Chanjo Kwa Wakati - Improving Vaccination Coverage and Timeliness in Rural Settings

Knowledge, Attitudes, Practice Clinical Trial

— MINT-II  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06024317
• Other study ID #: Pro00120675
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: June 30, 2027

Study information

• Verified date: September 2023
• Source: University of South Carolina
• Contact: Jan Ostermann, PhD
• Phone: 18037778747
• Email: jano[@]mailbox.sc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1200
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Incentives
• Knowledge, Attitudes, Practice
• Vaccination

Intervention

Behavioral:
• Chanjo Kwa Wakati - Knowledge Intervention
Counseling scripts assessing and addressing vaccination-related knowledge gaps
• Chanjo Kwa Wakati - Reminders
Reminders of upcoming vaccination due dates, sent to the mother's mobile phone
• Chanjo Kwa Wakati - Incentives
Conditional incentives for timely vaccination, tailored to each child's vaccination schedule
• Chanjo Kwa Wakati - Service notifications
Service notifications (e.g., related to stockouts or service non-availability), sent to the mother's mobile phone

Locations

Country	Name	City	State
Tanzania	National Institute for Medical Research	Dar Es Salaam

Sponsors (5)

Lead Sponsor	Collaborator
University of South Carolina	Duke University, Emory University, National Institute for Medical Research, Tanzania, University of North Carolina

Country where clinical trial is conducted

Tanzania, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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