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Urban Drinking Water and Health Outcomes – Early Phase Study for a Randomized Controlled Trial in Accra, Ghana
Last registered on December 12, 2014

Pre-Trial

Trial Information
General Information
Title
Urban Drinking Water and Health Outcomes – Early Phase Study for a Randomized Controlled Trial in Accra, Ghana
RCT ID
AEARCTR-0000572
Initial registration date
December 12, 2014
Last updated
December 12, 2014 10:32 AM EST
Location(s)
Region
Primary Investigator
Affiliation
University of Southampton
Other Primary Investigator(s)
PI Affiliation
School of Public Health, University of Ghana
PI Affiliation
University of Southampton
Additional Trial Information
Status
In development
Start date
2015-01-19
End date
2015-12-31
Secondary IDs
MR/M008940/1
Abstract
Use of sachet water (small quantities of drinking-water sold in plastic bags) is growing rapidly in West Africa, yet its health impact remains unmeasured and the appropriate regulatory environment remains ill-defined. This project assesses the feasibility of a possible intervention to reduce childhood diarrhoea through targeted, subsidised sachet water provision. We will explore practical issues involved in implementing the intervention and measuring changes in childhood diarrhoea incidence as a result of providing subsidised sachet water to households in Accra, Ghana with only intermittent piped water supplies. The microbiological quality of sachet water in Accra will be tested to determine its safety. Participating households will receive vouchers to obtain sachets (for free or at a 50% discount) from local water vendors. We shall measure childhood diarrhoea, household drinking-water and sachet use, and vendors’ sachet sales in the pilot to gain insights into how sachet voucher provision affects households and vendors. If feasible, we propose to conduct a larger randomized controlled trial to measure the health impact and cost-effectiveness of providing subsidised sachet water to young children in Accra. In this main trial, by examining differences in diarrhoea rates and growth in children in different study arms, we plan to assess whether greater sachet use as a result of subsidy or free provision protects against water-borne disease and thus contribute to child growth and development. This will allow us to assess whether the costs of sachet water regulation or subsidy are justified by reductions in diarrhoeal disease and child mortality.
External Link(s)
Registration Citation
Citation
Adanu, Richard, Allan Hill and Jim Wright. 2014. "Urban Drinking Water and Health Outcomes – Early Phase Study for a Randomized Controlled Trial in Accra, Ghana." AEA RCT Registry. December 12. https://doi.org/10.1257/rct.572-1.0.
Former Citation
Adanu, Richard, Allan Hill and Jim Wright. 2014. "Urban Drinking Water and Health Outcomes – Early Phase Study for a Randomized Controlled Trial in Accra, Ghana." AEA RCT Registry. December 12. https://www.socialscienceregistry.org/trials/572/history/3251.
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Experimental Details
Interventions
Intervention(s)
The primary intervention will be the fortnightly distribution of vouchers for sachet water. Households selected for Arm A will be provided with vouchers to obtain for free 2 litres of sachet water per day per eligible child for a period of three months. For the second set of households, Arm B, we will provide vouchers to obtain 2 litres of sachet water per day per eligible child but at a 50% discount. The water quantity used for the intervention is based on the daily recommended fluid intake. The WHO standards (Holliday-Segar Calculation) recommend a fluid intake of 100 ml/kg/day for children weighing less than < 10 kg, plus 50 ml/kg/day for each additional kg up to 20 kg. In Arms A and B, adult caregivers will be advised to make sure children drink the sachet water with which they are provided. Sachet water distribution will be managed through local vendors, who will be reimbursed for the vouchers collected. All study subjects (including those in the control arm) will receive training on appropriate diarrhoea treatment.
Intervention Start Date
2015-02-09
Intervention End Date
2015-05-08
Primary Outcomes
Primary Outcomes (end points)
The primary outcome is the cumulative incidence of diarrhoeal disease episodes during the 3-month observation period among children aged 6-36 months within participating households. Secondary outcomes include measures of the child's general health and treatment sought for child diarrhoea, including clinic visits and use of Oral Rehydration Salts (ORS).
Primary Outcomes (explanation)
Diarrhoea episodes will be recorded through a pictorial diarrhoea diary, which be collected on a fortnightly basis by the research team. Children's main care-givers will use these diaries to record the number of loose or watery stools per day and the number of bloody stools per day.
Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
A feasibility study for a three-arm randomised controlled trial involving 80 households in 4 Enumeration Areas in urban Accra, Ghana. Children’s carers in the control arm will receive education on diarrhoea prevention and treatment; the second arm will receive vouchers for 2 litres/day of free drinking-water sachets plus education, and the third group vouchers for 2 litres/day of subsidised sachets plus education. We will monitor diarrhoeal disease and related measures among participating children over a three month period of voucher distribution. We shall also undertake a cross-sectional sachet water quality survey to assess sachet safety at baseline.
Experimental Design Details
Randomization Method
Randomization in office by computer, constrained to balance numbers of households in each arm.
Randomization Unit
Unit of randomization: household
Was the treatment clustered?
No
Experiment Characteristics
Sample size: planned number of clusters
4 Enumeration Areas
Sample size: planned number of observations
80 households
Sample size (or number of clusters) by treatment arms
26 control; 27 fully subsidised water sachets; 27 partially subsidised water sachets.
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
As this is a proof-of-concept study to assess the feasibility of implementing a complex intervention (i.e. a system for distribution of vouchers for sachet water), the numbers of households above are not based on a power calculation.
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Noguchi Memorial Institute for Medical Research, University of Ghana
IRB Approval Date
2014-09-03
IRB Approval Number
006/14-15
IRB Name
University of Southampton Research Governance Office
IRB Approval Date
2014-09-23
IRB Approval Number
12241
Post-Trial
Post Trial Information
Study Withdrawal
Intervention
Is the intervention completed?
No
Is data collection complete?
Data Publication
Data Publication
Is public data available?
No
Program Files
Program Files
Reports and Papers
Preliminary Reports
Relevant Papers