Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02324075
Other study ID # SPO-113016
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2014
Est. completion date November 2015

Study information

Verified date December 2020
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Background (brief): 1. Burden: In low income neighborhoods in Dhaka many households share toilets which are often unsanitary and their discharge contaminates the community. 2. Knowledge gap: Behavior change messages have the potential to make people concerned about maintaining shared toilets quality, cleanliness and safety of the facility. There are many contributors to poor sanitation in low income neighborhoods in Dhaka but it's not clear that the situation can be improved with behavior change or even which specific messages to target. 3. Relevance: Water Sanitation for the Urban Poor (WSUP) is a nongovernmental organization working to improve shared sanitation facilities in Dhaka. They are interested in developing and evaluating a behavior change program to improve shared sanitation in Dhaka and to generate lessons that would be relevant for other low income urban settings globally. Hypothesis: A behavior change communication intervention can improve the quality and cleanliness of sanitation services available to low-income residents of Dhaka. Objectives: 1. To deliver behavior change messages (which target key behaviors influencing the quality and cleanliness of shared sanitation facilities) to randomly selected low-income communities in Dhaka. 2. To evaluate the effectiveness of a behavior change communication intervention designed to change targeted behaviors related to the quality and cleanliness of shared sanitation facilities. Methods: Local non-governmental organizations will deliver the intervention (behavior change communication package) in randomly selected communities. For this study the investigators will assess the impact of this intervention on the targeted behaviors using follow-up surveys and spot checks.


Description:

Hypothesis to be tested: A behavior change communication intervention can improve the quality and cleanliness of sanitation services available to low-income residents of Dhaka. Specific Objectives: 1. To deliver communication messages (selected as the most promising for changing target behaviors influencing the quality and cleanliness of shared sanitation facilities) to randomly selected low-income communities in Dhaka. 2. To evaluate the effectiveness of a behavior change communication intervention designed to change targeted behaviors related to the quality and cleanliness of shared sanitation facilities. Background The investigators contend that important barriers to improved sanitation in low-income communities in Dhaka include: 1) Low-income community residents lack the financial resources to purchase a better option. 2) The cost of land in Dhaka, which has increased 600 fold since the 1970s (Hossain, 2011), makes space for toilets expensive 3) A public sector characterized by weak institutions that lack funding and management capacity to implement and maintain effective sanitary infrastructure (Hossain, 2011) and 4) a pervasive informal local political system that maximizes the financial interests of politically connected elites over the communal interests of low-income community residents (Hackenbroch and Hossain, 2012, Hossain, 2011). More than one third of Dhaka residents live in informal settlements where government authorities do not accept responsibility for providing urban utilities including water and sanitation services (World Bank, 2007). A central motivation for politicians to avoid formalizing settlements is that informality keeps residents in a constant state of dependency on local party associates, a state which these local elites can use to extract a continuous stream of resources (Anjaria, 2006, Hossain, 2011). Behavior change communication messages cannot directly resolve these major barriers to improving community sanitation in low-income communities in Dhaka. Simple general messages, such as encouraging people to clean keep their sanitary facility clean to reduce the risk of disease transmission, are unlikely to be effective because they do not address the determinants of the poor availability, cleanliness and maintenance of shared sanitary facilities. By contrast, by developing behavior change messages that are informed by the experience and perspective of the target population this study can identify some opportunities where new information or a new social norm could alter some key behaviors. The pilot work found considerable interest in cleaner better maintained latrines. Inclusion of 2 low-cost hardware accessories, a waste bin so that materials such as condoms or sanitary pads can be discarded in ways that do not block the toilet and bucket to assist with rinsing the toilet after defecation makes it easier for communities to follow behavior change recommendations to support a cleaner shared latrine.The central question for this research project is: Can a strategically designed behavior change campaign supplemented with low-cost hardware accessories shift the current equilibrium of unhygienic shared sanitation facilities towards cleaner facilities in low-income communities of Dhaka? Research Design and Methods: SUMMARY: - Deliver behavior change communication messages using a behavior change communication intervention to randomly selected low-income communities in Dhaka. (Package of behavior change interventions for targeted behaviors: waste disposal, rules for latrine use and repair and maintenance) - Evaluate the effectiveness of the behavior change communication intervention in changing the targeted behaviors. DETAILS: o Deliver messages using a behavior change communication intervention to randomly selected low-income communities in Dhaka. The study team will add intervention components onto existing NGO interventions to increase impact and decrease cost. Thus, through extensive piloting informative work, the investigators have developed behavior change communication materials, based on specific behaviors targeted to improve latrine cleanliness and quality. The materials and messages will be used to train community health promoters (CHPs) that are currently working for the selected NGOs. Some materials will include sign boards for latrines that will be fixed to those areas randomly selected to receive the intervention. The intervention will also include enabling hardware, a waste bin for trash collection and the bucket for carrying water to flush the latrine. The intervention: these will be delivered by partner NGO community hygiene promoters. This intervention approach is aimed to leverage existing intervention delivery partners and thus add value across the sector. The investigators have identified an NGO partner with large urban programs including sanitation activities in Mirpur, Mohakhali and Mohammadpur. The survey team will work with partner NGOs and identify the coverage areas that are eligible for participation in the study. These include: 1. Some larger slums with 60 to 180 communal toilets and sanitation interventions provided by 3 to 12 community health promoters whose activities collectively cover the entire slum area. 2. Some smaller slums with 6-10 communal toilets available for around 150 to 300 households. These communal toilets were situated very close to one another, and this type of slum is served by a single community health promoter. 3. Some scattered slums which are very small compared to other slums. This type of slum consists of 15-50 households sharing one communal toilet. One community health promoter covers 4-8 scattered slums. The team will divide those selected slums into distinct clusters primarily based on community health promoter coverage area. If the area is very large, the CHP coverage areas will be sub-divided using geographic boundaries such as roads, bazaars, water bodies that clearly distinguish between distinct clusters. Each cluster will comprise: 1. an area covered by a single CHP 2. between 1 and 30 communal toilets A communal toilet consists of a structure with approximately 2 to 16 chambers that drain into a common septic tank. The clusters will be the unit of randomization for this study. At the beginning of the study, the study team will conduct a communal toilet listing to collect information on numbers of toilet users for each communal toilet. Once listing is done, a statistician who is independent of this project will randomly assign clusters to either the intervention or comparison arms. Clusters are separated geographically by streets, bazaars, fields, drainage or other settlements, and therefore investigators do not expect intervention messages or activities to spill over into control toilet clusters even when they are located very close by. For each intervention cluster, the field will also enroll a matched control cluster, matched on the number of toilet chambers per cluster. Investigators will use the following categories for matching: <5 chambers, 5-10 chambers, 11-15 chambers, 16-20 chambers, and >20 chambers assuming that based on the number of chambers, the numbers of users could vary. A statistician, who is not a resident of Bangladesh and who is not a member of the study project, will randomly assign clusters to intervention versus control. WSUP, on behalf of the intervention team, will sign contracts with the partner NGOs to implement the behavior change package. The behavior change messages and enabling hardware will be delivered by the partner NGOs through their community health promoters (CHPs). Investigators will help partner NGOs train CHPs in the components of the intervention to ensure that CHPs conduct group meetings and inter-personal communication that will effectively convey our intervention messages. The partner NGO will receive final behavior change communication materials from the study team and it will be responsible for printing and distribute these materials only to intervention communities. The research team will be involved with the implementation team to ensure that rollout occurs in the specified intervention clusters at the planned frequency and timing and that there is no messaging in the control clusters. Investigators will explain the plan for the fidelity assessment with the implementers and share the results as soon as they are available. • Evaluate the effectiveness of the behavior change communication intervention in changing the targeted behaviors. Behavior change campaigns that provoke discussion between viewers of the campaign and their social network are more likely to result in behavior change (Boulay et al., 2002, Hafstad and Aaro, 1997). The survey instrument includes objective uptake indicators, a measurement of exposure to the intervention, awareness of the behavior change package, frequency of discussion of the contents of the behavior change communication information with the respondent's social network, access to sanitation facilities and attitudes regarding the acceptability and cleanliness of these facilities. Investigators will conduct a pre-intervention baseline survey by drawing a systematic random sample of one adult user per communal toilet in both intervention and control clusters. The field team will sample equal numbers of users from intervention and control arms. The field team will visit the communal toilet and enroll the third household nearest to that communal toilet and administer the toilet user survey to one adult resident. If the selected user doesn't want to participate in the survey, the field team will approach a subsequent household for enrollment and also record the non-response. The field team will administer a toilet quality/cleanliness observation instrument to assess the primary objective indicators for all study toilets. To ensure inter-rater reliability of toilet observations among observers, a subset of communal toilet will be evaluated by two separate observers. Observer pairs will conduct their assessments during a 5-10 minutes interval, and their independent evaluations will be compared to make sure that our observers measure cleanliness consistently and objectively. Such research reliability observations will be conducted for initial 50 communal toilets, or until observer credibility can be effectively established and discrepancies minimized. Along with quantitative survey, field investigators will also explore local elite or landlord's view on their role and roles of others in constructing, maintaining, cleaning and emptying the communal toilet facilities by conducting qualitative interviews for the previously mentioned three types of slums. Field investigators will conduct in-depth interview with 4 different landlord or elite from mentioned each types of slums or they will interview until they have reached data saturation. Field investigators will interview those elites or landlords before the intervention commences and at the end of the intervention. The study team will conduct a baseline evaluation in intervention and control communities as well as an endline after the 6 months of intervention roll out. In addition, two months after initiation of the intervention, the field team will conduct a rapid fidelity assessment using the same survey instrument in a random subset of 50 intervention toilets. The purpose of this rapid assessment is to ensure that the behavior change intervention exposure is occurring at the expected level. If not, then the partner NGOs will be contacted and the problems addressed. The study team will compare the change in targeted behaviors observed in the intervention communities compared with changes observed in the control communities and so measure the amount of behavior change attributable to the intervention.


Recruitment information / eligibility

Status Completed
Enrollment 1226
Est. completion date November 2015
Est. primary completion date September 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years and older
Eligibility Inclusion Criteria: - Residents of low income communities in Dhaka who share toilet facilities with non-family members Exclusion Criteria: - Special groups whose ability to give voluntary informed consent might be compromised

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Behavior change
Non governmental organization delivers communication intervention with facilitating hardware, a waste bin and bucket

Locations

Country Name City State
Bangladesh Icddr,B Dhaka

Sponsors (2)

Lead Sponsor Collaborator
Stanford University Johns Hopkins Bloomberg School of Public Health

Country where clinical trial is conducted

Bangladesh, 

References & Publications (3)

Alam MU, Winch PJ, Saxton RE, Nizame FA, Yeasmin F, Norman G, Masud AA, Begum F, Rahman M, Hossain K, Layden A, Unicomb L, Luby SP. Behaviour change intervention to improve shared toilet maintenance and cleanliness in urban slums of Dhaka: a cluster-rando — View Citation

Saxton RE, Yeasmin F, Alam MU, Al-Masud A, Dutta NC, Yeasmin D, Luby SP, Unicomb L, Winch PJ. If I do not have enough water, then how could I bring additional water for toilet cleaning?! Addressing water scarcity to promote hygienic use of shared toilets — View Citation

Yeasmin F, Luby SP, Saxton RE, Nizame FA, Alam MU, Dutta NC, Masud AA, Yeasmin D, Layden A, Rahman H, Abbott R, Unicomb L, Winch PJ. Piloting a low-cost hardware intervention to reduce improper disposal of solid waste in communal toilets in low-income set — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Pans With Presence of Visible Feces Inside the Pan Assessment by observer in unannounced visit to the shared latrine to determine presence of visible feces inside the pan (both inside and outside the hole in the pan). Assessed at 6 months post intervention
Secondary Number of Pans With Presence of Visible Feces Outside the Pan Assessment by observer in unannounced visit to the shared latrine to determine presence of visible feces outside the pan. Assessed at 6 months post intervention
Secondary Visible Feces on the Path Leading up to the Latrine Assessment by observer in unannounced visit to the shared latrine to determine presence of feces on the path leading up to the shared toilet. Assessed at 6 months post intervention
Secondary Visible Feces Near the Latrine But Not on the Path Assessment by observer in unannounced visit to the shared latrine to determine presence of feces near the latrine but not on the path leading to the latrine. baseline and 6 months post intervention
Secondary Number of Functional Cubicle Toilets Assessment by observer in unannounced visit to the shared latrine to determine if the cubicle toilet is fully functional. Assessed at 6 months post intervention
Secondary Visible Feces Inside the Hole of the Pan Observer in unannounced visit assess if feces is visible inside the hole of the pan Assessed at 6 months post intervention
Secondary Latrine Cleanliness - Spit/Cough on Walls/Doors Assessment by observer in unannounced visit to the shared latrine to determine problems with cleanliness. Observations were made for spit/cough on walls/doors. The count of units that had the problem is presented for each problem type. Assessed at 6 months post intervention
Secondary Latrine Cleanliness - Cigarette Butts Assessment by observer in unannounced visit to the shared latrine to determine problems with cleanliness. Observations were made for cigarette butts in toilets. The count of units that had the problem is presented for each problem type. Assessed at 6 months post intervention
Secondary Latrine Cleanliness - Waterlogging Assessment by observer in unannounced visit to the shared latrine to determine problems with cleanliness. Observations were made for waterlogging in toilets. The count of units that had the problem is presented for each problem type. Assessed at 6 months post intervention
Secondary Latrine Cleanliness - Presence of Household Waste/Waste Wrapped in Polythene Assessment by observer in unannounced visit to the shared latrine to determine problems with cleanliness. Observations were made for presence of household waste/waste wrapped in polythene. The count of units that had the problem is presented for each problem type. Assessed at 6 months post intervention
Secondary Latrine Cleanliness - Presence of Rags/Sanitary Pads Assessment by observer in unannounced visit to the shared latrine to determine problems with cleanliness. Observations were made for presence of rags/sanitary pads. The count of units that had the problem is presented for each problem type. Assessed at 6 months post intervention
Secondary Latrine Cleanliness - Smell of Feces Assessment by observer in unannounced visit to the shared latrine to determine problems with cleanliness. Observations were made for smell of feces. The count of units that had the problem is presented for each problem type. Assessed at 6 months post intervention
Secondary Latrine Cleanliness - Smell of Urine Assessment by observer in unannounced visit to the shared latrine to determine problems with cleanliness. Observations were made for smell of urine. The count of units that had the problem is presented for each problem type. Assessed at 6 months post intervention
Secondary Latrine Cleanliness - Smell of Cigarettes Assessment by observer in unannounced visit to the shared latrine to determine problems with cleanliness. Observations were made for smell of cigarettes. The count of units that had the problem is presented for each problem type. Assessed at 6 months post intervention
See also
  Status Clinical Trial Phase
Completed NCT06283784 - Study To Evaluate The Efficacy of a Proprietary Mix of Live Probiotics In The Prophylaxis Of Diarrhea In Adult Patients N/A
Recruiting NCT03851835 - Multi-DOSE Oral Ondansetron for Pediatric Acute GastroEnteritis Phase 3
Completed NCT04003181 - The Pathogenesis of Chronic Diarrhoea After Treatment for Cancer in Cecum and the Ascending Colon N/A
Completed NCT03596827 - The Protective Immune Response to Attenuated Enterotoxigenic Escherichia Coli Infection N/A
Recruiting NCT05372068 - Cement flooRs AnD chiLd hEalth (CRADLE) N/A
Completed NCT03972618 - Evaluation of the Efficacy of Sawyer Point One Filters in Schools and Homes in the Dominican Republic N/A
Completed NCT05207618 - Utility of the Administration of Chesnut and Quebracho Extract for Irritable Bowel Syndrome Diarrhea Predominant N/A
Not yet recruiting NCT05052489 - Registry and Clinical Observation of Children With Diarrhoeal Disease
Completed NCT02541695 - Characterization of Resistance Against Live-attenuated Diarrhoeagenic E. Coli N/A
Completed NCT02428647 - Lao Zinc Study: Effects of Two Forms of Daily Preventive Zinc Versus Therapeutic Zinc Supplementation N/A
Completed NCT02197780 - Head-to-head Comparison of Two Fecal Biomarkers to Screen Children for IBD N/A
Completed NCT01739231 - Live Attenuated ETEC Vaccine ACE527 With and Without dmLT Adjuvant in Adults Phase 1/Phase 2
Completed NCT01968408 - Lactobacillus Reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children Phase 3
Completed NCT01371656 - Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation Phase 3
Not yet recruiting NCT01382199 - Recombinant Human Lactoferrin Administered Orally for the Prevention of Antibiotic Associated Diarrhea in Adult Patients Phase 3
Completed NCT01438645 - ScopeGuide-assisted Colonoscopy Versus Conventional Colonoscopy N/A
Terminated NCT01472211 - Water-based Zinc Intervention Trial in Zinc Deficient Children Phase 0
Terminated NCT01048567 - Efficacy and Safety of Lactobacillus Acidophilus/Rhamnosus Combination for the Prevention of Antibiotic-associated Diarrhea in the Elderly Phase 2
Completed NCT00914225 - Effect of Bednets and a Water Purification Device on HIV Disease Progression Among ART naïve Patients in Kenya N/A
Completed NCT00760851 - Yogurt Study in Children 2-4 Years Old Attending Daycare Phase 3