- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06662136
The Effect of Motivational Interviewing on HPV-DNA Testing
January 31, 2026 updated by: Muazez küçükkaya
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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BAYRAMPAŞA
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Istanbul, BAYRAMPAŞA, Turkey (Türkiye), 340000
- Bayrampaşa 1 nolu ASM
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Study Population
Family Health Center No. 1 located in Bayrampaşa district of Istanbul province
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Experimental group
Participants in the experimental group will be given motivational interviews about HPV at 4 different times and will also be given an educational brochure.
|
No application will be made to the participants in the control group
|
|
No Intervention: control group
Participants in the control group will not receive any intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From the beginning of the study until the 4th month.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Having an HPV-DNA test
Time Frame: From the beginning of the study until the 4th month.
|
The decision of women in the experimental group to have HPV-DNA testing will be questioned.
|
From the beginning of the study until the 4th month.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Muazez Küçükkaya, Istanbul University - Cerrahpasa
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Ghasemi 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 12, 2025
Primary Completion (Actual)
June 12, 2025
Study Completion (Actual)
June 12, 2025
Study Registration Dates
First Submitted
October 23, 2024
First Submitted That Met QC Criteria
October 25, 2024
First Posted (Actual)
October 28, 2024
Study Record Updates
Last Update Posted (Actual)
February 3, 2026
Last Update Submitted That Met QC Criteria
January 31, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Uterine Diseases
- Genital Diseases, Female
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Neoplasms
- Uterine Cervical Neoplasms
Other Study ID Numbers
- IstanbulUC-SBF-MK-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
I do not want to share the data due to the ethical principles of the research.
Study Data/Documents
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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