Intervention Study to Improve Maternal Handwashing

Not Applicable

Withdrawn

• Conditions: Infection; Neonatal
• Interventions: Behavioral: Clinic; Behavioral: Clinic + home; Behavioral: Clinic + home + handwashing device

• Registration Number: NCT02764528
• Lead Sponsor: State University of New York at Buffalo

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.

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 Timeline

• Study First Submitted: 2016-01-13
• Study Start: 2016-02-01
• Study First Submitted QC: 2016-05-03
• Study First Posted: 2016-05-06
• Primary Completion: 2016-12-01
• Status Verified: 2017-10
• Study Completion: 2018-08
• Last Update Submitted: 2022-09-22
• Last Update Posted: 2022-09-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clinic	Clinic	Handwashing promotion from healthcare workers at antenatal care clinic.
Clinic + home	Clinic + home	Handwashing promotion from healthcare workers at antenatal care clinic and from community health volunteers at home visits.
Clinic + home + handwashing device	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.

Primary Outcome Measures

Name	Time	Method
Frequency of washing hands with soap at potential pathogen transmission events by mothers of neonate	2 weeks post-natal	Direct observation of handwashing behavior of mothers at times when pathogens may be transmitted from the mother to the neonate

Secondary Outcome Measures

Name	Time	Method
Frequency of washing hands with soap at potential pathogen transmission events by caregivers of neonate (other than mother)	2 weeks post-natal	Direct observation of handwashing behavior of caregivers (other than mother) at times when pathogens may be transmitted from the caregiver to the neonate
Number of participants with soap and water present at a handwashing station	2 weeks post-natal	Observed presence of soap and/or water at a handwashing station
Cost-effectiveness	1 month post-partum	Approximate cost of the intervention per participant

Trial Locations

Locations (1)

Government funded antenatal care clinics; 🇰🇪 Igembe North And Igembe South Subcounties, Meru County, Kenya