Neonatal Death Clinical Trial
Official title:
CHV-NEO: Community-based Digital Communication to Support Neonatal Health
Neonatal mortality (defined as death in the first 28 days of life) remains unacceptably high in sub-Sarahan Africa. The concentrated risk of neonatal illness in the first weeks of life and its potential to rapidly deteriorate means that expanding mothers' access to timely information and support during this period is critical to reducing neonatal mortality. This cluster-randomized control trial aims to integrate a 2 way interactive SMS text messaging intervention into existing digital infrastructure supporting Community Health Volunteer (CHV) workflow in Western Kenya (dCHT) to enable remote communication by mothers with CHVs between home visits.
Status | Recruiting |
Enrollment | 2000 |
Est. completion date | August 2025 |
Est. primary completion date | August 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 14 Years and older |
Eligibility | Inclusion Criteria: - Pregnant - 26-36 weeks gestation - Daily access to a mobile phone (own or shared) - Willing to receive SMS - Age =14 years - Able to read and respond to text messages in English, Kiswahili or Luo, or have someone in the household who can help - Receiving antenatal care at study facility - Plan to be in the area for at least 3 months postpartum Exclusion Criteria: - participating in another study - previously participated in this study |
Country | Name | City | State |
---|---|---|---|
Kenya | Kenyatta National Hospital | Kisumu |
Lead Sponsor | Collaborator |
---|---|
University of Washington | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
Kenya,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Home Visit Coverage | Number of home visits performed by CHVs | 2 years of study implementation | |
Other | Clinic Referrals | Number of clinic referrals logged in dCHT by CHVs | 2 years of study implementation | |
Other | Provider Workload | Time on all CHV/supervisor duties | 2 years of study implementation | |
Other | Acceptability | Perception by CHVs that CHV-NEO is agreeable or satisfactory on the Acceptability of Intervention Measure (higher score is more acceptable) | 2 years of study implementation | |
Other | Adoption | Number of client SMS read by CHV | 2 years of study implementation | |
Other | Fidelity | Number of client SMS responded to by CHV on time per SOP | 2 years of study implementation | |
Primary | Neonatal Mortality | Death during 1st 28 days of life | 28 days postpartum | |
Secondary | Cord care | Number of participants with no application of substances to cord | 2-weeks postpartum | |
Secondary | Thermal Care | Number of participants giving infant a bath in 1st 24 hours of life | 24-hours postpartum | |
Secondary | Early Initiation of Breastfeeding | Number of participants initiating breastfeeding in 1st hour of life | 1-hour postpartum | |
Secondary | Appropriate Care-Seeking | Number of clinic visits reported with danger sign and/or hospital admission | 6-weeks postpartum | |
Secondary | Maternal Knowledge of Neonatal Danger Signs | Number of danger signs or symptoms successfully named | 6-weeks postpartum |
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