Intervention Study to Improve Maternal Handwashing

University at Buffalo (UB)

Status: Withdrawn

Conditions: Infection; Neonatal

Treatments: Behavioral: Clinic; Behavioral: Clinic + home; Behavioral: Clinic + home + handwashing device

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; Industry

Identifiers

NCT02764528

ESRC P176/2015 (Other Identifier)

748140-1

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 4 patient groups

Control

No Intervention group

Description:

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 group

Description:

Handwashing promotion from healthcare workers at antenatal care clinic.

Treatment:

Behavioral: Clinic

Clinic + home

Experimental group

Description:

Handwashing promotion from healthcare workers at antenatal care clinic and from community health volunteers at home visits.

Treatment:

Behavioral: Clinic + home

Clinic + home + handwashing device

Experimental group

Description:

Handwashing promotion from healthcare workers at antenatal care clinic and from community health volunteers at home visits with provision of one handwashing device.

Treatment:

Behavioral: Clinic + home + handwashing device