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

NCT ID: NCT06865495

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-14
• Study Completion Date: 2025-11-30

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).

Conditions

Handwashing Behaviour

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Handwashing Hardware and Supply Provision

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.

Group Type: EXPERIMENTAL

Handwashing Hardware and Supply Provision

Intervention Type: OTHER

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.

Hand Hygiene Behavioural Promotion

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

Group Type: EXPERIMENTAL

Hand Hygiene Behavioural Promotion

Intervention Type: BEHAVIORAL

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.

Handwashing Hardware and Supply Provision + Hand Hygiene Behavioural Promotion

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

Group Type: EXPERIMENTAL

Handwashing Hardware and Supply Provision

Intervention Type: OTHER

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.

Hand Hygiene Behavioural Promotion

Intervention Type: BEHAVIORAL

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.

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Handwashing 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.

Intervention Type: OTHER

Hand 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre for Infectious Disease Research in Zambia

OTHER

Sponsor Role: collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Dreibelbis, PhD

Role: PRINCIPAL_INVESTIGATOR

London School of Hygiene and Tropical Medicine

Locations

Centre for Infectious Disease Research in Zambia (CIDRZ)

Lusaka, , Zambia

Countries

Zambia

Other Identifiers

31387

Identifier Type: -

Identifier Source: org_study_id