NCT06570005

Brief Summary

The objective of this study is to evaluate the effects of a novel financial and capacity strengthening intervention (the 'Water Quality Assurance Fund' program) on water safety management in rural Ghana and Kenya. The investigators hypothesize the intervention will improve water system operator knowledge, chlorination practices, and water quality at the point of collection, as well as improve consumer satisfaction, awareness, and willingness-to-pay for water that is tested and treated.

Trial Health

60
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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
4,800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2022

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 6, 2022

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 20, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 26, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

August 26, 2024

Status Verified

August 1, 2024

Enrollment Period

2.8 years

First QC Date

August 20, 2024

Last Update Submit

August 22, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Adequate free chlorine residual in water at the point of collection

    Free chlorine residual in water at the point of collection above targeted levels of 0.2 mg/L.

    Baseline, 6-months, 12-months, 18-months, 24-months

Secondary Outcomes (9)

  • Detectable free chlorine residual in water at the point of collection

    Baseline, 6-months, 12-months, 18-months, 24-months

  • E. coli in water at the point of collection

    Baseline, 6-months, 12-months, 18-months, 24-months

  • Water system operator knowledge

    Baseline, 12-months, 24-months

  • Consumer awareness

    Baseline, 12-months, 24-months

  • Consumer satisfaction

    Baseline, 12-months, 24-months

  • +4 more secondary outcomes

Other Outcomes (3)

  • Water system chlorination frequency

    Baseline, 6-months, 12-months, 18-months, 24-months

  • Water system revenue

    Baseline, 6-months, 12-months, 18-months, 24-months

  • Households use of enrolled water for drinking

    Baseline, 12-months, 24-months

Study Arms (4)

Assurance Fund Intervention Arm 1

EXPERIMENTAL

In this study arm, intervention activities will start after initial baseline data collection.

Other: Water Quality Assurance Fund

Assurance Fund Intervention Arm 2

EXPERIMENTAL

The intervention activities are the same as those described in Arm 1. However, in this study arm, the intervention activities will start 6 months later than those in Arm 1. This arm will serve as a controlled comparison during those initial 6 months.

Other: Water Quality Assurance Fund

Assurance Fund Intervention Arm 3

EXPERIMENTAL

The intervention activities are the same as those described in Arm 1. However, in this study arm, the intervention activities will start 12 months later than those in Arm 1. This arm will serve as a controlled comparison during those initial 12 months.

Other: Water Quality Assurance Fund

Non-randomized Arm

EXPERIMENTAL

In Ghana only, there is a fourth study arm that will receive the intervention one month prior to Arm 1. This group was non-randomly selected and will primarily serve to support qualitative lessons learned from the Assurance Fund program.

Other: Water Quality Assurance Fund

Interventions

* At the water system level: Written legal agreements between water systems, centralized laboratories, and the organization facilitating the Assurance Fund will provide water systems with regular water quality testing and provide laboratories a guarantee of payments if water systems fail to pay for testing services on time (for up to three concurrent unpaid invoices). Regular debrief meetings will be held with water operators and local government authorities to discuss test results and water treatment options, and to encourage water systems to share water quality information with their consumers. Technical guidance to improve water treatment will be provided, if requested by water system operators or local government authorities. * At the community level: Community engagement, primarily at the onset, to inform the community about the water quality testing program and answer questions.

Assurance Fund Intervention Arm 1Assurance Fund Intervention Arm 2Assurance Fund Intervention Arm 3Non-randomized Arm

Eligibility Criteria

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

You may qualify if:

  • The district or county government was interested in participating in the Assurance Fund program and water systems within the district/county were accessible to a partner central laboratory that was able to provide water sample collection and testing services for a fee.
  • Water systems were functional.
  • Water systems were piped water systems (Kenya, Ghana) or mechanized boreholes with a single tapstand (Ghana).
  • Water systems could afford regular water quality testing from the selected laboratory.

You may not qualify if:

  • To be eligible to participate in household surveys, participants need to be at least 18 years of age and a customer of a eligible water system.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Aquaya Institute

Accra, Ghana

RECRUITING

The Aquaya Institute

Nairobi, Kenya

RECRUITING

MeSH Terms

Conditions

Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Valerie Bauza, PhD

    The Aquaya Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Valerie Bauza, PhD

CONTACT

Caroline Delaire, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Model Details: Stepped-wedge Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2024

First Posted

August 26, 2024

Study Start

December 6, 2022

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

August 26, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

De-identified individual participant data will be made available.

Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations