Intervention Study to Improve Maternal Handwashing

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.

Study Overview

• Status: Withdrawn
• Conditions: Infection; Neonatal
• Intervention / Treatment: Behavioral: Clinic; Behavioral: Clinic + home; Behavioral: Clinic + home + handwashing device

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Meru County
    • Igembe North And Igembe South Subcounties, Meru County, Kenya
      • Government funded antenatal care clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Excluded if another member of their household or compound/homestead enrolled in this study
• Excluded if enrolled in the formative research for this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; 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.
Experimental: Clinic; Handwashing promotion from healthcare workers at antenatal care clinic.	Behavioral: Clinic; 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.
Experimental: Clinic + home; Handwashing promotion from healthcare workers at antenatal care clinic and from community health volunteers at home visits.	Behavioral: Clinic + home; 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.
Experimental: Clinic + home + handwashing device; Handwashing promotion from healthcare workers at antenatal care clinic and from community health volunteers at home visits with provision of one handwashing device.	Behavioral: Clinic + home + handwashing device; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	1 week post-natal
Cost-effectiveness	Approximate cost of the intervention per participant	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	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	2 weeks post-natal

Collaborators and Investigators

• Sponsor: State University of New York at Buffalo
• Collaborators: United States Agency for International Development (USAID); Save the Children; Unilever R&D
• Investigators: Principal Investigator: Pavani K. Ram, M.D., State University of New York at Buffalo

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2016
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): August 1, 2018

Study Registration Dates

• First Submitted: January 13, 2016
• First Submitted That Met QC Criteria: May 3, 2016
• First Posted (Estimate): May 6, 2016

Study Record Updates

• Last Update Posted (Actual): September 23, 2022
• Last Update Submitted That Met QC Criteria: September 22, 2022
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Hygiene
• Other Study ID Numbers: 748140-1; ESRC P176/2015 (Other Identifier: Amref)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No