Software Interventions for Improving Hand Washing and Sanitation in Rural Tanzania: an Impact Evaluation
Primary Purpose
Diarrhea
Status
Completed
Phase
Not Applicable
Locations
Tanzania
Study Type
Interventional
Intervention
Hardware
CLTS
PHAST
RANAS
mini-RANAS
Placebo poster
Sponsored by
About this trial
This is an interventional prevention trial for Diarrhea focused on measuring Hand washing, WASH, RANAS, Behavior change
Eligibility Criteria
Inclusion Criteria:
- All people above 18 years of age.
Exclusion Criteria:
-
Sites / Locations
- Tanzania Red Cross Society
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
RANAS
Mini-RANAS
Control
Arm Description
Hardware CLTS+PHAST RANAS (contextualized)
Hardware CLTS+PHAST mini-RANAS (norms)
Hardware CLTS+PHAST Placebo
Outcomes
Primary Outcome Measures
Change in hand washing behavior
The primary outcome is the percentage of households washing hands. The outcome measure will be obtained by means of a self-developed WASH questionnaire, which involves both multiple choice questions and spot checks.
A household was defined to have correct HW behavior when they: 1) have a HW station available (spot check), 2) have water and soap available at the HW station (spot check), and 3) indicate to wash their hands with water and soap (questionnaire). The analysis will be repeated for each of the critical times. Critical times of interest include: after defecation or using the latrine, before cooking or handling food, before eating, and before feeding a child.
Secondary Outcome Measures
Change in latrine use behavior
Latrine use is assessed by means of a self-developed WASH questionnaire, involving both multiple choice questions and spot checks.
A household is defined to have correct latrine use behavior when: 1) they have a latrine available (spot check), 2) the latrine minimally includes walls, a roof, a door or curtain, and a slab or concrete floor (spot check), 3) the latrine is clean (spot check), 3) they indicate to normally use the latrine when defecating at home (questionnaire), and 4) they indicate to not defecate in the open when they are at home (questionnaire). A similar analysis will be performed for latrine use behavior when people are elsewhere.
Quality of the hand washing infrastructure
Hand washing infrastructure is assessed using a self-developed questionnaire and spot checks. The quality of the HW infrastructure is scored based on the type of HW facility (i.e. running water vs. bucket) (spot check), the presence of water and/or soap (spot check), and whether or not the station is always operational (questionnaire).
Change in health
Health is assessed using a self-developed health questionnaire. The questionnaire is used to probe the prevalence rates of diarrhea, vomiting, limitations of daily activities, and need for medical care due to diarrheal illness in the past two weeks. The questionnaire also probes about the prevalence rates of hospitalization due to diarrheal illness in the past twelve months. Prevalence is subdivided into people below 5 years of age and people above 5 years of age. In some questions, a distinction was also made between men and women.
Change in EQ-5D-3L
The EQ-5D-3L is a validated questionnaire, examining 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. All items are scored on a 3-point Likert scale. Results of the EQ-5D-3L can be used to calculate the quality-adjusted life-year (QALY), a generic measure of disease burden. The QALY will be used to determine the cost-effectiveness of each intervention arm.
Quality of the latrine infrastructure
Latrine infrastructure is assessed using a self-developed questionnaire and spot checks. The quality of the latrine infrastructure is scored based on the type of facility (i.e. does it have a roof, a door, etc.) (spot check), the cleanliness (spot check), and the number of people who use the latrine (questionnaire). Information about whether or not the pit has ever been emptied, and how will also be gathered (questionnaire) as this will allow for the measurement of Sustainable Development Goal (SDG) 6 according to the WHO/UNICEF JMP (https://washdata.org/) tools.
Full Information
NCT ID
NCT03709368
First Posted
October 2, 2018
Last Updated
March 8, 2022
Sponsor
Centre for Evidence-Based Practice, Belgium
Collaborators
Tanzania Red Cross Society, Muhimbili University of Health and Allied Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03709368
Brief Title
Software Interventions for Improving Hand Washing and Sanitation in Rural Tanzania: an Impact Evaluation
Official Title
Effect of Two add-on Software Interventions for Improving Hand Washing and Sanitation in Rural Tanzania: an Impact Evaluation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
April 23, 2018 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
May 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre for Evidence-Based Practice, Belgium
Collaborators
Tanzania Red Cross Society, Muhimbili University of Health and Allied Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
BACKGROUND. Diarrhea is ubiquitous, particularly among people in low- and middle-income countries. Unsafe drinking water, poor sanitation, and insufficient hygiene are responsible for nearly 90% of diarrhea-related mortalities. Despite extensive knowledge that has been obtained in recent years, there is no consensus as to the most efficacious approach to improve Water, Sanitation, and Hygiene behavior and health. With this study, we want to determine whether multi-faceted contextualized and non-contextualized WASH interventions have a differential impact.
OBJECTIVES. The primary objective is to determine the effectiveness of a contextualized and non-contextualized add-on intervention for improving hand washing (HW) behavior. Secondary objectives include the impact on latrine use, health, coverage of HW and latrine infrastructure, quality of life, and cost-effectiveness.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea
Keywords
Hand washing, WASH, RANAS, Behavior change
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1500 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RANAS
Arm Type
Experimental
Arm Description
Hardware CLTS+PHAST RANAS (contextualized)
Arm Title
Mini-RANAS
Arm Type
Experimental
Arm Description
Hardware CLTS+PHAST mini-RANAS (norms)
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Hardware CLTS+PHAST Placebo
Intervention Type
Other
Intervention Name(s)
Hardware
Intervention Description
Community sessions will be provided to each of the sub-villages (n=27) teaching participants how to build a tippy tap, how to build an improved latrine, and how to make liquid soap. In addition, an existing water gravity flow scheme will be rehabilitated and extended, 350 tippy taps and 350 pans for pour flush latrines will be distributed, and sanitation blocks will be built in four schools. Within these schools, SWASH school hygiene clubs will be organized.
Intervention Type
Behavioral
Intervention Name(s)
CLTS
Intervention Description
CLTS sanitation and HW sessions will be given. A first session will focus on sanitation, covering 7 exercises: 1) sanitation or social map, 2) transect walk, 3) shit calculation, 4) medical expenses, 5) shit flow diagram, and 6) water/shit demo, 7) community declaration. A second session will focus on HW, involving 10 exercises: 1) anal cleansing materials, 2) shit and shake, 3) cassava/egg demonstration, 4) charcoal smearing, 5) smelly hands, 6) feces on baby nappies, 7) scratch & smell, 8) wall contamination, 9) food sharing, 10) dirt under fingernails. These sessions will take approximately 3-5 hours each. Follow-up community meetings and household visits will take place to monitor improvement.
Intervention Type
Behavioral
Intervention Name(s)
PHAST
Intervention Description
PHAST sessions are based on the 'PHAST step-by-step guide: A participatory approach for the control of diarrhoeal disease' of the World Health Organization. Considering the overlap with some CLTS activities, only a selection of the full guideline will be enrolled, namely: 1) Health problems in our community, 2) Good and bad hygiene behaviors, 3) Investigating community practices, 4) How diseases spread, 5) Blocking the spread of disease, 6) Selecting the barriers, 7) Choosing sanitation improvements, and 8) Choosing improved hygiene behaviors. These 8 activities will be enrolled in approximately 40 community groups. Each activity will take between 30 minutes - 2 hours to complete.
Intervention Type
Behavioral
Intervention Name(s)
RANAS
Intervention Description
Nine household visits of 20-40 min each will be offered at a frequency of one visit every two months. The content of these add-on visits is based on the RANAS manual: 'Systematic Behavior Change in Water, Sanitation and Hygiene - A practical guide to using the RANAS approach' (www.ranasmosler.com). First, baseline data is gathered through a questionnaire to better understand the context that is at play. Next, this data is analyzed in a do'er non-do'er analysis. Only those behavioral factors that are significantly different between do'ers and non-do'ers will be included in the intervention, as these are, at least theoretically, considered to be decisive for HW and latrine use behavior in the current setting.
Intervention Type
Behavioral
Intervention Name(s)
mini-RANAS
Intervention Description
Nine household visits of 20-40 min each will be offered at a frequency of one visit every two months. The content of the mini-RANAS add-on intervention is based on the 'Norm Behavior Change Techniques' from the RANAS manual 'Systematic Behavior Change in Water, Sanitation and Hygiene - A practical guide to using the RANAS approach' (www.ranasmosler.com). During the mini-RANAS household visits, emphasis will be put on norms and volunteers will encourage participants to become a role model by improving HW and sanitation infrastructure and behavior.
Intervention Type
Other
Intervention Name(s)
Placebo poster
Intervention Description
One household visit will be offered. During this visit, a placebo poster will be distributed focusing on first aid. The topics to be discussed are burns, cuts and grazes. The main goal of this household visit is to avoid jealousy among the control cohort.
Primary Outcome Measure Information:
Title
Change in hand washing behavior
Description
The primary outcome is the percentage of households washing hands. The outcome measure will be obtained by means of a self-developed WASH questionnaire, which involves both multiple choice questions and spot checks.
A household was defined to have correct HW behavior when they: 1) have a HW station available (spot check), 2) have water and soap available at the HW station (spot check), and 3) indicate to wash their hands with water and soap (questionnaire). The analysis will be repeated for each of the critical times. Critical times of interest include: after defecation or using the latrine, before cooking or handling food, before eating, and before feeding a child.
Time Frame
The outcome is measured at baseline, and after 1 and 2 years of intervention. In addition, a measurement will occur 1 year after the intervention has finished to see whether improvements have been maintained.
Secondary Outcome Measure Information:
Title
Change in latrine use behavior
Description
Latrine use is assessed by means of a self-developed WASH questionnaire, involving both multiple choice questions and spot checks.
A household is defined to have correct latrine use behavior when: 1) they have a latrine available (spot check), 2) the latrine minimally includes walls, a roof, a door or curtain, and a slab or concrete floor (spot check), 3) the latrine is clean (spot check), 3) they indicate to normally use the latrine when defecating at home (questionnaire), and 4) they indicate to not defecate in the open when they are at home (questionnaire). A similar analysis will be performed for latrine use behavior when people are elsewhere.
Time Frame
The outcome is measured at baseline, and after 1 and 2 years of intervention. In addition, a measurement will occur 1 year after the intervention has finished to see whether improvements have been maintained.
Title
Quality of the hand washing infrastructure
Description
Hand washing infrastructure is assessed using a self-developed questionnaire and spot checks. The quality of the HW infrastructure is scored based on the type of HW facility (i.e. running water vs. bucket) (spot check), the presence of water and/or soap (spot check), and whether or not the station is always operational (questionnaire).
Time Frame
The outcome is measured at baseline, and after 1 and 2 years of intervention. In addition, a measurement will occur 1 year after the intervention has finished to see whether improvements have been maintained.
Title
Change in health
Description
Health is assessed using a self-developed health questionnaire. The questionnaire is used to probe the prevalence rates of diarrhea, vomiting, limitations of daily activities, and need for medical care due to diarrheal illness in the past two weeks. The questionnaire also probes about the prevalence rates of hospitalization due to diarrheal illness in the past twelve months. Prevalence is subdivided into people below 5 years of age and people above 5 years of age. In some questions, a distinction was also made between men and women.
Time Frame
The outcome is measured at baseline, and after 1 and 2 years of intervention. In addition, a measurement will occur 1 year after the intervention has finished to see whether improvements have been maintained.
Title
Change in EQ-5D-3L
Description
The EQ-5D-3L is a validated questionnaire, examining 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. All items are scored on a 3-point Likert scale. Results of the EQ-5D-3L can be used to calculate the quality-adjusted life-year (QALY), a generic measure of disease burden. The QALY will be used to determine the cost-effectiveness of each intervention arm.
Time Frame
The outcome is measured at baseline, and after 1 and 2 years of intervention. In addition, a measurement will occur 1 year after the intervention has finished to see whether improvements have been maintained.
Title
Quality of the latrine infrastructure
Description
Latrine infrastructure is assessed using a self-developed questionnaire and spot checks. The quality of the latrine infrastructure is scored based on the type of facility (i.e. does it have a roof, a door, etc.) (spot check), the cleanliness (spot check), and the number of people who use the latrine (questionnaire). Information about whether or not the pit has ever been emptied, and how will also be gathered (questionnaire) as this will allow for the measurement of Sustainable Development Goal (SDG) 6 according to the WHO/UNICEF JMP (https://washdata.org/) tools.
Time Frame
The outcome is measured at baseline, and after 1 and 2 years of intervention. In addition, a measurement will occur 1 year after the intervention has finished to see whether improvements have been maintained.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All people above 18 years of age.
Exclusion Criteria:
-
Facility Information:
Facility Name
Tanzania Red Cross Society
City
Kigoma
Country
Tanzania
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31311186
Citation
Dockx K, Van Remoortel H, De Buck E, Schelstraete C, Vanderheyden A, Lievens T, Kinyagu JT, Mamuya S, Vandekerckhove P. Effect of Contextualized Versus Non-Contextualized Interventions for Improving Hand Washing, Sanitation, and Health in Rural Tanzania: Study Design of a Cluster Randomized Controlled Trial. Int J Environ Res Public Health. 2019 Jul 15;16(14):2529. doi: 10.3390/ijerph16142529.
Results Reference
derived
Links:
URL
http://www.cebap.org
Description
Related Info
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Software Interventions for Improving Hand Washing and Sanitation in Rural Tanzania: an Impact Evaluation
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