CClinicalTrials.gg
RecruitingNCT05485441Updated Jul 10, 2023

The Community Nurse as a Public Health Determinant

An interventional study of Digital Educational Intervention in HPV and Nurse's Role, sponsored by University of Bari Aldo Moro. Recruiting at 1 site in Italy. Open to participants aged 11 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-10.

Sponsored by University of Bari Aldo Moro · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Primary completion was expected by Jul 2024, 2 years 3 months ago, but the record still lists the study as recruiting.
  • Started Feb 2023; still recruiting 3 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
800
Allocation
Non-randomized
Ages
11 Years to 70 Years
Sex
All
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Study 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).

Read the detailed description

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.
02

Conditions studied

  • HPV
  • Nurse's Role
03

In context

Lead sponsor

University of Bari Aldo Moro is the lead sponsor of 29 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
11 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
800 participants (estimated)

Study arms

  • Experimental
    Students

    The students

    Other: Digital Educational Intervention

  • Experimental
    Parents

    The parents

    Other: Digital Educational Intervention

Interventions

  • OtherDigital 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)

06

What researchers measure

Primary outcomes

  1. Children's vaccination uptake

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

    Time frame: 90 days

  2. 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).

    Time frame: 90

  3. 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").

    Time frame: 90

  4. 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)

    Time frame: 90

  5. 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)

    Time frame: 90

Secondary outcomes

  1. Parent's hesitancy about vaccination

    Measured through the Questionnaire - Parent Attitudes about Childhood Vaccines Survey (PACV) - The total score ranges from 0 to 100: a parent is considered non-hesitant if he or she scores \<50 and hesitant with a value of ≥50

    Time frame: 90 days

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Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • 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. PubMed 29641945 ↗
  • 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. PubMed 28404501 ↗
  • 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. PubMed 21763384 ↗
  • 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. PubMed 20975088 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05485441
Lead sponsor
University of Bari Aldo Moro
Responsible party
Pasquale Stefanizzi (Assistant Professor, University of Bari Aldo Moro) — Principal investigator
First posted
Aug 3, 2022
Start date
Feb 2, 2023
Primary completion
Jul 2024 (estimated)
Completion
Aug 2024 (estimated)
Last update
Jul 10, 2023

Study contacts

Pasquale Stefanizzi
Contact
pasquale.stefanizzi@uniba.it
+390805592055
Giancarlo Cicolini
Contact
giancarlo.cicolini@uniba.it
+390805478456
Giancarlo Cicolini
principal investigator · Researcher

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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