Leveraging Community Health Workers and a Digital Health System to Improve the Timeliness of Child Well Visits (MINT-II/HKW)

December 18, 2025 updated by: Jan Ostermann, University of South Carolina

Leveraging Community Health Workers and a Responsive Digital Health System to Improve Rates and Timeliness of Child Well Visits in the First Year of Life

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Background and Objective:

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.

Study Type

Interventional

Enrollment (Estimated)

800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Tanzania
      • Dar es Salaam, Tanzania
        • National Institute for Medical Research
        • Contact:
          • Esther Ngadaya, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria for the Cross-sectional sample:

  • mothers of children ages 12-23 months
  • residing in the sampling area

Inclusion Criteria for the Longitudinal sample:

  • 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:

  • 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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delay in days (continuous) for the child well visit due at age 14 weeks
Time Frame: Assessed during the endline survey, an average follow-up period of 1 year
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.
Assessed during the endline survey, an average follow-up period of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delay > 28 days (binary) for the child well visit due at age 14 weeks
Time Frame: Assessed during the endline survey, an average follow-up period of 1 year
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.
Assessed during the endline survey, an average follow-up period of 1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Receipt of all recommended services during the child's first year of life (binary)
Time Frame: Assessed during the endline survey, an average follow-up period of 1 year
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.
Assessed during the endline survey, an average follow-up period of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Carolina

Collaborators

Emory University
Duke University
National Institute for Medical Research, Tanzania
University of North Carolina

Investigators

  • Principal Investigator: Jan Ostermann, PhD, University of South Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

August 28, 2023

First Submitted That Met QC Criteria

August 28, 2023

First Posted (Actual)

September 6, 2023

Study Record Updates

Last Update Posted (Actual)

December 26, 2025

Last Update Submitted That Met QC Criteria

December 18, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00120675

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data from this study will be available from the National Institute for Medical Research, Muhimbili Research Centre, Tanzania, but restrictions apply that are governed by consent forms and data transfer agreements. Data may be made available by the authors upon reasonable request and with permission of the National Medical Research Review Committee at the National Institute for Medical Research (NIMR) in Tanzania.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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