Enhancing Maternal Vaccine Knowledge and Uptake: The InTroDuce-Programme Trial

April 27, 2026 updated by: Lau Hung Chiun, Universiti Putra Malaysia

Effectiveness of the Influenza and Tdap (Tetanus, Diphtheria, Acellular Pertussis) Vaccination Educational and Learning Module (InTroDuce-Programme) in Improving Knowledge and Future Uptake of Vaccination Among Pregnant Mothers in Primary Care Clinics: A Randomised Control Trial Secondary IDs

The goal of this InTroDuce-Programme interventional trial aims to test whether a web-based educational program can improve pregnant women's knowledge about Influenza and Tdap vaccinations and increase their intention to get vaccinated in the future. The main questions it aims to answer are:

Does the InTroDuce-Programme increase knowledge and future intention of pregnant mothers to get vaccinated against Influenza and Tdap? How does demographic factors, attitudes and barriers affect vaccination decisions among pregnant mothers?

Researchers will compare InTroDuce-Programme to standard care (routine antenatal care) to see if InTroDuce-Programme works to improve knowledge and future intention of pregnant mothers to be vaccinated against Influenza and Tdap. Participants will:

Receive the web-based educational module (InTroDuce-Programme), which covers the importance, safety, and effectiveness of vaccinations, as well as addressing common concerns.

Be followed up one month after the intervention. Answer questionnaires before and after the intervention to measure changes in vaccination knowledge and future intention to get vaccinated

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

1.0 Background and Significance

Maternal vaccination is a crucial public health strategy to protect mothers and infants from infectious diseases like influenza and pertussis. Pregnant women face higher risks of complications due to physiological and immunological changes, with a fourfold increased likelihood of influenza-related hospitalization. Similarly, pertussis is particularly severe in infants under two months. In Malaysia, the Ministry of Health recommends influenza and Tdap vaccines during pregnancy, but uptake remains low due to safety concerns, limited provider recommendations, and access issues. Digital interventions, particularly video-based education, have shown promise in addressing vaccine hesitancy. To tackle these barriers, the InTroDuce-Programme, a comprehensive web-based educational module, has been developed to improve vaccination knowledge and uptake.

2.0 Objective

General objective: To evaluate the effectiveness of the InTroDuce-Programme in improving knowledge and future uptake of influenza and Tdap vaccination among pregnant mothers.

Specific objectives:

  1. To determine the sociodemographic factors and clinical variables among study population.
  2. To determine the prevalence of future vaccination uptake following the InTroDuce-Programme.
  3. To evaluate the level of participants' attitudes and barriers towards future vaccination uptake before and after the InTroDuce-Programme.
  4. To determine the effectiveness of the InTroDuce-Programme in improving knowledge and future uptake of influenza and Tdap vaccination among pregnant mothers.
  5. To determine the factors associated with low future uptake of vaccine with socio-demographic factors (age, race, income, education) among pregnant mothers.

3.0 Methodology

3.1 Study Design

This randomised controlled trial (RCT) will be conducted in four primary care clinics in Hulu Langat district which are Klinik Kesihatan Kajang, Klinik Kesihatan Bangi, Klinik Kesihatan Batu 9 and Klinik Kesihatan Balakong. The study duration is 12 months, with recruitment over 6 months. A second follow-up will be conducted one month after providing the InTroDuce-Programme. Two clinics will be randomly assigned to administer the InTroDuce-Programme, while the other two will be provided with standard care, in order to minimise contamination.

Cluster definition based on urban and suburban classification Klinik Kesihatan Kajang and Klinik Kesihatan Bangi are classified as urban, while Klinik Kesihatan Batu 9 and Klinik Kesihatan Balakong are classified as suburban. These clinics were selected due to their geographic and demographic similarity, coupled with variability in socioeconomic, educational, cultural, and attitudinal factors. This selection ensures a balanced representation of diverse populations, enhancing the generalizability and applicability of the study findings. The approach is particularly valuable for comprehensively understanding the factors that influence vaccine knowledge and uptake among pregnant mothers.

Random Allocation of Clinics Random Assignment: One clinic from each category (urban and suburban) will be randomly assigned to either the intervention or control group using an online random number generator. This method ensures unbiased allocation and maintains the balance of geographic representation in both groups.

The rationale for Randomization is to minimise contamination. Randomizing at the clinic level (cluster randomization) rather than at the individual level will help reduce the risk of contamination, where participants in the same clinic may share information or influence each other's behaviour. By assigning entire clinics to either intervention or control, the study ensures that participants within each clinic receive consistent and isolated exposure to the educational materials or standard care.

3.2 Sample Size

The sample size is 351 participants, accounting for a 20% non-response rate. This is based on expected uptake rates of 55% in the intervention group and 36% in the control group.

3.3 Data Collection

A validated, adapted questionnaire will be used in this study to assess vaccine-related knowledge, attitudes, future uptake intentions, and factors influencing vaccination decisions.

3.4 Statistical Analysis

Primary Outcome: Knowledge improvement, analyzed via paired t-tests or Mann-Whitney U tests.

Secondary Outcomes: Logistic regression for factors associated with low uptake intentions.

Study Type

Interventional

Enrollment (Estimated)

351

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Malaysia
    • Selangor
      • Bandar Baru Bangi, Selangor, Malaysia, 43650
        • Recruiting
        • Klinik Kesihatan Bangi
        • Contact:
        • Principal Investigator:
          • Dr Siti Rohani Bt Mohamed Alias, Family Med
      • Cheras, Selangor, Malaysia, 43200
        • Recruiting
        • Klinik Kesihatan Batu 9
        • Contact:
        • Principal Investigator:
          • Dr Nor Hazlin Bt Talib, Family Med
      • Cheras, Selangor, Malaysia, 43300
        • Recruiting
        • Klinik Kesihatan Balakong
        • Contact:
        • Principal Investigator:
          • Dr Nadiah Binti Md Alwi, Family Med
      • Kajang, Selangor, Malaysia, 43000
        • Recruiting
        • Klinik Kesihatan Kajang
        • Contact:
          • Dr Nur Harnani bt Abdullah, Family Med
          • Phone Number: +60 17-623 3545
          • Email: nanee801@yahoo.com
        • Contact:
        • Sub-Investigator:
          • Dr Izzah Hazwani binti Dzulkifli, Family Med

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Pregnant women aged 18 years and older
  • Before or equal to 32 weeks of gestation as we need to follow-up the patients again at 36 weeks of gestation before delivery occurs.
  • Able to understand and consent to participation in the study.

Exclusion Criteria:

  • Pregnant women with severe anaphylactic or allergic reactions to previous dose of influenza or Tdap vaccination.
  • Non-Malaysian

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Standard antenatal care
Experimental: Intervention
Influenza and Tdap Vaccination Web-based Educational and Learning Module (InTroDuce-Programme)
Behavioral: Influenza and Tdap Vaccination Educational and Learning Module
Influenza and Tdap learning and educational module delivered via website. The module will cover importance of vaccination for both pregnant women and infant, safety and efficacy of the influenza and TdaP vaccines, timing of vaccination, and addressing common concerns and misconceptions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knowledge of Influenza and Tdap Vaccination
Time Frame: 1 month post-intervention
knowledge score about the importance, safety, and benefits of vaccination (vaccine literacy) will be assessed through pre- and post-intervention questionnaire
1 month post-intervention
Vaccination Future Uptake
Time Frame: 1 month post-intervention
Intention of future vaccine uptake of the influenza and Tdap vaccines will be assessed using questionnaire
1 month post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Barriers to vaccination uptake
Time Frame: 1 month post-intervention
Identification of barriers to vaccination uptake and socio-demographic factors influencing outcomes.
1 month post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiti Putra Malaysia

Investigators

  • Principal Investigator: Hung Chiun Lau, Dr Fam Med, Universiti Putra Malaysia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

February 3, 2025

First Submitted That Met QC Criteria

February 3, 2025

First Posted (Actual)

February 7, 2025

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • InTroDuce-Programme

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Influenza

Clinical Trials on Influenza and Tdap Vaccination Educational and Learning Module

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe