Handwashing BehaviourBCLabNCT06865495
Evaluating the Individual and Combined Effects of Hand Hygiene Promotion and Hardware Provision on Handwashing With Soap in Lusaka, Zambia
A study testing Handwashing Hardware and Supply Provision and Hand Hygiene Behavioural Promotion in people with Handwashing Behaviour, run by London School of Hygiene and Tropical Medicine at 1 site in Zambia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Handwashing Behaviour
- What is being tested?
- Handwashing Hardware and Supply Provision and Hand Hygiene Behavioural Promotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 1 siteZambia
- Study dates
- 14 Mar 2025to 27 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Handwashing Hardware and Supply Provision, Hand Hygiene Behavioural Promotion
- Keywords
- handwashing, hygiene, urban
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Handwashing Hardware and Supply ProvisionOther
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 PromotionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Handwashing Hardware and Supply Provision | Experimental | 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. Receives: Other: Handwashing Hardware and Supply Provision |
| Hand Hygiene Behavioural Promotion | Experimental | Households in this arm will receive five bi-weekly educational visits, with a sixth follow-up visit four weeks later (6 visits in total). Receives: Behavioral: Hand Hygiene Behavioural Promotion |
| Handwashing Hardware and Supply Provision + Hand Hygiene Behavioural Promotion | Experimental | Households in this arm will receive both the hardware and supply provision and hand hygiene behavioural promotion interventions. Receives: Other: Handwashing Hardware and Supply Provision; Behavioral: Hand Hygiene Behavioural Promotion |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Handwashing with soap (HWWS) at all handwashing opportunities
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.
Measured: Measured at baseline and endline (6-months after intervention delivery begins)
Secondary outcomes (4)
Handwashing with soap (HWWS) at each specific handwashing opportunity.
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.
Measured: Measured at baseline and endline (6-months after intervention delivery begins)
Hand-rinsing measured as a three-level outcome: no action, hand-rinsing or handwashing with soap at all handwashing opportunities.
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.
Measured: Measured at baseline and endline (6-months after intervention delivery begins)
Handwashing Facility Presence
The probability that a household has a fully functional handwashing facility with water and soap present.
Measured: Measured at baseline and endline (6-months after intervention delivery begins)
Handwashing knowledge and reported practice.
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.
Measured: Measured at baseline and endline (6-months after intervention delivery begins)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start14 Mar 2025
- Primary completion27 Nov 2025
- Study completion27 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Handwashing BehaviourStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,800 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Infectious Disease Research in Zambia
- Responsible party
- Sponsor
- Investigators
- Robert Dreibelbis, PhD, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06865495
- Sponsor's protocol ID
- 31387
- Acronym
- BCLab
- Status last verified
- Jun 2026
- First submitted
- 24 Feb 2025
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be fully anonymised and posted on a public repository for third party use. To completely anonymise the data prior to uploading it onto an open data site any information that holds the potential to identify the respondents will be redacted.
Publications
Davies K, Chipungu J, Mwila-Kazimbaya K, Bick S, Nyirenda HC, Sharma A, Dreibelbis R. Study protocol for a multi-arm, parallel group randomised controlled trial evaluating the isolated and combined effects of behavioural promotion and hardware provision on handwashing with soap in peri-urban Lusaka, Zambia. BMJ Open. 2026 Sep 28;16(9):e110563. doi: 10.1136/bmjopen-2025-110563.
PubMed 42805653
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06865495
- Acronym / sponsor ID
- BCLab / 31387
- Conditions
- Handwashing Behaviour
- Keywords
- handwashing, hygiene, urban
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,800 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Centre for Infectious Disease Research in Zambia
- Study start
- 14 Mar 2025 (actual)
- Primary completion
- 27 Nov 2025 (actual)
- Study completion
- 27 Nov 2025 (actual)
- First posted
- 7 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Handwashing Hardware and Supply Provision | Experimental | Other: Handwashing Hardware and Supply ProvisionHouseholds 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. |
| Hand Hygiene Behavioural Promotion | Experimental | Behavioral: Hand Hygiene Behavioural PromotionHouseholds in this arm will receive five bi-weekly educational visits, with a sixth follow-up visit four weeks later (6 visits in total). |
| Handwashing Hardware and Supply Provision + Hand Hygiene Behavioural Promotion | Experimental | Other: Handwashing Hardware and Supply Provision, Behavioral: Hand Hygiene Behavioural PromotionHouseholds in this arm will receive both the hardware and supply provision and hand hygiene behavioural promotion interventions. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Handwashing Hardware and Supply ProvisionHouseholds 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. | Other | Handwashing Hardware and Supply Provision, Handwashing Hardware and Supply Provision + Hand Hygiene Behavioural Promotion |
| Hand Hygiene Behavioural PromotionThe 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. | Behavioural | Hand Hygiene Behavioural Promotion, Handwashing Hardware and Supply Provision + Hand Hygiene Behavioural Promotion |
Primary outcome
Handwashing with soap (HWWS) at all handwashing opportunities
Time frame: Measured 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.
4 secondary outcomes
Handwashing with soap (HWWS) at each specific handwashing opportunity.
Time frame: Measured at baseline and endline (6-months after intervention delivery begins)
Hand-rinsing measured as a three-level outcome: no action, hand-rinsing or handwashing with soap at all handwashing opportunities.
Time frame: Measured at baseline and endline (6-months after intervention delivery begins)
Handwashing Facility Presence
Time frame: Measured at baseline and endline (6-months after intervention delivery begins)
Handwashing knowledge and reported practice.
Time frame: Measured at baseline and endline (6-months after intervention delivery begins)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Derived from this study: PubMed 42805653Davies K, Chipungu J, Mwila-Kazimbaya K, Bick S, Nyirenda HC, Sharma A, Dreibelbis R. Study protocol for a multi-arm, parallel group randomised controlled trial evaluating the isolated and combined effects of behavioural promotion and hardware provision on handwashing with soap in peri-urban Lusaka, Zambia. BMJ Open. 2026 Sep 28;16(9):e110563. doi: 10.1136/bmjopen-2025-110563.
- Individual participant dataSharing planned: Yes. All data will be fully anonymised and posted on a public repository for third party use. To completely anonymise the data prior to uploading it onto an open data site any information that holds the potential to identify the respondents will be redacted.
Related trials for Handwashing Behaviour
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Game-Based Handwashing Education in Preschool Children
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Dreibelbis, PhD principal investigator
London School of Hygiene and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Handwashing Hardware and Supply Provision and Hand Hygiene Behavioural Promotion in people with Handwashing Behaviour, run by London School of Hygiene and Tropical Medicine at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Handwashing with soap (HWWS) at all handwashing opportunities (time frame: Measured at baseline and endline (6-months after intervention delivery begins)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06865495, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.