Clinical trial NCT06024317: Chanjo Kwa Wakati - Improving Vaccination Coverage and Timeliness in Rural Settings
Official title: "Chanjo Kwa Wakati" - Leveraging Community Health Workers and a Responsive Digital Health System to Improve Vaccination Coverage and Timeliness in Rural Settings
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vaccination
Short Message Service (SMS)
Incentives
Knowledge, Attitudes, Practice
Keywords: Childhood vaccinations
Timeliness
Vaccine hesitancy
Digital Health
Community Health Workers
Tanzania
Low and middle-income country
SMS reminder
Conditional incentive
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: Duke University
name: Emory University
name: University of North Carolina
name: National Institute for Medical Research, Tanzania
First posted: 2023-09-06
Enrollment: 1200
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This type 1 effectiveness-implementation hybrid study uses a cluster-randomized trial design to evaluate intervention effectiveness.
Primary purpose: HEALTH_SERVICES_RESEARCH

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 (Chanjo Kwa Wakati; "Timely Vaccination" in Kiswahili) can improve vaccination timeliness in rural Tanzania. The hypothesis is that Chanjo Kwa Wakati will improve the timeliness and rates of completion of vaccinations due by age 1 year compared to the standard of care. Researchers will compare outcomes between an early vs. delayed intervention arm, and a prospectively enrolled sample of children with a cross-sectional retrospective sample. 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.

Detailed description: 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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Penta 3 delay in days (continuous)
timeFrame: Assessed during the endline survey, an average follow-up period of 1 year
Secondary outcomes:
measure: Penta 3 delay > 28 days (binary)
timeFrame: Assessed during the endline survey, an average follow-up period of 1 year
Other outcomes:
measure: Penta 3 coverage (binary)
timeFrame: Assessed during the endline survey, an average follow-up period of 1 year
measure: Coverage of all recommended vaccines (binary)
timeFrame: Assessed during the endline survey, an average follow-up period of 1 year
Locations:
city: Dar Es Salaam
country: Tanzania
facility: National Institute for Medical Research
Study officials:
affiliation: University of South Carolina
name: Jan Ostermann, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.
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.