title: Evidence based community mobilization for dengue prevention in Nicaragua and Mexico (Camino Verde, the Green Way): cluster randomized controlled trial Household costs of dengue illness: secondary outcomes from a randomised controlled trial of dengue prevention in Guerrero state, Mexico Mobilising communities for Aedes aegypti control: the SEPA approach Aedes aegypti breeding ecology in Guerrero: cross-sectional study of mosquito breeding sites from the baseline for the Camino Verde trial in Mexico The Camino Verde intervention in Nicaragua, 2004–2012 Household costs for personal protection against mosquitoes: secondary outcomes from a randomised controlled trial of dengue prevention in Guerrero state, Mexico The women made it work: fuzzy transitive closure of the results chain in a dengue prevention trial in Mexico Informed community mobilization for dengue prevention in households with and without a regular water supply: Secondary analysis from the Camino Verde trial in Nicaragua Community-led trials: Intervention co-design in a cluster randomised controlled trial Coverage and beliefs about temephos application for control of dengue vectors and impact of a community-based prevention intervention: secondary analysis from the Camino Verde trial in Mexico Camino Verde (The Green Way): evidence-based community mobilisation for dengue control in Nicaragua and Mexico: feasibility study and study protocol for a randomised controlled trial Community cost-benefit discussions that launched the Camino Verde intervention in Nicaragua When communities are really in control: ethical issues surrounding community mobilisation for dengue prevention in Mexico and Nicaragua Beyond efficacy in water containers: Temephos and household entomological indices in six studies between 2005 and 2013 in Managua, Nicaragua Pupal productivity in rainy and dry seasons: findings from the impact survey of a randomised controlled trial of dengue prevention in Guerrero, Mexico CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomised trials. “Where we put little fish in the water there are no mosquitoes:” a cross-sectional study on biological control of the Aedes aegypti vector in 90 coastal-region communities of Guerrero, Mexico
abstract: Objective To test whether community mobilization adds effectiveness to conventional dengue control . Design Pragmatic open label parallel group cluster r and omized controlled trial . Those assessing the outcomes and analyzing the data were blinded to group assignment . Central ized computerized r and omization after the baseline study allocated half the sites to intervention , stratified by country , evidence of recent dengue virus infection in children aged 3 - 9 , and vector indices . Setting R and om sample of communities in Managua , capital of Nicaragua , and three coastal regions in Guerrero State in the south of Mexico . Participants Residents in a r and om sample of census enumeration areas across both countries : 75 intervention and 75 control clusters ( about 140 households each ) were r and omized and analyzed ( 60 clusters in Nicaragua and 90 in Mexico ) , including 85 182 residents in 18 838 households . Interventions A community mobilization protocol began with community discussion of baseline results . Each intervention cluster adapted the basic intervention — chemical-free prevention of mosquito reproduction — to its own circumstances . All clusters continued the government run dengue control program . Main outcome measures Primary outcomes per protocol were self reported cases of dengue , serological evidence of recent dengue virus infection , and conventional entomological indices ( house index : households with larvae or pupae/households examined ; container index : containers with larvae or pupae/containers examined ; Breteau index : containers with larvae or pupae/households examined ; and pupae per person : pupae found/number of residents ) . Per protocol secondary analysis examined the effect of Camino Verde in the context of temephos use . Results With cluster as the unit of analysis , serological evidence from intervention sites showed a lower risk of infection with dengue virus in children ( relative risk reduction 29.5 % , 95 % confidence interval 3.8 % to 55.3 % ) , fewer reports of dengue illness ( 24.7 % , 1.8 % to 51.2 % ) , fewer houses with larvae or pupae among houses visited ( house index ) ( 44.1 % , 13.6 % to 74.7 % ) , fewer containers with larvae or pupae among containers examined ( container index ) ( 36.7 % , 24.5 % to 44.8 % ) , fewer containers with larvae or pupae among houses visited ( Breteau index ) ( 35.1 % , 16.7 % to 55.5 % ) , and fewer pupae per person ( 51.7 % , 36.2 % to 76.1 % ) . The numbers needed to treat were 30 ( 95 % confidence interval 20 to 59 ) for a lower risk of infection in children , 71 ( 48 to 143 ) for fewer reports of dengue illness , 17 ( 14 to 20 ) for the house index , 37 ( 35 to 67 ) for the container index , 10 ( 6 to 29 ) for the Breteau index , and 12 ( 7 to 31 ) for fewer pupae per person . Secondary per protocol analysis showed no serological evidence of a protective effect of temephos . Conclusions Evidence based community mobilization can add effectiveness to dengue vector control . Each site implementing the intervention in its own way has the advantage of local customization and strong community engagement . Trial registration IS RCT Background Dengue is a serious public health problem with an important economic impact . This study used data from a cluster r and omised controlled trial of community mobilisation for dengue prevention to estimate the household costs of treatment of dengue illness . It examined the economic impact of the trial intervention in the three coastal regions of Mexico ’s Guerrero State . Methods The 2010 baseline survey covered households in a r and om sample of 90 clusters in the coastal regions ; the clusters were r and omly allocated to intervention or control and re-surveyed in 2012 . The surveys asked about dengue cases in the last 12 months , expenditures on their treatment , and work or school days lost by patients and care givers . We did not assign monetary value to days lost , since a lost day to a person of low earning power is of equal or higher value to that person than to one who earns more . Results The 12,312 households in 2010 reported 1020 dengue cases in the last 12 months ( 1.9 % of the sample population ) . Most ( 78 % ) were ambulatory cases , with a mean cost of USD 51 and 10.8 work/school days , rising to USD 96 and 11.4 work/school days if treated by a private physician . Hospitalised cases cost USD 28–94 in government institutions and USD 392 in private hospitals ( excluding additional inpatient charges ) , as well as 9.6–17.3 work/school days . Dengue cases cost households an estimated 412,825 work/school days throughout the three coastal regions . In the follow up survey , 6.1 % ( 326/5349 ) of households in intervention clusters and 7.9 % ( 405/5139 ) in control clusters reported at least one dengue case . The mean of days lost per case was similar in intervention and control clusters , but the number of days lost from dengue and all elements of costs for dengue cases per 1000 population were lower in intervention clusters . If the total population of the three coastal regions had received the intervention , some 149,401 work or school days lost per year could have been prevented . Conclusion The economic effect of dengue on households , including lost work days , is substantial . The Camino Verde trial intervention reduced household costs for treatment of dengue cases . Trial registration The trial was registered as IS RCT N:27,581,154 Camino Verde ( the Green Way ) is an evidence -based  community  mobilisation tool for prevention of dengue and other mosquito-borne viral diseases . Its effectiveness was demonstrated in a cluster-r and omised controlled trial conducted in 2010–2013 in Nicaragua and Mexico . The common approach that brought functional consistency to the Camino Verde intervention in both Mexico and Nicaragua is Socialisation of Evidence for Participatory Action (SEPA).In this article , we explain the SEPA concept and its theoretical origins , giving examples of its previous application in different countries and context s. We describe how the approach was used in the Camino Verde intervention , with details that show commonalities and differences in the application of the approach in Mexico and Nicaragua . We discuss issues of cost , replicability and sustainability , and comment on which components of the intervention were most important to its success . In complex interventions , multiple components act in synergy to produce change . Among key factors in the success of Camino Verde were the use of community volunteers called brigadistas , the house-to-house visits they conducted , the use of evidence derived from the communities themselves , and community ownership of the undertaking . Communities received the intervention by r and om assignment ; dengue was not necessarily their greatest concern . The very nature of the dengue threat dictated many of the actions that needed to be taken at household and neighbourhood levels to control it . But within these parameters , communities exercised a large degree of control over the intervention and displayed considerable ingenuity in the process . Trial registration IS RCT N27581154 Background Underst and ing the breeding patterns of Aedes aegypti in households and the factors associated with infestation are important for implementing vector control . The baseline survey of a cluster r and omised controlled trial of community mobilisation for dengue prevention in Mexico and Nicaragua collected information about the containers that are the main breeding sites , identified possible actions to reduce breeding , and examined factors associated with household infestation . This paper describes findings from the Mexican arm of the baseline survey . Methods In 2010 field teams conducted household surveys and entomological inspections in 11,995 households from 90 representative communities in the three coastal regions of Guerrero State , Mexico . We characterized Ae . aegypti breeding sites and examined the effect of two preventive measures : temephos application in water containers , and keeping the containers covered . We examined associations with household infestation , using bivariate and multivariate analysis adjusted for clustering effects . Results We conducted entomological inspections in 11,995 households . Among 45,353 water containers examined , 6.5 % ( 2958/45,353 ) were positive for larvae and /or pupae . Concrete tanks ( pilas ) and barrels ( tambos ) together accounted for 74 % of pupal productivity . Both covering water containers and inserting temephos were independently associated with a lower risk of presence of larvae or pupae , with the effect of covering ( OR 0.22 ; 95 % CIca 0.15–0.27 ) stronger than that of temephos ( OR 0.66 ; 95 % CIca 0.53–0.84 ) . Having more than four water containers was associated with household infestation in both rural areas ( OR 1.42 ; 95 % CIca 1.17–1.72 ) and urban areas ( 1.81 ; 1.47–2.25 ) , as was low education of the household head  ( rural : 1.27 ; 1.11–1.46 , and urban : 1.39 ; 1.17–1.66 ) . Additional factors in rural areas were : household head without paid work ( 1.31 ; 1.08–1.59 ) ; being in the Acapulco region ( 1.91 ; 1.06–3.44 ) ; and using anti-mosquito products  ( 1.27 ; 1.09–1.47 ) . In urban areas only , presence of temephos was associated with a lower risk of household infestation ( 0.44 ; 0.32–0.60 ) . Conclusion Concrete tanks and barrels accounted for the majority of pupal productivity .  Covering water containers could be an effective means of Ae . aegypti vector control , with a bigger effect than using temephos . These findings were useful in planning and implementing the Camino Verde trial intervention in Mexico Camino Verde ( the Green Way ) is an evidence -based community mobilisation tool for prevention of dengue and other mosquito-borne viral diseases . Its effectiveness was demonstrated in a cluster-r and omised controlled trial conducted in 2010–2013 in Nicaragua and Mexico . The Nicaraguan arm of the trial was preceded , from 2004 to 2008 , by a feasibility study that provided valuable lessons and trained facilitators for the trial itself . Here , guided by the Template for Intervention Description and Replication ( TIDieR ) , we describe the  Camino Verde intervention in Nicaragua , presenting its rationale , its time and location , activities , material s used , the main actors , modes of delivery , how it was tailored to encourage community engagement , modifications made from the feasibility study to the trial itself , and how fidelity to the process originally design ed was maintained . We also present information on costs and discuss the place of this study within the literature on implementation science . Trial registration IS RCT N27581154 Background Dengue is a serious public health issue that affects households in endemic areas in terms of health and also economically , imposing costs for prevention and treatment of cases . The Camino Verde cluster-r and omised controlled trial in Mexico and Nicaragua assessed the impact of evidence -based community engagement in dengue prevention .  The Mexican arm of the trial was conducted in 90 r and omly selected communities in three coastal regions of Guerrero State . This study reports an analysis of a secondary outcome of the trial : household use of and expenditure on anti-mosquito products .  We examined whether the education and mobilisation activities of the trial motivated people to spend less on anti-mosquito products . Methods We carried out a household question naire survey in the trial communities in 2010 ( 12,312 households ) and 2012 ( 5349 households in intervention clusters , 5142 households in control clusters ) , including questions about socio-economic status , self-reported dengue illness , and purchase of and expenditure on insecticide anti-mosquito products in the previous month . We examined expenditures on anti-mosquito products  at baseline in relation to social vulnerability and we compared use of and expenditures on these products between intervention and control clusters in 2012 . Results In 2010 , 44.2 % of 12,312 households reported using anti-mosquito products , with a mean expenditure of USD4.61 per month among those who used them . Socially vulnerable households spent less on the products . In 2012 , after the intervention , the proportion of households who purchased anti-mosquito products in the last month was significantly lower in intervention clusters ( 47.8 % ; 2503/5293 ) than in control clusters ( 53.3 % ; 2707/5079 ) ( difference − 0.05 , 95 % CIca −0.100 to −0.010 ) . The mean expenditure on the products , among those households who bought them , was USD6.43 ; 30.4 % in the intervention clusters and 36.7 % in the control clusters spent more than this ( difference − 0.06 , 95 % CIca −0.12 to −0.01 ) . These expenditures on anti-mosquito products represent 3.3 % and 3.8 % respectively of monthly household income for the poorest 10 % of the population in 2012 . Conclusions The Camino Verde community mobilisation intervention , as well as being effective in reducing dengue infections , was effective in reducing household use of and expenditure on insecticide anti-mosquito products . Trial registration ( IS RCT N27581154 ) Background A modified theory of planned behaviour ( acronym CASCADA ) proposes that Conscious knowledge precedes a change in Attitude , which in turn precedes positive deviations from negative Subjective norms , intention to Change , perception of Agency to change , Discussion of possible action , and Action itself . We used this as a results chain to investigate gender-specific behaviour dynamics in chemical-free dengue prevention . Methods Secondary analysis of the Mexican arm of a cluster r and omised controlled trial used household survey data on intermediate outcomes of dengue prevention behaviour . We used a matrix of odds ratios between outcomes , transformed to a symmetrical range ( −1 , 1 ) , to compute fuzzy transitive closure of the results chain for  control and intervention clusters , then for male and female respondents separately in each group . Transitive closure of a map computes the influence of each factor on each other factor , taking account of all influences in the system . Cumulative net influence was the sum of influences across the results chain . Results Responses of 5042 women and 1143 men in 45 intervention clusters contrasted with those of 5025 women and 1179 men in 45 control clusters . Control clusters showed a distal block ( negative influence ) in the results chain with a cumulative net influence of 0.88 ; intervention clusters showed no such block and a cumulative net influence of 1.92 . Female control respondents , like the overall control picture , showed a distal block , whereas female intervention responses showed no such blocks ( cumulative net influence 0.78 and 1.73 respectively ) . Male control respondents showed weak distal blocks . Male intervention responses showed several new negative influences and a reduction of cumulative net influence ( 1.38 in control and 1.11 in intervention clusters ) . Conclusions The overall influence of the intervention across the results chain fits with the trial findings , but is different for women and men . Among women , the intervention overcame blocks and increased the cumulative net influence of knowledge on action . Among men , the intervention did not reinforce prevention behaviour . This might be related to emphasis , during the intervention , on women ’s participation and empowerment . The fuzzy transitive closure of the CASCADA map usefully highlights the differences between gender-specific results chains . Trial registration IS RCT N27581154 Background Studies in different countries have identified irregular water supply as a risk factor for dengue virus transmission . In 2013 , Camino Verde , a cluster-r and omised controlled trial in Managua , Nicaragua , and Mexico ’s Guerrero State , demonstrated impact of evidence -based community mobilisation on recent dengue infection and entomological indexes of infestation by Aedes aegypti mosquitoes . This secondary analysis of data from the trial impact survey asks : ( 1 ) what is the importance of regular water supply in neighbourhoods with and without the trial intervention and ( 2 ) can community interventions like Camino Verde reasonably exclude households with adequate water supply ? Methods Entomological data collected in the dry season of 2013 in intervention and control communities allow contrasts between households with regular and irregular water supplies . Indicators of entomological risk included the House Index and pupa positive household index . Generalised linear mixed models with cluster as a r and om effect compared households with and without regular water , and households in intervention and control communities . Results For the House Index , regular water supply was associated with a protection in both intervention households ( OR 0.7 , 95%CI 0.6–0.9 ) and control households ( OR 0.6 , 95%CI 0.5–0.8 ) . For the pupa positive household index , we found a similar protection from regular water supply in intervention households ( OR 0.6 , 95%CI 0.4–0.8 ) and control households ( OR 0.7 , 95%CI 0.5–0.9 ) . The Camino Verde intervention had a similar impact on House Index in households with regular water supply ( OR 0.7 , 95%CI 0.5–1.0 ) and irregular water supply ( OR 0.6 , 95%CI 0.4–0.8 ) ; for the pupa positive household index , the effect of the intervention was very similar in households with regular ( OR0.5 , 95%CI 0.3–0.8 ) and irregular ( OR 0.5 , 95%CI 0.3–0.9 ) water supply . Conclusion While Aedes aegypti control efforts based on informed community mobilisation had a strong impact on households without a regular water supply , this intervention also impacted entomological indices in households with a regular water supply . These households should not be excluded from community mobilisation efforts to reduce the Aedes aegypti vector . Trial registration IS RCT N27581154 In conventional r and omised controlled trials ( RCTs ) , research ers design the interventions . In the Camino Verde trial , each intervention community design ed its own programmes to prevent dengue . Instead of fixed actions or menus of activities to choose from , the trial r and omised clusters to a participatory research protocol that began with sharing and discussing evidence from a local survey , going on to local authors hip of the action plan for vector control . Adding equitable stakeholder engagement to RCT infrastructure anchors the research culturally , making it more meaningful to stakeholders . Replicability in other conditions is straightforward , since all intervention clusters used the same engagement protocol to discuss and to mobilize for dengue prevention . The ethical codes associated with RCTs play out differently in community-led pragmatic trials , where communities essentially choose what they want to do . Several discussion groups in each intervention community produced multiple plans for prevention , recognising different time lines . Some chose fast turnarounds , like elimination of breeding sites , and some chose longer term actions like garbage disposal and improving water supplies . A big part of the skill set for community-led trials is being able to st and back and simply support communities in what they want to do and how they want to do it , something that does not come naturally to many vector control programs or to RCT research ers . Unexpected negative outcomes can come from the turbulence implicit in participatory research . One example was the  gender dynamic  in the Mexican arm of the Camino Verde trial . Strong involvement of women in dengue control activities seems to have discouraged men in setting s where activity in public spaces or outside of the home would ordinarily be considered a “ male competence”.Community-led trials address the tension between one-size-fits-all programme interventions and local needs . Whatever the conventional wisdom about how prevention works at a system level , programmes have to be perceived as locally relevant and they must engage stakeholders who make them work . Locally , each participating community has to know the intervention is relevant to them ; they have to want to do it . That happens much more easily if they design the programme themselves Background Temephos in domestic water containers remains a mainstay of Latin American government programmes for control of Aedes aegypti and associated illnesses , including dengue . There is little published evidence about coverage of routine temephos programmes . A cluster r and omised controlled trial of community mobilisation in Mexico and Nicaragua reduced vector indices , dengue infection , and clinical dengue cases . Secondary analysis from the Mexican arm of the trial examined temephos coverage and beliefs , and the impact of the trial on these outcomes . Methods The trial impact survey in December 2012 , in 10,491 households in 45 intervention and 45 control clusters , asked about visits from the temephos programme , retention of applied temephos , and views about temephos and mosquito control . Fieldworkers noted if temephos was present in water containers . Results Some 42.4 % of rural and 20.7 % of urban households reported no temephos programme visits within the last 12 months . Overall , 42.0 % reported they had  temephos placed in their water containers less than 3 months previously . Fieldworkers observed  temephos  in at least one container in 21.1 % of households . Recent temephos application and observed temephos  were both significantly more common in urban households , when other household variables were taken into account ; in rural areas , smaller households were more likely to have temephos present . Most households ( 74.4 % ) did not think bathing with water containing temephos carried any health risk . Half ( 51 % ) believed drinking or cooking with such water could be harmful and 17.6 % were unsure . Significantly fewer households in intervention sites ( 16.5 % ) than in control sites ( 26.0 % ) ( Risk Difference − 0.095 , 95 % confidence interval − 0.182 to −0.009 ) had temephos observed in their water ; more households in intervention clusters ( 41.8 % ) than in control clusters ( 31.6 % ) removed the applied  temephos  quickly . Although fewer households in intervention sites ( 82.7 % ) compared with control sites ( 86.7 % ) ( RD -0.04 , 95 % CI -0.067 to −0.013 ) agreed temephos and fumigation was the best way to avoid mosquitoes , the proportion believing this remained very high . Conclusion Coverage with the government temephos programme was low , especially in rural areas . Despite an intervention encouraging non-chemical mosquito control , most households continued to believe that chemicals are the best control method .Trial registration IS RCT N:27581154 Background Since the Aedes aegypti mosquitoes that transmit dengue virus can breed in clean water , WHO-endorsed vector control strategies place sachets of organophosphate pesticide , temephos ( Abate ) , in household water storage containers . These and other pesticide-dependent approaches have failed to curb the spread of dengue and multiple dengue virus serotypes continue to spread throughout tropical and subtropical regions worldwide . A feasibility study in Managua , Nicaragua , generated instruments , intervention protocol s , training schedules and impact assessment tools for a cluster r and omised controlled trial of community-based approaches to vector control comprising an alternative strategy for dengue prevention and control in Nicaragua and Mexico . Methods / Design The Camino Verde ( Green Way ) is a pragmatic parallel group trial of pesticide-free dengue vector control , adding effectiveness to the st and ard government dengue control . A r and om sample from the most recent census in three coastal regions of Guerrero state in Mexico will generate 90 study clusters and the equivalent sampling frame in Managua , Nicaragua will generate 60 clusters , making a total of 150 clusters each of 137–140 households . After a baseline study , computer-driven r and omisation will allocate to intervention one half of the sites , stratified by country , evidence of recent dengue virus infection in children aged 3–9 years and , in Nicaragua , level of community organisation . Following a common evidence -based education protocol , each cluster will develop and implement its own collective interventions including house-to-house visits , school-based programmes and inter-community visits . After 18 months , a follow-up study will compare dengue history , serological evidence of recent dengue virus infection ( via measurement of anti-dengue virus antibodies in saliva sample s ) and entomological indices between intervention and control sites . Discussion Our hypothesis is that informed community mobilisation adds effectiveness in controlling dengue . Trial registration IS RCT N27581154 Background Recent literature on community intervention research stresses system change as a condition for durable impact . This involves highly participatory social processes leading to behavioural change . Methods Before launching the intervention in the Nicaraguan arm of Camino Verde , a cluster-r and omised controlled trial to show that pesticide-free community mobilisation adds effectiveness to conventional dengue controls , we held structured discussion s with leaders of intervention communities on costs of dengue illness and dengue control measures taken by both government and households . These discussion s were the first step in an effort at Socialising Evidence for Participatory Action ( SEPA ) , a community mobilisation method used successfully in other context s. Theoretical grounding came from community psychology and behavioural economics . Results The leaders expressed surprise at how large and unexpected an economic burden dengue places on households . They also acknowledged that large investments of household and government re sources to combat dengue have not had the expected results . Many were not ready to see community preventive measures as a substitute for chemical controls but all the leaders approved the formation of “ brigades ” to promote chemical-free household control efforts in their own communities . Conclusions Discussion s centred on household budget decisions provide a good entry point for research ers to engage with communities , especially when the evidence showed that current expenditures were providing a poor return . People became motivated not only to search for ways to reduce their costs but also to question the current response to the problem in question . This in turn helped create conditions favourable to community mobilisation for change . Trial registration IS RCT N27581154 Abstract We discuss two ethical issues raised by Camino Verde , a 2011–2012 cluster-r and omised controlled trial in Mexico and Nicaragua , that reduced  dengue risk though community mobilisation . The issues arise from the approach adopted by the intervention , one called Socialisation of Evidence for Participatory Action . Community volunteer teams informed householders of evidence about dengue , its costs and the life-cycle of Aedes aegypti mosquitoes , while showing them the mosquito larvae in their own water receptacles , without prescribing solutions . Each community responded in an informed manner but on its own terms . The approach involves partnerships with communities , presenting evidence in a way that brings conflicting views and interests to the surface and encourages communities themselves to deal with the result ing tensions . One such tension is that between individual and community rights . This tension can be resolved creatively in concrete day-to-day circumstances provided those seeking to persuade their neighbours to join in efforts to benefit community health do so in an atmosphere of dialogue and with respect for personal autonomy . A second tension arises between research ers ’ responsibilities for ethical conduct of research and community autonomy in the conduct of an intervention . An ethic of respect for individual and community autonomy must infuse community intervention research from its inception , because as research ers succeed in fostering community self-determination their direct influence in ethical matters diminishes . Trial registration : IS RCT N Background A cluster-r and omized controlled trial of  community mobilisation for dengue prevention in Mexico and Nicaragua reported , as a secondary finding , a higher risk of dengue virus infection in households where inspectors found temephos in water containers . Data from control sites in the preceding pilot study and the Nicaragua trial arm provided six time points ( 2005 , 2006 , 2007 and 2011 , 2012 , 2013 ) to examine potentially protective effects of temephos on entomological indices under every day conditions of the national vector control programme . Methods Three household entomological indicators for Aedes aegypti breeding were Household Index , Households with pupae , and Pupae per Person . The primary exposure indicator at the six time points was temephos identified physically during the entomological inspection . A stricter criterion for exposure at four time points included households reporting temephos application during the last 30 days and temephos found on inspection . Using generalized linear mixed modelling with cluster as a r and om effect and temephos as a potential fixed effect , at each time point we examined possible determinants of lower entomological indicators . Results Between 2005 and 2013 , temephos exposure was not significantly associated with a reduction in any of the three entomological indices , whether or not the exposure indicator included timing of temephos application . In six of 18 multivariate models at the six time points , temephos exposure was associated with higher entomological indices ; in these models , we could exclude any protective effect of temephos with 95 % confidence . Conclusion Our failure to demonstrate a significant protective association between temephos and entomological indices might be explained by several factors . These include ecological adaptability of the vector , resistance of Aedes to the pesticide , operational deficiencies of vector control programme , or a decrease in preventive actions by households result ing from a false sense of protection fostered by the central ized government programme using chemical agents . Whatever the explanation , the implication is that temephos affords less protection under routine field conditions than expected from its efficacy under experimental conditions . Trial registration IS RCT N 27581154 Background The follow-up survey of a cluster-r and omised controlled trial of evidence -based community mobilisation for dengue control in Nicaragua and Mexico included entomological information from the 2012 rainy and dry seasons . We used data from the Mexican arm of the trial to assess the impact of the community action on pupal production of the dengue vector Aedes aegypti in both rainy and dry seasons . Methods Trained field workers  inspected household water containers in 90 clusters and collected any pupae or larvae present for entomological examination . We calculated indices of pupae per person and pupae per household , and traditional entomological indices of container index , household index and Breteau index , and compared these between rainy and dry seasons and between intervention and control clusters , using a cluster t-test to test significance of differences . Results In 11,933 houses in the rainy season , we inspected 40,323 containers and found 7070 Aedes aegypti pupae . In the dry season , we inspected 43,461 containers and counted 6552 pupae . All pupae and entomological indices were lower in the intervention clusters ( IC ) than in control clusters ( CC ) in both the rainy season ( RS ) and the dry season ( DS ) : pupae per container 0.12 IC and 0.24 CC in RS , and 0.10 IC and 0.20 CC in DS ; pupae per household 0.46 IC and 0.82 CC in RS , and 0.41 IC and 0.83 CC in DS ; pupae per person 0.11 IC and 0.19 CC in RS , and 0.10 IC and 0.20 CC in DS ; household index 16 % IC and 21 % CC in RS , and 12.1 % IC and 17.9 % CC in DS ; container index 7.5 % IC and 11.5 % CC in RS , and 4.6 % IC and 7.1 % CC in DS ; Breteau index 27 % IC and 36 % CC in RS , and 19 % IC and 29 % CC in DS . All differences between the intervention and control clusters were statistically significant , taking into account clustering . Conclusions The trial intervention led to significant decreases in pupal and conventional entomological indices in both rainy and dry seasons . Trial registration IS RCT N27581154 R and omised controlled trials , when appropriately design ed , conducted , and reported , represent the gold st and ard in evaluating healthcare interventions . However , r and omised trials can yield biased results if they lack method ological rigour [ 1 ] . To assess a trial accurately , readers of a published report need complete , clear , and transparent information on its methodology and findings . Unfortunately , attempted assessment s frequently fail because authors of many trial reports neglect to provide lucid and complete descriptions of that critical information [ 2,3,4 ] . That lack of adequate reporting fuelled the development of the original CONSORT ( Consoli date d St and ards of Reporting Trials ) statement in 1996 [ 5 ] and its revision five years later [ 6,7,8 ] . While those statements improved the reporting quality for some r and omised controlled trials [ 9,10 ] , many trial reports still remain inadequate [ 2 ] . Furthermore , new method ological evidence and additional experience has accumulated since the last revision in 2001 . Consequently , we organised a CONSORT Group meeting to up date the 2001 statement [ 6,7,8 ] . We introduce here the result of that process , CONSORT 2010 . Background In the Mexican state of Guerrero , some households place fish in water storage containers to prevent the development of mosquito larvae . Studies have shown that larvivorous fish reduce larva count in household water containers , but there is a lack of evidence about whether the use of fish is associated with a reduction in dengue virus infection . We used data from the follow up survey of the Camino Verde cluster r and omised controlled trial of community mobilisation to reduce dengue risk to study this association . Methods The survey in 2012 , among 90 clusters in the three coastal regions of Guerrero State , included a question naire to 10,864 households about socio-demographic factors and self-reported cases of dengue illness in the previous year .  Paired saliva sample s provided serological evidence of recent dengue infection among 4856 children aged 3–9 years . An entomological survey in the same households looked for larvae and pupae of Aedes aegypti and recorded presence of fish and temephos in water containers . We examined associations with the two outcomes of recent dengue infection and reported dengue illness in bivariate analysis and then multivariate analysis using generalized linear mixed modelling . Results Some 17 % ( 1730/10,111 ) of households had fish in their water containers . The presence of fish was associated with lower levels of recent dengue virus infection in children aged 3–9 years ( OR 0.64 ; 95 % CI 0.45–0.91 ) , as was living in a rural area ( OR 0.57 ; 95 % CI 0.45–0.71 ) , and being aged 3–5 years ( OR 0.65 ; 95 % CI 0.51–0.83 ) . Factors associated with lower likelihood of self-reported dengue illness were : the presence of fish ( OR 0.79 ; 95 % CI 0.64–0.97 ) , and living in a rural area ( OR 0.74 ; 95 % CI 0.65–0.84 ) . Factors associated with higher likelihood of self-reported dengue illness were : higher education level of the household head ( OR 1.28 ; 95 % CI 1.07–1.52 ) , living in a household with five people or less ( OR 1.33 ; 95 % CI 1.16–1.52 ) and household use of insecticide anti-mosquito products ( OR 1.68 ; 95 % CI 1.47–1.92 ) . Conclusions Our study suggests that fish in water containers may reduce the risk of dengue virus infection and dengue illness . This could be a useful part of interventions to control the Aedes aegypti vector
target: The Camino Verde trial of community mobilisation for control of dengue reported a significant impact on entomological indices of the Aedes aegypti vector , and on serological dengue virus infection and self-reported dengue cases .
background: One reason for doing r and omised controlled trials ( RCTs ) is that experiments can be convincing .
  Early epidemiological experimenters , such as Jenner and the smallpox vaccine and Snow and his famous Broad Street pump h and le , already knew the answer they were demonstrating ; they used the experiments as knowledge translation devices to convince others .
  More sophisticated modern experiments include cluster r and omised controlled trials ( C RCTs ) for experiments in the public health setting .
  Those who are convinced by a trial and want to act , need to know how the trial relates to their own context , what contributed to success , and what might make it even more effective .