Human Papillomavirus InfectionHPVNCT07097766
The Effect of Health Belief Model-Based Education and Motivational Interviewing on HPV (Human Papilloma Virus) Knowledge and Vaccine Awareness in Women
A study testing "HBM-Based Education and Motivational Interviewing" in people with Human Papillomavirus Infection, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effect of an educational intervention based on the Health Belief Model (HBM) combined with motivational interviewing on women's knowledge about Human Papillomavirus (HPV) infection and their awareness of HPV vaccination. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus Infection
- What is being tested?
- "HBM-Based Education and Motivational Interviewing"
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged between 18-45 years
- Voluntary participation and providing informed consent
- Not previously vaccinated against HPV
- Ability to attend all three educational and motivational interview sessions
- Literacy sufficient to complete study questionnaires
Who cannot join
- Women under 18 or over 45 years old
- Prior HPV vaccination
- Cognitive or psychiatric conditions that hinder participation
- Currently participating in another HPV-related education or intervention study
- Inability to attend all sessions of the intervention program
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Zeynep Kamil Kadın ve Çocuk Hastalıkları Eğitim ve Araştırma Hastanesi
Üsküdar, Istanbul, 34000
seda Ayyıldız, PhD(c), +905533187315, sedaoltulu_89@hotmail.com
About this study
Official title: The Effect of Health Belief Model-Based Education and Motivational Interviewing on Human Papillomavirus (HPV) Infection Knowledge Level and HPV Vaccine Awareness Among Women
This study aims to evaluate the effect of an educational intervention based on the Health Belief Model (HBM) combined with motivational interviewing on women's knowledge about Human Papillomavirus (HPV) infection and their awareness of HPV vaccination. The study will be conducted among women aged 18-45 who have not received the HPV vaccine. Participants in the intervention group will receive structured education and motivational interviews, while the control group will receive no intervention. Changes in HPV knowledge and vaccine awareness will be measured before and after the intervention using validated scales. The goal is to improve preventive behaviors and increase vaccine uptake through behavior-based education.
Read the detailed description
This randomized controlled trial is designed to assess the impact of education and motivational interviewing grounded in the Health Belief Model (HBM) on women's knowledge regarding HPV and awareness of the HPV vaccine. The study population consists of 18-45-year-old literate women who have not previously received HPV vaccination.
Participants will be randomly assigned to either an intervention group or a control group. The intervention group will receive a 3-session structured education program based on HBM constructs (perceived susceptibility, perceived severity, perceived benefits, perceived barriers, cues to action, and self-efficacy), supported by motivational interviewing techniques. The control group will receive no intervention.
Data collection will include pre- and post-intervention assessments using a validated HPV knowledge scale and vaccine awareness questionnaire. The expected outcome is a statistically significant improvement in knowledge and awareness in the intervention group.
This study aims to contribute to public health efforts in HPV prevention and vaccination promotion by utilizing a behavioral model in community education.
- Conditions
- Human Papillomavirus Infection
- Being tested
- "HBM-Based Education and Motivational Interviewing"
- Keywords
- HPV, Human Papillomavirus, HPV Vaccine, Health Belief Model, Motivational Interviewing, Vaccine Awareness, Women's Health, Cervical Cancer Prevention
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"HBM-Based Education and Motivational Interviewing"Behavioural
This intervention consists of a structured 3-session educational program and motivational interviews based on the Health Belief Model (HBM). It aims to increase knowledge about HPV infection and improve HPV vaccination awareness among women aged 18-45.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Not described Receives: Behavioral: "HBM-Based Education and Motivational Interviewing" |
| Control Group | No intervention | This group will not receive any educational intervention or motivational interviewing. Standard care or routine health information will be provided as per usual practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV Knowledge Score
Participants' total score on an HPV knowledge questionnaire designed to assess understanding of HPV infection, transmission, and prevention.
Measured: 4 weeks after the intervention
Secondary outcomes (1)
HPV Vaccination Awareness Score
Participants' awareness level regarding HPV vaccination, measured using a structured 10-item survey.
Measured: 4 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus InfectionStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either an intervention group receiving HBM-based education and motivational interviewing, or a control group receiving no intervention. Outcomes will be assessed before and after the intervention.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Ayyıldız, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07097766
- Sponsor's protocol ID
- SAYYILDIZ2025HPV
- Acronym
- HPV
- Status last verified
- Jul 2025
- First submitted
- 24 Jul 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD and supporting documents will be available starting 6 months after the publication of the primary study results and will remain available for 5 years.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Health Belief Model-Based Education and Motivational Interviewing on Human Papillomavirus (HPV) Infection Knowledge Level and HPV Vaccine Awareness Among Women
- ClinicalTrials.gov ID
- NCT07097766
- Acronym / sponsor ID
- HPV / SAYYILDIZ2025HPV
- Conditions
- Human Papillomavirus Infection
- Keywords
- HPV, Human Papillomavirus, HPV Vaccine, Health Belief Model, Motivational Interviewing, Vaccine Awareness, Women's Health, Cervical Cancer Prevention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 31 Jul 2025 (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.
This study aims to evaluate the effect of an educational intervention based on the Health Belief Model (HBM) combined with motivational interviewing on women's knowledge about Human Papillomavirus (HPV) infection and their awareness of HPV vaccination. The study will be conducted among women aged 18-45 who have not received the HPV vaccine. Participants in the intervention group will receive structured education and motivational interviews, while the control group will receive no intervention. Changes in HPV knowledge and vaccine awareness will be measured before and after the intervention using validated scales. The goal is to improve preventive behaviors and increase vaccine uptake through behavior-based education.
Detailed description
This randomized controlled trial is designed to assess the impact of education and motivational interviewing grounded in the Health Belief Model (HBM) on women's knowledge regarding HPV and awareness of the HPV vaccine. The study population consists of 18-45-year-old literate women who have not previously received HPV vaccination.
Participants will be randomly assigned to either an intervention group or a control group. The intervention group will receive a 3-session structured education program based on HBM constructs (perceived susceptibility, perceived severity, perceived benefits, perceived barriers, cues to action, and self-efficacy), supported by motivational interviewing techniques. The control group will receive no intervention.
Data collection will include pre- and post-intervention assessments using a validated HPV knowledge scale and vaccine awareness questionnaire. The expected outcome is a statistically significant improvement in knowledge and awareness in the intervention group.
This study aims to contribute to public health efforts in HPV prevention and vaccination promotion by utilizing a behavioral model in community education.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either an intervention group receiving HBM-based education and motivational interviewing, or a control group receiving no intervention. Outcomes will be assessed before and after the intervention.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: "HBM-Based Education and Motivational Interviewing" |
| Control Group | No intervention | –This group will not receive any educational intervention or motivational interviewing. Standard care or routine health information will be provided as per usual practice. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women aged between 18-45 years
- Voluntary participation and providing informed consent
- Not previously vaccinated against HPV
- Ability to attend all three educational and motivational interview sessions
- Literacy sufficient to complete study questionnaires
Key exclusion criteria (5 listed)
- Women under 18 or over 45 years old
- Prior HPV vaccination
- Cognitive or psychiatric conditions that hinder participation
- Currently participating in another HPV-related education or intervention study
- Inability to attend all sessions of the intervention program
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 |
|---|---|---|
| "HBM-Based Education and Motivational Interviewing"This intervention consists of a structured 3-session educational program and motivational interviews based on the Health Belief Model (HBM). It aims to increase knowledge about HPV infection and improve HPV vaccination awareness among women aged 18-45. | Behavioural | Intervention Group |
Primary outcome
HPV Knowledge Score
Time frame: 4 weeks after the intervention
Participants' total score on an HPV knowledge questionnaire designed to assess understanding of HPV infection, transmission, and prevention.
1 secondary outcome
HPV Vaccination Awareness Score
Time frame: 4 weeks after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: Yes. IPD and supporting documents will be available starting 6 months after the publication of the primary study results and will remain available for 5 years.
Related trials for Human Papillomavirus Infection
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Active, not recruitingPhase 4
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "HBM-Based Education and Motivational Interviewing" in people with Human Papillomavirus Infection, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 31 Jul 2025. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact seda Ayyıldız, doctora student (+905533187315, sedaoltulu_89@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HPV Knowledge Score (time frame: 4 weeks after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2025.