NCT06865495

Brief Summary

The goal of this study is to assess the individual and combined effects of hand hygiene behavioural promotion and handwashing hardware and supply provision on handwashing with soap behaviour at handwashing opportunities in households in peri-urban communities in Lusaka, Zambia. Households will be randomly allocated to one of the four groups: AB) Hand hygiene behavioural promotion + handwashing hardware and supply provision, A) handwashing hardware and supply provision only, B) hand hygiene behavioural promotion only or C) No intervention. Researchers will compare handwashing behaviour between the four groups to see which is most effective.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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

First Submitted

Initial submission to the registry

February 24, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 7, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

March 14, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

September 16, 2025

Status Verified

February 1, 2025

Enrollment Period

8 months

First QC Date

February 24, 2025

Last Update Submit

September 9, 2025

Conditions

Keywords

handwashinghygieneurban

Outcome Measures

Primary Outcomes (1)

  • Handwashing with soap (HWWS) at all handwashing opportunities

    The probability of HWWS within three minutes of any handwashing opportunity (before cooking, before eating, before feeding a child, before breastfeeding, after toilet use, after handling child/adult faeces or cleaning a child's bottom, after contact with animals and after coughing/sneezing) in the correct sequence (e.g., before or after the relevant opportunity); measured through direct observation of individual behaviour over a a three-hour observation period.

    Measured at baseline and endline (6-months after intervention delivery begins)

Secondary Outcomes (4)

  • Handwashing with soap (HWWS) at each specific handwashing opportunity.

    Measured at baseline and endline (6-months after intervention delivery begins)

  • Hand-rinsing measured as a three-level outcome: no action, hand-rinsing or handwashing with soap at all handwashing opportunities.

    Measured at baseline and endline (6-months after intervention delivery begins)

  • Handwashing Facility Presence

    Measured at baseline and endline (6-months after intervention delivery begins)

  • Handwashing knowledge and reported practice.

    Measured at baseline and endline (6-months after intervention delivery begins)

Other Outcomes (2)

  • Diarrhoeal Illness

    Measured at baseline and endline (6-months after intervention delivery begins)

  • Respiratory Illness

    Measured at baseline and endline (6-months after intervention delivery begins)

Study Arms (4)

Handwashing Hardware and Supply Provision

EXPERIMENTAL

Households in this arm will receive a locally available handwashing facility called the Kalingalinga bucket and be given supplies to make soapy water. They will receive a 3-month visit to check the facility is functioning.

Other: Handwashing Hardware and Supply Provision

Hand Hygiene Behavioural Promotion

EXPERIMENTAL

Households in this arm will receive five bi-weekly educational visits, with a sixth follow-up visit four weeks later (6 visits in total).

Behavioral: Hand Hygiene Behavioural Promotion

Handwashing Hardware and Supply Provision + Hand Hygiene Behavioural Promotion

EXPERIMENTAL

Households in this arm will receive both the hardware and supply provision and hand hygiene behavioural promotion interventions.

Other: Handwashing Hardware and Supply ProvisionBehavioral: Hand Hygiene Behavioural Promotion

Control

NO INTERVENTION

Households in this arm will receive no intervention during the study period. They will receive the most effective intervention combination after the study is complete.

Interventions

Households will be given a locally available handwashing facility called the Kalingalinga bucket. Intervention delivery workers will set-up the handwashing facility, and demonstrate how it works, including where to place soap on the stand. Households will also be given supplies and materials to make their own liquid soap from locally available soap products (soapy water). Discussions will also be held on HWF maintenance. This component of the intervention should take no longer than 30 minutes. Intervention delivery workers will return to households after three months (one visit) to ensure there are no issues with the handwashing station (e.g., broken stand or tap), to bring more liquid soap and to remind households how to make soapy water.

Handwashing Hardware and Supply ProvisionHandwashing Hardware and Supply Provision + Hand Hygiene Behavioural Promotion

The hand hygiene behavioural promotion intervention employs interactive storytelling and visual aids to promote handwashing with soap. Intervention delivery workers will act as storytellers, narrating stories about three characters with different handwashing habits. The intervention progresses through five bi-weekly visits, with a final sixth visit 4 weeks after the fifth visit. The 30-minute visits progress through different stages: (1) identifying behaviours, (2) understanding disease risks, (3) encouraging practical solutions and (4) promoting practice. The penultimate stage of the intervention focuses on reflection and commitment, encouraging participants to assess their behaviours and pledge to adopt improved hygiene practices. The final visit allows participants to reflect on the whole intervention and covers information participants would like to revisit.

Hand Hygiene Behavioural PromotionHandwashing Hardware and Supply Provision + Hand Hygiene Behavioural Promotion

Eligibility Criteria

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

You may qualify if:

  • At least one adult (aged 18 or older) who can consent to the study on behalf of all members of the household.
  • At least one child under the age of 5.

You may not qualify if:

  • Already own a similar handwashing facility (e.g., sink, handwashing station).
  • Not permanent residents of the selected community and/or plans to leave the community within the next 3-6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Infectious Disease Research in Zambia (CIDRZ)

Lusaka, Zambia

Location

Study Officials

  • Robert Dreibelbis, PhD

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 24, 2025

First Posted

March 7, 2025

Study Start

March 14, 2025

Primary Completion

November 1, 2025

Study Completion

November 1, 2025

Last Updated

September 16, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

All data will be fully anonymised and posted on a public repository for third party use. To completely anonymise the data prior to uploading it onto an open data site any information that holds the potential to identify the respondents will be redacted.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
Data will be made available within 2 years of endline data collection.
Access Criteria
To be determined.

Locations