NCT06662136

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 28, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

February 12, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2025

Completed
Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

October 23, 2024

Last Update Submit

January 31, 2026

Conditions

Keywords

Human papillomavirusWomanMidwife

Outcome Measures

Primary Outcomes (1)

  • 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.

    From the beginning of the study until the 4th month.

Secondary Outcomes (1)

  • Having an HPV-DNA test

    From the beginning of the study until the 4th month.

Study Arms (2)

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.

Behavioral: motivasional intereview

control group

NO INTERVENTION

Participants in the control group will not receive any intervention

Interventions

No application will be made to the participants in the control group

Experimental group

Eligibility Criteria

Age30 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bayrampaşa 1 nolu ASM

Istanbul, BAYRAMPAŞA, 340000, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

Related Links

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Muazez Küçükkaya

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: motivational interviewing to the experimental group
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 23, 2024

First Posted

October 28, 2024

Study Start

February 12, 2025

Primary Completion

June 12, 2025

Study Completion

June 12, 2025

Last Updated

February 3, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

I do not want to share the data due to the ethical principles of the research.

Available IPD Datasets

Individual Participant Data Set Access

Locations