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

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
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06865495
Acronym
BCLab
Enrollment
1800
Registered
2025-03-07
Start date
2025-03-14
Completion date
2025-11-27
Last updated
2026-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Handwashing Behaviour

Keywords

handwashing, hygiene, urban

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).

Interventions

OTHERHandwashing Hardware and Supply Provision

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.

BEHAVIORALHand 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.

Sponsors

London School of Hygiene and Tropical Medicine
Lead SponsorOTHER
Centre for Infectious Disease Research in Zambia
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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.

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.

Design outcomes

Primary

MeasureTime frameDescription
Handwashing with soap (HWWS) at all handwashing opportunitiesMeasured 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

MeasureTime frameDescription
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 PresenceMeasured 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.

Countries

Zambia

Contacts

PRINCIPAL_INVESTIGATORRobert Dreibelbis, PhD

London School of Hygiene and Tropical Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 19, 2026