Results of including family water filters to Rwanda’s Group-Primarily based Environmental Well being Promotion Programme: a cluster-randomized managed trial in Rwamagana district

We carried out a cluster randomized managed trial in Rwamagana district to find out whether or not including a household-based water filter with secure storage to the CBEHPP might be efficient in bettering consuming water high quality.

Intervention

The intervention beneath analysis is the supply and promotion of the LifeStraw Household 2.0 filters within the CBEHPP program. The filter is a tabletop point-of-use water therapy system that features an 80 μm pre-filter to take away coarse materials, 20 nm hollow-fiber ultrafiltration membrane, backwash lever, and lined storage container with 5.5 L capability. The system meets the WHO’s “complete safety” guideline for family water therapy applied sciences³⁶; it may well filter as much as 18,000 liters of water, which ought to be capable of provide a household of 5 with clear consuming water for 3 to 5 years, with none alternative of elements³⁷.

Supply and promotion of the filter is thru the CBEHPP, which organizes village-level CHCs with a most membership of 100 households. Golf equipment purpose to satisfy weekly and are led by volunteer CHC facilitators which are educated to ship a 20-module curriculum designed by the Ministry of Well being. The filter-integrated intervention duties CHC facilitators to moreover function the first service suppliers of the filter. The CBEHPP filter integration was meant to have “lighter contact” engagement in comparison with the supply of filters within the Tubeho Neza marketing campaign. Main variations between the approaches embody Tubeho Neza’s extra supply of improved cookstoves, unique concentrating on of households belonging to the bottom financial quartile, mass media campaigns, and supplementary promotional actions reminiscent of common CHW cooperative and group conferences and frequent family visits (Barstow et al. 2016).

Bradshaw et al.³⁸ publish additional particulars on the intervention and supply of their course of analysis. CHC facilitators have been educated to advertise the filter and to restore or exchange nonfunctional models. Eligible households have been invited to obtain the filter at a mass-distribution occasion held on the essential well being heart serving the geographical sector. Following the distribution, CHC facilitators carried out particular person family visits to show households the right way to use the filter and supply a promotional poster. Households have been instructed to not use the filter till the preliminary go to was accomplished. A second promotional family go to by CHC facilitators was accomplished ~6 months later to watch repairs/performance, use, and satisfaction with the filter. CHC facilitators moreover strengthened messaging in CHC conferences. Households that have been eligible to obtain the filter included CHC members and had at the least one little one beneath the age of 5 or had at the least one pregnant girl residing within the family. All eligible households have been in a position to obtain the filter no matter being chosen to take part within the research.

Catholic Aid Companies (CRS) and SNV, two of the federal government’s major implementing NGO companions of CBEHPP, delivered the intervention with their native associate African Evangelistic Enterprise (AEE). The NGOs implement CBEHPP and its CHC mannequin by way of Gikuriro, a USAID WASH and diet program. SNV, CRS, and AEE have been supported on this preliminary distribution and promotion by Amazi Yego, the social enterprise that collaborated within the Tubeho Neza filter promotion in Western Province¹⁷. Amazi Yego educated CRS, SNV, and AEE and shared experiences in filter supply. Amazi Yego was additionally considerably concerned in designing the implementation protocol, offering promotional materials to be supplied to house owners and implementing the intervention alongside CRS/SNV/AEE.

Research design

We employed a cluster-randomized managed trial design to evaluate the consequences of the intervention on point-of-use (POU) consuming water high quality as the first end result; we additionally assess intervention protection and use and results on reported diarrhea as secondary outcomes. The trial was carried out over 13–16 months in two follow-up visits. Rwamagana is a primarily rural district in Rwanda’s Jap Province and has a inhabitants of 313,461 individuals³⁹. Rwamagana was chosen as a result of it’s situated in Jap Province, which has one of many highest charges of fecal contamination of consuming water within the nation⁴ and since it was one of many districts the implementers labored in. SNV and CRS are lively in all 474 villages throughout Rwamagana.

Sixty villages (clusters) have been randomly chosen, with 30 receiving the intervention (CBEHPP + filter) and 30 serving as controls (CBEHPP alone). Villages have been randomly chosen from an inventory of the 474 eligible villages utilizing likelihood proportional-to-size sampling (PPS) with out alternative utilizing samplepps in Stata 16 software program⁴⁰. PPS was finished primarily based on the implementer’s reported dimension of the CHC in every village.

Households in chosen villages have been eligible to take part within the research in the event that they have been verified eligible to obtain the intervention (CHC member households who had at the least one little one beneath 5 or pregnant particular person residing within the family at time of baseline) and had a family member that was over 18 years of age obtainable to consent to enrollment. A listing of eligible households was made for every of the 60 villages by consulting the district registers, CHC registers, and with the CHC facilitators. Eligible households per village ranged from 10–72 households. Twenty-five households have been randomly chosen to be enrolled within the research from every village checklist utilizing easy random sampling utilizing the pattern perform to randomly order households in R statistical software program⁴¹. Different eligible households have been deemed as alternative research households. Enumerators have been instructed to aim every of the randomly chosen 25 households twice at the least 2 h aside throughout the day. If households couldn’t be reached or have been in any other case discovered to be ineligible, enumerators enrolled one of many alternative households primarily based on a random order. To finish a village, at the least half of the eligible households within the village wanted to have been enrolled, however a cap of 25 households per village was enforced because of logistical constraints.

Randomization and blinding

Random allocation of the intervention and management teams was finished on the village stage. To assist guarantee geographical stability between arms, random allocation of the intervention was stratified by the 13 sectors inside the district. A person unaffiliated with the challenge carried out the allocation. The information assortment staff, village-level implementers/leaders (e.g., CHC facilitators, village leaders, CHWs, AEE employees) and taking part households have been blinded to the allocation throughout baseline knowledge assortment. Enumerators and households couldn’t be blinded after implementation because of the nature of the intervention. The first knowledge analyst moreover oversaw and managed the info assortment, and subsequently, couldn’t be blinded. The principal investigator remained blinded all through the research length.

Baseline and follow-ups

A baseline survey was carried out from December 2018 to March 2019 previous to intervention supply. The intervention was delivered from March to June 2019. A midline survey was carried out 5–7 months (median 6 months) following intervention supply from October to December 2019. The endline survey was initially deliberate to be carried out 6 months later. Nonetheless, because of authorities lockdowns and restrictions from COVID-19, the endline survey was delayed by roughly 2 months and was accomplished 13–16 months (median 14 months) after intervention supply from July-September 2020. We aimed to have equal variety of intervention and management villages visited in a day. We collected consuming water samples and knowledge on family and demographic traits, reported and noticed WASH entry primarily based on the WHO/UNICEF Joint Monitoring Programme (JMP) core family survey questions⁴², reported and noticed water therapy and dealing with practices, and caretaker-reported well being of kids beneath 5. Questions have been directed to the first cooks aged 18 and over. If the first prepare dinner was unavailable or beneath 18, questions have been directed to a different family member aged 18 and over. Respondents have been requested to verify questions on particular person youngsters with their respective major caregivers in the event that they have been obtainable. Survey knowledge have been collected and managed utilizing REDCap digital knowledge seize instruments hosted at Emory College⁴³.

Main and secondary outcomes

The first end result is detectable E. coli contamination of consuming water. Following the WHO/UNICEF JMP core family survey questions, every respondent was requested to serve consuming water. A 100 mL pattern was collected at every follow-up go to in a sterile Whirl-Pak® bag containing sodium thiosulfate (Nasco, Madison, WI, USA) and stored on ice till examined inside 8 h with CompactDry™ (Nissui Pharmaceutical, Tokyo, Japan) media plates utilizing membrane filtration procedures prescribed by UNICEF⁴⁴. Samples have been initially diluted to 50 mL with a purpose to scale back the probability of plates that have been too quite a few to rely (TNTC). If consuming water samples have been visibly turbid, then they have been subsequently diluted to twenty mL, 10 mL, and 5 mL primarily based on the severity of turbidity. Plates have been incubated at 30 levels Celsius for twenty-four hours utilizing an IncuBox Thermocult (Boehringer, Mannheim, Germany). One technician then counted and recorded particular person E. coli CFU on every plate. Random spot checks have been carried out by managers to validate counts. Water high quality outcomes have been double entered by two completely different employees. Plates that have been TNTC have been assigned a stage of 300 CFUs. Not less than one duplicate and clean of distilled water have been examined with samples day by day. For duplicate samples, the outcomes of each counts have been summed and divided by the full quantity processed. With a view to receive standardized totals per 100 mL, we normalized the CFU rely by the full quantity processed and multiplied the outcome by 100.

Secondary well being outcomes embody caregiver-reported diarrhea and healthcare visits for diarrhea inside the earlier 7-days in youngsters beneath 5 years of age and beneath 2 years of age at follow-up visits. For reporting diarrhea within the earlier 7-days, we adopted the World Well being Group (WHO) commonplace definition, which defines diarrhea as three or extra unfastened stools in a 24-hour interval that may take the form of a container⁴⁵. For reporting healthcare visits, we requested caregivers in the event that they sought medical care from a well being clinic or CHW for any reported diarrhea instances inside the earlier 7-days following the WHO definition of diarrhea or caregiver’s interpretation of diarrhea. We additionally collected knowledge on whether or not youngsters had a toothache within the earlier 7-days to function damaging management to account for courtesy bias⁴⁶.

We collected knowledge on filter protection, use, and acceptability at midline and endline visits. To measure filter protection, we noticed whether or not the family had the filter and if the filter was in good situation on the time of go to (e.g., assembled correctly, working faucet, no leaking, undamaged container, satisfactory flowrate, and skill to backwash). To measure filter use, we collected knowledge on whether or not the filter was noticed to have water in it on the time of go to and whether or not the family reported utilizing the filter, filling the filter within the earlier 7-days, treating consuming water, and if a baby beneath 5 drank filtered water the day past. To measure filter acceptability, we requested households to fee their acceptability of the looks of filtered water, scent, style of filtered water, and time to filter water on a scale from 1 to 4, with 3 and 4 being acceptable and really acceptable, respectively.

Statistical strategy

The research was powered to detect a 25% discount in prevalence of detectable E. coli micro organism in point-of-use water samples, measured at every family go to. The variety of households required in every group was derived by first utilizing Diggle, Heagerty, Liang, and Zeger’s⁴⁷ components for estimating sample-size necessities for variations in proportions throughout a number of time factors. The results of this equation was then adjusted to account for each village-level clustering and the assumed 15% fee of attrition. We assumed 50% prevalence of E. coli presence in consuming water samples within the management group primarily based on nationwide water high quality surveys. We additional assumed an intra-village correlation of 0.14 and intra-household ICC of 0.21 primarily based on earlier research¹⁸, 2 visits postbaseline, and 25 households per village would meet eligibility necessities. This gave us a pattern dimension requirement of 51 villages to have 80% energy for a 25% discount. To additional accommodate the uncertainties of CHC enrollment charges and village dimension, we aimed to enroll as much as 1300 households throughout 60 villages.

We outlined the first end result because the presence of E. coli micro organism in 100 mL samples of consuming water. Because the samples have been diluted for functions of this evaluation, the presence of E. coli CFU follows the restrict of detection (LOD) in response to the amount processed. The laboratory outcomes confirmed that the full quantity of water processed for family samples that didn’t show any CFUs (e.g., non-detect plates) ranged from 50 mL to 100 mL. Subsequently, outcomes have been categorized right into a binary variable, the place non-detectable E. coli contamination is total reported as <2 CFU/100 mL water (e.g., LOD for a 50 mL pattern). We moreover categorized E. coli presence into two different binary outcomes in response to WHO danger class cutoffs for moderate-to-high (≥10 CFU/100 mL) and really excessive (≥100 CFU/100 mL) contamination²⁰. We examined the latter outcomes primarily based on findings from meta-analysis on water high quality and diarrhea, which discovered a marked enhance in illness danger for households when fecal contamination exceeded 10 TTC/100 mL³³. We calculated arithmetic and Williams technique of CFU counts to account for the skewed distribution. The Williams imply is calculated by including 1 to all values, taking the geometric imply, after which subtracting the imply by 1⁴⁸. Williams imply have been used to account for values lower than 1. Non-detect plates have been included within the imply calculation as half of their particular LOD.

The impact of the intervention was assessed primarily based on group task, no matter uptake of the intervention (i.e. intention-to-treat). For the household-level major outcomes on E. coli presence in consuming water and the individual-level secondary outcomes on little one well being, we used binomial regression with a log hyperlink and generalized estimating equations (GEE) with strong commonplace errors to account for village-level clustering^49,50. For the kid well being fashions, we adjusted for intercourse and age in months. We estimated prevalence ratios by calculating the exponential of the mannequin coefficients for the group task. Statistically vital impact of the task have been decided through the use of a two-sided Sort I error fee of 0.05. We offer pattern proportions and 95% confidence intervals for outcomes on filter protection, acceptability, and use within the intervention group.

Covariate adjustment for imbalance

We reviewed the baseline knowledge to see if there have been giant variations (>10% distinction) between arms in socio-economic and family variables which are established determinants of consuming water high quality or childhood diarrhoea (Desk 1). Covariates that had little variation within the research inhabitants (e.g., over 95% prevalence or lower than 5% prevalence) have been excluded from adjustment. We then examined the connection between major and secondary outcomes and imbalanced covariates of concern (e.g., socioeconomic standing, entry to handwashing location, and entry to improved sanitation) in particular person bivariate analyses. Socioeconomic standing was related to diarrheal prevalence in youngsters beneath 5 and a couple of (p < 0.05). Entry to a handwashing location was related (p < 0.05) with solely very excessive ranges of E. coli micro organism (≥100 CFU/100 mL) and to diarrheal prevalence in youngsters beneath 5 (p < 0.05). Entry to sanitation was not related to any end result. We adjusted for socio-economic standing and entry to handwashing station in separate sensitivity analyses and in contrast outcomes to unadjusted fashions to see if there have been appreciable variations in results of the intervention. Water high quality results noticed in unadjusted fashions have been similar to fashions adjusted for entry to handwashing. Results on under-5 little one diarrhoea prevalence from the intervention had a 5 p.c distinction between the unadjusted mannequin and adjusted mannequin with socioeconomic standing. Results on under-5 little one diarrhoea prevalence from the intervention had lower than one p.c distinction between the unadjusted mannequin and adjusted mannequin with entry to handwashing location. Subsequently, we selected to solely alter for socio-economic standing in all ultimate fashions. Unadjusted and adjusted fashions are introduced collectively in Tables 3 and 4.

Clustering issues

Present GEE statistical packages are restricted in that they solely enable for adjusting for one stage of clustering. We adjusted on the village-level as a result of it’s the highest stage of clustering that’s of concern and the unit of randomization⁵¹, which ought to intrinsically alter for decrease ranges of clustering⁴⁹. In sensitivity analyses, we adjusted for household-level clustering to account for longitudinal sampling, however didn’t see main variations within the water high quality or diarrhea results in comparison with the fashions adjusted for village-level clustering. The comparability in introduced within the water high quality leads to Supplementary Desk 2.

All analyses have been finished utilizing Stata 16 (Stata Company, School station, TX, USA)⁵².

Ethics and registration

The trial is registered beneath the Pan African Scientific Trial Registry, Trial ID = PACTR201812547047839. The protocol acquired moral approval and was yearly renewed by the Emory College Institutional Overview Board (CR001-IRB00106424) and Rwanda Nationwide Ethics Committee (IRB 0001497). We obtained signed knowledgeable consent from the principle survey respondent throughout enrollment.