Methods |
Cluster RCT |
Participants |
Number: 113 HHs at end of study (after 14.4% LTFU from baseline) Inclusion criteria: pregnant women in their second/third trimester and caregivers of children aged < 3 months |
Interventions |
Interventions (3 arms)
Water (baseline: 38 HHs, end of study: 36 HHs, 9 villages): installing chlorine dispensers at respondents' reported water sources within the village (usually a protected spring, well, or other source of groundwater) and behaviour change messaging focused on treatment of drinking water with chlorine at all times and storage in a covered container and emphasis of convenience of use at the point of collection and the prevention of recontamination by chlorination.
Sanitation (baseline: 31 HHs, end of study: 25 HHs, 8 villages) (arm relevant to this review and used in analysis): Hardware: sanitation compounds received a faeces disposal sani‐scooper tool similar to a dustpan with a metal paddle (1 for each HH in the compound, cost approximately USD 2.25), a plastic child's potty (1 for each HH in the compound with a child aged < 3 years, cost approximately USD 1.07), and improvements to their existing latrine (consisting of a plastic latrine slab with a built‐in drop‐hole cover if the latrine floor was not concrete and simple mud walls, roof, and door if not present) or construction of a new latrine if they had none (which cost approximately USD 21.88 for the slab and up to approximately USD 237.50 for a new latrine). In addition there were monthly HH visits for behaviour change communication, including: songs, interactive games, and visual aids (calendars, cue cards, picture sheets). The sanitation intervention's primary behaviour change messages emphasized preventing faecal contamination of the environment and safe removal of faeces (human and animal) from the environment facilitated by the potty, sani‐scooper, and latrine. The sanitation behaviour change messages also focused on contamination pathways, behaviours that could lead to exposure, and motivators and barriers of the targeted behaviours.
Hygiene: (baseline: 33 HHs, end of study: 24 HHs, 8 villages): HHs received 2 locally manufactured dual tippy‐tap handwashing stations (2 separate pedal‐controlled jugs: 1 with soapy water and 1 with plain water): 1 for near their latrine and 1 for their cooking area, and behaviour change messaging emphasized HWWS at critical times defined as after faecal contact (e.g. after defecation and after cleaning a child who has defecated) and before handling food (e.g. before preparing food, eating, or feeding a child).
Control (baseline: 30 HHs, end of study: 24 HHs, 9 villages): no intervention |
Outcomes |
Child illness and growth (not sufficiently powered for it) Uptake of interventions:
presence of total and free chlorine in water
use of the chlorine dispenser
what the respondent had done, if anything, to dispose of the most recent child defecation (all children aged < 3 years in HH). Appropriate disposal: the child defecated directly in the latrine, or the child defecated in a nappy or potty and the parent immediately dumped the faeces into the latrine.
observation of faeces in compound
use of the sani‐scooper
handwashing frequency
observed cleanliness of hands
|
Notes |
Location: 34 rural villages near Bungoma, Western Kenya Length of study: 6 months (November 2011 to May 2012) Publication status: journal |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Each village was assigned a randomly generated number using Stata, and intervention assignments were made to villages in ascending numerical order. |
Allocation concealment (selection bias) |
Low risk |
Centrally allocated. |
Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
No blinding. |
Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
No blinding and some of the outcomes were self‐reported. |
Incomplete outcome data (attrition bias)
All outcomes |
High risk |
LTFU was high and different across arms. |
Selective reporting (reporting bias) |
High risk |
Did not report on some of the measures collected. However, authors stated that the conclusions were not affected. |
Other bias |
Unclear risk |
— |
Similarity of baseline outcome measurements |
Unclear risk |
— |
Similarity of baseline characteristics |
Unclear risk |
— |
Adequate allocation of intervention concealment during the study |
Unclear risk |
— |
Adequate protection against contamination |
Unclear risk |
— |
Confounders adequately adjusted for in analysis/design |
Unclear risk |
— |
Recruitment bias |
Low risk |
Assignment of individuals to clusters was done before randomization by having village elders define the boundaries of their village and specify in which village all potentially eligible respondents lived. |
Baseline imbalance |
Low risk |
There were some significant baseline imbalances in child faeces disposal practices. The authors adjusted for baseline imbalance (presented in supplementary table 3), which did not change the conclusions. |
Loss of clusters |
Low risk |
No loss of clusters |
Incorrect analysis |
Low risk |
Used robust standard errors |