The Community Nurse as a Public Health Determinant

NCT ID: NCT05485441

Last Updated: 2023-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-02

Study Completion Date

2024-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To date, there have been no interventional studies aimed at increasing HPV vaccination rates by making use of digital and involving all stakeholders within this process: nurses, physicians, caregivers, parents, and children/adolescents according to the PPI principle.

The primary objective of the project is to identify the effectiveness of a digital educational intervention, conducted by a multidisciplinary healthcare team and targeting adolescents of both sexes in secondary schools. The outcome measures will be: engagement, increased knowledge and self-efficacy, and vaccination uptake.

This project will identify new models for addressing public health needs. The secondary aim is to evaluate parents' attitudes toward vaccination pre- and post-intervention education.

A quasi-experimental, pre-post educational intervention study will be conducted by adopting a convenience sampling will be adopted at secondary schools in Bari (Puglia, Italy).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study will be carried out in a multiphasic mode. All steps are described below.

* First Phase (T0): the Community Nurses (CN) will send, via e-mail to all parents, a questionnaire aimed at investigating their children's vaccination status, hesitation to vaccination, sources of information, and information needs about vaccination. Then, upon prior arrangement with the school Principal, the CN will, in-person, distribute a questionnaire to all participating students to explore adolescents' knowledge about HPV vaccination, their involvement in vaccine decision-making, their feelings, and perceived self-efficacy.
* Second Phase (T1): the CN, after analyzing all the responses from the questionnaires administered to both parents (to investigate hesitations to vaccination) and students (on students' knowledge, involvement, feelings, self-efficacy), will set up an educational intervention, involving the members of expert (nurses and physicians' experts in public health).

Description of the educational intervention

The educational intervention will be provided (at T1) in two ways:

(I) a video lecture in e-learning mode lasting about an hour, aimed at adolescents, using the School Institute's platform for distance education, using audiovisual systems and slide presentations in Power Point format; learner-learner interactions will be possible through e-mail messages, real-time individual chats and asynchronous discussion forum conversations including comment sections.. The event will be recorded so that both adolescents and parents can access it at their convenience.

The educational content will generally take into account the following topic areas: a) basic information on HPV, modes of prevention and contagion, vaccination and sexual health; b) epidemiology on cervical cancer, incidence and mortality rates; c) preventive measures (vaccines, condoms, screening tests); and d) discussion with privileged witnesses who have experienced contagion.

No form of clinical counseling will be carried out during the video lectures. (II) the promotion of 2-minute "videopills" on the social channels most frequently used by students (dedicated youtube channel/school portal) in which clinical experts (pediatrician, hygienist, health care assistant, and CN) will raise awareness of the importance of HPV vaccination in adolescents, providing brief information on modes of transmission, prevention, and health effects of the virus.

\- Third Phase (T2) - follow up In the last phase (three months after the intervention), parents will be contacted again by the CN, by telephone, to assess whether they have been vaccinated against HPV. At the same time, the effectiveness of the educational intervention will be evaluated by administering the same instruments used at T0.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HPV Nurse's Role

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Students

The students

Group Type EXPERIMENTAL

Digital Educational Intervention

Intervention Type OTHER

The educational intervention will be provided (at T1) in two ways:

(I) a video lecture in e-learning mode lasting about an hour, aimed at adolescents, using the School Institute's platform for distance education (II) the promotion of 2-minute "videopills" on the social channels most frequently used by students (dedicated youtube channel/school portal)

Parents

The parents

Group Type EXPERIMENTAL

Digital Educational Intervention

Intervention Type OTHER

The educational intervention will be provided (at T1) in two ways:

(I) a video lecture in e-learning mode lasting about an hour, aimed at adolescents, using the School Institute's platform for distance education (II) the promotion of 2-minute "videopills" on the social channels most frequently used by students (dedicated youtube channel/school portal)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Digital Educational Intervention

The educational intervention will be provided (at T1) in two ways:

(I) a video lecture in e-learning mode lasting about an hour, aimed at adolescents, using the School Institute's platform for distance education (II) the promotion of 2-minute "videopills" on the social channels most frequently used by students (dedicated youtube channel/school portal)

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Students aged 11- 13 years and their parents.
* Students with disabilities, with visual and hearing impairment, with the suppor of their support teacher.

Exclusion Criteria

* Students and/or parents who do not agree to participate
* Students and/or parents who do not provide informed consent
* Students and/or parents who do not provide a telephone number and e-mail address to be contacted
Minimum Eligible Age

11 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Bari Aldo Moro

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Pasquale Stefanizzi

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Giancarlo Cicolini

Role: PRINCIPAL_INVESTIGATOR

Researcher

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Aldo Moro of Bari

Bari, Apulia, Italy

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Pasquale Stefanizzi

Role: CONTACT

+390805592055

Giancarlo Cicolini

Role: CONTACT

+390805478456

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Pasquale Stefanizzi

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

Napolitano F, D'Alessandro A, Angelillo IF. Investigating Italian parents' vaccine hesitancy: A cross-sectional survey. Hum Vaccin Immunother. 2018 Jul 3;14(7):1558-1565. doi: 10.1080/21645515.2018.1463943. Epub 2018 May 14.

Reference Type BACKGROUND
PMID: 29641945 (View on PubMed)

Forster AS, McBride KA, Davies C, Stoney T, Marshall H, McGeechan K, Cooper SC, Skinner SR. Development and validation of measures to evaluate adolescents' knowledge about human papillomavirus (HPV), involvement in HPV vaccine decision-making, self-efficacy to receive the vaccine and fear and anxiety. Public Health. 2017 Jun;147:77-83. doi: 10.1016/j.puhe.2017.02.006. Epub 2017 Mar 18.

Reference Type BACKGROUND
PMID: 28404501 (View on PubMed)

Opel DJ, Taylor JA, Mangione-Smith R, Solomon C, Zhao C, Catz S, Martin D. Validity and reliability of a survey to identify vaccine-hesitant parents. Vaccine. 2011 Sep 2;29(38):6598-605. doi: 10.1016/j.vaccine.2011.06.115. Epub 2011 Jul 16.

Reference Type BACKGROUND
PMID: 21763384 (View on PubMed)

Gottvall M, Tyden T, Hoglund AT, Larsson M. Knowledge of human papillomavirus among high school students can be increased by an educational intervention. Int J STD AIDS. 2010 Aug;21(8):558-62. doi: 10.1258/ijsa.2010.010063.

Reference Type BACKGROUND
PMID: 20975088 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UNIBA-HPV-001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Knowledge and Attitude About HPV Vaccines
NCT01043341 COMPLETED PHASE4