Sexually Transmitted Infections in Migrant Women

August 11, 2026 updated by: Emine Aksut Akcay, Kahramanmaras Sutcu Imam University

The Effect of Sexual Health Self-Efficacy and Reproductive Autonomy in Migrant Women Through Sexual Transmission Infections A Randomized Controlled Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Sexuality is a fundamental aspect of human life that encompasses biological, psychological, and social dimensions and is shaped by individuals' personality traits, life experiences, and social conditions. Sexual satisfaction and adjustment are related not only to physical processes but also to psychological well-being and interpersonal relationships. In this context, sexual self-efficacy-defined as an individual's belief in their ability to manage emotions and behaviors in sexual situations-plays an important role, while reproductive autonomy refers to the ability to freely decide whether and when to have children. Migrant women may be more vulnerable in these areas due to various social and structural barriers; therefore, efforts aimed at strengthening sexual health self-efficacy and reproductive autonomy are considered important.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
      • Kahramanmaraş, Turkey (Türkiye)
        • Kahramanmaras Sutcu Imam University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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,

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental: experimental group
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
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
No Intervention: No Intervention: Control Group
No intervention will be made in the control group.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The primary endpoint will be the difference in mean knowledge scores between baseline (pre-intervention) and post-intervention assessments.
Time Frame: Pre-intervention (week 0), post-intervention (week 8), and 3-month follow-up.
  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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The primary endpoint will be the change in the mean RAS score between baseline (pre-intervention) and post-intervention assessments.
Time Frame: Immediately after the intervention is completed.
1. Level of Reproductive Autonomy: Participants' level of reproductive autonomy will be assessed using the scale developed by Upadhyay et al. The Reproductive Autonomy Scale (RAS), developed by (2014) and validated and proven reliable in Turkish by Dursun and Gözüyeşil (2023), will be used for evaluation. The scale consists of 14 items and three sub-dimensions (Decision Making, Coercion Avoidance, Communication). The unit of measurement is the scale score, which is calculated as the average score obtained by dividing the total score by the number of items. Higher scores indicate higher reproductive autonomy.
Immediately after the intervention is completed.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kahramanmaras Sutcu Imam University

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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2026

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KahramanmarasSIUniversity (Registry Identifier: KahramanmarasSIUniversity)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

I do not approve of sharing ipd

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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