NCT07471412

Brief Summary

The main objective of this study is to evaluate the effect of structured sexual health education for immigrant women on their levels of sexual health self-efficacy and reproductive autonomy using a randomized controlled design.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Mar 2026

Shorter than P25 for not_applicable

Status
not yet 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 Progress45%
Mar 2026Sep 2026

Study Start

First participant enrolled

March 1, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 13, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

Same day

First QC Date

March 9, 2026

Last Update Submit

March 24, 2026

Conditions

Sexually Transmitted Disease

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint will be the difference in mean knowledge scores between baseline (pre-intervention) and post-intervention assessments.

    1. Level of Knowledge Regarding Sexually Transmitted Infections (STIs): Participants' level of knowledge regarding STIs will be assessed using knowledge questions included in a data collection form prepared by the researchers. The measurement tool is a structured questionnaire. The unit of measurement is the number of correct answers, and the total score obtained indicates the level of knowledge about STIs. Higher scores indicate a higher level of knowledge. 2. Level of Sexual Self-Efficacy: Participants' level of sexual self-efficacy will be assessed using the Sexual Self-Efficacy Scale (SSES), developed by Humphreys and Kennett (2010) and adapted into Turkish by Çelik (2012). The scale is an 8-point Likert-type scale consisting of 5 items. The unit of measurement is the total scale score, and the score range is 5-40. Higher scores indicate a higher level of sexual self-efficacy.

    Pre-intervention (week 0), post-intervention (week 8), and 3-month follow-up.

Secondary Outcomes (1)

  • The primary endpoint will be the change in the mean RAS score between baseline (pre-intervention) and post-intervention assessments.

    Immediately after the intervention is completed.

Study Arms (2)

Experimental: experimental group

EXPERIMENTAL

Application Description: The experimental group will receive education on sexually transmitted diseases and will be administered reproductive autonomy and sexual self-efficacy scales.

Behavioral: education

No Intervention: Control Group

NO INTERVENTION

No intervention will be made in the control group.

Interventions

educationBEHAVIORAL

Training Sessions and Topics Session 1: Sexually Transmitted Infections and Women's Health Definition and types of STIs Symptoms and asymptomatic courses in women Relationship of STIs with reproductive health and HIV risk Transmission routes and the importance of testing Session 2: Sexual Health Self-Efficacy and Protective Behaviors The concept of sexual health self-efficacy Protection methods and correct condom use Seeking healthcare and requesting testing Communication with healthcare professionals Session 3: Reproductive Autonomy, Communication, and Rights Reproductive autonomy and decision-making Communication with partners and setting boundaries Confidentiality and consent in healthcare Coping with stigma

Experimental: experimental group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To be eligible, applicants must:
  • Be 18 years of age or older,
  • Have immigrant status and reside in Turkey,
  • Be one of the women who applied to or benefited from the services of the

You may not qualify if:

  • Being under 18 years of age,
  • Refusal to give informed consent for participation in the study,
  • Having a serious cognitive impairment or psychiatric condition that may prevent regular participation in the training and data collection process,
  • Having a severe language barrier that prevents communication during the study process and that cannot be overcome with translation or written materials,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Sadock, V. A. (1989). Psychosexual dysfunctions and treatment. In H. I. Kaplan & B. J. Sadock (Eds.), Comprehensive textbook of psychiatry (5th ed.). Baltimore, MD: Williams & Wilkins.

    BACKGROUND

  • Reissing, E. D., Laliberté, G. M., & Davis, H. J. (2005). Young women's sexual adjustment: The role of sexual self-schema, sexual self-efficacy, sexual aversion and body attitudes. The Canadian Journal of Human Sexuality, 14(3-4).

    BACKGROUND

  • Grace, K. T., & Anderson, J. C. (2018). Reproductive coercion: A systematic review. Trauma, Violence, & Abuse, 19(4), 371-390. doi:10.1177/1524838016663935

    BACKGROUND

  • Eysenck, H. J. (1971). Hysterical personality and sexual adjustment, attitudes and behavior. Journal of Sex Research, 7, 274-281.

    BACKGROUND

  • Creti, L., & Libman, E. (1989). Cognitions and sexual expression in the aging. Journal of Sex & Marital Therapy, 15, 83-101.

    BACKGROUND

  • Bailes, S., Creti, L., Fichten, C. S., Libman, E., Brender, W., & Amsel, R. (1998). Sexual self-efficacy scale for female functioning. In C. M. Davis, W. L. Yarber, R. Bauserman, G. Schreer, & S. L. Davis (Eds.), Handbook of sexuality-related measures (pp. 531-534). London, England: Sage.

    BACKGROUND

MeSH Terms

Conditions

Sexually Transmitted Diseases

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Central Study Contacts

Emine Aksüt Akçay

CONTACT

05077247884bau_sirinim@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: education-centered randomized controlled experimental study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 9, 2026

First Posted

March 13, 2026

Study Start

March 1, 2026

Primary Completion

March 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

I do not approve of sharing ipd