Evaluating the Individual and Combined Effects of Hand Hygiene Promotion and Hardware Provision on Handwashing With Soap in Lusaka, Zambia

Not Applicable

Not yet recruiting

• Conditions: Handwashing Behaviour

• Registration Number: NCT06865495
• Lead Sponsor: London School of Hygiene and Tropical Medicine

Brief Summary

The goal of this study is to assess the individual and combined effects of hand hygiene promotion and hardware provision on handwashing with soap behaviour at critical handwashing timepoints in households in peri-urban communities in Lusaka, Zambia.

Households will be randomly allocated to one of the four groups: AB) Hand hygiene promotion + Hardware provision, A) Hardware only, B) Hand hygiene promotion only or C) No intervention.

Researchers will compare handwashing behaviour between the four groups to see which is most effective.

Detailed Description

This study is a factorial randomised-controlled trial. A total of 1800 households within five wards in Lusaka will be enrolled. Eligible households include households with at least one child under the age of 5, with no fixed handwashing facility, and at least one adult (18+) who can consent to the study. Households must also be permanent residents of the communities.

Households will be randomly assigned to one of four arms (450 households per arm) (1:1:1:1): (AB) hand hygiene promotion + handwashing hardware provision, (A) handwashing hardware provision only, (B) hand hygiene promotion only, (C) control group (receive most effective intervention after the study ends).

For households receiving the hardware intervention, a handwashing facility with supplies to make liquid soap (soapy water) will be provided and left with households for six months, with a visit at 3-months to check the handwashing facility is functioning and to provide more soap supplies. For households receiving the hand hygiene promotion intervention, bi-weekly household visits (30 minutes) will be conducted over a three-month period for a total of 5 planned "touch points".

Handwashing with soap (HWWS) at critical handwashing junctures (before cooking, before eating, before feeding a child, after toilet use, after handling child/adult faeces or cleaning a child's bottom, after contact with animals and after coughing/sneezing) will be measured using 3-hour structured observations of one household member per household, conducted at baseline and endline (6-months are intervention delivery begins).

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-24
• Study Start: 2025-03
• Study First Submitted QC: 2025-03-04
• Last Update Submitted: 2025-03-04
• Study First Posted: 2025-03-07
• Last Update Posted: 2025-03-07
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1800

Inclusion Criteria

• 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.
• No fixed handwashing facility (e.g., sink or handwashing station)
• Permanent residents of the selected community.

Exclusion Criteria

• No adult (aged 18 or older) can provide consent.
• No child under the age of 5.
• Already own a similar handwashing facility (e.g., sink, handwashing station).
• Not permanent residents of the selected community.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Handwashing with soap (HWWS) at all critical handwashing junctures	Measured at baseline and endline (6-months after intervention delivery begins)	% of critical junctures (before cooking, before eating, before feeding a child, after toilet use, after handling child/adult faeces or cleaning a child's bottom, after contact with animals and after coughing/sneezing) where hands are washed with soap; measured through direct observation of individual behaviour over a a three-hour observation period.

Secondary Outcome Measures

Name	Time	Method
Handwashing with soap (HWWS) at each specific handwashing juncture.	Measured at baseline and endline (6-months after intervention delivery begins)	% of each critical junctures (before cooking, before eating, before feeding a child, after toilet use, after handling child/adult faeces or cleaning a child's bottom, after contact with animals and after coughing/sneezing) where hands are washed with soap; measured through direct observation of individual behaviour over a a three-hour observation period.
Hand-rinsing measured as a three-level outcome: no action, hand-rinsing or handwashing with soap at critical handwashing junctures.	Measured at baseline and endline (6-months after intervention delivery begins)	% of critical junctures (before cooking, before eating, before feeding a child, after toilet use, after handling child/adult faeces or cleaning a child's bottom, after contact with animals and after coughing/sneezing) where hands are washed with soap, hands rinsed with water only, or no action taken; measured through direct observation of individual behaviour over a a three-hour observation period.
Handwashing Facility Presence	Measured at baseline and endline (6-months after intervention delivery begins)	Observed presence of a fully functional handwashing facility with water and soap.
Handwashing knowledge and reported practice.	Measured at baseline and endline (6-months after intervention delivery begins)	Knowledge: Number of critical junctures (before cooking, before eating, before feeding a child, after toilet use, after handling child/adult faeces or cleaning a child's bottom, after contact with animals and after coughing/sneezing) for handwashing with soap correctly specified in response to the question "When do you think it is important to wash hands with soap?".; Reported practice: Number of critical junctures (before cooking, before eating, before feeding a child, after toilet use, after handling child/adult faeces or cleaning a child's bottom, after contact with animals and after coughing/sneezing) for handwashing with soap reported in response to the question "When did you wash your hands with soap yesterday?"; Both questions assessed through survey of open-ended questions with pre-coded responses and multiple rounds of probing.

Trial Locations

Locations (1)

Centre for Infectious Disease Research in Zambia (CIDRZ); 🇿🇲 Lusaka, Zambia