NCT03709368

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 23, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 17, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

March 9, 2022

Status Verified

March 1, 2022

Enrollment Period

3.1 years

First QC Date

October 2, 2018

Last Update Submit

March 8, 2022

Conditions

Keywords

Hand washingWASHRANASBehavior change

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    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

    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

    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 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

    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.

Study Arms (3)

RANAS

EXPERIMENTAL

Hardware CLTS+PHAST RANAS (contextualized)

Other: HardwareBehavioral: CLTSBehavioral: PHASTBehavioral: RANAS

Mini-RANAS

EXPERIMENTAL

Hardware CLTS+PHAST mini-RANAS (norms)

Other: HardwareBehavioral: CLTSBehavioral: PHASTBehavioral: mini-RANAS

Control

ACTIVE COMPARATOR

Hardware CLTS+PHAST Placebo

Other: HardwareBehavioral: CLTSBehavioral: PHASTOther: Placebo poster

Interventions

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.

ControlMini-RANASRANAS
CLTSBEHAVIORAL

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.

ControlMini-RANASRANAS
PHASTBEHAVIORAL

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.

ControlMini-RANASRANAS
RANASBEHAVIORAL

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.

RANAS
mini-RANASBEHAVIORAL

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.

Mini-RANAS

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.

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All people above 18 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanzania Red Cross Society

Kigoma, Tanzania

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Diarrhea

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2018

First Posted

October 17, 2018

Study Start

April 23, 2018

Primary Completion

May 31, 2021

Study Completion

May 31, 2021

Last Updated

March 9, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations