Leveraging Community Health Workers and a Digital Health System to Improve the Timeliness of Child Well Visits
NCT ID: NCT06024317
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
800 participants
INTERVENTIONAL
2026-03-01
2027-07-31
Brief Summary
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Detailed Description
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In Tanzania, only 68% of children receive key recommended preventive health interventions within their first year of life. Prior research identified substantial rural-urban disparities in rates and timeliness of preventive service receipt in Tanzania, with children in rural settings being more like to receive delayed or no services. This type 1 effectiveness implementation hybrid study will evaluate the effect of Huduma Kwa Wakati ("Timely Services" in Kiswahili), a community-based, integrated digital health intervention, on the timeliness of child well visits and receipt of recommended preventive services in children's first year of life. The intervention combines a knowledge intervention, mobile phone-based reminders, and incentives with the goal to promote timely service receipt.
Methods:
The study will be conducted in the catchment areas of 40 rural health facilities in two predominantly rural regions in Tanzania. From each catchment area, three cohorts of mother-child dyads, one retrospective cohort and two prospective cohorts, will be enrolled into the study. The prospective cohort, comprising mothers from eighty communities ("clusters") within these catchment areas, will be randomized to an intervention or control arm. The timeliness (primary outcome) and coverage (secondary outcome) of child well visits will be observed for 1200 children (800 prospective children and 400 retrospective children). Details of the clinical trial refer to the prospective cohort of 800 mother-child dyads. Study logs, fidelity checklists, quantitative surveys, child health records, and qualitative interviews with mothers and key informants will be used to inform the five constructs of the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework. Results will be used to develop an implementation blueprint that can guide future adaptations, sustainability, and scale-up of Huduma Kwa Wakati.
Hypothesis:
The hypothesis is that Huduma Kwa Wakati is effective for increasing the timeliness of child well visits and rates of preventive services receipt before age 1 year compared to the standard of care.
Expected impact:
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 recommended health service receipt among children from sub-Saharan Africa, and identify implementation strategies to facilitate the deployment of integrated interventions in low- and middle-income country settings.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Intervention arm (Huduma Kwa Wakati)
Within the catchment areas of 40 health facilities, 40 communities ("clusters"; 1 per catchment area) will be assigned to the intervention arm. 40 communities ("clusters"; 1 per catchment area) will be assigned to the control arm. 10 pregnant women in their last trimester of pregnancy will be enrolled from each cluster. Women enrolled from intervention clusters will receive all components of the Huduma Kwa Wakati intervention.
Huduma Kwa Wakati - Knowledge Intervention
Counseling scripts assessing and addressing child health-related knowledge gaps
Huduma Kwa Wakati - Reminders
Reminders of upcoming well visit due dates, sent to the mother's mobile phone
Huduma Kwa Wakati - Incentives
Conditional incentives for timely service receipt, tailored to each child's well visit schedule
Huduma Kwa Wakati - Service notifications
Service notifications (e.g., related to stockouts or service non-availability), sent to the mother's mobile phone
Control (Standard of care)
Within the catchment areas of 40 health facilities, 40 communities ("clusters"; 1 per catchment area) will be assigned to the intervention arm. 40 communities ("clusters"; 1 per catchment area) will be assigned to the control arm. 10 pregnant women in their last trimester of pregnancy will be enrolled from each cluster. Women enrolled from control arm will receive baseline and follow-up assessments only.
No interventions assigned to this group
Interventions
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Huduma Kwa Wakati - Knowledge Intervention
Counseling scripts assessing and addressing child health-related knowledge gaps
Huduma Kwa Wakati - Reminders
Reminders of upcoming well visit due dates, sent to the mother's mobile phone
Huduma Kwa Wakati - Incentives
Conditional incentives for timely service receipt, tailored to each child's well visit schedule
Huduma Kwa Wakati - Service notifications
Service notifications (e.g., related to stockouts or service non-availability), sent to the mother's mobile phone
Eligibility Criteria
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Inclusion Criteria
* residing in the sampling area
* pregnant women in their last trimester of pregnancy
* residing in the sampling area
* expected to reside in the sampling area until the child reaches age 1 year
Exclusion Criteria
15 Years
FEMALE
No
Sponsors
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Duke University
OTHER
Emory University
OTHER
University of North Carolina
OTHER
National Institute for Medical Research, Tanzania
OTHER_GOV
University of South Carolina
OTHER
Responsible Party
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Jan Ostermann
Associate Professor
Principal Investigators
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Jan Ostermann, PhD
Role: PRINCIPAL_INVESTIGATOR
University of South Carolina
Locations
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National Institute for Medical Research
Dar es Salaam, , Tanzania
Countries
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Central Contacts
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Facility Contacts
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Esther Ngadaya, MD, PhD
Role: primary
References
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Yelverton V, Hair NL, Ghosh SH, Mfinanga SG, Ngadaya E, Baumgartner JN, Ostermann J, Vasudevan L. Beyond coverage: Rural-urban disparities in the timeliness of childhood vaccinations in Tanzania. Vaccine. 2022 Sep 2;40(37):5483-5493. doi: 10.1016/j.vaccine.2022.07.020. Epub 2022 Aug 10.
Vasudevan L, Baumgartner JN, Moses S, Ngadaya E, Mfinanga SG, Ostermann J. Parental concerns and uptake of childhood vaccines in rural Tanzania - a mixed methods study. BMC Public Health. 2020 Oct 20;20(1):1573. doi: 10.1186/s12889-020-09598-1.
Ostermann J, Vasudevan L, Baumgartner JN, Ngadaya E, Mfinanga SG. Do mobile phone-based reminders and conditional financial transfers improve the timeliness of childhood vaccinations in Tanzania? Study protocol for a quasi-randomized controlled trial. Trials. 2019 Jul 4;20(1):397. doi: 10.1186/s13063-019-3430-4.
Ostermann J, Hair NL, Moses S, Ngadaya E, Godfrey Mfinanga S, Brown DS, Noel Baumgartner J, Vasudevan L. Is the intention to vaccinate enough? Systematic variation in the value of timely vaccinations and preferences for monetary vs non-monetary incentives among pregnant women in southern Tanzania. Vaccine X. 2023 Jan 23;13:100266. doi: 10.1016/j.jvacx.2023.100266. eCollection 2023 Apr.
Vasudevan L, Ostermann J, Moses SM, Ngadaya E, Mfinanga SG. Patterns of Mobile Phone Ownership and Use Among Pregnant Women in Southern Tanzania: Cross-Sectional Survey. JMIR Mhealth Uhealth. 2020 Apr 8;8(4):e17122. doi: 10.2196/17122.
Vasudevan L, Ostermann J, Thielman N, Baumgartner JN, Solomon D, Mosses A, Hobbie A, Hair NL, Liang C, van Zwetselaar M, Mfinanga S, Ngadaya E. Leveraging Community Health Workers and a Responsive Digital Health System to Improve Vaccination Coverage and Timeliness in Resource-Limited Settings: Protocol for a Cluster Randomized Type 1 Effectiveness-Implementation Hybrid Study. JMIR Res Protoc. 2024 Jan 12;13:e52523. doi: 10.2196/52523.
Other Identifiers
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Pro00120675
Identifier Type: -
Identifier Source: org_study_id