A Tool Kit to Improve Vaccine Confidence in the Philippines

Measles Clinical Trial

Official title: A Cluster Randomized Controlled Trial to Evaluate the Effectiveness of an Educational Toolkit Among Poor Communities in Improving Vaccination Confidence in the Philippines

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

This cluster randomized controlled trial (RCT) aims to assess the feasibility and efficacy of an educational toolkit co-developed with local stakeholders to enhance confidence in measles, mumps, rubella (MMR) and polio vaccines in the Philippines. The toolkit contains information and messages about the following four aspects of MMR and polio vaccines: 1) comprehensive introduction of MMR and polio; 2) vaccines safety and efficacy; 3) MMR and polio vaccination guidelines with vaccination schedules and locations; and 4) myths and misconceptions. The educational toolkit will be presented using a 10-minute translated video converted from PowerPoint slides in one session. Reminder messages regarding vaccination will then be delivered in following sessions by health educators. The educational toolkit, as well as the adapted PowerPoint slide deck and accompanying script, was collaboratively developed with health educators from International Care Ministries (ICM). Professional translators have translated the finalized English version of the slide deck and script into the local dialects. Subsequently, ICM produced a video featuring a health worker presenting the toolkit, synchronized with the voiceover and PowerPoint slides.

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 is entitled "First Light" and is produced by ICM's own internal media team. It 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 cluster RCT to assess the impact of these soap opera videos on outcomes such as aspirations about the future, investments on children's education, social capital, health, hope, and economic outcomes. A 'cluster' is defined as a community participating in the Transform Program. Each community consists of 30 participants, forming the basic unit for our intervention and analysis. Randomization will be performed at the community level by the ICM, and the 180 communities participating in the Transform program will be randomly assigned to one of the two arms (intervention and control). 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 measles, mumps, rubella (MMR) and polio vaccination among children of the Transform Program participants and 2) knowledge and attitudes towards these vaccines among the participants. Differences in the two outcomes will be compared between the intervention and control arms using appropriate statistical analysis. Additionally, the relevance, applicability, and feasibility of the toolkit will be assessed using qualitative research methods. The investigators will purposively select 30 end-users to conduct semi-structured interviews, which aim to understand the accuracy and appropriateness of the toolkit content, user perception of the toolkit's relevance, and overall satisfaction with the toolkit. Finally, the investigators will conduct a cost-effectiveness analysis to compare the cost, participants' attitude towards MMR and polio vaccines, and the immunization rates of children in the immediate families of participants associated with our intervention versus no intervention over the entire intervention time horizon. ;

Related Conditions & MeSH terms

• Measles
• Polio

• NCT number: NCT06218368
• Study type: Interventional
• Source: University of Toronto
• Contact: Shishi Wu, PhD
• Phone: +1 6047823674
• Email: shishi.wu@utoronto.ca
• Status: Recruiting
• Phase: N/A
• Start date: January 31, 2024
• Completion date: February 25, 2025