Chanjo Kwa Wakati - Improving Vaccination Coverage and Timeliness in Rural Settings (MINT-II)

"Chanjo Kwa Wakati" - Leveraging Community Health Workers and a Responsive Digital Health System to Improve Vaccination Coverage and Timeliness in Rural Settings

Background and Objective:

Tanzania is one of 20 countries where the majority of un- and under-vaccinated children reside. Prior research identified substantial rural-urban disparities in rates and timeliness of childhood vaccination in Tanzania, with children in rural settings being more like to receive delayed or no vaccinations. This type 1 effectiveness implementation hybrid study will evaluate the effect of Chanjo Kwa Wakati ("Timely Vaccination" in Kiswahili), a community-based, integrated digital health intervention, on vaccination timeliness. The intervention combines a vaccination knowledge intervention, mobile phone-based reminders, and incentives with the goal to promote timely childhood vaccinations.

Methods:

The study will be conducted in two predominantly rural regions in Tanzania with high numbers of un- or under-vaccinated children. Forty rural health facilities and their catchment areas ("clusters") will be randomized to an early or delayed onset study arm. From each cluster, three cohorts of mother-child dyads, one retrospective cohort and two prospective cohorts, will be enrolled into the study. For all vaccines due during the first year of life, timeliness (primary outcome) and coverage (secondary outcome) will be observed for 1200 children (600 intervention children and 600 non-intervention children). Study logs, fidelity checklists, quantitative surveys, vaccination 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 Chanjo Kwa Wakati.

Hypothesis:

The hypothesis is that Chanjo Kwa Wakati is effective for increasing the timeliness of childhood vaccinations due by age 1 year compared to the standard of care.

Expected impact:

This study will address the lack of rigorous evidence on the effectiveness of an community-based digital health intervention for promoting vaccination coverage and timeliness among children from sub-Saharan Africa, and identify implementation strategies to facilitate the deployment of integrated vaccination interventions in low- and middle-income country settings.

Study Overview

• Status: Not yet recruiting
• Conditions: Knowledge, Attitudes, Practice; Incentives; Vaccination; Short Message Service (SMS)
• Intervention / Treatment: Behavioral: Chanjo Kwa Wakati - Knowledge Intervention; Behavioral: Chanjo Kwa Wakati - Reminders; Behavioral: Chanjo Kwa Wakati - Incentives; Behavioral: Chanjo Kwa Wakati - Service notifications

• Study Type: Interventional
• Enrollment (Estimated): 1200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jan Ostermann, PhD; Phone Number: 18037778747; Email: jano@mailbox.sc.edu
• Study Contact Backup: Name: Lavanya Vasudevan, PhD; Email: lavanya.vasudevan@emory.edu

Study Locations

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

Participation Criteria

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, including antenatal care and at least weekly routine childhood immunization. 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early onset; 20 clusters will be assigned to the early onset arm. A cross-sectional cohort and two longitudinal cohorts will be enrolled from each cluster. Both longitudinal cohorts will receive all components of the Chanjo Kwa Wakati intervention.	Behavioral: Chanjo Kwa Wakati - Knowledge Intervention; Counseling scripts assessing and addressing vaccination-related knowledge gaps; Behavioral: Chanjo Kwa Wakati - Reminders; Reminders of upcoming vaccination due dates, sent to the mother's mobile phone; Behavioral: Chanjo Kwa Wakati - Incentives; Conditional incentives for timely vaccination, tailored to each child's vaccination schedule; Behavioral: Chanjo Kwa Wakati - Service notifications; Service notifications (e.g., related to stockouts or service non-availability), sent to the mother's mobile phone
Experimental: Delayed onset; 20 clusters will be assigned to the delayed onset arm. A cross-sectional cohort and two longitudinal cohorts will be enrolled from each cluster. The second longitudinal cohort will receive all components of the Chanjo Kwa Wakati intervention.	Behavioral: Chanjo Kwa Wakati - Knowledge Intervention; Counseling scripts assessing and addressing vaccination-related knowledge gaps; Behavioral: Chanjo Kwa Wakati - Reminders; Reminders of upcoming vaccination due dates, sent to the mother's mobile phone; Behavioral: Chanjo Kwa Wakati - Incentives; Conditional incentives for timely vaccination, tailored to each child's vaccination schedule; Behavioral: Chanjo Kwa Wakati - Service notifications; Service notifications (e.g., related to stockouts or service non-availability), sent to the mother's mobile phone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Penta 3 delay in days (continuous)	The average number of days between the Penta3 vaccination due date (at age 14 weeks) and the date on which the child received the vaccination. Dates abstracted from the child's immunization card.	Assessed during the endline survey, an average follow-up period of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Penta 3 delay > 28 days (binary)	The percentage of participants with a delay >28 days between the Penta 3 vaccination due date (at age 14 weeks) and the date on which the vaccination was received. Dates abstracted from the child's immunization card.	Assessed during the endline survey, an average follow-up period of 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Penta 3 coverage (binary)	The percentage of children who received the Penta 3 vaccination. Coverage abstracted from the child's immunization card.	Assessed during the endline survey, an average follow-up period of 1 year
Coverage of all recommended vaccines (binary)	The percentage of children who received all vaccines recommended by age 1 year. Coverage abstracted from the child's immunization card.	Assessed during the endline survey, an average follow-up period of 1 year

Collaborators and Investigators

• 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

General Publications

• 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. Erratum In: Vaccine. 2023 Mar 31;41(14):2425.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 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): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Tanzania; Digital Health; Community Health Workers; Low and middle-income country; Vaccine hesitancy; SMS reminder; Childhood vaccinations; Timeliness; Conditional incentive
• 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