NCT06356636

Brief Summary

The goal of this interventional study is to evaluate the impacts of Financial Inclusion improvement sanitation and Health (FINISH) interventions in Kenya's Homa Bay County and Uganda's Kamwenge District among children under five. The main questions it aims to answer are:

  1. 1.What is the estimated impact of the FINISH model on health outcomes (diarrhoea occurrence and hygienic behaviour) as well as social (school attendance and sanitation) in the intervention groups?
  2. 2.What are the perspectives, attitudes, and practices of various stakeholders (communities, governments, entrepreneurs, and financiers) regarding the FINISH model?
  3. 3.What is the cost-effectiveness of the FINISH model, including the amount of leverage funds generated?

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,090

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

January 1, 2022

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 10, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

4 years

First QC Date

February 26, 2024

Last Update Submit

April 4, 2024

Conditions

Keywords

clusterrandomized controlled trialsanitationevaluationopen defecationUgandaKenya

Outcome Measures

Primary Outcomes (1)

  • Health outcome, measured as, Proportion of households with diarrhoea occurrence in children under five years, and social outcome measured as proportion of households whose children missed school due to diarrhoea occurrence

    Diarrhoea occurrence in children under 5 years is measured as:- In the past two weeks child/children under 5 years who have had three or more loose or watery stools. households whose children missed school due to diarrhoea occurrence, is measured as proportion of households whose children missed school due to diarrhoeal disease in the past 30 days

    4 years, which includes baseline data collection, implementation and endline data collection

Study Arms (2)

Treatment group

ACTIVE COMPARATOR

The intervention arm involves communities within Homa Bay County in Kenya and Kamwenge District in Uganda, where the FINISH Mondial initiative is implemented. This intervention aims to improve sanitation and health through a public-private partnership model, engaging communities, governments, entrepreneurs, and financiers to enhance sanitation services and supply chains.

Behavioral: Financial Inclusion Improves Sanitation and Health

Control group

NO INTERVENTION

The control arm includes communities in Siaya County in Kenya and Bushenyi in Uganda, where the FINISH intervention is not implemented, serving as a comparison to evaluate the effectiveness of the intervention.

Interventions

This innovative model engages transformative partnerships which include four key stakeholders (communities, communities, governments, entrepreneurs, and financiers) to improve sanitation services and supply value chains. The work is two-sided: to create demand for improved sanitation facilities in communities while facilitating microcredit access for people and sanitation businesses on the supply side.

Treatment group

Eligibility Criteria

Age0 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsThis study targets both males and females in the intervention sites
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • to be updated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Homa Bay county

Homa Bay, Kenya

RECRUITING

MeSH Terms

Conditions

Behavior

Interventions

Health

Intervention Hierarchy (Ancestors)

Population Characteristics

Central Study Contacts

Josphat Martin Muchangi

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
to be updated
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The participants are divided into two or more groups, with each group receiving a different intervention or a control condition. The outcomes of each group are compared at the end of the study to assess the effectiveness of the intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2024

First Posted

April 10, 2024

Study Start

January 1, 2022

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

April 10, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share

Locations