Clinical trial NCT01214785: Cluster Randomised Trial of Improved Sanitation in Rural Orissa, India
Official title: Assessing the Effect of Improved Rural Sanitation on Diarrhoea and Intestinal Nematode Infections: a Cluster Randomised Controlled Trial in Orissa, India
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diarrhoea
Soil-transmitted Helminth Infection
Nutritional Status
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: WaterAid
name: Xavier Institute of Management, Bhubaneswar
name: Bill and Melinda Gates Foundation
name: International Initiative for Impact Evaluation
name: Department for International Development, United Kingdom
name: University of California, Davis
name: Emory University
name: Asian Institute of Public Health
name: Kalinga Institute of Industrial Technology
First posted: 2010-10-05
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study is a cluster-randomized, controlled trial conducted among 100 villages (including approximately 3500 households and 20,000 people) in Puri district, State of Orissa, India. The study aims to assess the impact of the construction and use of latrines in rural settings on diarrhoeal disease, helminth infections and nutritional status. The study will also report on the cost and cost-effectiveness of the intervention and its impact on lost days at school and work as well as on expenditures on drugs and medical treatment. The study will document how the intervention actually impacts exposure to human excreta along principal transmission pathways by evaluating the impact on (i) faecal contamination of drinking water, (ii) the presence of mechanical vectors (flies) in food preparation areas, and (iii) the presence of faeces in and around participating households and villages. The study will also explore the extent to which different levels of acquisition and use of on-site sanitation among householders impact disease throughout the community.


Eligibility criteria: Inclusion Criteria:

Village level:

* Little existing sanitation coverage (\<10%)
* WaterAid and implementing partners expects normal scale up
* Stable and reasonably acceptable water supply
* No other WASH interventions planned or anticipated in next 30 months
* Reasonable year-round access by road to permit household visits by surveillance staff

Household level:

* Presence of a child\<4 or a pregnant woman
* Consent to participate
* Reside permanently in the village

Primary outcomes:
measure: Diarrhoea (<5s)
timeFrame: 21 months
Secondary outcomes:
measure: Soil-transmitted helminth infection
timeFrame: baseline and endline
measure: Weight-for-age (<5s)
timeFrame: 21 months
measure: lost days at school and work
timeFrame: 21 months
measure: healthcare expenditure
timeFrame: 21 months
measure: latrine coverage and use
timeFrame: 21 months
measure: bacteriological water quality
timeFrame: 21 months
measure: fly counts
timeFrame: 21 months
measure: Height-for-age
timeFrame: baseline and endline
measure: Diarrhoea (all ages)
timeFrame: 21 months
Other outcomes:
Locations:
city: Bhubaneswar
country: India
facility: Xavier Institute of Management
state: Orissa
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Thomas Clasen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Routray P, Torondel B, Jenkins MW, Clasen T, Schmidt WP. Processes and challenges of community mobilisation for latrine promotion under Nirmal Bharat Abhiyan in rural Odisha, India. BMC Public Health. 2017 May 16;17(1):453. doi: 10.1186/s12889-017-4382-9.
citation: Freeman MC, Majorin F, Boisson S, Routray P, Torondel B, Clasen T. The impact of a rural sanitation programme on safe disposal of child faeces: a cluster randomised trial in Odisha, India. Trans R Soc Trop Med Hyg. 2016 Jul;110(7):386-92. doi: 10.1093/trstmh/trw043.
citation: Clasen T, Boisson S, Routray P, Torondel B, Bell M, Cumming O, Ensink J, Freeman M, Jenkins M, Odagiri M, Ray S, Sinha A, Suar M, Schmidt WP. Effectiveness of a rural sanitation programme on diarrhoea, soil-transmitted helminth infection, and child malnutrition in Odisha, India: a cluster-randomised trial. Lancet Glob Health. 2014 Nov;2(11):e645-53. doi: 10.1016/S2214-109X(14)70307-9. Epub 2014 Oct 9.
citation: Boisson S, Sosai P, Ray S, Routray P, Torondel B, Schmidt WP, Bhanja B, Clasen T. Promoting latrine construction and use in rural villages practicing open defecation: process evaluation in connection with a randomised controlled trial in Orissa, India. BMC Res Notes. 2014 Aug 1;7:486. doi: 10.1186/1756-0500-7-486.