NCT07017387

Brief Summary

The aim of this study is to evaluate the effect of two different health education methods (one based on motivational interviewing) on women's HPV knowledge, cervical cancer health beliefs, and screening behaviors in women aged 30-65. A total of 96 healthy women who are registered at the Incirli Family Health Center in Ankara, meet the inclusion criteria, and volunteer to participate will be randomly assigned to three groups (32 participants per group). The control group will receive standard healthcare services. The first intervention group will receive three sessions of motivational interviewing-based health education on cervical cancer prevention through home visits, along with an informational brochure. The second intervention group will receive health education and a brochure, followed by a reminder session via phone. At the end of the study, participants in the control group will be offered the intervention of their choice.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

May 9, 2025

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2025

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 12, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2025

Completed
Last Updated

September 2, 2025

Status Verified

August 1, 2025

Enrollment Period

1 month

First QC Date

May 25, 2025

Last Update Submit

August 29, 2025

Conditions

Keywords

cervical cancermotivational interviewinghealth educationHPV

Outcome Measures

Primary Outcomes (3)

  • Change in screening behavior

    Binary outcome (Yes/No) capturing whether the participant underwent screening during the follow-up period. If Yes, the result is recorded; if No, the reason for non-participation is documented.

    8 weeks after intervention

  • Change in Health Belief About Cervical Cancer and Pap Smear as Measured by the Cervical Cancer and Pap Smear Health Belief Model Scale (35 items)

    The 35-item scale (Güvenç et al., 2011) has five subscales: Benefits \& Motivation (8 items), Barriers (14), Perceived Severity (7), Perceived Susceptibility (3), Health Motivation (3). Responses use a 5-point Likert scale (1 = Strongly disagree to 5 = Strongly agree). Subscale scores are summed; higher scores reflect stronger beliefs, except Barriers, where higher scores indicate more perceived barriers.

    8 weeks after intervention

  • Change in HPV Knowledge Score Measured by the 33-item HPV Knowledge Scale

    The 33-item HPV Knowledge Scale (Demir \& Özdemir, 2019) assesses knowledge of HPV infection, screening, and vaccination. Each item is answered Yes/No/Don't know and scored 1 (for correct) or 0 (for incorrect/unknown). Total scores range 0-33; higher scores indicate greater knowledge.

    8 weeks after intervention

Secondary Outcomes (1)

  • Change in Self-Rated Knowledge About Cervical Cancer and Screening Assessed by a 0-10 Visual Analog Scale (VAS)

    8 weeks after intervention

Study Arms (3)

Arm 2: Health Education

EXPERIMENTAL

Participants will receive one face-to-face health education session and a brochure, followed by two reminder sessions via phone.

Behavioral: Health education

Arm 3: Control Group

NO INTERVENTION

Participants will receive standard healthcare services. At the end of the study, they will be offered the intervention of their choice.

Arm 1: Motivational Interviewing-Based Health Education

EXPERIMENTAL

Participants will receive three sessions of face-to-face health education using motivational interviewing techniques through home visits, along with an informational brochure.

Behavioral: Motivational interviewing based health education

Interventions

Participants will receive three sessions of face-to-face health education using motivational interviewing techniques through home visits, along with an informational brochure.

Arm 1: Motivational Interviewing-Based Health Education

Participants will receive one face-to-face health education session and a brochure, followed by two reminder sessions via phone.

Arm 2: Health Education

Eligibility Criteria

Age30 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being between 30 and 65 years of age
  • Being literate
  • Agreeing to participate in the study
  • Being female
  • Being married
  • Having no history of cervical cancer in first-degree relatives (mother/sister)
  • Not having undergone cervical cancer screening in the last five years
  • Not having been diagnosed with cancer

You may not qualify if:

  • Being pregnant or in the postpartum period
  • Having been diagnosed with any type of cancer
  • Having a hearing or speech impairment, or a mental disorder
  • Using medication due to psychotic treatments
  • Having undergone a hysterectomy
  • Having had cervical cancer screening within the last five years
  • Having received all three doses of the HPV vaccine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Incirli Family Health Center

Ankara, Kecioren, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Health EducationUterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Adherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

Serpil Ozdemir, PhD, RN, Associate professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 25, 2025

First Posted

June 12, 2025

Study Start

May 9, 2025

Primary Completion

June 11, 2025

Study Completion

September 12, 2025

Last Updated

September 2, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations