Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2025-12-25 @ 12:52 PM
Study NCT ID:
NCT06865495
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-16
First Post:
2025-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Individual and Combined Effects of Hand Hygiene Promotion and Hardware Provision on Handwashing With Soap in Lusaka, Zambia
Sponsor:
London School of Hygiene and Tropical Medicine
Organization:
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BCLab
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.
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).
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: