InfectionNCT02764528
Intervention Study to Improve Maternal Handwashing
A study testing Clinic, Clinic + home and Clinic + home + handwashing device in people with Infection and Neonatal, run by State University of New York at Buffalo at 1 site in Kenya.
Trial summary
The purpose of the handwashing intervention trial is to determine whether an interactive, storytelling approach to promoting handwashing with soap by health care workers can improve mothers' handwashing behavior during the first month of her child's life. Read more about this study
- Who is it for?
- Any age, women only
- What is being tested?
- Clinic, Clinic + home and Clinic + home + handwashing device
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteKenya
- Study dates
- 1 Feb 2016to Aug 2018
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pregnant women
- Seeking routine (non-emergency) care at a participating antenatal care clinic during the study period
- Between 30 and 36 weeks pregnant (calculated based on last known menstrual period) when they seek antenatal care
- Live within 30 minutes or 1-2 km one-way travel from the clinic
- Plan to remain in the study area for at least one month post-partum
- Willing to allow the field worker to visit her home following the antenatal care visit on the day of enrollment to conduct baseline assessments at the household
- Sought antenatal care from a qualified medical provider for the first time at or after 28 weeks gestation
Who cannot join
- Excluded if another member of their household or compound/homestead enrolled in this study
- Excluded if enrolled in the formative research for this study
Trial locations and contacts
1 site in 1 country.
Kenya1 site
Government funded antenatal care clinics
Igembe North and Igembe South Subcounties, Meru County
About this study
Official title: Effects of Promoting Handwashing With Soap to Improve Maternal Handwashing Behavior During the Neonatal Period
The purpose of the handwashing intervention trial is to determine whether an interactive, storytelling approach to promoting handwashing with soap by health care workers can improve mothers' handwashing behavior during the first month of her child's life.
Read the detailed description
Infectious diseases, such as umbilical cord infection, pneumonia, and sepsis, are responsible for about a quarter of neonatal deaths. Contaminated hands likely play a role in transmitting pathogens to a neonate, therefore handwashing with soap has the potential to interrupt transmission and improve neonatal health. The primary objective of this study is to develop and evaluate a scalable, cost-effective handwashing promotion program to improve handwashing behavior among mothers and caregivers of neonates. The investigators will first conduct a qualitative study to assess the feasibility and acceptability of a set of interventions. The investigators propose to evaluate the impact of the intervention components, designed as three progressively intense interventions, using a randomized controlled trial with elements of a stepped wedge design. The study will be conducted in Meru County, Kenya, enrolling a total of 800 pregnant women who seek non-emergency antenatal care at a government health facility during a 1 year period. Clinic based health care workers and community health volunteers will disseminate the intervention using an interactive storytelling approach. The focus of the interactions between the health care workers and volunteers and the participant will be on addressing barriers to handwashing through interactive question and answer sessions, rather than a didactic, educational session. The investigators will assess the impact of interventions on observed maternal and caregiver handwashing behavior and estimate the cost effectiveness for each intervention.
- Being tested
- Clinic, Clinic + home, Clinic + home + handwashing device
- Keywords
- Hygiene
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClinicBehavioural
Pregnant women will receive handwashing promotion from a trained facility-based health care worker during her regular antenatal visit at a healthcare clinic. To the extent feasible, everyone accompanying the pregnant woman will be invited to take part in the behavior change communication session. The participant will be provided with several bars of soap to take home and she will be encouraged to maintain a designated place for washing hands (with soap and water) at the home. A poster indicating the key events for handwashing with soap will be posted at the clinic and smaller posters will be given to the participant to post in her home. A system will be established to send regular SMS messages to the participant promote handwashing with soap during the neonatal period.
Clinic + homeBehavioural
Women will receive all components of the clinic-based handwashing promotion in addition to handwashing promotion during 3-4 home visits before their expected delivery date and during the neonatal period from a community health volunteer. All household members present will be invited to join in the session, with emphasis on including all caregivers of the neonate.
Clinic + home + handwashing deviceBehavioural
Women will receive all components of the clinic + home-based handwashing promotion intervention in addition to one handwashing device (i.e. tap and basin to use as a handwashing station) during the first home visit by the community health volunteer. The community health volunteer will work with the woman and her family to identify the location where the neonate will be most of the time in order to position the handwashing station as close to the neonate as possible.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Women will receive standard antenatal care but will not receive any additional handwashing promotion, soap, or handwashing device during their enrollment. At the end of data collection, handwashing with soap will be recommended to participants in the control arm and their families. |
| Clinic | Experimental | Handwashing promotion from healthcare workers at antenatal care clinic. Receives: Behavioral: Clinic |
| Clinic + home | Experimental | Handwashing promotion from healthcare workers at antenatal care clinic and from community health volunteers at home visits. Receives: Behavioral: Clinic + home |
| Clinic + home + handwashing device | Experimental | Handwashing promotion from healthcare workers at antenatal care clinic and from community health volunteers at home visits with provision of one handwashing device. Receives: Behavioral: Clinic + home + handwashing device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of washing hands with soap at potential pathogen transmission events by mothers of neonate
Direct observation of handwashing behavior of mothers at times when pathogens may be transmitted from the mother to the neonate
Measured: 1 week post-natal
Frequency of washing hands with soap at potential pathogen transmission events by mothers of neonate
Direct observation of handwashing behavior of mothers at times when pathogens may be transmitted from the mother to the neonate
Measured: 2 weeks post-natal
Secondary outcomes (5)
Frequency of washing hands with soap at potential pathogen transmission events by caregivers of neonate (other than mother)
Direct observation of handwashing behavior of caregivers (other than mother) at times when pathogens may be transmitted from the caregiver to the neonate
Measured: 1 week post-natal
Number of participants with soap and water present at a handwashing station
Observed presence of soap and/or water at a handwashing station
Measured: 1 week post-natal
Cost-effectiveness
Approximate cost of the intervention per participant
Measured: 1 month post-partum
Frequency of washing hands with soap at potential pathogen transmission events by caregivers of neonate (other than mother)
Direct observation of handwashing behavior of caregivers (other than mother) at times when pathogens may be transmitted from the caregiver to the neonate
Measured: 2 weeks post-natal
Number of participants with soap and water present at a handwashing station
Observed presence of soap and/or water at a handwashing station
Measured: 2 weeks post-natal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study start1 Feb 2016 (estimated)
- Primary completion1 Dec 2016 (estimated)
- Study completionAug 2018 (estimated)
Why it stopped: Donor altered priorities for available funding and eliminated the project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies 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
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- Save the Children, United States Agency for International Development (USAID), Unilever R&D
- Responsible party
- Sponsor
- Investigators
- Pavani K. Ram, M.D., Principal investigator, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02764528
- Sponsor's protocol ID
- 748140-1
- Other IDs
- ESRC P176/2015
- Status last verified
- Oct 2017
- First submitted
- 13 Jan 2016
- Last updated
- 23 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Promoting Handwashing With Soap to Improve Maternal Handwashing Behavior During the Neonatal Period
- ClinicalTrials.gov ID
- NCT02764528
- Acronym / sponsor ID
- 748140-1
- Keywords
- Hygiene
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Donor altered priorities for available funding and eliminated the project
- Enrolment
- 0 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- Save the Children, United States Agency for International Development (USAID), Unilever R&D
- Study start
- 1 Feb 2016 (estimated)
- Primary completion
- 1 Dec 2016 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 6 May 2016 (estimated)
- 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 purpose of the handwashing intervention trial is to determine whether an interactive, storytelling approach to promoting handwashing with soap by health care workers can improve mothers' handwashing behavior during the first month of her child's life.
Detailed description
Infectious diseases, such as umbilical cord infection, pneumonia, and sepsis, are responsible for about a quarter of neonatal deaths. Contaminated hands likely play a role in transmitting pathogens to a neonate, therefore handwashing with soap has the potential to interrupt transmission and improve neonatal health. The primary objective of this study is to develop and evaluate a scalable, cost-effective handwashing promotion program to improve handwashing behavior among mothers and caregivers of neonates. The investigators will first conduct a qualitative study to assess the feasibility and acceptability of a set of interventions. The investigators propose to evaluate the impact of the intervention components, designed as three progressively intense interventions, using a randomized controlled trial with elements of a stepped wedge design. The study will be conducted in Meru County, Kenya, enrolling a total of 800 pregnant women who seek non-emergency antenatal care at a government health facility during a 1 year period. Clinic based health care workers and community health volunteers will disseminate the intervention using an interactive storytelling approach. The focus of the interactions between the health care workers and volunteers and the participant will be on addressing barriers to handwashing through interactive question and answer sessions, rather than a didactic, educational session. The investigators will assess the impact of interventions on observed maternal and caregiver handwashing behavior and estimate the cost effectiveness for each intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Women will receive standard antenatal care but will not receive any additional handwashing promotion, soap, or handwashing device during their enrollment. At the end of data collection, handwashing with soap will be recommended to participants in the control arm and their families. |
| Clinic | Experimental | Behavioral: ClinicHandwashing promotion from healthcare workers at antenatal care clinic. |
| Clinic + home | Experimental | Behavioral: Clinic + homeHandwashing promotion from healthcare workers at antenatal care clinic and from community health volunteers at home visits. |
| Clinic + home + handwashing device | Experimental | Behavioral: Clinic + home + handwashing deviceHandwashing promotion from healthcare workers at antenatal care clinic and from community health volunteers at home visits with provision of one handwashing device. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Pregnant women
- Seeking routine (non-emergency) care at a participating antenatal care clinic during the study period
- Between 30 and 36 weeks pregnant (calculated based on last known menstrual period) when they seek antenatal care
- Live within 30 minutes or 1-2 km one-way travel from the clinic
- Plan to remain in the study area for at least one month post-partum
Key exclusion criteria (2 listed)
- Excluded if another member of their household or compound/homestead enrolled in this study
- Excluded if enrolled in the formative research for this study
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 |
|---|---|---|
| ClinicPregnant women will receive handwashing promotion from a trained facility-based health care worker during her regular antenatal visit at a healthcare clinic. To the extent feasible, everyone accompanying the pregnant woman will be invited to take part in the behavior change communication session. The participant will be provided with several bars of soap to take home and she will be encouraged to maintain a designated place for washing hands (with soap and water) at the home. A poster indicating the key events for handwashing with soap will be posted at the clinic and smaller posters will be given to the participant to post in her home. A system will be established to send regular SMS messages to the participant promote handwashing with soap during the neonatal period. | Behavioural | Clinic |
| Clinic + homeWomen will receive all components of the clinic-based handwashing promotion in addition to handwashing promotion during 3-4 home visits before their expected delivery date and during the neonatal period from a community health volunteer. All household members present will be invited to join in the session, with emphasis on including all caregivers of the neonate. | Behavioural | Clinic + home |
| Clinic + home + handwashing deviceWomen will receive all components of the clinic + home-based handwashing promotion intervention in addition to one handwashing device (i.e. tap and basin to use as a handwashing station) during the first home visit by the community health volunteer. The community health volunteer will work with the woman and her family to identify the location where the neonate will be most of the time in order to position the handwashing station as close to the neonate as possible. | Behavioural | Clinic + home + handwashing device |
Primary outcome
Frequency of washing hands with soap at potential pathogen transmission events by mothers of neonate
Time frame: 1 week post-natal
Direct observation of handwashing behavior of mothers at times when pathogens may be transmitted from the mother to the neonate
Frequency of washing hands with soap at potential pathogen transmission events by mothers of neonate
Time frame: 2 weeks post-natal
Direct observation of handwashing behavior of mothers at times when pathogens may be transmitted from the mother to the neonate
5 secondary outcomes
Frequency of washing hands with soap at potential pathogen transmission events by caregivers of neonate (other than mother)
Time frame: 1 week post-natal
Number of participants with soap and water present at a handwashing station
Time frame: 1 week post-natal
Cost-effectiveness
Time frame: 1 month post-partum
Frequency of washing hands with soap at potential pathogen transmission events by caregivers of neonate (other than mother)
Time frame: 2 weeks post-natal
Number of participants with soap and water present at a handwashing station
Time frame: 2 weeks post-natal
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
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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.
Pavani K. Ram, M.D. principal investigator
State University of New York at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinic, Clinic + home and Clinic + home + handwashing device in people with Infection and Neonatal, run by State University of New York at Buffalo at 1 site in Kenya.
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 7 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: withdrawn, as of the sponsor's last update on 23 Sep 2022. 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 Kenya. 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 was withdrawn before enrolling participants, so there are no results.
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?
Frequency of washing hands with soap at potential pathogen transmission events by mothers of neonate (time frame: 1 week post-natal). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2022.