HPV InfectionNCT06562595
What is the Optimal Training Model for Cervical Awareness?
A study testing Education Intervention in people with HPV Infection and Cervical Cancer, run by Izmir City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Cervical cancer represents the fourth most prevalent malignant disease and the fourth leading cause of mortality among women on a global scale. Despite screening and preventive vaccination efforts, cervical cancer remains a significant cause of morbidity and mortality in low- and middle-income countries. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV Infection, Cervical Cancer, Cervical Dysplasia
- What is being tested?
- Education Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2024to 30 Sep 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being over 18 and under 40
- Female doctors, female nurses and female health technicians
- Working in our hospital
- Having sufficient mental capacity
- Not having a visual or auditory disability
- Volunteering to participate in the study
Who cannot join
- Under 18 and over 40
- Not being a healthcare worker
- Not having enough mental capacity
- Having a visual or auditory disability
- Patients who did not volunteer to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Cervical cancer represents the fourth most prevalent malignant disease and the fourth leading cause of mortality among women on a global scale. Despite screening and preventive vaccination efforts, cervical cancer remains a significant cause of morbidity and mortality in low- and middle-income countries.
Read the detailed description
A number of studies have been conducted with the aim of raising awareness about HPV and cervical cancer. However, there is currently no evidence-based consensus on the most effective method of education. The objective of this study is to identify the optimal training method by conducting a randomised controlled trial among healthcare professionals. The training methods under consideration are as follows: 1) Video-based training, 2) Classical lecture training, 3) Brochure, 4) Audio recording (Radio broadcast).
Prior to the commencement of the designated training methods, participants will be required to complete a web-based pre-test. Subsequent to this, the system will automatically assign each participant to a training intervention. Upon completion of the training programme, participants will be required to undertake a second test, the results of which will inform the selection of the most effective training method.
This study will be conducted separately in several distinct healthcare professional groups. Each randomized controlled trial will include 400 participants.
Planned groups include:
Public health nurses
Medical doctors
Medical interns
Midwives
The objective is to identify the most effective educational intervention for improving awareness of HPV and cervical cancer prevention within each group.
- Conditions
- HPV Infection, Cervical Cancer, Cervical Dysplasia
- Being tested
- Education Intervention
- Medical subject headings
- Papillomavirus Infections, Uterine Cervical Neoplasms, Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education InterventionBehavioural
Training will be provided to the participants, with the objective of determining the most accurate training method on HPV and cervical awareness.
| Study group | Role | What they receive |
|---|---|---|
| Video Assisted | Experimental | Those participants who are automatically assigned to the video training arm will be required to complete a 25-point initial assessment, after which they will be presented with a video. Subsequently, the same test will be administered once more, and the initial and subsequent scores of the participant will be recorded in the case report form. Receives: Behavioral: Education Intervention |
| Classical Lectures | Experimental | The initial assessment, comprising 25 items, will be administered to participants who have been randomly assigned to the control group. This group will be invited to attend a seminar at our clinic, during which a PowerPoint presentation will be delivered. Following the conclusion of the presentation, the same assessment will be repeated, and the participant's initial and second scores will be recorded in the case report form. Receives: Behavioral: Education Intervention |
| Brochure | Experimental | Those participants who are automatically assigned to the brochure arm will be required to complete a 25-point initial test. Participants assigned to this arm will receive a web-based brochure on HPV and smear information (via free messaging services). At the conclusion of the brochure review, the same test will be administered again, and the participant's initial and second scores will be recorded in the case report form. Receives: Behavioral: Education Intervention |
| Sound Recording (Radio Broadcast) | Experimental | Participants who have been automatically assigned to the Sound Recording (Radio Broadcast) arm will be required to complete a 25-point initial assessment. This assessment will be administered via a web-based platform, accessible through free messaging services. Following the completion of the Sound Recording (Radio Broadcast), the same assessment will be repeated. The initial and second scores will then be recorded in the case report form. Receives: Behavioral: Education Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test Score, Pre-Training
Participants will first take a test where they will receive a maximum of 25 points and a minimum of 0 points. Then the participants will be automatically assigned to one of the 4 training models, then the trainings will be given and the same test will be applied to the participants again.
By looking at the second test and first test scores, it will be determined which training model increases the participant's score more. Thus, we will be able to understand which form of education increases HPV and cervical awareness in our society.
Measured: After completion of the 25-item assessment tests (first and second test) and training, an average of 1 month.
Test Score, Post-Training
Participants will first take a test where they will receive a maximum of 25 points and a minimum of 0 points. Then the participants will be automatically assigned to one of the 4 training models, then the trainings will be given and the same test will be applied to the participants again.
By looking at the second test and first test scores, it will be determined which training model increases the participant's score more. Thus, we will be able to understand which form of education increases HPV and cervical awareness in our society.
Measured: After completion of the 25-item assessment tests (first and second test) and training, an average of 1 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start15 Aug 2024
- Primary completion15 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV InfectionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The training methods employed comprise four arms: 1. Video-based training, 2. Classical lecturing, 3. Brochure, 4. Voice recording (Radio broadcast).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Celal Akdemir, Izmir City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562595
- Sponsor's protocol ID
- ISH
- Status last verified
- May 2025
- First submitted
- 19 Aug 2024
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: What is the most efficacious method of disseminating information about the human papilloma virus (HPV) and cervical cancer awareness?
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Optimal Training Model for Cervical Awareness?
- ClinicalTrials.gov ID
- NCT06562595
- Acronym / sponsor ID
- ISH
- Conditions
- HPV Infection, Cervical Cancer, Cervical Dysplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Izmir City HospitalOther government
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 20 Aug 2024 (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.
Cervical cancer represents the fourth most prevalent malignant disease and the fourth leading cause of mortality among women on a global scale. Despite screening and preventive vaccination efforts, cervical cancer remains a significant cause of morbidity and mortality in low- and middle-income countries.
Detailed description
A number of studies have been conducted with the aim of raising awareness about HPV and cervical cancer. However, there is currently no evidence-based consensus on the most effective method of education. The objective of this study is to identify the optimal training method by conducting a randomised controlled trial among healthcare professionals. The training methods under consideration are as follows: 1) Video-based training, 2) Classical lecture training, 3) Brochure, 4) Audio recording (Radio broadcast).
Prior to the commencement of the designated training methods, participants will be required to complete a web-based pre-test. Subsequent to this, the system will automatically assign each participant to a training intervention. Upon completion of the training programme, participants will be required to undertake a second test, the results of which will inform the selection of the most effective training method.
This study will be conducted separately in several distinct healthcare professional groups. Each randomized controlled trial will include 400 participants.
Planned groups include:
Public health nurses
Medical doctors
Medical interns
Midwives
The objective is to identify the most effective educational intervention for improving awareness of HPV and cervical cancer prevention within each group.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- The training methods employed comprise four arms: 1. Video-based training, 2. Classical lecturing, 3. Brochure, 4. Voice recording (Radio broadcast).
| Arm | Type | Receives |
|---|---|---|
| Video Assisted | Experimental | Behavioral: Education InterventionThose participants who are automatically assigned to the video training arm will be required to complete a 25-point initial assessment, after which they will be presented with a video. Subsequently, the same test will be administered once more, and the initial and subsequent scores of the participant will be recorded in the case report form. |
| Classical Lectures | Experimental | Behavioral: Education InterventionThe initial assessment, comprising 25 items, will be administered to participants who have been randomly assigned to the control group. This group will be invited to attend a seminar at our clinic, during which a PowerPoint presentation will be delivered. Following the conclusion of the presentation, the same assessment will be repeated, and the participant's initial and second scores will be recorded in the case report form. |
| Brochure | Experimental | Behavioral: Education InterventionThose participants who are automatically assigned to the brochure arm will be required to complete a 25-point initial test. Participants assigned to this arm will receive a web-based brochure on HPV and smear information (via free messaging services). At the conclusion of the brochure review, the same test will be administered again, and the participant's initial and second scores will be recorded in the case report form. |
| Sound Recording (Radio Broadcast) | Experimental | Behavioral: Education InterventionParticipants who have been automatically assigned to the Sound Recording (Radio Broadcast) arm will be required to complete a 25-point initial assessment. This assessment will be administered via a web-based platform, accessible through free messaging services. Following the completion of the Sound Recording (Radio Broadcast), the same assessment will be repeated. The initial and second scores will then be recorded in the case report form. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Being over 18 and under 40
- Female doctors, female nurses and female health technicians
- Working in our hospital
- Having sufficient mental capacity
- Not having a visual or auditory disability
Key exclusion criteria (5 listed)
- Under 18 and over 40
- Not being a healthcare worker
- Not having enough mental capacity
- Having a visual or auditory disability
- Patients who did not volunteer to participate in the study
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 |
|---|---|---|
| Education InterventionTraining will be provided to the participants, with the objective of determining the most accurate training method on HPV and cervical awareness. | Behavioural | Brochure, Classical Lectures, Sound Recording (Radio Broadcast), Video Assisted |
Primary outcome
Test Score, Pre-Training
Time frame: After completion of the 25-item assessment tests (first and second test) and training, an average of 1 month.
Participants will first take a test where they will receive a maximum of 25 points and a minimum of 0 points. Then the participants will be automatically assigned to one of the 4 training models, then the trainings will be given and the same test will be applied to the participants again. By looking at the second test and first test scores, it will be determined which training model increases the participant's score more. Thus, we will be able to understand which form of education increases HPV and cervical awareness in our society.
Test Score, Post-Training
Time frame: After completion of the 25-item assessment tests (first and second test) and training, an average of 1 month.
Participants will first take a test where they will receive a maximum of 25 points and a minimum of 0 points. Then the participants will be automatically assigned to one of the 4 training models, then the trainings will be given and the same test will be applied to the participants again. By looking at the second test and first test scores, it will be determined which training model increases the participant's score more. Thus, we will be able to understand which form of education increases HPV and cervical awareness in our society.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Individual participant dataSharing planned: Yes. What is the most efficacious method of disseminating information about the human papilloma virus (HPV) and cervical cancer awareness?
Related trials for HPV Infection
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A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)
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RecruitingObservational study
The Natural History of Severe Viral Infections and Characterization of Immune Defects in Patients Without Known Immunocompromise
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Active, not recruiting
Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S03)
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education Intervention in people with HPV Infection and Cervical Cancer, run by Izmir City Hospital 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 6 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: finished, as of the sponsor's last update on 20 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test Score, Pre-Training (time frame: After completion of the 25-item assessment tests (first and second test) and training, an average of 1 month.). The study lists 2 primary outcomes in all. 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 20 May 2025.