# Abstract

 

## Background Poor sanitation is thought to be a major cause of enteric infections among young children. However, there are no previously published randomized trials to measure the health impacts of large-scale sanitation programs. India's Total Sanitation Campaign (TSC) is one such program that seeks to end the practice of open defecation by changing social norms and behaviors, and providing technical support and financial subsidies. The objective of this study was to measure the effect of the TSC implemented with capacity building support from the World Bank's Water and Sanitation Program in Madhya Pradesh on availability of individual household latrines (IHLs), defecation behaviors, and child health (diarrhea, highly credible gastrointestinal illness [HCGI], parasitic infections, anemia, growth). 

## Methods and Findings We conducted a cluster-randomized, controlled trial in 80 rural villages. Field staff collected baseline measures of sanitation conditions, behaviors, and child health (May--July 2009), and revisited households 21 months later (February--April 2011) after the program was delivered. The study enrolled a random sample of 5,209 children \<5 years old from 3,039 households that had at least one child \<24 months at the beginning of the study. A random subsample of 1,150 children \<24 months at enrollment were tested for soil transmitted helminth and protozoan infections in stool. The randomization successfully balanced intervention and control groups, and we estimated differences between groups in an intention to treat analysis. The intervention increased percentage of households in a village with improved sanitation facilities as defined by the WHO/UNICEF Joint Monitoring Programme by an average of 19% (95% CI for difference: 12%--26%; group means: 22% control versus 41% intervention), decreased open defecation among adults by an average of 10% (95% CI for difference: 4%--15%; group means: 73% intervention versus 84% control). However, the intervention did not improve child health measured in terms of multiple health outcomes (diarrhea, HCGI, helminth infections, anemia, growth). Limitations of the study included a relatively short follow-up period following implementation, evidence for contamination in ten of the 40 control villages, and bias possible in self-reported outcomes for diarrhea, HCGI, and open defecation behaviors. 

## Conclusions The intervention led to modest increases in availability of IHLs and even more modest reductions in open defecation. These improvements were insufficient to improve child health outcomes (diarrhea, HCGI, parasite infection, anemia, growth). The results underscore the difficulty of achieving adequately large improvements in sanitation levels to deliver expected health benefits within large-scale rural sanitation programs. 

## Trial Registration ClinicalTrials.gov [NCT01465204](#) *Please see later in the article for the Editors' Summary* # Results 

## Enrolment, Baseline Balance, and Attrition [Figure 2](#) depicts the study participants flow. The baseline survey enrolled a sample of 3,390 children \<5 years from 1,954 households from 80 villages. In the follow-up survey the sample size was increased to 5,209 children \<5 years from 3,039 households. As reported in [Table 2](#), baseline covariates in intervention and control groups were well balanced with four exceptions. First, 89% of the households in the intervention group had access to improved water sources---tap/piped water, tube well and protected dug wells---compared to 80% of households in the control group. In contrast, a larger proportion of control households (54%) were observed to have soap and water at hand-washing locations used after defecation than in intervention households (44%). On average, more children were found to be anemic in the control group (93%) than in the intervention group (88%). Finally, average height-for-age Z-scores were also slightly imbalanced (−1.38 intervention versus −1.81 control). ::::table-wrap

10.1371/journal.pmed.1001709.t002

::: caption



##

##

## Baseline characteristics by randomized intervention groups, 2009.

:::

![](<>)

Characteristics Intervention (I) Control (C)

______________________________________________________________________

```
                                                                               N[a](#)            Mean or Percent   N[a](#)   Mean or Percent
```

**Household characteristics**\
Age in months for children \<5 years[b](#) 1,683 21.89 1,707 22.12
Age of HH head in years 976 45.34 978 43.18
Whether HH head went to school 954 49.90% 952 52.73%
Government category of HH as BPL 976 34.53% 978 38.96%
Government category of HH as schedule caste/tribe 935 69.73% 905 71.38%
*Pucca* (better quality) HH construction 976 57.07% 978 60.43%
Monthly HH income (Rupees) 976 11,293 978 11,022
**WASH infrastructure and behaviors**\
HH access to improved water source 976 89.24% 978 79.65%
Reported drinking water treatment at home 976 68.34% 978 66.26%
Interviewer observed soap and water at hand-washing place used post defecation 969 44.48% 972 54.22%
PCG reports hand washing w/soap after fecal contact in last 24 hours 978 61.76% 985 64.16%
**Child nutrition**\
Child ever breastfed[c](#) 1,026 99.03% 1,037 98.55%
Child still breastfeeding[c](#) 1,013 91.21% 1,021 89.52%
Iron pills, syrup given[c](#) 1,019 7.36% 1,033 5.91%
Drugs for intestinal worms given in past 6 months[c](#) 1,025 19.12% 1,033 15.97%
Did receive VitA dose last 6 months[c](#) 1,013 37.41% 1,032 36.14%
**Sanitation**\
Reported main sanitation facility is JMP defined improved sanitation facility 975 13.64% 978 12.37%
Reported main sanitation facility is any type of IHL/is not open defecation 975 18.36% 978 20.96%
Reported correct disposal of child feces 976 15.98% 978 13.39%
Interviewer did not observe feces in living area around HH 973 41.11% 976 38.11%
**Water microbiology**\
HH drinking water is contaminated with *E. coli* 172 95.93% 174 97.70%
**Health status**\
Diarrhea 7-day prevalence[b](#) 1,683 13.19% 1,707 12.13%
HCGI 7-day prevalence[b](#) 1,683 15.27% 1,707 15.06%
ALRI 7-day prevalence[b](#) 1,683 11.47% 1,707 10.13%
Weight-for-age Z-score[c](#) 957 −2.20 943 −2.18
Length/height-for-age Z-score[c](#) 932 −1.38 933 −1.81
Arm circumference-for-age Z-score[c](#) 921 −1.31 895 −1.33
Weight-for-height Z-score[c](#) 895 −1.68 879 −1.43
Anemic: Hb\<110 g/l[c](#) 293 88.05% 329 92.71%

*N* is the base number of observations (the denominator) for the
reported percentages or the sample size used to estimate the reported
means. *N* is the number of households except for the variables measured
at the child level (as indicated by **^b^** and **^c^**) where *N* is
the number of children. *N* varies across different variables because of
measurements in only a subset of the sample by design,
non-response/refusal, and the loss due to measurement errors.

For children less than 60 months of age.

For children less than 24 months of age.

ALRI, acute lower respiratory illness; CFU, colony forming units; Hb,
Hemoglobin; HH, household; PCG, primary care giver; VitA, vitamin A;
WASH, water, sanitation and hygiene.:::: Attrition was not differential by randomized group on the basis of observable characteristics (see [Table S1](#)). Of the 1,954 households enrolled at the baseline, 1,655 were located at the 21-month follow-up survey (15% attrition) without any significant difference between the intervention (16%) and the control (15%) groups. Characteristics remained balanced between intervention and control groups in remaining households. 

## Compliance to Randomization The study measured intervention implementation in multiple ways because of the complexity of the TSC program. These measures included: reported implementation by Block coordinators, expenditure of funds documented by official program records, and interviews with local village officials. Out of 40 intervention villages, staff collected administrative information on 39 villages from the TSC Block coordinators (government officers). The coordinators reported that 15/39 intervention villages received some CLTS activities, 33/39 villages applied for a NGP award prior to the follow-up survey. According to Block coordinators' records, 25/39 villages had 100% households with IHLs, 11/39 villages had 80%--99% households with IHLs, and three of 39 villages with 37%--68% households with IHLs. Block coordinators also reported that 21/39 villages received 100% of the funds allocated under the TSC program, 12/39 villages received between 50% and 99%, and six of 39 villages received \<50% of their allocated funds. The latest disbursement of the TSC funds was given to 36/39 intervention villages at least 4 to 5 months before the follow-up survey, which would offer sufficient time for IHLs to be constructed and used for 3 or more months. The study review meetings with Block coordinators also identified that some control villages were contaminated during the study period: TSC activities were initiated in eight control villages within a few months of baseline survey and possibly in two additional control villages a few months prior to the follow-up survey; official records were not available for control villages to ascertain this information objectively. As per the follow-up survey in these ten contaminated villages, the household level coverage of JMP defined improved sanitation facilities increased from 17.4% at baseline to 41.4% at the follow-up, which is similar to the program effect we observed in the intervention group. The household level coverage of JMP defined improved sanitation facilities in uncontaminated control villages increased from 10.7% to 16.2% in the same period. The study's long follow-up period (21 months) and the highly publicized and politicized nature of the TSC program may have contributed to this contamination. Information from additional sources (village secretaries, school teachers, *Anganwadi* [pre-school] workers in the village, and the rapid assessment from random sample of households) confirmed that TSC activities translated into a higher recollection and knowledge of the TSC program in the intervention villages compared to the control villages. We also found that households in intervention villages were more aware of CLTS activities, had higher knowledge of TSC, and experienced more personal visits to convince them to build and use IHLs ([Table 3](#)). ::::table-wrap
10.1371/journal.pmed.1001709.t003

::: caption



##

##

## Effect of the intervention on program outputs, behavioral outcomes, and water quality, 2011.

:::

![](<>)

Outputs and Outcomes Control Group[a](#) Intervention Group[a](#) ITT Unadjusted[b](#) ITT Adjusted[c](#)

______________________________________________________________________

```
                                                                               *N*                   Mean                       *N*                    Mean                 Difference [95% CI][d](#)              Difference [95% CI][d](#)
```

**Program exposure**\
HH received WASH message from mass media 1,511 0.272 1,523 0.295 0.023 [−0.033 to 0.080] 0.000 [−0.048 to 0.048]
HH received WASH message from personal visits 1,472 0.099 1,479 0.240 0.140 [0.097--0.183][\*\*\*](#) 0.127 [0.081--0.172][\*\*\*](#)
HH participated or is aware of CLTS activities 1,514 0.157 1,525 0.291 0.135 [0.083--0.186][\*\*\*](#) 0.140 [0.089--0.191][\*\*\*](#)
HH knew of TSC/NGP 1,514 0.211 1,525 0.273 0.062 [0.011--0.114][\*\*](#) 0.053 [0.004--0.103][\*\*](#)
**Drinking water supply and hand-washing Infrastructure**\
HH access to improved water source 1,514 0.949 1,525 0.970 0.021 [−0.001 to 0.043][\*](#) 0.007 [−0.014 to 0.027]
Interviewer observed soap and water at hand-washing place used post defecation 1,269 0.436 1,334 0.494 0.056 [−0.006 to 0.118][\*](#) 0.052 [−0.002 to 0.105][\*](#)
**IHL access and sanitation behaviors**\
HH with JMP defined improved sanitation facilities 1,512 0.226 1,522 0.414 0.188 [0.118--0.258][\*\*\*](#) 0.177 [0.107--0.246][\*\*\*](#)
HH with any type of IHL 1,514 0.242 1,525 0.441 0.198 [0.126--0.270][\*\*\*](#) 0.189 [0.116--0.263][\*\*\*](#)
Interviewer assessed that HH is using IHL (any type) 1,504 0.167 1,520 0.272 0.104 [0.047--0.161][\*\*\*](#) 0.093 [0.042--0.144][\*\*\*](#)
Reported daily OD by men 1,514 0.841 1,525 0.746 −0.095 [−0.152 to −0.039][\*\*\*](#) −0.087 [−0.135 to −0.038][\*\*\*](#)
Reported daily OD by women 1,514 0.835 1,525 0.732 −0.102 [−0.159 to −0.045][\*\*\*](#) −0.091 [−0.141 to −0.041][\*\*\*](#)
Reported daily OD by children 1,514 0.892 1,525 0.839 −0.053 [−0.095 to −0.011][\*\*](#) −0.054 [−0.088 to −0.020][\*\*\*](#)
Reported correct child feces disposal 1,514 0.184 1,525 0.271 0.087 [0.045--0.129][\*\*\*](#) 0.075 [0.036--0.113][\*\*\*](#)
Interviewer did not observe human/animal feces in HH living area 1,500 0.398 1,512 0.404 0.006 [−0.045 to 0.057] 0.019 [−0.026 to 0.065]
**Drinking water quality**\
*E. coli* present in household drinking water 403 0.821 404 0.767 −0.055 [−0.111 to 0.000][\*](#) −0.032 [−0.101 to 0.036]
*E. coli* present in the source from where household collected drinking water 280 0.743 231 0.701 −0.115 [−0.269, 0.040] −0.016 [−0.180, 0.149]

The number of observations used to estimate means of the intervention
and the control groups is the same as the number of observations used in
ITT-unadjusted analysis.

Explanatory variables in the unadjusted model include the treatment
assignment and indicator variables for Blocks. Therefore, the ITT
effects for outcomes may not be exactly the difference between the
listed mean in intervention and control groups in previous columns.

Because of missing adjustment variables data, the observations used in
adjusted analysis are fewer than those used in unadjusted analysis. The
number of observations used is seven to 113 less than that in unadjusted
analysis.

Following the commonplace norms, statistical significance is indicated
as:

significant at α = 0.01;

significant at α = 0.05;

significant at α = 0.10.

Please note that *p*-values are not adjusted for multiple comparisons
following guidance from Schulz and Grimes [[43]](#).

CFU, colony forming units; HH, household; OD, open defecation; TSC/NGP,
Total Sanitation Campaign/*Nirmal Gram Puraskar*; WASH, water,
sanitation and hygiene.:::: 

## IHL Coverage and Sanitation-Related Behaviors [Table 3](#) reports the intervention's effect on IHL availability (JMP defined improved sanitation facilities and any type of IHLs) and open defecation behaviors by household members. The intervention increased the coverage of JMP defined improved sanitation facility by average 19 percentage points (95% CI 12%--26%; *p*-value\<0.001) in intervention villages compared to control villages (41.4% intervention versus 22.6% control). The intervention increased the coverage of any type of IHL facility by 20 percentage points (95% CI 13%--27%; *p*-value\<0.001) in intervention villages compared to control villages (44.1% intervention versus 24.2% control). These results indicate that available IHLs were predominantly JMP defined improved sanitation facilities and very few rudimentary latrines or latrines defined as unimproved by the JMP were built. These results are consistent with the TSC design that promoted latrine models that can safely contain the feces. Although on average fewer households in intervention villages were likely to report daily open defecation compared to control villages for adult men (75% intervention versus 84% control; mean difference: 9.5%; *p*-value = 0.001), adult women (73% intervention versus 83% control; mean difference: 10%; *p*-value\<0.001), and children \<5 years (84% intervention versus 89% control; mean difference: 5%; *p*-value = 0.014), these reductions in reported open defecation behaviors were smaller than the gains in IHL availability. Amongst the 630 households in intervention villages that had JMP defined improved sanitation facilities at follow-up, 41% reported that adult men or women still practiced daily open defecation; this same figure was 28% among the 339 control village households at follow-up (not reported in results table). A follow-up debriefing question to households who had IHL identified that the main reasons for daily open defecation in spite of having IHL were culture, habit, or preference for defecating in open followed by inadequate water availability. 

## Drinking Water Quality In control villages, 82% (331/403) of household drinking water samples tested positive for *E. coli* compared to 77% (310/404) of samples in intervention villages (mean difference: 5.5%; *p*-value = 0.050) ([Table 3](#)). [Table S2](#) lists the distribution of positive household samples by different *E. coli* contamination level categories. Of 511 water source samples tested, 74% (208/280) of the sources in control villages and 70% (162/231) in intervention villages tested positive for *E. coli* but the difference was not statistically significant (*p*-value = 0.143). 

## Caregiver Reported Illness Diarrhea prevalence did not differ between groups (7.4% intervention versus 7.7% control; *p*-value = 0.687) ([Table 4](#)). HCGI prevalence also did not differ between groups (11.5% intervention versus 12.0% control; *p*-value = 0.692) ([Table 4](#)). We observed no significant differences between groups in negative control caregiver-reported outcomes including bruising/abrasions (1.4% intervention versus 1.3% control) and itchy skin/scalp (2.5% intervention versus 2.2% control) suggesting that differential outcome reporting bias for diarrhea and HCGI was unlikely. ::::table-wrap
10.1371/journal.pmed.1001709.t004

::: caption



##

##

## Effect of the intervention on health outcomes, 2011.

:::

![](<>)

Health Outcomes Control Group[a](#) Intervention Group[a](#) ITT Unadjusted[b](#) ITT Adjusted[c](#)

______________________________________________________________________

```
                                                        *N*                   Mean                       *N*                    Mean                 Difference [95% CI][d](#)            Difference [95% CI][d](#)
```

**Caregiver reported illness in the last 7 days**[e](#)\
Diarrhea 2,609 0.077 2,600 0.074 −0.003 [−0.019 to 0.013] −0.002 [−0.019 to 0.015]
HCGI 2,609 0.120 2,600 0.115 −0.004 [−0.026 to 0.017] −0.002 [−0.024 to 0.020]
Acute lower respiratory illness 2,609 0.128 2,600 0.163 0.038 [0.003--0.073][\*\*](#) 0.049 [0.009--0.089][\*\*](#)
**Enteric parasite infections**[f](#)\
Any protozoan present 569 0.257 581 0.217 −0.040 [−0.089 to 0.008] −0.027 [−0.082 to 0.029]
*Entamoeba histolytica* present 569 0.025 581 0.033 0.008 [−0.009 to 0.024] 0.009 [−0.009 to 0.028]
*Giardia lamblia* present 569 0.232 581 0.184 −0.048 [−0.096 to −0.001][\*\*](#) −0.036 [−0.088 to 0.015]
Any helminth present 569 0.056 581 0.059 0.001 [−0.021 to 0.023] −0.005 [−0.028 to 0.018]
*Ascaris lumbricoides* present 569 0.044 581 0.043 −0.002 [−0.021 to 0.017] −0.011 [−0.031 to 0.010]
Any enteric parasite present 569 0.309 581 0.270 −0.040 [−0.087 to 0.006][\*](#) −0.032 [−0.083 to 0.020]
**Anemia and anthropometry**[e](#)\
Anemic: Hb\<110 g/l 1,922 0.508 1,919 0.562 0.050 [−0.011 to 0.110] 0.033 [−0.030 to 0.096]
Child weight (to 0.1 kg) 2,161 10.277 2,154 10.069 −0.229 [−0.492 to 0.033][\*](#) −0.130 [−0.345 to 0.085]
Child height (to 0.1 cm) 2,185 82.312 2,175 81.682 −0.678 [−1.362 to 0.006][\*](#) −0.242 [−0.789 to 0.304]
Child arm circumference (to 0.1 cm) 2,191 13.805 2,197 13.783 −0.004 [−0.145 to 0.138] −0.022 [−0.167 to 0.123]
Weight-for-age Z-score 2,161 −1.833 2,154 −1.921 −0.095 [−0.253 to 0.063] −0.094 [−0.246 to 0.058]
Length/height-for-age Z-score 2,185 −2.155 2,175 −2.189 −0.034 [−0.195 to 0.127] −0.040 [−0.223 to 0.144]
MUAC-for-age Z-score 2,191 −1.337 2,197 −1.337 0.020 [−0.115 to 0.155] −0.022 [−0.151 to 0.108]
Weight-for-height Z-score 2,054 −0.834 2,054 −0.847 −0.018 [−0.195 to 0.160] 0.029 [−0.142 to 0.199]
BMI Z-score 2,052 −0.604 2,052 −0.664 −0.062 [−0.241 to 0.117] −0.019 [−0.191 to 0.153]

The number of observations used to estimate means of the intervention
and the control groups is the same as the number of observations used in
ITT-unadjusted analysis.

Explanatory variables in the unadjusted model include the treatment
assignment and indicator variables for Blocks. Therefore, the ITT
effects for outcomes may not be exactly the difference between the
listed mean in intervention and control groups in previous columns.

Because of missing adjustment variables data, the observations used in
adjusted analysis are fewer than those used in unadjusted analysis.

Following the commonplace norms, statistical significance is indicated
as:

\*\*significant at α = 0.05;

\*significant at α = 0.10.

Please note that *p*-values are not adjusted for multiple comparisons
following guidance from Schulz and Grimes [[43]](#).

For children less than 60 months of age.

For children less than 60 months of age. The eldest child less than 60
months of age selected from a household.

BMI, body mass index; Hb, hemoglobin; HH, household; OD, open
defecation.:::: 

## Enteric Parasite Infections In the subsample of 1,150 children with stool collection, 5.7% (66/1150) had helminth infections and the majority (50/66) were *Ascaris* infections. All remaining infections were tapeworms; no children were infected with *T. trichiura* or hookworm. We observed no difference in helminth prevalence between intervention and control groups. *Giardia* infection was common, and consistent with slightly improved water quality in the intervention group, we found lower *Giardia* prevalence among children in intervention villages (18%) compared to children in control villages (23%) (mean difference: 4.8%; *p*-value = 0.047). We detected no *Cryptosporidium* infections in the study children, and a low prevalence of *E. histolytica* (33 out of 1,150; 2.9%). 

## Anemia and Anthropometry Anemia was prevalent in the study children (54%) and children were small according to international growth standards ([Table 4](#)). However, we found no differences between the randomized groups in anemia prevalence or growth outcomes. 

## Subgroup Results [Table 5](#) presents the results of subgroup analyses of the effect of the intervention on households with or without any type of IHL at baseline and BPL or non-BPL households. As expected, the program had the largest improvements on JMP defined improved sanitation facilities, IHL use as assessed by enumerators, and reduced reported open defecation by household members in households that did not have IHL (any type) at baseline and in BPL households. This finding is consistent with the TSC design that targeted households without IHLs and offered larger IHL construction subsidies for BPL households. Among BPL households, the intervention increased JMP defined improved sanitation facilities coverage by 30 percentage points (48% intervention versus 18% control; *p*-value\<0.001) and it reduced open defecation among women by 17 percentage points (73% intervention versus 90% control; *p*-value\<0.001). Despite larger improvements in these intermediate outcomes among BPL households or households without IHL at baseline, we did not observe consistent improvement in health outcomes in these subgroups ([Table 5](#)). ::::table-wrap
10.1371/journal.pmed.1001709.t005

::: caption



##

##

## Differential effect of the intervention by population subgroups, 2011.

:::

![](<>)

Characteristics Control Group[a](#) Intervention Group[a](#) ITT Unadjusted[b](#) ITT Adjusted[c](#)

______________________________________________________________________

```
                                                       *N*                   Mean                       *N*                    Mean                 Difference [95% CI][d](#)              Difference [95% CI][d](#)
```

**HH with JMP defined improved sanitation facilities**\
All HH 1,512 0.224 1,522 0.414 0.189 [0.119--0.259][\*\*\*](#) 0.178 [0.108--0.247][\*\*\*](#)
HH with IHL (any type) at baseline 190 0.979 212 0.967 −0.018 [−0.056 to 0.020] 0.001 [−0.027 to 0.029]
HH with no IHL (any type) at baseline 1,319 0.114 1,297 0.318 0.202 [0.139--0.264][\*\*\*](#) 0.209 [0.142--0.277][\*\*\*](#)
BPL HH 551 0.181 452 0.476 0.307 [0.227--0.388][\*\*\*](#) 0.320 [0.234--0.406][\*\*\*](#)
Non-BPL HH 961 0.249 1,070 0.388 0.135 [0.059--0.210][\*\*\*](#) 0.108 [0.027--0.189][\*\*\*](#)
**Reported daily OD by women**\
All HH 1,514 0.835 1,525 0.732 −0.102 [−0.159 to −0.045][\*\*\*](#) −0.091 [−0.141 to −0.041][\*\*\*](#)
HH with IHL (any type) at baseline 191 0.105 214 0.103 0.000 [−0.078 to 0.077] 0.005 [−0.070 to 0.080]
HH with no IHL (any type) at baseline 1,320 0.941 1,297 0.837 −0.101 [−0.140 to −0.062][\*\*\*](#) −0.097 [−0.140 to −0.054][\*\*\*](#)
BPL HH 551 0.902 453 0.733 −0.178 [−0.241 to −0.115][\*\*\*](#) −0.169 [−0.233 to −0.105][\*\*\*](#)
Non-BPL HH 963 0.796 1,072 0.732 −0.061 [−0.129 to 0.006][\*](#) −0.029 [−0.097 to 0.040]
***E. coli*** **present in household drinking water**\
All HH 403 0.821 404 0.767 −0.055 [−0.111 to 0.000][\*](#) −0.032 [−0.101 to 0.036]
HH with IHL (any type) at baseline 54 0.796 60 0.817 0.004 [−0.183 to 0.192] −0.003 [−0.137 to 0.131]
HH with no IHL (any type) at baseline 347 0.827 340 0.765 −0.064 [−0.121 to −0.006][\*\*](#) −0.055 [−0.135 to 0.026]
BPL HH 147 0.803 111 0.739 −0.069 [−0.169 to 0.031] −0.076 [−0.198 to 0.047]
Non-BPL HH 256 0.832 293 0.778 −0.054 [−0.125 to 0.017] −0.042 [−0.128 to 0.043]
**Diarrhea in the past 7 days**[e](#)\
All HH 2,609 0.077 2,600 0.074 −0.003 [−0.019 to 0.013] −0.002 [−0.019 to 0.015]
HH with IHL (any type) at baseline 302 0.063 343 0.035 −0.034 [−0.072 to 0.003][\*](#) −0.037 [−0.083 to 0.010]
HH with no IHL (any type) at baseline 2,302 0.079 2,231 0.080 0.001 [−0.016 to 0.018] 0.003 [−0.015 to 0.021]
BPL HH 949 0.085 783 0.078 −0.005 [−0.031 to 0.021] 0.004 [−0.022 to 0.029]
Non-BPL HH 1,660 0.072 1,817 0.073 0.000 [−0.019 to 0.019] −0.001 [−0.023 to 0.021]
***Ascaris lumbricoides*** **infection**[f](#)\
All HH 569 0.044 581 0.043 −0.002 [−0.021 to 0.017] −0.011 [−0.031 to 0.010]
HH with IHL (any type) at baseline 82 0.037 92 0.043 −0.004 [−0.051 to 0.043] −0.005 [−0.087 to 0.078]
HH with no IHL (any type) at baseline 487 0.045 482 0.041 −0.004 [−0.025 to 0.017] −0.013 [−0.033 to 0.006]
BPL HH 221 0.045 160 0.044 0.008 [−0.030 to 0.046] 0.023 [−0.026 to 0.072]
Non-BPL HH 348 0.043 421 0.043 −0.001 [−0.027 to 0.026] −0.022 [−0.046 to 0.001][\*](#)
***Giardia lamblia*** **infection**[f](#)\
All HH 569 0.232 581 0.184 −0.048 [−0.096 to −0.001][\*\*](#) −0.036 [−0.088 to 0.015]
HH with IHL (any type) at baseline 82 0.232 92 0.185 −0.115 [−0.221 to −0.008][\*\*](#) −0.060 [−0.206 to 0.086]
HH with no IHL (any type) at baseline 487 0.232 482 0.185 −0.041 [−0.094 to 0.011] −0.036 [−0.094 to 0.023]
BPL HH 221 0.226 160 0.144 −0.073 [−0.141 to −0.005][\*\*](#) −0.059 [−0.139 to 0.020]
Non-BPL HH 348 0.236 421 0.200 −0.041 [−0.098 to 0.016] −0.027 [−0.088 to 0.035]

The number of observations used to estimate means of the intervention
and the control groups is the same as the number of observations used in
ITT-unadjusted analysis.

Explanatory variables in the unadjusted model include the treatment
assignment and indicator variables for Blocks. Therefore, the ITT
effects for outcomes may not be exactly the difference between the
listed mean in intervention and control groups in previous columns.

Because of missing adjustment variables data, the observations used in
adjusted analysis are fewer than those used in unadjusted analysis.

Following the commonplace norms, statistical significance is indicated
as:

\*\*\*significant at α = 0.01;

\*\*significant at α = 0.05;

\*significant at α = 0.10.

Please note that *p*-values are not adjusted for multiple comparisons
following guidance from Schulz and Grimes [[43]](#).

For children less than 60 months of age.

For children less than 60 months of age. The eldest child less than 60
months of age selected from a household.

BPL, based on verification of household's food ration card; HH,
household; non-BPL, households who do not have/show BPL ration card; OD,
open defecation.::::


Extracted trial result:
Outcome: Open defecation - children (binary)
Intervention: Total Sanitation Campaign
Comparator: Control
Intervention events: 1279
Intervention group size: 1,525
Comparator events: 1350
Comparator group size: 1,514
Notes: Used percent to calculate outcomes for binary variables.