DiarrheaNCT03709368
Software Interventions for Improving Hand Washing and Sanitation in Rural Tanzania: an Impact Evaluation
A study testing Hardware, CLTS and PHAST in people with Diarrhea, run by Centre for Evidence-Based Practice, Belgium at 1 site in Tanzania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diarrhea
- What is being tested?
- Hardware, CLTS and PHAST
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,500 participants
- Where
- 1 siteTanzania
- Study dates
- 23 Apr 2018to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All people above 18 years of age.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Two add-on Software Interventions for Improving Hand Washing and Sanitation in Rural Tanzania: an Impact Evaluation
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.
- Conditions
- Diarrhea
- Being tested
- Hardware, CLTS, PHAST, RANAS, mini-RANAS
- Keywords
- Hand washing, WASH, RANAS, Behavior change
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HardwareOther
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.
CLTSBehavioural
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.
PHASTBehavioural
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.
RANASBehavioural
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.
mini-RANASBehavioural
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.
Placebo posterOther
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.
| Study group | Role | What they receive |
|---|---|---|
| RANAS | Experimental | Hardware CLTS+PHAST RANAS (contextualized) Receives: Other: Hardware; Behavioral: CLTS; Behavioral: PHAST; Behavioral: RANAS |
| Mini-RANAS | Experimental | Hardware CLTS+PHAST mini-RANAS (norms) Receives: Other: Hardware; Behavioral: CLTS; Behavioral: PHAST; Behavioral: mini-RANAS |
| Control | Active comparator | Hardware CLTS+PHAST Placebo Receives: Other: Hardware; Behavioral: CLTS; Behavioral: PHAST; Other: Placebo poster |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (5)
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.
Measured: 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.
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).
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start23 Apr 2018
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Evidence-Based Practice, Belgium
- Sponsor type
- University, hospital or other
- Collaborators
- Tanzania Red Cross Society, Muhimbili University of Health and Allied Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03709368
- Sponsor's protocol ID
- TAN-001
- Status last verified
- Mar 2022
- First submitted
- 2 Oct 2018
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31311186
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Two add-on Software Interventions for Improving Hand Washing and Sanitation in Rural Tanzania: an Impact Evaluation
- ClinicalTrials.gov ID
- NCT03709368
- Acronym / sponsor ID
- TAN-001
- Conditions
- Diarrhea
- Keywords
- Hand washing, WASH, RANAS, Behavior change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Centre for Evidence-Based Practice, BelgiumUniversity, hospital or other
- Collaborators
- Tanzania Red Cross Society, Muhimbili University of Health and Allied Sciences
- Study start
- 23 Apr 2018 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 17 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RANAS | Experimental | Other: Hardware, Behavioral: CLTS, Behavioral: PHAST, Behavioral: RANASHardware CLTS+PHAST RANAS (contextualized) |
| Mini-RANAS | Experimental | Other: Hardware, Behavioral: CLTS, Behavioral: PHAST, Behavioral: mini-RANASHardware CLTS+PHAST mini-RANAS (norms) |
| Control | Active comparator | Other: Hardware, Behavioral: CLTS, Behavioral: PHAST, Other: Placebo posterHardware CLTS+PHAST Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All people above 18 years of age.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HardwareCommunity 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. | Other | Control, Mini-RANAS, RANAS |
| CLTSCLTS 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. | Behavioural | Control, Mini-RANAS, RANAS |
| PHASTPHAST 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. | Behavioural | Control, Mini-RANAS, RANAS |
| RANASNine 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. | Behavioural | RANAS |
| mini-RANASNine 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. | Behavioural | Mini-RANAS |
| Placebo posterOne 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. | Other | Control |
Primary outcome
Change in hand washing behavior
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.
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.
5 secondary outcomes
Change in latrine use behavior
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.
Quality of the hand washing infrastructure
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.
Change in health
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.
Change in EQ-5D-3L
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.
Quality of the latrine infrastructure
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Derived from this study: PubMed 31311186Dockx 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Diarrhea
RecruitingPhase 3
VE303 for Prevention of Recurrent Clostridioides Difficile Infection
Clostridium Difficile, Clostridium Difficile Infections
Not yet recruiting
Inactivated KAWAI Bacteria for Diarrhea Prevention During Pelvic Radiotherapy in Postoperative Cervical Cancer
Cervical Cancer
Enrolling by invitation
Hypernatremia Fluid Therapy in Childhood Diarrhoea
Hypernatremia, Acute Watery Diarrhea
Active, not recruitingPhase 3
Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen
Carcinoid Syndrome, Carcinoid
Recruiting
Bacillus Clausii Versus Multistrain Probiotics for Acute Watery Diarrhea in Children
Acute Watery Diarrhea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hardware, CLTS and PHAST in people with Diarrhea, run by Centre for Evidence-Based Practice, Belgium at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hand washing behavior (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03709368, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022.