Clinical trial NCT06865495: Evaluating the Individual and Combined Effects of Hand Hygiene Promotion and Hardware Provision on Handwashing With Soap in Lusaka, Zambia
Official title: Evaluating the Individual and Combined Effects of Hand Hygiene Promotion and Hardware Provision on Handwashing With Soap Behaviour in Urban and Peri-urban Lusaka, Zambia: a Factorial Randomised-controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Handwashing Behaviour
Keywords: handwashing
hygiene
urban
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Centre for Infectious Disease Research in Zambia
First posted: 2025-03-07
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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).

Eligibility criteria: Eligibility is assessed at the household level.

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.

Primary outcomes:
measure: Handwashing with soap (HWWS) at all critical handwashing junctures
timeFrame: Measured at baseline and endline (6-months after intervention delivery begins)
Secondary outcomes:
measure: Handwashing with soap (HWWS) at each specific handwashing juncture.
timeFrame: Measured at baseline and endline (6-months after intervention delivery begins)
measure: Hand-rinsing measured as a three-level outcome: no action, hand-rinsing or handwashing with soap at critical handwashing junctures.
timeFrame: Measured at baseline and endline (6-months after intervention delivery begins)
measure: Handwashing Facility Presence
timeFrame: Measured at baseline and endline (6-months after intervention delivery begins)
measure: Handwashing knowledge and reported practice.
timeFrame: Measured at baseline and endline (6-months after intervention delivery begins)
Other outcomes:
measure: Diarrhoeal Illness
timeFrame: Measured at baseline and endline (6-months after intervention delivery begins)
measure: Respiratory Illness
timeFrame: Measured at baseline and endline (6-months after intervention delivery begins)
Locations:
city: Lusaka
country: Zambia
facility: Centre for Infectious Disease Research in Zambia (CIDRZ)
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Robert Dreibelbis, PhD
role: PRINCIPAL_INVESTIGATOR
References: