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

London School of Hygiene and Tropical Medicine

Status: Active, not recruiting

Conditions: Handwashing Behaviour

Treatments: Other: Handwashing Hardware and Supply Provision; Behavioral: Hand Hygiene Behavioural Promotion

Study type: Interventional

Funder types: Other

Identifiers

NCT06865495

31387

Details and patient eligibility

About

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.

Full 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).

Enrollment: 1,800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

1,800 participants in 4 patient groups

Handwashing Hardware and Supply Provision

Experimental group

Description:

Households in this arm will receive a locally available handwashing facility called the Kalingalinga bucket and be given supplies to make soapy water. They will receive a 3-month visit to check the facility is functioning.

Treatment:

Other: Handwashing Hardware and Supply Provision

Hand Hygiene Behavioural Promotion

Experimental group

Description:

Households in this arm will receive five bi-weekly educational visits, with a sixth follow-up visit four weeks later (6 visits in total).

Treatment:

Behavioral: Hand Hygiene Behavioural Promotion

Handwashing Hardware and Supply Provision + Hand Hygiene Behavioural Promotion

Experimental group

Description:

Households in this arm will receive both the hardware and supply provision and hand hygiene behavioural promotion interventions.

Treatment:

Behavioral: Hand Hygiene Behavioural Promotion

Other: Handwashing Hardware and Supply Provision

Control

No Intervention group

Description:

Households in this arm will receive no intervention during the study period. They will receive the most effective intervention combination after the study is complete.