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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06160999
Other study ID # HUM00235620
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date December 31, 2026

Study information

Verified date December 2023
Source University of Michigan
Contact Abram Wagner, PhD
Phone 7347632330
Email awag@umich.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2400
Est. completion date December 31, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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
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.

Locations

Country Name City State
Indonesia Universitas Syiah Kuala Banda Aceh Aceh

Sponsors (1)

Lead Sponsor Collaborator
University of Michigan

Country where clinical trial is conducted

Indonesia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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