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NCT Number: NCT06024317

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

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.

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Key information

Age range

15 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Institute for Medical Research

Dar es Salaam, Tanzania

Location contact

Esther Ngadaya, MD, PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jan Ostermann, PhD

CONTACT

[email protected]

18037778747

Lavanya Vasudevan, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Collaborators

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

Registry information

Official study title

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

Acronym: MINT-II/HKW

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 6, 2023
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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