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

NCT06024317 | Not Yet Recruiting

• 1 other identifier: Pro00120675
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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

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

Keywords

Timeliness; Digital Health; Community Health Workers; Tanzania; Low and middle-income country; SMS reminder; Conditional incentive; Preventive services; Children

Outcome Measures

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.

  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

  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)

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

Study Arms (2)

Intervention arm (Huduma Kwa Wakati)

EXPERIMENTAL

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; Behavioral: Huduma Kwa Wakati - Reminders; Behavioral: Huduma Kwa Wakati - Incentives; Behavioral: Huduma Kwa Wakati - Service notifications

Control (Standard of care)

NO INTERVENTION

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.

Interventions

Huduma Kwa Wakati - Knowledge Intervention BEHAVIORAL

Counseling scripts assessing and addressing child health-related knowledge gaps

Intervention arm (Huduma Kwa Wakati)

Huduma Kwa Wakati - Reminders BEHAVIORAL

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

Intervention arm (Huduma Kwa Wakati)

Huduma Kwa Wakati - Incentives BEHAVIORAL

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

Intervention arm (Huduma Kwa Wakati)

Huduma Kwa Wakati - Service notifications BEHAVIORAL

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

Intervention arm (Huduma Kwa Wakati)

Eligibility Criteria

• Age: 15 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• expected to reside in the sampling area until the child reaches age 1 year

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University of South Carolina: lead
• Duke University: collaborator
• Emory University: collaborator
• University of North Carolina: collaborator
• National Institute for Medical Research, Tanzania: collaborator

Study Sites (1)

National Institute for Medical Research

Dar es Salaam, Tanzania

Location

Related Publications (6)

• 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.

  PMID: 35961796 BACKGROUND

• 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.

  PMID: 33081744 BACKGROUND

• 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.

  PMID: 31272487 BACKGROUND

• 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.

  PMID: 36814594 BACKGROUND

• 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.

  PMID: 32267240 BACKGROUND

• 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.

  PMID: 38214956 DERIVED

MeSH Terms

Conditions

Behavior

Study Officials

• Jan Ostermann, PhD

  University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan Ostermann, PhD

CONTACT

18037778747; jano@mailbox.sc.edu

Lavanya Vasudevan, PhD

CONTACT

lavanya.vasudevan@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This type 1 effectiveness-implementation hybrid study uses a cluster-randomized trial design to evaluate intervention effectiveness.

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 6, 2023
• Study Start: March 1, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TA (1)