HPVNCT05485441
The Community Nurse as a Public Health Determinant
A study testing Digital Educational Intervention in people with HPV and Nurse's Role, run by University of Bari Aldo Moro at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- HPV, Nurse's Role
- What is being tested?
- Digital Educational Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteItaly
- Study dates
- 2 Feb 2023to Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Students aged 11- 13 years and their parents.
- Students with disabilities, with visual and hearing impairment, with the suppor of their support teacher.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University Aldo Moro of Bari
Bari, Apulia, 70124
Pasquale Stefanizzi, pasquale.stefanizzi@uniba.it
About this study
Official title: The Community Nurse as a Public Health Determinant: a Quasi-experimental and Interventional Study of Promotion of Papillomavirus Vaccination in the School Population
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.
Read more
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.
- Conditions
- HPV, Nurse's Role
- Being tested
- Digital Educational Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Educational InterventionOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Students | Experimental | The students Receives: Other: Digital Educational Intervention |
| Parents | Experimental | The parents Receives: Other: Digital Educational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's vaccination uptake
Measured through a telephonic interview to parents, difference in vaccination rates (% before/after)
Measured: 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).
Measured: 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").
Measured: 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)
Measured: 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)
Measured: 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
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start2 Feb 2023
- Primary completionJul 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HPVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bari Aldo Moro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pasquale Stefanizzi, University of Bari Aldo Moro
- Investigators
- Giancarlo Cicolini, Principal investigator, Researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05485441
- Sponsor's protocol ID
- UNIBA-HPV-001
- Status last verified
- Jul 2023
- First submitted
- 12 Jul 2022
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 29641945Forster 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 28404501Opel 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 21763384Gottvall 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Community Nurse as a Public Health Determinant: a Quasi-experimental and Interventional Study of Promotion of Papillomavirus Vaccination in the School Population
- ClinicalTrials.gov ID
- NCT05485441
- Acronym / sponsor ID
- UNIBA-HPV-001
- Conditions
- HPV, Nurse's Role
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University of Bari Aldo MoroUniversity, hospital or other
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 3 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Students | Experimental | Other: Digital Educational InterventionThe students |
| Parents | Experimental | Other: Digital Educational InterventionThe parents |
Who may qualify
- Ages
- 11 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Students aged 11- 13 years and their parents.
- Students with disabilities, with visual and hearing impairment, with the suppor of their support teacher.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Educational InterventionThe 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) | Other | Parents, Students |
Primary outcome
Children's vaccination uptake
Time frame: 90 days
Measured through a telephonic interview to parents, difference in vaccination rates (% before/after)
Children's knowledge on HPV vaccination
Time frame: 90
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).
Children's self-efficacy in receiving the vaccine
Time frame: 90
Measured through the Questionnaire - HAVIQ Adolescente Vaccine Intervention Questionnaire; 100-point scale (0="not at all confident"; 100="completely confident").
Children's fear and anxiety towards vaccination
Time frame: 90
Measured through the Questionnaire - HAVIQ Adolescente Vaccine Intervention Questionnaire; 5-point Likert scale (from 1=strongly disagree to 5=strongly agree)
Children's involvement in vaccine decision making
Time frame: 90
Measured through the Questionnaire - HAVIQ Adolescente Vaccine Intervention Questionnaire; 5-point Likert scale (from 1=strongly disagree to 5=strongly agree)
1 secondary outcome
Parent's hesitancy about vaccination
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- Background: PubMed 29641945Napolitano 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.
- Background: PubMed 28404501Forster 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.
- Background: PubMed 21763384Opel 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.
- Background: PubMed 20975088Gottvall 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giancarlo Cicolini principal investigator
Researcher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Educational Intervention in people with HPV and Nurse's Role, run by University of Bari Aldo Moro at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pasquale Stefanizzi (+390805592055, pasquale.stefanizzi@uniba.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's vaccination uptake (time frame: 90 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05485441, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2023.