Clinical trial NCT02764528: Intervention Study to Improve Maternal Handwashing
Official title: Effects of Promoting Handwashing With Soap to Improve Maternal Handwashing Behavior During the Neonatal Period
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Infection
Neonatal
Keywords: Hygiene
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: Save the Children
name: United States Agency for International Development (USAID)
name: Unilever R&D
First posted: 2016-05-06
Enrollment: 0
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Frequency of washing hands with soap at potential pathogen transmission events by mothers of neonate
timeFrame: 1 week post-natal
measure: Frequency of washing hands with soap at potential pathogen transmission events by mothers of neonate
timeFrame: 2 weeks post-natal
Secondary outcomes:
measure: Frequency of washing hands with soap at potential pathogen transmission events by caregivers of neonate (other than mother)
timeFrame: 1 week post-natal
measure: Number of participants with soap and water present at a handwashing station
timeFrame: 1 week post-natal
measure: Cost-effectiveness
timeFrame: 1 month post-partum
measure: Frequency of washing hands with soap at potential pathogen transmission events by caregivers of neonate (other than mother)
timeFrame: 2 weeks post-natal
measure: Number of participants with soap and water present at a handwashing station
timeFrame: 2 weeks post-natal
Other outcomes:
Locations:
city: Igembe North And Igembe South Subcounties
country: Kenya
facility: Government funded antenatal care clinics
state: Meru County
Study officials:
affiliation: State University of New York at Buffalo
name: Pavani K. Ram, M.D.
role: PRINCIPAL_INVESTIGATOR
References: