Clinical Research Directory

Media Orientation to Improve Childhood Vaccine Uptake and Address Parent and Caregivers Vaccine-related Anxiety: A Pilot Study

Vaccine hesitancy-defined as delayed acceptance or refusal of vaccines despite availability-remains a significant barrier to childhood immunisation uptake in Nigeria, a country with high zero-dose unvaccinated children. Several factors limit vaccine uptake, including poor awareness, misinformation, fear, anxiety and a perceived sense of conspiracy. Yet, a gap exists to address this urgent problem. The proposed study seeks to pilot the feasibility and acceptability of a novel co-produced media campaign intervention called ASSURed awareness campaign to encourage childhood vaccine uptakE (ASSURE) with parent-caregivers who are not or partially up to date with their child's vaccination. The ASSURE intervention is designed to encourage vaccine uptake and access, reduce vaccine hesitancy whilst addressing vaccine-related anxiety. The ASSURE intervention is low-intensity, lasting approximately 3-5-minute designed to raise awareness of the need for vaccination uptake and its implications for children, including their development and well-being whist addressing vaccine related anxiety and fears. The proposed study is also to pilot and test the instrument to determine effectiveness and cost effectiveness including the mechanism on why the intervention might potentially work.

A Tool Kit to Improve Vaccine Confidence in the Philippines

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.

Nursing Strategies to Increase Vaccination Rates in Adolescents: Education, Video Animation and Games

Purpose: This study aims to evaluate how immunization education, video animation, and game interventions based on the Health Belief Model (HBM) affect the immunization decisions of late adolescents. The findings could contribute to the development of targeted interventions to increase vaccine acceptance among adolescents. Hypotheses: Does the educational intervention, video animation, and game application affect adolescents' knowledge of vaccines? Do these interventions influence adolescents' positive attitudes towards vaccines? Will the interventions lead to significant changes in adolescents' health beliefs, especially regarding perceived risks, benefits, and barriers? Do the interventions increase vaccine acceptance and vaccination rates among adolescents? Do the interventions reduce vaccine hesitancy among adolescents? Can the Health Belief Model-based interventions provide an effective communication strategy to increase vaccine acceptance? Method: The research will be conducted from March 3 to March 30, 2025. Participants will undergo immunization education, video animation, and game applications. Expert opinions will be consulted for developing educational materials, videos, and games. Institutional approval will be obtained, and an informed consent form will be distributed to participants. Those who volunteer will be assigned numbers, and participants for the intervention and control groups will be selected using simple random sampling. Interventions: Educational Material: Aimed at increasing awareness about vaccines, the education focuses on the perceived risks, benefits, and barriers to vaccination. Video Animation: A video that explains how vaccines work, strengthen the immune system, and address perceived risks and benefits. Game Application: A simulation game called "infected interaction," where participants learn about the spread of infectious diseases during social interactions. Inclusion Criteria: Inclusion: Adolescents aged 18-21, willing to participate, complete research forms, and attend the sessions. Exclusion: Withdrawal from the study. Variables: Independent Variables: Gender, age, income, school, chronic illness, etc. Dependent Variables: Scale scores. Data Collection Tools: Adolescent Introductory Questionnaire: A form with 14 questions about demographic information and attitudes toward vaccination. Vaccine Hesitancy Scale: A 9-item scale measuring vaccine hesitancy. Self-Efficacy Scale: A 23-item scale to assess adolescents' self-efficacy in various contexts. Statistical Analysis: Sample size was determined by power analysis: 210 participants (105 intervention, 105 control). Data will be analyzed using IBM SPSS Statistics V 26. Normal distribution will be assessed with the Shapiro-Wilk test, and homogeneity of variance will be tested with Levene's test. Pre- and post-test scores will be compared using repeated measures ANOVA. A p-value of \<0.05 will be considered statistically significant. Expected Outcomes: Increased Knowledge: It is expected that educational interventions and video animations will improve adolescents' knowledge about vaccines, potentially influencing their attitudes. Positive Attitude Change: The intervention may lead to more positive attitudes towards vaccination. Changes in Health Beliefs: The intervention could alter adolescents' perceived risks, benefits, and personal beliefs regarding vaccines. Increased Vaccine Acceptance: The study may demonstrate that these interventions increase vaccine acceptance and vaccination rates. Effective Communication Strategies: The study may identify effective communication strategies for increasing vaccine acceptance among adolescents. Contribution to Public Health: This research could show that interventions targeting adolescents may play a critical role in improving public health by reducing the spread of infectious diseases.

Feasibility Trial of a Multi-level Media Production and Social Marketing Campaign to Reduce HPV Vaccine Hesitancy

Since 2019, the HPV working group of the University of Virginia Cancer Center's Southwest Virginia Community Advisory Board has developed and executed strategies to increase regional HPV vaccination rates. Members collaboratively developed Appalachian Voices for Health, a multi-level media production and social marketing intervention. This novel intervention builds on the past efforts of the working group and the engaged organizations; takes into account the impact of vaccine hesitancy on HPV vaccination uptake; and incorporates best practices. Through the intervention, Nursing and Dental Assistant students from Mountain Empire Community College will develop PSAs after receiving training about HPV vaccination and health communication. These PSAs will be used in a social marketing campaign executed through a regional transportation system managed by Mountain Empire Older Citizens. Specifically, the trial's aims are three-fold: assess the intervention's impact on community members' and students' HPV vaccine hesitancy (Aim 1) and perceptions and actions related to HPV vaccination (Aim 2) and evaluate other feasibility indicators at the community-, student-, organizational-, and process levels (Aim 3). The research team will use a concurrent mix-methods approach to assess feasibility indicators. Aims will be assessed using surveys, focus groups, meeting minutes, and implementation records. Data will be analyzed using descriptive and inferential statistics and content coding. Determination of the intervention's feasibility will consider the achievement benchmarks for feasibility indicators individually and collectively. Data will be used to inform refinement and future testing of Appalachian Voices for Health.