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A phase III trial to evaluate the efficacy, fabric integrity and community acceptance of Netprotect using a recommended long-lasting insecticidal net as positive control.

ABSTRACT: BACKGROUND: The evaluation of new long-lasting insecticidal bed nets (LLINs) is coordinated by the WHO Pesticide Evaluation Scheme (WHOPES). In 2007, Netprotect® was granted WHOPES interim recommendation after Phase I and II evaluations. Present study evaluates Netprotect in a Phase III trial in rural Cambodia. METHODS: A randomized, prospective longitudinal study design was used to assess the performance of Netprotect over a period of three years, using conventionally-treated nets and a WHOPES recommended LLIN (PermaNet 2.0) as positive controls. The primary outcomes were the physical integrity, insecticide content and cone bioassay performance using. RESULTS: The baseline deltamethrin concentration of 43% of Netprotect nets were below the tolerance limit while 27% of PermaNet 2.0 nets were above the target dose limits. By 36 months Netprotect retained 35% while PermaNet 2.0 retained 49% of baseline insecticide dose. Moreover the proportion of the inactive deltamethrin R-alpha isomer in the Netprotect nets was 33% at the baseline and increased to 69% after three years while it was low and almost constant for PermaNet® 2.0 (3-7%). Only 71% of Netprotect met the WHO criteria for bio-efficacy after three years while at least 80% is required. Moreover Netprotect nets failed for the WHOPES criteria after 12 and 24 months. The reference LLIN met the WHOPES criteria throughout the study. Over the entire three years the reference LLIN did obtain significant higher mosquito mortality than Netprotect. The physical integrity was based on the proportionate hole index and after three years, 25% of Netprotect and 30% of PermaNet 2.0 were in a mediocre or poor state. CONCLUSION: Netprotect did not meet the minimum WHO criteria for bio-efficacy after 12, 24 and 36 months. The use of a reference LLIN as positive control was helpful for data interpretation. However, for future three-year studies, it is essential that before initiating any study nets should be checked for their specifications and this for both the candidate LLIN as well as for the reference LLIN. Moreover, to improve the accuracy of the success rate of the candidate LLIN more nets should be tested for their bio-efficacy at the end of the trial.

SUBMITTER: Van Roey K

PROVIDER: S-EPMC4105388 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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A phase III trial to evaluate the efficacy, fabric integrity and community acceptance of Netprotect using a recommended long-lasting insecticidal net as positive control.

Van Roey Karel K Sovannaroth Siv S Sochantha Tho T Touch Mao Srey MS Pigeon Olivier O Sluydts Vincent V Durnez Lies L Coosemans Marc M

Malaria journal 20140707

<h4>Background</h4>The evaluation of new long-lasting insecticidal bed nets (LLINs) is coordinated by the WHO Pesticide Evaluation Scheme (WHOPES). In 2007, Netprotect® was granted WHOPES interim recommendation after Phase I and II evaluations. Present study evaluates Netprotect in a Phase III trial in rural Cambodia.<h4>Methods</h4>A randomized, prospective longitudinal study design was used to assess the performance of Netprotect over a period of three years, using conventionally-treated nets ...[more]

PMID: 24998677

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Project description:BackgroundDengue, recognized by the WHO as the most important mosquito-borne viral disease in the world, is a growing problem. Currently, the only effective way of preventing dengue is vector control. Standard methods have shown limited effect, and there have been calls to develop new integrated vector management approaches. One novel tool, protecting houses with long lasting insecticidal screens on doors and windows, is being trialled in a cluster randomised controlled trial by a joint UADY/WHO TDR/IDRC study in various districts of Acapulco, Mexico, with exceptionally high levels of crime and insecurity.This study investigated the community's perspectives of long lasting insecticidal screens on doors and windows in homes and in schools, in order to ascertain their acceptability, to identify challenges to further implementation and opportunities for future improvements.MethodsThis was a sequential mixed-methods study. The quantitative arm contained a satisfaction survey administered to 288 houses that had received the intervention examining their perspectives of both the intervention and dengue prevention in general. The qualitative arm consisted of Focus Group Discussions (FGDs) with those who had accepted the intervention and key informant interviews with: schoolteachers to discuss the use of the screens in schools, program staff, and community members who had refused the intervention.ResultsOverall satisfaction and acceptance of the screens was very high, with only some operational and technical complaints relating to screen fragility and the installation process. However, the wider social context of urban violence and insecurity was a major barrier to screen acceptance. Lack of information dissemination and community collaboration were identified as project weaknesses.ConclusionsThe screens are widely accepted by the population, but the project implementation could be improved by reassuring the community of its legitimacy in the context of insecurity. More community engagement and better information sharing structures are needed.The screens could be a major new dengue prevention tool suitable for widespread use, if further research supports their entomological and epidemiological effectiveness and their acceptability in different social and environmental contexts. Further research is needed looking at the impact of insecurity of dengue prevention programmes.

Project description:BackgroundLong-lasting insecticidal nets (LLINs) are expected to last for at least 3 years, but whilst this may be achieved from an insecticidal perspective, physical protection is frequently compromised much earlier because of the rapid accumulation of holes during use. To understand why LLINs are so susceptible to loss of physical integrity, thousands of hole damage sites in LLINs retrieved from the field in Africa and Asia were forensically studied to identify the persistent underlying causes.MethodsA total of 525 LLINs consisting of six different brands from five different countries across Africa and Asia were collected from the field after 1 to 3 years in use. More than 42,000 individual sites of hole damage were analysed based on the morphology and size of each individual hole, aided by optical microscopy (OM) and scanning electron microscopy (SEM). The fracture morphology enabled positive identification of the underlying mechanisms of the damage.ResultsAcross all LLINs and geographical settings, mechanical damage is the primary cause of holes and loss of physical integrity in LLINs (63.14% by frequency and 81.52% by area). Snagging is the single most frequent mechanical damage mechanism, whilst the largest sized holes in LLINs result from seam failure and tearing. Abrasion and hole enlargement are also responsible for a progressive loss in the physical integrity of nets. Collectively, these five modes of mechanical damage can be expected to result from normal use of LLINs by households. Evidence of deliberate cutting, burn holes and rodent damage was observed to a lesser degree, which LLINs are not designed to withstand.ConclusionsLoss of physical integrity in LLINs is an inevitable consequence of using a vector control product that has an inherently low resistance to mechanical damage during normal use. To improve performance, new specifications based on laboratory textile testing is needed, to assess the resistance of LLIN products to the primary causes of mechanical damage when in use, which are snagging, tearing, abrasion and hole enlargement. Seam construction also needs to meet a revised minimum standard to reduce the risk of a rapid loss of physical integrity during use.

Project description:BackgroundFollowing guidance from the US President's Malaria Initiative, durability monitoring of DawaPlus® 2.0 brand of long-lasting insecticidal net (LLIN) distributed during the 2015/16 mass campaign was set up in three ecologically different states: Zamfara, Ebonyi and Oyo.MethodsThis was a prospective cohort study of representative samples of households from each location, recruited at baseline, 1 to 6 months after the mass campaign. All campaign nets in the households were labelled and followed up over a period of 36 months in Zamfara and Ebonyi and 24 months in Oyo. Primary outcome was the "proportion of nets surviving in serviceable condition" based on attrition and integrity measures and the median survival in years. The outcome for insecticidal durability was determined by bio-assay from sub-samples of campaign nets.ResultsA total of 439 households (98% of target) and 1096 campaign nets (106%) were included in the study. Definite outcomes could be determined for 92% of the cohort nets in Zamfara, 88% in Ebonyi and 75% in Oyo. All-cause attrition was highest in Oyo with 47% no longer present after 24 months, 53% in Ebonyi and 28% in Zamfara after 36 months. Overall only 1% of all campaign nets were used for other purposes. Estimated survival in serviceable condition of the campaign nets was 80% in Zamfara, 55% in Ebonyi (36 months follow-up) and 75% in Oyo (24 months follow-up) corresponding to median survival of 5.3, 3.3, 3.2 years, respectively. Factors associated with better survival were exposure to social messaging combined with a positive net-care attitude and only adult users. Failing to fold the net when hanging and having children under 5 years of age in the household negatively impacted net survival. Insecticidal effectiveness testing at final survey showed knock-down rates of 50-69%, but 24-h mortality above 95% resulting in 100% optimal performance in Ebonyi and Oyo and 97% in Zamfara.ConclusionsResults confirm the strong influence of net-use environment and behavioural factors in the physical survival of the same LLIN brand, which can increase the time until 50% of nets are no longer serviceable by up to 2 years.

Project description:Long-lasting insecticidal nets (LLINs) supplemented with the synergist piperonyl butoxide have been developed in response to growing pyrethroid resistance; however, their durability in the field remains poorly described. A pragmatic cluster-randomised trial was embedded into Ugandaʼs 2017–2018 LLIN distribution to compare the durability of LLINs with and without PBO. A total of 104 clusters (health sub-districts) were included with each receiving one of four LLIN products, two with pyrethroid + PBO (Olyset Plus and PermaNet 3.0) and two pyrethroid-only (Olyset Net and PermaNet 2.0). Nets were sampled at baseline, 12 and 25 months post-distribution to assess physical condition, chemical content, and bioefficacy. Physical condition was quantified using proportionate Hole Index and chemical content measured using high-performance liquid chromatography. Bioefficacy was assessed with three-minute World Health Organisation (WHO) Cone and Wireball assays using pyrethroid-resistant Anopheles gambiae, with 1-h knockdown and 24-h mortality recorded. There was no difference in physical durability between LLIN products assessed (P = 0.644). The pyrethroid content of all products remained relatively stable across time-points but PBO content declined by 55% (P < 0.001) and 58% (P < 0.001) for Olyset Plus and PermaNet 3.0 respectively. Both PBO LLINs were highly effective against pyrethroid-resistant mosquitoes when new, knocking down all mosquitoes. However, bioefficacy declined over time with Olyset Plus knocking down 45.72% (95% CI: 22.84–68.62%, P = 0.021) and Permanent 3.0 knocking down 78.57% (95% CI: 63.57–93.58%, P < 0.001) after 25 months. Here we demonstrate that both Olyset Plus and PermaNet 3.0 are as durable as their pyrethroid-only equivalents and had superior bioefficacy against pyrethroid-resistant An. gambiae. However, the superiority of PBO-LLINs decreased with operational use, correlating with a reduction in total PBO content. This decline in bioefficacy after just two years is concerning and there is an urgent need to assess the durability of PBO LLINs in other settings. Graphical abstract Image 1 Highlights • Olyset Plus and PermaNet 3.0 nets effective against pyrethroid-resistant Anopheles gambiae when new.• Killing effect of both nets halved after two years.• Nets in ‘traditional’ thatched-roof housing at high risk of damage.

Project description:BackgroundLong-lasting insecticidal nets (LLINs) are the primary malaria prevention and control intervention in many parts of sub-Saharan Africa. While LLINs are expected to last at least 3 years under normal use conditions, they can lose effectiveness because they fall out of use, are discarded, repurposed, physically damaged, or lose insecticidal activity. The contributions of these different interrelated factors to durability of nets and their protection against malaria have been unclear.MethodsStarting in 2009, LLIN durability studies were conducted in seven countries in Africa over 5 years. WHO-recommended measures of attrition, LLIN use, insecticidal activity, and physical integrity were recorded for eight different net brands. These data were combined with analyses of experimental hut data on feeding inhibition and killing effects of LLINs on both susceptible and pyrethroid resistant malaria vectors to estimate the protection against malaria transmission-in terms of vectorial capacity (VC)-provided by each net cohort over time. Impact on VC was then compared in hypothetical scenarios where one durability outcome measure was set at the best possible level while keeping the others at the observed levels.ResultsThere was more variability in decay of protection over time by country than by net brand for three measures of durability (ratios of variance components 4.6, 4.4, and 1.8 times for LLIN survival, use, and integrity, respectively). In some countries, LLIN attrition was slow, but use declined rapidly. Non-use of LLINs generally had more effect on LLIN impact on VC than did attrition, hole formation, or insecticide loss.ConclusionsThere is much more variation in LLIN durability among countries than among net brands. Low levels of use may have a larger impact on effectiveness than does variation in attrition or LLIN degradation. The estimated entomological effects of chemical decay are relatively small, with physical decay probably more important as a driver of attrition and non-use than as a direct cause of loss of effect. Efforts to maximize LLIN impact in operational settings should focus on increasing LLIN usage, including through improvements in LLIN physical integrity. Further research is needed to understand household decisions related to LLIN use, including the influence of net durability and the presence of other nets in the household.

Project description:BACKGROUND:In Loreto Department, Peru, a successful 2005-2010 malaria control programme (known as PAMAFRO) included massive distribution of long-lasting insecticidal nets (LLINs). Additional local distribution of LLINs occurred in individual villages, but not between 2012 and 2015. A 2011-2012 study of the primary regional malaria vector Anopheles darlingi detected a trend of increased exophagy compared with pre-PAMAFRO behaviour. For the present study, An. darlingi were collected in three villages in Loreto in 2013-2015 to test two hypotheses: (1) that between LLIN distributions, An. darlingi reverted to pre-intervention biting behaviour; and, (2) that there are separate sub-populations of An. darlingi in Loreto with distinct biting behaviour. RESULTS:In 2013-2015 An. darlingi were collected by human landing catch during the rainy and dry seasons in the villages of Lupuna and Cahuide. The abundance of An. darlingi varied substantially across years, villages and time periods, and there was a twofold decrease in the ratio of exophagic:endophagic An. darlingi over the study period. Unexpectedly, there was evidence of a rainy season population decline in An. darlingi. Plasmodium-infected An. darlingi were detected indoors and outdoors throughout the night, and the monthly An. darlingi human biting rate was correlated with the number of malaria cases. Using nextRAD genotyping-by-sequencing, 162 exophagic and endophagic An. darlingi collected at different times during the night were genotyped at 1021 loci. Based on model-based and non-model-based analyses, all genotyped An. darlingi belonged to a homogeneous population, with no evidence for genetic differentiation by biting location or time. CONCLUSIONS:This study identified a decreasing proportion of exophagic An. darlingi in two villages in the years between LLIN distributions. As there was no evidence for genetic differentiation between endophagic and exophagic An. darlingi, this shift in biting behaviour may be the result of behavioural plasticity in An. darlingi, which shifted towards increased exophagy due to repellence by insecticides used to impregnate LLINs and subsequently reverted to increased endophagy as the nets aged. This study highlights the need to target vector control interventions to the biting behaviour of local vectors, which, like malaria risk, shows high temporal and spatial heterogeneity.

Project description:BACKGROUND: Long-lasting insecticidal nets (LLINs) reduce malaria transmission by protecting individuals from infectious bites, and by reducing mosquito survival. In recent years, millions of LLINs have been distributed across sub-Saharan Africa (SSA). Over time, LLINs decay physically and chemically and are destroyed, making repeated interventions necessary to prevent a resurgence of malaria. Because its effects on transmission are important (more so than the effects of individual protection), estimates of the lifetime of mass distribution rounds should be based on the effective length of epidemiological protection. METHODS: Simulation models, parameterised using available field data, were used to analyse how the distribution's effective lifetime depends on the transmission setting and on LLIN characteristics. Factors considered were the pre-intervention transmission level, initial coverage, net attrition, and both physical and chemical decay. An ensemble of 14 stochastic individual-based model variants for malaria in humans was used, combined with a deterministic model for malaria in mosquitoes. RESULTS: The effective lifetime was most sensitive to the pre-intervention transmission level, with a lifetime of almost 10 years at an entomological inoculation rate of two infectious bites per adult per annum (ibpapa), but of little more than 2 years at 256 ibpapa. The LLIN attrition rate and the insecticide decay rate were the next most important parameters. The lifetime was surprisingly insensitive to physical decay parameters, but this could change as physical integrity gains importance with the emergence and spread of pyrethroid resistance. CONCLUSIONS: The strong dependency of the effective lifetime on the pre-intervention transmission level indicated that the required distribution frequency may vary more with the local entomological situation than with LLIN quality or the characteristics of the distribution system. This highlights the need for malaria monitoring both before and during intervention programmes, particularly since there are likely to be strong variations between years and over short distances. The majority of SSA's population falls into exposure categories where the lifetime is relatively long, but because exposure estimates are highly uncertain, it is necessary to consider subsequent interventions before the end of the expected effective lifetime based on an imprecise transmission measure.

Project description:BackgroundThe World Health Organization (WHO) cone bioassay is a key method used to evaluate the bioefficacy of long-lasting insecticidal nets (LLINs) used for malaria control. These tests also play an important role in LLIN product prequalification and longitudinal monitoring. Standardization of these assays is therefore important. While many parameters for WHO cone bioassays are defined in the respective WHO guidelines, others are not. One of these undefined parameters is the exact configuration of the bioassay boards. In cone bioassays, LLIN samples are pinned onto a bioassay board for testing. Anecdotal evidence suggests that bioassay boards with holes behind the LLIN samples lead to greater exposure to insecticide, as the mosquitoes are 'forced to stand on the net material'. This may increase the key assay outcomes of 60 min knockdown (KD60) and 24 h mortality (M24). The present study tested this hypothesis in two facilities using two fully susceptible mosquito colonies.MethodsWHO cone bioassays were performed using bioassay boards with holes and boards without holes in parallel, following WHO guidelines. Five brands of LLINs with four new and unwashed whole net samples per brand were used (total of n = 20 whole nets). Five pieces per whole net sample were prepared in duplicate resulting in a total of n = 100 pairs. Knock-down (KD) was recorded in 10 min intervals within the first hour after exposure and mortality was recorded at 24 h. Assays with Anopheles farauti were done at the Papua New Guinea Institute of Medical Research (PNGIMR) and assays with Aedes aegypti were done at James Cook University, Australia.ResultsResults varied not only with bioassay board configuration but also with mosquito colony. In particular, with An. farauti, a significantly higher M24 was observed when boards with holes were used, while this was not observed with Ae. aegypti. WHO cone bioassay results were systematically biased between the two facilities such that the use of An. farauti at PNGIMR predicted higher KD60 and M24.ConclusionThe present study highlights the need for further harmonization of WHO cone bioassay methodology. Parameters such as bioassay board configuration and mosquito species systematically affect the observations, which impedes generalizability of WHO cone bioassay outcomes.

Dataset Information

A phase III trial to evaluate the efficacy, fabric integrity and community acceptance of Netprotect using a recommended long-lasting insecticidal net as positive control.

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A phase III trial to evaluate the efficacy, fabric integrity and community acceptance of Netprotect using a recommended long-lasting insecticidal net as positive control.

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