Leveraging Community Health Workers and a Digital Health System to Improve the Timeliness of Child Well Visits

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age15+
SponsorUniversity of South Carolina

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Huduma Kwa Wakati - Knowledge Intervention

    Behavioral

    Counseling scripts assessing and addressing child health-related knowledge gaps

  • Huduma Kwa Wakati - Reminders

    Behavioral

    Reminders of upcoming well visit due dates, sent to the mother's mobile phone

  • Huduma Kwa Wakati - Incentives

    Behavioral

    Conditional incentives for timely service receipt, tailored to each child's well visit schedule

  • Huduma Kwa Wakati - Service notifications

    Behavioral

    Service notifications (e.g., related to stockouts or service non-availability), sent to the mother's mobile phone

Treatment groups

800 Participants
are divided into 2 treatment groups
Group A: Intervention arm (Huduma Kwa Wakati)Experimental treatment 4 interventions
Group B: Control (Standard of care)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Assessed during the endline survey, an average follow-up period of 1 year

Secondary outcomes

1

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.

Time frame
Assessed during the endline survey, an average follow-up period of 1 year

Other outcomes

1

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.

Time frame
Assessed during the endline survey, an average follow-up period of 1 year

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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