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

Not Applicable

Active, not 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 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.

Detailed Description

The study is a superiority, multi-arm, parallel group 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 (i.e., expect to remain in the community for the next 3-6 months).

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

For households receiving the hardware and supply 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 behavioural promotion intervention, 5 bi-weekly household visits (30 minutes) will be conducted, with a sixth follow-up visit four weeks later, for a total of 6 planned "touch points".

Handwashing with soap (HWWS) at handwashing opportunities (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) 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 First Submitted QC: 2025-03-04
• Study First Posted: 2025-03-07
• Study Start: 2025-03-14
• Last Update Submitted: 2025-09-09
• Last Update Posted: 2025-09-16
• Primary Completion: 2025-11
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Handwashing with soap (HWWS) at all handwashing opportunities	Measured at baseline and endline (6-months after intervention delivery begins)	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.

Secondary Outcome Measures

Name	Time	Method
Handwashing with soap (HWWS) at each specific handwashing opportunity.	Measured at baseline and endline (6-months after intervention delivery begins)	The probability of HWWS at each specific 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); 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 all handwashing opportunities.	Measured at baseline and endline (6-months after intervention delivery begins)	The probability of either HWWS, hand rinsing with water only, or taking no action 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.
Handwashing Facility Presence	Measured at baseline and endline (6-months after intervention delivery begins)	The probability that a household has a fully functional handwashing facility with water and soap present.
Handwashing knowledge and reported practice.	Measured at baseline and endline (6-months after intervention delivery begins)	Knowledge: Number of opportunities (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) 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 opportunities (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) 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