polyphenolic rich African salvia officinalis, gaultheria procumbens in a natural base of olea europaea, butyrospermun parkii, cera alba and theobroma cacao protected the nail beds via their reported anti-inflammatory, analgesic, anti-oxidant and anti-microbial properties. Methods: 60 patients (23 male, 37 female) were randomized to apply to their nail bed (tds) the natural balm or a petroleum balm suitably scented for a placebo control. Demographics, type and number of chemotherapy cycles did not differ between the two groups, recruited between Sept 2016-Sept 2017. At baseline and at the end of chemotherapy both patients and physicians measured outcomes of nail health. Patients completed a Dermatology Life Quality questionnaire and a linear severity scale; physician completed a Nail Psoriasis Index (NPSI) and a linear severity scale based on clinical examination and photographs. Differences were analyzed using an unpaired t-test; significance level α = 0.05 at 95% confidence intervals (CI); probability (p). Results: The mean change in nail health outcomes over the course of chemotherapy were: (see table). Conclusions: The polyphenolics rich essential oils and plant-based waxes in this nail bed balm profoundly reduced chemotherapy related nail damage and improved nail related quality of life compared to a plain petroleum based balm. A future evaluation combining nail bed cooling and this natural balm is planned. Clinical trial information: 015-001866-24. [Table: see text]

scholarly journals Effects of the ACT OUT! Social Issue Theater Program on Social-Emotional Competence and Bullying in Youth and Adolescents: Protocol for a Cluster Randomized Controlled Trial

10.2196/17900 ◽  
2020 ◽  
Vol 9 (4) ◽  
pp. e17900
Author(s):  
Jon Agley ◽  
Wasantha Jayawardene ◽  
Mikyoung Jun ◽  
Daniel L Agley ◽  
Ruth Gassman ◽  
...  
Keyword(s):  
Social Issue ◽  
Emotional Competence ◽  
Controlled Trial ◽  
Effective Means ◽  
The United States ◽  
School Level ◽  
Social Emotional ◽  
Social Emotional Competence ◽  
Theater Program ◽  
Cluster Randomized

Background Students in the United States spend a meaningful portion of their developmental lives in school. In recent years, researchers and educators have begun to focus explicitly on social and emotional learning (SEL) in the school setting. Initial evidence from meta-analyses suggests that curricula designed to promote SEL likely produce benefits in terms of social-emotional competence (SEC) and numerous related behavioral and affective outcomes. At the same time, there are often barriers to implementing such curricula as intended, and some researchers have questioned the strength of the evaluation data from SEL programs. As part of the effort to improve programming in SEL, this paper describes the protocol for a cluster randomized trial of the ACT OUT! Social Issue Theater program, a brief psychodramatic intervention to build SEC and reduce bullying behavior in students. Objective The objective of this trial is to examine if a short dose of interactive psychodrama can affect SEC metrics and bullying experiences in schoolchildren in either the short (2-week) or medium (6-month) term. Methods The ACT OUT! trial is a cluster randomized superiority trial with 2 parallel groups. The unit of measurement is the student, and the unit of randomization is the classroom. For each grade (fourth, seventh, and 10th), an even number of classrooms will be selected from each school—half will be assigned to the intervention arm and half will be assigned to the control arm. The intervention will consist of 3 moderated psychodramatic performances by trained actors, and the control condition will be the usual school day. Outcome data will be collected at baseline (preintervention), 2-week postintervention (short term), and 6-month postintervention (medium term). Outcomes will include social-emotional competency; self-reported bullying and experiences of being bullied; receptivity to the program; and school-level data on truancy, absenteeism, and referrals to school displinary action for bullying. A power analysis adjusted for clustering effect, design effect, and potential attrition yielded a need for approximately 1594 students, consisting of an estimated 80 classrooms split evenly into intervention and control arms. Results This study was funded in June 2019; approved by the Indiana University Institutional review board on September 17, 2019; began subject recruitment on November 5, 2019; and prospectively registered with ClinicalTrials.gov. Conclusions Many states have issued recommendations for the integration of SEL into schools. The proposed study uses a rigorous methodology to determine if the ACT OUT! psychodramatic intervention is a cost-effective means of bolstering SEC and reducing bullying incidence in schools. Trial Registration ClinicalTrials.gov NCT04097496; https://clinicaltrials.gov/ct2/show/NCT04097496 International Registered Report Identifier (IRRID) PRR1-10.2196/17900

scholarly journals Efficacy of a Spatial Repellent for Control of Aedes-Borne Virus Transmission: A Cluster Randomized Trial in Iquitos, Peru

2021 ◽  
Author(s):  
Amy C. Morrison ◽  
Robert C. Reiner ◽  
William H. Elson ◽  
Helvio Astete ◽  
Carolina Guevara ◽  
...  
Keyword(s):  
Aedes Aegypti ◽  
Vector Control ◽  
Protective Efficacy ◽  
Capture Rate ◽  
Adult Mosquito ◽  
Support Vector ◽  
Mixed Effect ◽  
Spatial Repellent ◽  
Cluster Randomized ◽  
The Impact

ABSTRACTBackgroundOver half the world’s population is at risk for viruses transmitted by Aedes mosquitoes, such as, dengue and Zika. The primary vector, Aedes aegypti, thrives in urban environments. Despite decades of effort, cases and the geographic range of Aedes-borne viruses (ABV) continue to expand. To date, there are no rigorously proven vector control interventions that prevent ABV diseases. Spatial repellents, a new option, are designed to decrease human exposure to ABV by releasing active ingredients into the air that disrupt mosquito-human contact.MethodsA parallel, cluster-randomized controlled trial was conducted in Iquitos, Peru to quantify the impact of a transfluthrin-based spatial repellent on ABV infection. From 2,907 households across 26 clusters (13 per arm), 1,578 participants were assessed for seroconversion (primary endpoint) by survival analysis. Incidence of acute disease was calculated among 16,683 participants (secondary endpoint). Bi-monthly adult mosquito collections were conducted to compare Ae. aegypti abundance, blood-fed capture rate and parity status through mixed effect difference-in-difference analyses.ResultsThe spatial repellent significantly reduced ABV infection by 34.1% (95% CI 6.9%, ∞); p = 0.0236, z=1.98). Aedes aegypti abundance and blood-fed capture rates were significantly reduced by 28.6% (95% CI 24.1%, ∞); z=-9.11) and 12.4% (95% CI 4.2%, ∞); z=-2.43), respectively.ConclusionsOur trial provides the first conclusive evidence of significant protective efficacy by any chemical vector control intervention, in this case a spatial repellent, to reduce the risk of ABV transmission. Results support vector control as a beneficial component to ABV disease prevention.Trial registration numberNCT03553277 (clinicaltrials.gov)

scholarly journals Efficacy of a Spatial Repellent for Control of Malaria in Indonesia: A Cluster-Randomized Controlled Trial

2020 ◽  
Vol 103 (1) ◽  
pp. 344-358 ◽  
Author(s):  
Din Syafruddin ◽  
Puji B. S. Asih ◽  
Ismail Ekoprayitno Rozi ◽  
Dendi Hadi Permana ◽  
Anggi Puspa Nur Hidayati ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Spatial Repellent ◽  
Cluster Randomized

scholarly journals Evaluation of an unconditional cash transfer program targeting children’s first-1,000–days linear growth in rural Togo: A cluster-randomized controlled trial

PLoS Medicine ◽  
2020 ◽  
Vol 17 (11) ◽  
pp. e1003388
Author(s):  
Justine Briaux ◽  
Yves Martin-Prevel ◽  
Sophie Carles ◽  
Sonia Fortin ◽  
Yves Kameli ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Protective Effect ◽  
Linear Growth ◽  
Controlled Trial ◽  
Cash Transfer ◽  
Community Activities ◽  
Positive Effects ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
Unconditional Cash Transfer

Background In 2014, the government of Togo implemented a pilot unconditional cash transfer (UCT) program in rural villages that aimed at improving children’s nutrition, health, and protection. It combined monthly UCTs (approximately US$8.40 /month) with a package of community activities (including behavior change communication [BCC] sessions, home visits, and integrated community case management of childhood illnesses and acute malnutrition [ICCM-Nut]) delivered to mother–child pairs during the first “1,000 days” of life. We primarily investigated program impact at population level on children’s height-for-age z-scores (HAZs) and secondarily on stunting (HAZ < −2) and intermediary outcomes including household’s food insecurity, mother–child pairs’ diet and health, delivery in a health facility and low birth weight (LBW), women’s knowledge, and physical intimate partner violence (IPV). Methods and findings We implemented a parallel-cluster–randomized controlled trial, in which 162 villages were randomized into either an intervention arm (UCTs + package of community activities, n = 82) or a control arm (package of community activities only, n = 80). Two different representative samples of children aged 6–29 months and their mothers were surveyed in each arm, one before the intervention in 2014 (control: n = 1,301, intervention: n = 1,357), the other 2 years afterwards in 2016 (control: n = 996, intervention: n = 1,035). Difference-in-differences (DD) estimates of impact were calculated, adjusting for clustering. Children’s average age was 17.4 (± 0.24 SE) months in the control arm and 17.6 (± 0.19 SE) months in the intervention arm at baseline. UCTs had a protective effect on HAZ (DD = +0.25 z-scores, 95% confidence interval [CI]: 0.01–0.50, p = 0.039), which deteriorated in the control arm while remaining stable in the intervention arm, but had no impact on stunting (DD = −6.2 percentage points [pp], relative odds ratio [ROR]: 0.74, 95% CI: 0.51–1.06, p = 0.097). UCTs positively impacted both mothers’ and children’s (18–23 months) consumption of animal source foods (ASFs) (respectively, DD = +4.5 pp, ROR: 2.24, 95% CI: 1.09–4.61, p = 0.029 and DD = +9.1 pp, ROR: 2.65, 95% CI: 1.01–6.98, p = 0.048) and household food insecurity (DD = −10.7 pp, ROR: 0.63, 95% CI: 0.43–0.91, p = 0.016). UCTs did not impact on reported child morbidity 2 week’s prior to report (DD = −3.5 pp, ROR: 0.80, 95% CI: 0.56–1.14, p = 0.214) but reduced the financial barrier to seeking healthcare for sick children (DD = −26.4 pp, ROR: 0.23, 95% CI: 0.08–0.66, p = 0.006). Women who received cash had higher odds of delivering in a health facility (DD = +10.6 pp, ROR: 1.53, 95% CI: 1.10–2.13, p = 0.012) and lower odds of giving birth to babies with birth weights (BWs) <2,500 g (DD = −11.8, ROR: 0.29, 95% CI: 0.10–0.82, p = 0.020). Positive effects were also found on women’s knowledge (DD = +14.8, ROR: 1.86, 95% CI: 1.32–2.62, p < 0.001) and physical IPV (DD = −7.9 pp, ROR: 0.60, 95% CI: 0.36–0.99, p = 0.048). Study limitations included the short evaluation period (24 months) and the low coverage of UCTs, which might have reduced the program’s impact. Conclusions UCTs targeting the first “1,000 days” had a protective effect on child’s linear growth in rural areas of Togo. Their simultaneous positive effects on various immediate, underlying, and basic causes of malnutrition certainly contributed to this ultimate impact. The positive impacts observed on pregnancy- and birth-related outcomes call for further attention to the conception period in nutrition-sensitive programs. Trial registration ISRCTN Registry ISRCTN83330970.

scholarly journals A randomized controlled trial evaluating antioxidant–essential oil gel as a treatment for gingivitis in orthodontic patients

2016 ◽  
Vol 86 (3) ◽  
pp. 407-412 ◽  
Author(s):  
Benjamin J. Martin ◽  
Phillip M. Campbell ◽  
Terry D. Rees ◽  
Peter H. Buschang
Keyword(s):  
Treatment Group ◽  
Essential Oil ◽  
Controlled Trial ◽  
Effective Means ◽  
Control Group ◽  
Placebo Control ◽  
Topical Gel ◽  
Percentage Points ◽  
Orthodontic Patients ◽  
T1 And T2

ABSTRACT Objective:  To evaluate the treatment effect of an antioxidant–essential oil gel on orthodontic patients with generalized gingivitis. The gel contains the essential oils menthol and thymol and the antioxidants ferulic acid and phloretin. Materials and Methods:  Thirty patients from the university’s orthodontic clinic were screened for gingivitis and randomly allocated into treatment and placebo-control groups. Each patient was evaluated at three orthodontic treatment visits (T1, T2, and T3). A periodontal examination, including probing depth (PD), bleeding on probing (BOP), gingival index (GI), and plaque index (PI) was performed at each visit. Between T1 and T2, patients were instructed to apply a topical gel (active or placebo) to their gingiva twice daily after brushing. From T2 to T3, patients were instructed to discontinue use of the gel. Results:  The treatment group showed statistically significant (P &lt; .05) reductions of BOP (−13.6 percentage points) and GI (−0.14) between T1 and T2, and significant increases in BOP (13.3 percentage points) and GI (0.14) between T2 and T3. Except for an increase in the GI between T2 and T3, the control group showed no significant changes in BOP or GI over time. The only other significant changes that occurred pertained to the treatment group, which showed significant increases in PD (0.08 mm) and PI (0.18) between T2 and T3. Conclusion:  Application of a topical antioxidant-essential oil gel is an effective means of reducing inflammation in orthodontic patients with gingivitis.

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