Improving Uptake of Pediatric Vaccines Through Religious Conferences and Vaccines-in-a-van in Aceh, Indonesia (TABRIE)

TABRIE: Trusted Faces, Familiar Places (CGHE)

The goal of this cluster, randomized controlled trial is to study the impact of mobile vaccine clinics and religious conferences on pediatric vaccination coverage. The main questions will be: does vaccination coverage change in geographic areas with the mobile vaccine clinics vs those areas without mobile vaccine clinics; and does vaccination coverage change in geographic areas with religious conferences on vaccination vs those areas without religious conferences. In repeated surveys, adult participants will respond about their children's vaccination status. Participants will not be individually randomized to the interventions. Rather, their geographical area will be randomized.

Study Overview

• Status: Recruiting
• Conditions: Vaccination
• Intervention / Treatment: Behavioral: Religious conferences; Behavioral: Vaccine-in-a-van

Detailed Description

This project seeks to create a paradigm shift in how the public views and utilizes vaccination services. Currently, community health centers remain the default setting for vaccination, and clinicians the default administrators. However, the general population may have difficulty accessing these clinics or trusting traditional vaccination providers, particularly if they are members of marginalized communities that have experienced medical discrimination. This project applies a two-pronged approach by addressing issues of trust and ease of access among the general population. This project is innovative by: a) mobilizing religious communities to discuss vaccines (to counter reported lack of information about vaccines among unvaccinated families) and b) training more community health workers in vaccination and in physically delivering vaccines through a "Vaccine-in-a-van" concept to facilitate ease in accessing vaccines. By mobilizing these individuals in the community settings where people live, work, worship, and learn, this project will expand vaccine information and services.

More specifically, this project plans to work with local health leaders in a low vaccination community in Aceh, Indonesia to identify social institutions that are part of children and families' daily lives; these could include houses of worship, schools, or community centers. This project will fund a mobile vaccine delivery unit to go to these locations to physically bring vaccines to the people and to link them with existing immunization clinic infrastructure. This project will also work towards changing the culture of child health and vaccination through substantial discussions and conversations with multiple levels of religious leaders at conferences.

• Study Type: Interventional
• Enrollment (Estimated): 2400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abram Wagner, PhD; Phone Number: 7347632330; Email: awag@umich.edu

Study Locations

• Indonesia
  • Aceh
    • Banda Aceh, Aceh, Indonesia, 23111
      • Recruiting
      • Universitas Syiah Kuala
      • Contact: Harapan, PhD; Email: harapan@usk.ac.id

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults 18+, and
• Proficient in Bahasa Indonesia, and
• Plan to live in neighborhood for next year
• Parent of child <5, or
• Planning to have a child within next year

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Religious Conference; Clusters will have religious conference.	Behavioral: Religious conferences; The conference will invite local subdistrict-level imams and other religious leaders, along with a range of community health workers, including those not traditionally trained to give vaccines. During the conference there will be some sessions with everyone, and some that are broken down by profession. The conference topics will be developed in conjunction with the religious leaders, but will focus on the importance of infant health
No Intervention: Religious Conference control; Clusters will have not religious conference. Clusters' background characteristics matched to the Conference arm.
Experimental: Vaccine-in-a-van; Clusters will have deployment of a mobile vaccine clinic ("vaccine-in-a-van").	Behavioral: Vaccine-in-a-van; For the vaccine-in-a-van concept, our community health worker will travel to different areas in the test subdistricts. These locations will be decided on in conjunction with the local health department and the research team's knowledge of the area. We will target areas which would have families with young children, particularly: schools, mosques, and sports fields. The purpose of the van will be to bring vaccines to the community, but also to put a human face (our community health worker) to vaccines outside of a clinical setting.
No Intervention: Vaccine-in-a-van control; Clusters will not have a deployment of a mobile vaccine clinic ("vaccine-in-a-van"). Clusters' background characteristics matched to the Van arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Full vaccination	Number of participants fully vaccinated. Full vaccination means 1 dose of BCG; 3 doses of DTP; 3 doses of polio vaccine; 1 dose of measles-containing vaccine	Records from vaccination cards or clinic records 6 months since the start of the intervention

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Abram Wagner, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 29, 2023
• First Submitted That Met QC Criteria: November 29, 2023
• First Posted (Actual): December 7, 2023

Study Record Updates

• Last Update Posted (Actual): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: HUM00235620

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Reproducibility and replicability of studies are both extremely important. Therefore, we plan to upload a final dataset (along with code detailing my statistical analysis) to a public repository. This dataset will have personally identifiable information removed - and the geographic location will be coded by a number to prevent individuals being able to locate members of the study and identify them.
• IPD Sharing Time Frame: Study data will be made available by December 31, 2026
• IPD Sharing Access Criteria: This will be publicly available.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No