The Community Nurse as a Public Health Determinant

NCT05485441 | Unknown

• 1 other identifier: UNIBA-HPV-001
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

HPV; Nurse's Role

Outcome Measures

Primary Outcomes (5)

• Children's vaccination uptake

  Measured through a telephonic interview to parents, difference in vaccination rates (% before/after)

  90 days

• Children's knowledge on HPV vaccination

  Measured through: (1) the Questionnaire - HAVIQ Adolescente Vaccine Intervention Questionnaire; 5-point Likert scale (from 1=strongly disagree to 5=strongly agree). (2) 10 items with dichotomous "yes/no" responses. Each correct answer will be assigned a score of 1, each answer not given or incorrect, zero. The total score ranges from 0 (no knowledge) to 10 (highest level of knowledge).

  90

• Children's self-efficacy in receiving the vaccine

  Measured through the Questionnaire - HAVIQ Adolescente Vaccine Intervention Questionnaire; 100-point scale (0="not at all confident"; 100="completely confident").

  90

• Children's fear and anxiety towards vaccination

  Measured through the Questionnaire - HAVIQ Adolescente Vaccine Intervention Questionnaire; 5-point Likert scale (from 1=strongly disagree to 5=strongly agree)

  90

• Children's involvement in vaccine decision making

  Measured through the Questionnaire - HAVIQ Adolescente Vaccine Intervention Questionnaire; 5-point Likert scale (from 1=strongly disagree to 5=strongly agree)

  90

Secondary Outcomes (1)

• Parent's hesitancy about vaccination

  90 days

Study Arms (2)

Students

EXPERIMENTAL

The students

Other: Digital Educational Intervention

Parents

EXPERIMENTAL

The parents

Other: Digital Educational Intervention

Interventions

Digital Educational Intervention 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; Students

Eligibility Criteria

• Age: 11 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bari Aldo Moro: lead

Study Sites (1)

University Aldo Moro of Bari

Bari, Apulia, 70124, Italy

RECRUITING

Related Publications (4)

• 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.

  PMID: 29641945 BACKGROUND

• 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.

  PMID: 28404501 BACKGROUND

• 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.

  PMID: 21763384 BACKGROUND

• 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.

  PMID: 20975088 BACKGROUND

Study Officials

• Giancarlo Cicolini

  Researcher

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pasquale Stefanizzi

CONTACT

+390805592055; pasquale.stefanizzi@uniba.it

Giancarlo Cicolini

CONTACT

+390805478456; giancarlo.cicolini@uniba.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: August 3, 2022
• Study Start: February 2, 2023
• Primary Completion: July 1, 2024
• Study Completion: August 1, 2024
• Last Updated: July 10, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)