NCT06160999

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 7, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

2.3 years

First QC Date

November 29, 2023

Last Update Submit

January 14, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

Religious Conference

EXPERIMENTAL

Clusters will have religious conference.

Behavioral: Religious conferences

Religious Conference control

NO INTERVENTION

Clusters will have not religious conference. Clusters' background characteristics matched to the Conference arm.

Vaccine-in-a-van

EXPERIMENTAL

Clusters will have deployment of a mobile vaccine clinic ("vaccine-in-a-van").

Behavioral: Vaccine-in-a-van

Vaccine-in-a-van control

NO INTERVENTION

Clusters will not have a deployment of a mobile vaccine clinic ("vaccine-in-a-van"). Clusters' background characteristics matched to the Van arm.

Interventions

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

Religious Conference

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.

Vaccine-in-a-van

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitas Syiah Kuala

Banda Aceh, Special Region of Aceh, 23111, Indonesia

Location

Related Publications (1)

  • Ladhania R, Ichsan I, Koumpias AM, Yufika A, Indah R, Liansyah TM, Wagner AL, Harapan H. Improving uptake of pediatric vaccines through religious conferences and mobile vaccine clinics in Aceh, Indonesia (TABRIE): study protocol for a stepped wedge cluster randomized controlled trial. Trials. 2025 Nov 21;26(1):528. doi: 10.1186/s13063-025-09170-5.

Study Officials

  • Abram Wagner, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Model Details: This is a stepped wedge design with a cross-sectional sampling structure.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Epidemiology and Research Assistant Professor, Global Public Health, School of Public Health

Study Record Dates

First Submitted

November 29, 2023

First Posted

December 7, 2023

Study Start

September 1, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

January 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, ANALYTIC CODE
Time Frame
Study data will be made available by December 31, 2026
Access Criteria
This will be publicly available.

Locations