Clinical trial NCT06815250: Enhancing Maternal Vaccine Knowledge and Uptake: the InTroDuce-Programme Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Vaccination Uptake
Knowledge
Tetanus, Diphtheria and Acellular Pertussis Vaccination
Influenza
Web Based Intervention
Vaccine Knowledge
Keywords: Influenza vaccination
Tdap vaccination
Educational module
Pregnant mothers
Vaccine knowledge
Vaccine uptake
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 351
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: web-based educational video on Influenza and Tdap vaccine (InTroDuce-Programme)
Primary purpose: PREVENTION

Brief summary: 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Knowledge of Influenza and Tdap Vaccination
timeFrame: 1 month post-intervention
measure: Vaccination Future Uptake
timeFrame: 1 month post-intervention
Secondary outcomes:
measure: Barriers to vaccination uptake
timeFrame: 1 month post-intervention
Other outcomes:
Locations:
city: Bandar Baru Bangi
country: Malaysia
facility: Klinik Kesihatan Bangi
state: Selangor
city: Cheras
country: Malaysia
facility: Klinik Kesihatan Batu 9
state: Selangor
city: Cheras
country: Malaysia
facility: Klinik Kesihatan Balakong
state: Selangor
city: Kajang
country: Malaysia
facility: Klinik Kesihatan Kajang
state: Selangor
Study officials:
affiliation: Universiti Putra Malaysia
name: Hung Chiun Lau, Dr Fam Med
role: PRINCIPAL_INVESTIGATOR
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