A Tool Kit to Improve Vaccine Confidence in the Philippines

NCT06218368 | Active Not Recruiting

• 1 other identifier: PRCT2021710
• Study Type: interventional
• Target: 5,400
• Locations: 1 country
• Sites: 1

Brief Summary

This cluster randomized controlled trial (RCT) aims to evaluate the feasibility and efficacy of an educational toolkit in enhancing measles, mumps, rubella (MMR) and polio vaccine confidence in the Philippines. The toolkit contains four aspects: an introduction to MMR and polio vaccines, vaccine safety and efficacy, vaccination guidelines (including schedules and locations), and debunking myths and misconceptions. Presented as a 10-minute video and followed by reminder messages from health educators, the toolkit was developed in collaboration with International Care Ministries (ICM) health educators and translated into local dialects. Our toolkit will be embedded in a RCT called the Soap Opera Trial, which is designed and run by the ICM leveraging their community-based Transform Program. The standard Transform Program consists of 15 weeks of education sessions delivered by local health educators through traditional lectures in each community. The trial aims to evaluate the impact of a variation to their standard Transform Program, which uses aspirational videos to deliver education about food security, livelihood, and health. The soap opera to be shown in the video includes drama and plot twists similar to a typical television show but highlights lessons about income creation, health care, and resilience, which are key behaviors and outcomes that can help the poor lift themselves out of poverty. The ICM will conduct this RCT to assess the impact of these soap opera videos on outcomes such as aspirations about the future. A total of 180 communities participating in the Transform program will be randomly assigned to one of the two arms. In the intervention arm, the participants will receive our vaccine toolkit intervention (including educational video and reminding messages about MMR and polio vaccines) and 15 soap opera videos alongside standard Transform Program, while participants in the control arm will receive the standard Transform Program, in which the education sessions are delivered through lectures. The effectiveness of the toolkit will be evaluated by 1) the rate of MMR and polio vaccination among children of the Transform Program participants and 2) knowledge and attitudes towards these vaccines among the participants. Additionally, the relevance, applicability, and feasibility of the toolkit will be assessed using qualitative research methods, and cost-effectiveness of the intervention will be assessed.

Conditions

Measles; Polio; Vaccination Hesitancy

Outcome Measures

Primary Outcomes (1)

• First-dose measles-containing-vaccine (MCV) coverage rate

  The rate of first-dose measles-containing-vaccine (MCV) vaccination among children aged 12 months among the family of participants

  6 months after intervention

Secondary Outcomes (3)

• Two-dose MCV coverage rate

  6 months after intervention

• Polio vaccination rate

  6 months after intervention

• Mean knowledge score

  6 months after intervention

Study Arms (2)

Intervention

EXPERIMENTAL

Participants in the intervention arm will receive our vaccine toolkit intervention, which includes two main components: 1) our educational toolkit on MMR and polio vaccination in the form of a video, which will be introduced and presented to the participants from Week 12 to Week 15 of the Transform program, 2) reminding messages regarding vaccination, which will be delivered following the video session and embedded in Saving Groups program run in the communities. Additionally, participants in the intervention arm will also receive a series of 15 soap opera videos, one for each week, to complement the 15-week Transform Program's education session, which is the core intervention of the Soap Opera Trial developed and run by the ICM.

Behavioral: Educational toolkit on MMR and polio vaccination

Control

NO INTERVENTION

In the control group, participants will attend the standard 15-week Transform program, with education sessions delivered through traditional lectures by health educators from ICM on the topics of income creation, education, food security, and resilience. Our educational toolkit of MMR and polio vaccination will not be provided and there will be no specific reminders or discussions regarding MMR and polio vaccinations.

Interventions

Educational toolkit on MMR and polio vaccination BEHAVIORAL

The educational video about vaccines was adapted from a health educational toolkit that aims to promote community confidence in vaccines in the ultra-poor Philippine households. This toolkit contains persuasive messaging on vaccination guidelines, vaccines safety and efficacy, and myths and misconceptions of MMR and polio vaccines. Participants in the intervention arm will receive our educational video about MMR and polio vaccines. Additionally, health educators from ICM will teach the participants to understand their vaccination cards and orally remind them to have their children vaccinated at each week's Transform Program session from week 12 until week 15. After the end of the Transform Program, about 40-50% of the participants in the intervention arm will attend another community-based program run by ICM called the Savings Groups, where the participants will receive weekly reminding messages about MMR and polio vaccination in their group meetings for three months.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals reside in the participating communities where ICM recruits for the Transform Program.
• Individuals meet the criteria and definition of ultra-poor based on the ICM's screening\*.
• Individuals give oral informed consent to participate in the health education sessions which includes the delivery of our toolkit. There must be 30 eligible participants before a community will be approved to participate in the ICM Transform Program.
• All participating communities of the ICM Soap Opera trial who provided consents to health education sessions will be eligible to participate in the vaccine confidence trial. Participants will be screened using a poverty score card, loosely based on the Progress out of Poverty Index (PPI) developed for the Philippines (Innovations for Poverty Action, 2014) and self-reported household income. Participants in households that meet the definition of ultra-poor by income (\< 22 Philippine pesos per person per day) are prioritized to be recruited for the Transform Program.

You may not qualify if:

• \- Individuals who refuse to participate will not be included in the trial.

Sponsors & Collaborators

• University of Toronto: lead
• International Care Ministries, the Philippines: collaborator

Study Sites (1)

International Care Ministries

Manila, Philippines

Location

Related Publications (1)

• Wu S, Dong Q, Zhang Z, Pang S, Thorpe K, Kelly M, Haldane V, Lau L, Wei X. Effectiveness of an Education Toolkit Delivered by Soap Operas Among Communities Living in Extreme Poverty in Improving Vaccination Confidence in the Philippines: Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2025 Oct 30;14:e77022. doi: 10.2196/77022.

  PMID: 41166704 DERIVED

MeSH Terms

Conditions

Measles; Poliomyelitis; Vaccination Hesitancy

Interventions

Poliovirus Vaccines

Condition Hierarchy (Ancestors)

Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections; Myelitis; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases; Vaccination Refusal; Treatment Refusal; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Xiaolin Wei, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 17, 2023
• First Posted: January 23, 2024
• Study Start: January 31, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After publication in peer-reviewed journals.
• Access Criteria: The research team will aim to publish them in open access journals as priority so that all other researchers will freely access to them.

Locations

PH (1)