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

NCT06024317 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2025-12-26

No results posted yet for this study

Summary

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.

Conditions

  • Short Message Service (SMS)
  • Incentives
  • Knowledge, Attitudes, Practice
  • Preventive Services

Interventions

BEHAVIORAL

Huduma Kwa Wakati - Knowledge Intervention

Counseling scripts assessing and addressing child health-related knowledge gaps

BEHAVIORAL

Huduma Kwa Wakati - Reminders

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

BEHAVIORAL

Huduma Kwa Wakati - Incentives

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

BEHAVIORAL

Huduma Kwa Wakati - Service notifications

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

Sponsors & Collaborators

  • Duke University

    collaborator OTHER
  • Emory University

    collaborator OTHER
  • University of North Carolina

    collaborator OTHER
  • National Institute for Medical Research, Tanzania

    collaborator OTHER_GOV
  • University of South Carolina

    lead OTHER

Principal Investigators

  • Jan Ostermann, PhD · University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2027-07-31
Completion
2027-07-31

Countries

  • Tanzania

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06024317 on ClinicalTrials.gov