Study Stopped
Donor altered priorities for available funding and eliminated the project
Intervention Study to Improve Maternal Handwashing
Effects of Promoting Handwashing With Soap to Improve Maternal Handwashing Behavior During the Neonatal Period
2 other identifiers
interventional
N/A
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Feb 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2016
CompletedStudy Start
First participant enrolled
February 1, 2016
CompletedFirst Posted
Study publicly available on registry
May 6, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedSeptember 23, 2022
October 1, 2017
10 months
January 13, 2016
September 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
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)
1 week post-natal
Number of participants with soap and water present at a handwashing station
1 week post-natal
Cost-effectiveness
1 month post-partum
Frequency of washing hands with soap at potential pathogen transmission events by caregivers of neonate (other than mother)
2 weeks post-natal
Number of participants with soap and water present at a handwashing station
2 weeks post-natal
Study Arms (4)
Control
NO INTERVENTIONWomen 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
EXPERIMENTALHandwashing promotion from healthcare workers at antenatal care clinic.
Clinic + home
EXPERIMENTALHandwashing promotion from healthcare workers at antenatal care clinic and from community health volunteers at home visits.
Clinic + home + handwashing device
EXPERIMENTALHandwashing promotion from healthcare workers at antenatal care clinic and from community health volunteers at home visits with provision of one handwashing device.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Excluded if another member of their household or compound/homestead enrolled in this study
- Excluded if enrolled in the formative research for this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- State University of New York at Buffalolead
- Save the Childrencollaborator
- United States Agency for International Development (USAID)collaborator
- Unilever R&Dcollaborator
Study Sites (1)
Government funded antenatal care clinics
Igembe North and Igembe South Subcounties, Meru County, Kenya
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pavani K. Ram, M.D.
State University of New York at Buffalo
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2016
First Posted
May 6, 2016
Study Start
February 1, 2016
Primary Completion
December 1, 2016
Study Completion
August 1, 2018
Last Updated
September 23, 2022
Record last verified: 2017-10