Cervical CancersNCT06662136
The Effect of Motivational Interviewing on HPV-DNA Testing
A study testing motivasional intereview in people with Cervical Cancers, run by Muazez küçükkaya at 1 site in Turkey (Türkiye).
Trial summary
The aim of this randomized controlled study was to examine the effects of Health Belief Model Based Motivational Interviewing on HPV-DNA testing in women according to the Precautionary Acceptance Process. Read more about this study
- Who is it for?
- Ages 30 to 45 years, women only
- Conditions the study is for
- Cervical Cancers
- What is being tested?
- motivasional intereview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Feb 2025to 12 Jun 2025
- 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 30 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 30-45 registered at Family Health Centre No. 1,
- Who currently have or have had an active sex life,
- Women who have not undergone an HPV-DNA test in the last five years,
- Women who can read and write, have no communication problems, and can use a smartphone and WhatsApp,
- Women with no diagnosed psychiatric problems,
- Women who agreed to participate in the study.
Who cannot join
- Women who were unable to complete the entire study due to any circumstances during the data collection phases,
- Women who voluntarily withdrew from the study were excluded.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bayrampaşa 1 nolu ASM
Istanbul, BAYRAMPAŞA, 340000
About this study
Official title: The Effect of Health Belief Model-Based Motivational Interviews on Women's HPV-DNA Testing According to the Precautionary Acceptance Process
The aim of this randomized controlled study was to examine the effects of Health Belief Model Based Motivational Interviewing on HPV-DNA testing in women according to the Precautionary Acceptance Process.
Read the detailed description
Human papillomavirus (HPV) infection is the main determinant of cervical cancer in women. Current studies indicate that cervical cancers are caused by sexually transmitted HPV infection and 84% of HPV-associated cancer lesions are cervical cancer. HPV infection causes more than 14 million people to become infected with HPV annually and 80% of sexually active individuals to become infected with HPV during their lifetime. Today, more than 200 HPV types have been identified. According to the International Agency for Research on Cancer, high-risk HPV genotypes including 16, 18, 31, 33, 45, 52, and 58 are responsible for approximately 90% of anogenital HPV-positive cancers worldwide, while low-risk genotypes HPV 6 and 11 are responsible for 90% of genital warts. Cancer is an important public health problem that increases the risk of mortality and morbidity in women all over the world. Gynecological cancers can be prevented by changing/abandoning risk factors, cases can be detected at an early stage with early diagnosis and screening programs, and a chance for treatment can be found. However, it is known that women do not apply to health institutions or postpone them due to reasons such as ignoring health problems, lack of information, embarrassment, and economic problems. The World Health Organization (WHO) emphasizes that at least one-third of cancer cases can be prevented with preventive care strategies and recommends the implementation of low-cost and long-term strategies in cancer control. All health professionals have important roles and responsibilities in the care and treatment processes in the successful implementation of cancer prevention, early diagnosis and screening programs. High cancer screening rates in the general population are associated with the health beliefs of the individual. According to the Health Belief Model (HBM); perceived barriers are the perceptions of factors that prevent or make it difficult to perform a protective behavior related to health. If individuals are sensitive that a health problem will seriously harm them, they think that the harm that will come to them will decrease when they take action. They believe that if they do not take action, more severe consequences may arise than the burden (cost, time, etc.) of the factors that create the perception of barriers. Motivational interviewing (MI) is a collaborative conversation style to strengthen a person\'s own motivation and commitment to change. Motivational interviewing is an evidence-based, successful intervention approach to facilitate positive behavioral change and is frequently used in substance abuse, mental health, primary and special health areas. Studies have shown the effectiveness of motivational interviews, especially SIM-based motivational interviews. The Precautionary Acceptance Process Model (PAPM) is a method that states that people may be in different motivational stages during the process of showing a behavior, therefore the same intervention applied to people evaluated in a single pot may not be effective for everyone, and the Precautionary Acceptance Process Model (PAPM), which is known to a limited extent in our country, is a suitable model especially in preventive health service practices, health protection and development programs. In the prevention of cervical cancer, health personnel working especially in primary health care services actively play a role in increasing the awareness levels of women in the society they serve and in directing them to early diagnosis. In this context, it is thought that midwives, especially those in the first stage, should be at the forefront with their education and consultancy roles in addition to their practitioner roles, as they reach women of all ages .
- Conditions
- Cervical Cancers
- Being tested
- motivasional intereview
- Keywords
- Human papillomavirus, Woman, Midwife
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motivasional intereviewBehavioural
No application will be made to the participants in the control group
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Active comparator | Participants in the experimental group will be given motivational interviews about HPV at 4 different times and will also be given an educational brochure. Receives: Behavioral: motivasional intereview |
| control group | No intervention | Participants in the control group will not receive any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Learning about HPV
The program was planned as 4 sessions and the duration of the interview was 20-30 minutes. The women in the experimental group will be given 4 motivational interviews and a training brochure. Questionnaire/scale forms will be administered 4 times in total: The scales will be administered as a pre-test before the intervention, an interim test after the second motivational interview, a final test after the fourth motivational interview, and a final test two months after the last interview. The total score to be obtained from HPV-BÖ is between 0-33 and a high score indicates a high level of knowledge about HPV, HPV screening tests and the HPV vaccine The "Cervical Cancer and Pap-smear Test Health Belief Model Scale" will be used to understand the situations that prevent women from taking the HPV-DNA test.
Measured: From the beginning of the study until the 4th month.
Secondary outcomes (1)
Having an HPV-DNA test
The decision of women in the experimental group to have HPV-DNA testing will be questioned.
Measured: From the beginning of the study until the 4th month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start12 Feb 2025
- Primary completion12 Jun 2025
- Study completion12 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cervical CancersStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- motivational interviewing to the experimental group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muazez küçükkaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muazez küçükkaya, Istanbul University - Cerrahpasa
- Investigators
- Muazez Küçükkaya, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06662136
- Sponsor's protocol ID
- IstanbulUC-SBF-MK-1
- Status last verified
- Jan 2026
- First submitted
- 23 Oct 2024
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I do not want to share the data due to the ethical principles of the research.
Publications
Lewandowska AM, Lewandowski T, Rudzki M, Rudzki S, Laskowska B. Cancer prevention - review paper. Ann Agric Environ Med. 2021 Mar 18;28(1):11-19. doi: 10.26444/aaem/116906. Epub 2020 Mar 12.
PubMed 33775063Ghasemi M, Savabi-Esfahani M, Noroozi M, Satari M. Prediction of cervical cancer screening: application of the information-motivation-behavioral skills model. BMC Cancer. 2024 Mar 19;24(1):351. doi: 10.1186/s12885-024-12098-9.
PubMed 38504202
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Health Belief Model-Based Motivational Interviews on Women's HPV-DNA Testing According to the Precautionary Acceptance Process
- ClinicalTrials.gov ID
- NCT06662136
- Acronym / sponsor ID
- IstanbulUC-SBF-MK-1
- Conditions
- Cervical Cancers
- Keywords
- Human papillomavirus, Woman, Midwife
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Muazez küçükkayaUniversity, hospital or other
- Study start
- 12 Feb 2025 (actual)
- Primary completion
- 12 Jun 2025 (actual)
- Study completion
- 12 Jun 2025 (actual)
- First posted
- 28 Oct 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.
The aim of this randomized controlled study was to examine the effects of Health Belief Model Based Motivational Interviewing on HPV-DNA testing in women according to the Precautionary Acceptance Process.
Detailed description
Human papillomavirus (HPV) infection is the main determinant of cervical cancer in women. Current studies indicate that cervical cancers are caused by sexually transmitted HPV infection and 84% of HPV-associated cancer lesions are cervical cancer. HPV infection causes more than 14 million people to become infected with HPV annually and 80% of sexually active individuals to become infected with HPV during their lifetime. Today, more than 200 HPV types have been identified. According to the International Agency for Research on Cancer, high-risk HPV genotypes including 16, 18, 31, 33, 45, 52, and 58 are responsible for approximately 90% of anogenital HPV-positive cancers worldwide, while low-risk genotypes HPV 6 and 11 are responsible for 90% of genital warts. Cancer is an important public health problem that increases the risk of mortality and morbidity in women all over the world. Gynecological cancers can be prevented by changing/abandoning risk factors, cases can be detected at an early stage with early diagnosis and screening programs, and a chance for treatment can be found. However, it is known that women do not apply to health institutions or postpone them due to reasons such as ignoring health problems, lack of information, embarrassment, and economic problems. The World Health Organization (WHO) emphasizes that at least one-third of cancer cases can be prevented with preventive care strategies and recommends the implementation of low-cost and long-term strategies in cancer control. All health professionals have important roles and responsibilities in the care and treatment processes in the successful implementation of cancer prevention, early diagnosis and screening programs. High cancer screening rates in the general population are associated with the health beliefs of the individual. According to the Health Belief Model (HBM); perceived barriers are the perceptions of factors that prevent or make it difficult to perform a protective behavior related to health. If individuals are sensitive that a health problem will seriously harm them, they think that the harm that will come to them will decrease when they take action. They believe that if they do not take action, more severe consequences may arise than the burden (cost, time, etc.) of the factors that create the perception of barriers. Motivational interviewing (MI) is a collaborative conversation style to strengthen a person\'s own motivation and commitment to change. Motivational interviewing is an evidence-based, successful intervention approach to facilitate positive behavioral change and is frequently used in substance abuse, mental health, primary and special health areas. Studies have shown the effectiveness of motivational interviews, especially SIM-based motivational interviews. The Precautionary Acceptance Process Model (PAPM) is a method that states that people may be in different motivational stages during the process of showing a behavior, therefore the same intervention applied to people evaluated in a single pot may not be effective for everyone, and the Precautionary Acceptance Process Model (PAPM), which is known to a limited extent in our country, is a suitable model especially in preventive health service practices, health protection and development programs. In the prevention of cervical cancer, health personnel working especially in primary health care services actively play a role in increasing the awareness levels of women in the society they serve and in directing them to early diagnosis. In this context, it is thought that midwives, especially those in the first stage, should be at the forefront with their education and consultancy roles in addition to their practitioner roles, as they reach women of all ages .
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- motivational interviewing to the experimental group
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Active comparator | Behavioral: motivasional intereviewParticipants in the experimental group will be given motivational interviews about HPV at 4 different times and will also be given an educational brochure. |
| control group | No intervention | –Participants in the control group will not receive any intervention |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women aged 30-45 registered at Family Health Centre No. 1,
- Who currently have or have had an active sex life,
- Women who have not undergone an HPV-DNA test in the last five years,
- Women who can read and write, have no communication problems, and can use a smartphone and WhatsApp,
- Women with no diagnosed psychiatric problems,
Key exclusion criteria (2 listed)
- Women who were unable to complete the entire study due to any circumstances during the data collection phases,
- Women who voluntarily withdrew from the study were excluded.
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 |
|---|---|---|
| motivasional intereviewNo application will be made to the participants in the control group | Behavioural | Experimental group |
Primary outcome
Learning about HPV
Time frame: From the beginning of the study until the 4th month.
The program was planned as 4 sessions and the duration of the interview was 20-30 minutes. The women in the experimental group will be given 4 motivational interviews and a training brochure. Questionnaire/scale forms will be administered 4 times in total: The scales will be administered as a pre-test before the intervention, an interim test after the second motivational interview, a final test after the fourth motivational interview, and a final test two months after the last interview. The total score to be obtained from HPV-BÖ is between 0-33 and a high score indicates a high level of knowledge about HPV, HPV screening tests and the HPV vaccine The "Cervical Cancer and Pap-smear Test Health Belief Model Scale" will be used to understand the situations that prevent women from taking the HPV-DNA test.
1 secondary outcome
Having an HPV-DNA test
Time frame: From the beginning of the study until the 4th month.
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 3 Feb 2026.
- Results publication: PubMed 33775063Lewandowska AM, Lewandowski T, Rudzki M, Rudzki S, Laskowska B. Cancer prevention - review paper. Ann Agric Environ Med. 2021 Mar 18;28(1):11-19. doi: 10.26444/aaem/116906. Epub 2020 Mar 12.
- Results publication: PubMed 38504202Ghasemi M, Savabi-Esfahani M, Noroozi M, Satari M. Prediction of cervical cancer screening: application of the information-motivation-behavioral skills model. BMC Cancer. 2024 Mar 19;24(1):351. doi: 10.1186/s12885-024-12098-9.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. I do not want to share the data due to the ethical principles of the research.
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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.
Muazez Küçükkaya principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing motivasional intereview in people with Cervical Cancers, run by Muazez küçükkaya 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 2 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 3 Feb 2026. 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?
Learning about HPV (time frame: From the beginning of the study until the 4th month.). 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 NCT06662136, which also lists 2 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 3 Feb 2026.