Clinical trial NCT06662136: The Effect of Motivational Interviewing on HPV-DNA Testing
Official title: The Effect of Health Belief Model-Based Motivational Interviews on Women's HPV-DNA Testing According to the Precautionary Acceptance Process
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Cancers
Keywords: Human papillomavirus
Woman
Midwife
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2024-10-28
Enrollment: 86
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: motivational interviewing to the experimental group
Primary purpose: SCREENING

Brief 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.

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\&amp;#39;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 .

Eligibility criteria: Inclusion Criteria:

* Women between the ages of 30-45 who are registered to the Family Health Center No. 1,

  * Those who are currently or have an active sexual life in the past,
  * Those who have never had an HPV DNA test,
  * Those who are undecided about having an HPV DNA test,
  * Those who are literate,
  * Those who do not have a diagnosed psychiatric problem,
  * Those who agree to participate in the study.

Exclusion Criteria:

* Those who had HPV DNA testing

  * Those who had hearing or visual impairments that would prevent communication
  * Those who could not talk on the phone or use social media (whatsapp, e-mail, etc.)
  * Those who did not agree to participate in the study were determined as women.

Primary outcomes:
measure: Learning about HPV
timeFrame: From the beginning of the study until the 6th month.
Secondary outcomes:
measure: Having an HPV-DNA test
timeFrame: From the beginning of the study until the 6th month.
Other outcomes:
Locations:
city: İ̇stanbul
country: Turkey
facility: Bayrampaşa 1 nolu ASM
state: Bayrampaşa
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Muazez Küçükkaya
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.