About this trial
The goal of this cluster-randomized type 1 effectiveness implementation hybrid trial is to evaluate whether a community health worker led, integrated digital health intervention (Huduma Kwa Wakati; "Timely Services" in Kiswahili) can improve rates of timely well visits and receipt of key recommended preventive interventions among children in their first year of life. The hypothesis is that Huduma Kwa Wakati will improve the timeliness and rates of completion of child well visits and receipt of recommended preventive services before age 1 year, compared to the standard of care. Researchers will compare outcomes among children enrolled from intervention clusters and no-intervention comparison clusters. Outcomes will also be compared to a cross-sectional retrospective comparison sample. This study will address the lack of rigorous evidence on the effectiveness of a community-based digital health intervention for promoting rates and timeliness of preventive service receipt among children from sub-Saharan Africa, and identify implementation strategies to facilitate the deployment of integrated community-based digital health interventions in low- and middle-income country settings.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
mothers of children ages 12-23 months
residing in the sampling area
pregnant women in their last trimester of pregnancy
residing in the sampling area
Disqualifiers
Women who are not living in catchment areas of participating health facilities (which routinely provide maternal and child health services). Facilities must be operational, must have at least 2 community health workers, and must have reported at least 100 pregnancies or births in the year prior to study implementation.)
Trial design
Parallel
Treatments tested in this trial
Huduma Kwa Wakati - Knowledge Intervention
BehavioralCounseling scripts assessing and addressing child health-related knowledge gaps
Huduma Kwa Wakati - Reminders
BehavioralReminders of upcoming well visit due dates, sent to the mother's mobile phone
Huduma Kwa Wakati - Incentives
BehavioralConditional incentives for timely service receipt, tailored to each child's well visit schedule
Huduma Kwa Wakati - Service notifications
BehavioralService notifications (e.g., related to stockouts or service non-availability), sent to the mother's mobile phone
Treatment groups
Trial outcomes
Primary outcomes
Delay in days (continuous) for the child well visit due at age 14 weeks
The average number of days between the due date of the 14 week well visit and the date on which the child actually attends this visit. Dates abstracted from the child's health book.
Secondary outcomes
Delay > 28 days (binary) for the child well visit due at age 14 weeks
The percentage of participants with a delay \>28 days between the visit due date (at age 14 weeks) and the date on which the visit was attended. Dates abstracted from the child's health book.
Other outcomes
Receipt of all recommended services during the child's first year of life (binary)
The percentage of children who attended all visits and received all services recommended by age 1 year. Coverage abstracted from the child's health book.
Sponsors and contacts
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University of South Carolina
Lead sponsor
Duke University
Collaborator
Emory University
Collaborator
University of North Carolina
Collaborator
National Institute for Medical Research, Tanzania
Collaborator
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