Clinical Research Directory

Caring for Frail Patients Through Vaccination

The CareVax project aims to find frail patients at Fondazione Policlinico Universitario 'A. Gemelli' IRCCS who could benefit from vaccinations against pneumococcal, Zoster, flu, HBV and SARS-CoV-2. This will reduce hospital stays, long-term effects, and deaths related to these diseases, as outlined in the PNPV (National Plan for Vaccine Prevention) 2017-2019 and Ministry of Health circulars from September, October, December 2022, and January 2023. Eligible patients, upon consent, will be identified by applying an automated algorithm to the patient's electronic health record and vaccination history contained in the regional vaccination registry. Identified patients will be contacted either directly if they are admitted to the inpatient wards of the Fondazione Policlinico Universitario "A.Gemelli" IRCCS (FPG) Hospital, or by messaging or e-mail in the case of access to the FPG for follow-up or routine visits or day hospital or day surgery service. Patients contacted, depending on their frail condition, will be booked for vaccination at an hospital vaccine clinic (extremely vulnerable patients) or a Local Health Unit (ASL Roma1) vaccine clinic respectively (frail patients). The project envisages a validation phase of the algorithm, through the evaluation of its concordance with the judgement of a blinded clinician on a small group of patients Patients' engagement and a proper communication system with them will be carried through an interoperable digital system aimed at booking the new vaccination appointment, reminding it and providing patients with all the information needed.

Enhancing Vaccination Uptake Through Points Redemption Based Financial Incentives and Digital Platforms: an Open-label Cluster Randomized Controlled Trial Utilizing Community Mobilization and Empowerment Strategies

The overall goal is to develop and optimize a health digital platform and points redemption-based financial incentive interventions for the promotion of non-National Immunization Program (non-NIP) vaccination uptake and related preventative behaviors in China, and formulate a low-cost, labor-saving and replicable pattern. The primary objective is to develop and optimize a digital platform-based point-redemption and financial incentive system and evaluate the effectiveness of the interventions for improving non-NIP vaccines coverage and related preventive behaviors.The main questions it aims to answer are: H1: Participants allocated to the intervention group will demonstrate a 3% increase in vaccine doses of targeted non-NIP vaccines, including HPV vaccines, influenza vaccines, pneumonia vaccines, rotavirus vaccines, varicella vaccines, and haemophilus Influenza Type B polysaccharide conjugate (Hib) vaccines, compared to those in the control group at the 12-month follow-up. H2: Participants allocated to the intervention group will exhibit a 5% increase in the prevalence of related preventive behaviors compared to those in the control group at the 12-month follow-up. Researchers will compare the financial incentive intervention to the routine activities to see if the intervention works to improve the vacciantion rate of non-NIP vaccines. Participants will: 1. Participants can automatically input their health behaviors through the digital platform, and the back-end will verify the information with data provided by the township hospitals or community health centers. 2. A QR code will be implemented at each township hospital or community health center. Participants will scan the QR code after completing vaccination or other related preventive behaviors. The digital platform will automatically record points for each completed behavior. 3. Use accumulated points to redeem gifts on the system, including household goods, electronic products, and free or discounted health services.

Characteristics of Human Papillomavirus (HPV) Infections and HPV Vaccine Attitudes Among Slovenian Women After the Introduction of HPV Vaccination

Cervical cancer (CC), primarily caused by persistent infection with high-risk human papillomavirus (HPV) types, remains a significant public health issue. Despite the availability of prophylactic HPV vaccines and improved screening methods, vaccination coverage and uptake remain suboptimal in many countries, including Slovenia. In 2020, the WHO launched a global strategy to eliminate CC, emphasizing 90% HPV vaccination coverage among girls, 70% screening of women at key ages, and 90% treatment of identified cases by 2030. The EVEN FASTER concept proposes that targeting a specific age group of women-those bridging unvaccinated and vaccinated cohorts-with simultaneous HPV screening and vaccination may significantly reduce HPV transmission. Swedish data support this, showing a 62-64% reduction in high-risk HPV infections following combined interventions in women aged 23-30. In Slovenia, HPV vaccination has been available since 2006 for girls, and since 2021 for boys, with average uptake around 50%. However, no comparable model has been implemented or studied locally. This proposed clinical study will assess HPV vaccine acceptability among women in Slovenia, identify barriers to uptake, define an optimal target age group for intervention, and evaluate the effectiveness of offering concurrent screening and vaccination to accelerate CC prevention in this region. Women will be invited to participate during their preventive gynecological examination within Slovenia's national cervical cancer screening program (ZORA). Inclusion criteria include regular cervical smears (CS) every 3 years following a previously normal result, first or second CS after entering the ZORA program, follow-up CS after abnormal cytology, non-neoplastic findings, or cervical procedures, and CS due to clinical indications. Exclusion criteria include pregnancy, menstruation, cervical or vaginal inflammation, other medical conditions preventing CS collection, prior hysterectomy, prior CS taken for this study, or known hypersensitivity to HPV vaccine components. Eligible women will be invited by the attending gynecologist and nurse. After the exam, participants will complete an anonymous questionnaire covering demographics, screening history, vaccination status, and vaccine attitudes. Assistance will be provided if needed. Women aged ≤35 who are unvaccinated will receive counseling on HPV vaccination, including benefits and risks. Those consenting will receive free vaccination with the nonavalent Gardasil®9 vaccine, following a three-dose schedule (0, 1-2, 6 months). Around 500 women aged ≤35 are expected in this sub-group, with fewer than half anticipated to accept vaccination. Data will be anonymized and analyzed using SPSS (p \< 0.05).

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

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