Picado 2010a ASIA.

Methods	Trial design: Cluster‐RCT. Unit of randomization: Hamlets. Number of clusters: 26 (13 intervention and 13 control clusters; 12,691 people). Entomological data collection: Done in Picado 2010b, an excluded non‐randomized entomological study based in this trial. Clinical data collection: Cases of VL were double checked with patients' records. Suspected people were examined by a physician who was blinded to the status of the cluster and tested with a rapid Kalazar Detect Rapid Test and classified as probable or certain VL. Asymptomatic infections were clinically followed up for a minimum of six months. Trained field workers carried out verbal autopsies on all deaths recorded during the trial. Two independent physicians ascertained cause of death. L. donovani infections as measured by seroconversion with the direct agglutination test at 12 and 24 months after the intervention, November to December 2007 and 2008, respectively. Seroconversion was considered only in people who had negative results on the direct agglutination test (≤ 1:800) in the baseline survey (or their first blood sample). Length of follow‐up: 30 months (from November 2006 to May 2009) for cases of VL and 12 to 24 months after the intervention for seroconversions. Analysis: Analysed at cluster level.
Participants	Clusters were paired on the basis of incidence of VL between 2003 and 2005. Eligibility criteria: In May 2006, they selected and included in the trial 26 (16 in India, 10 in Nepal) high incidence clusters out of 34 clusters with a high number of reported cases of VL (22 in India, 12 in Nepal) based on the following criteria: At least one case of VL in 2003, 2004, and 2005, indicating continuous L. donovani transmission. A minimum 0.8% average annual incidence rate of VL from 2003 to 2005. A population ranging from 350 to 1500 people. A minimum distance of 1 km between clusters. The 26 clusters were stratified by country (16 in India and 10 in Nepal) and population size (6 and 4, respectively, having over 710 residents) and then paired by previous average incidence rate of VL. Clusters in each pair were randomly allocated to group 1 or 2. The random selection of clusters into groups was undertaken in Excel (Microsoft), and the difference in the total number of cases of VL reported in the past three years between group 1 and 2 had to be less than 10%. All individuals living for at least six months a year in the clusters were eligible, but blood sampling was restricted to individuals aged over 2 years. Endemic disease: VL caused by L. donovani.
Interventions	Longlasting ITNs (PermaNet® 2.0, treated with deltamethrin 55 mg/m²; Vestergaard‐Frand‐ sen, Denmark; 75 denier, 25 holes/cm² coated fibres). Distributed in December 2006. No intervention as control. The control clusters were allowed to continue using any existing conventional strategies for personal protection. They were not provided with ITNs nor was the use of untreated nets promoted.
Outcomes	Number of new cases of VL assessed at quarterly bases for 30 months. Presence of the parasite by seroconversion with the direct agglutination test assessed at 12 and 24 months after the intervention.
Notes	Country: India (Muzaffarpur district) and Nepal (Sunsari, and Morang districts). Trial dates: November 2006 to May 2009. Trial sponsor: Funded by the European Union under its 6th Framework Program (INCODEV/Project 015374). Contract no INCO‐CT 2005‐01537, KALANET project. Sample size: Calculated. Compliance assessment: Done. "In intervention clusters, 8920/9829 (91%) of the individuals slept regularly (that is, over 80% of the nights) under a treated net. Those observations were confirmed by an additional acceptability survey (V Vanlerberghe, personal communication, January 2010). The use of untreated nets in the control group was variable; 7012/9981 (70%) used a bed net at least once during the trial but only 2978/9981 (30%) used it regularly throughout the year as most of the households did not have enough nets for all their members."
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"The intervention was then randomly allocated to one of the groups by tossing a coin in the presence of observers."
Allocation concealment (selection bias)	Unclear risk	Not reported.
Blinding (performance bias and detection bias) participants	Unclear risk	This was not stated.
Blinding (performance bias and detection bias) investigators	Unclear risk	This was not stated.
Blinding (performance bias and detection bias) Assessors	Low risk	"All clinically suspected cases detected during the trial were classified as probable or certain visceral leishmaniasis by a clinician who was blinded to the status of the cluster".
Incomplete outcome data (attrition bias) All outcomes	Low risk	No clusters were lost to follow‐up. Analyses and dropouts per group and reasons described. The proportion of people lost to follow‐up (not present or with one or no blood sample) was slightly higher in the control group (21%, (644 +1466)/9981) than in the intervention group (19%, (545+1347)/9829). But the characteristics of the participants lost to follow‐up in both groups were similar (mean age 22 v 23, males 62% v 63%, mean socioeconomic status 2.0 v 2.2, in intervention and control groups respectively).
Selective reporting (reporting bias)	Low risk	All outcomes mentioned in the methods were reported in the results.
Baseline measurements	Low risk	Yes (table). Intervention and control groups were well balanced at individual and cluster levels, but the prevalence of positive results on the direct agglutination test at baseline in India was almost twice as high as in Nepal, despite the previous annual incidence of VL being similar.
Statistical adjustment for clustering	Low risk	Data were analysed at the cluster level. No adjustment for clustering needed as analysis was done at the cluster level.
Other bias	Low risk	Trial authors declared no competing interests. The trial founder had no role in the trial design, data collection and analysis, interpretation or reporting of this work, or the decision to submit the work for publication. Competing interests: All authors completed the Unified Competing Interest form and declared: "no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years, no other relationships or activities that could appear to have influenced the submitted work".