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Active, Not Recruiting

NCT Number: NCT07145749

Examining the Effects of Theory-based Education on Individuals' Sexual Behavior.

The research was planned to examine the effect of the transtheoretic theory-based education given to individuals followed in AMATEM on their sexual risk-taking status, AIDS knowledge level and AIDS prevention self-efficacy.

Research Hypotheses H0: Transtheoretical theory-based education given to individuals followed in AMATEM has no effect on their sexual risk taking, AIDS knowledge level and protection self-efficacy.

H1-1: Transtheoretic theory-based education given to individuals followed in AMATEM has an effect on the level of sexual risk taking.

H1-2: The transtheoretic theory-based education given to individuals followed in AMATEM is A

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sakarya Sağlik Bilimleri Enstitüsü

Sakarya, Serdi̇van, 54440, Turkey (Türkiye)

About this study

Substance abuse is a public health problem as old as human history. Globally, increasing substance use disorder has become a public health problem that harms individuals and then societies, and has negative effects on many dimensions such as economic, social and security. In addition to its history dating back to ancient times, the content and effects of the substances used have changed over time and spread more rapidly in societies as a result of the production of easily accessible concentrated forms. Substances of abuse are categorized in two ways. These include a variety of illegal and legally sanctioned substances. The most common types of illegal substances include cannabis, amphetamine, ketamine, methamphetamine, cocaine, ecstasy and heroin, which are largely banned in most countries. Tobacco and alcohol are two types of legally sanctioned substances that are widely used by different social groups across different societies and cultures. In the treatment of substance use disorder, behavioral change can be achieved with theory-based training provided in addition to pharmacological treatment. The theory-based approach in nursing practices increases the quality of health services provided and guides nurses. The Transtheoretical Model (TTM) or Stages of Change Model developed by Prochaska and Diclemente (1982) describes the change of healthy life behaviors in individuals in stages. As a result of the literature review, it was seen that the transtheoretical model is frequently used in order to reduce symptoms in addiction and other chronic diseases, improve health, and provide healthy life behaviors to individuals. The individuals followed in AMATEM, which constitute the sample of our research, are at greater risk of sexually transmitted HIV by exhibiting risky sexual behavior. It is thought that TTM-based training integrated into substance use treatment in order to reduce the tendency towards uncontrolled sexual behaviors as a result of substance use disorder and the risk of infectious diseases as a result will create healthy behavioral change in individuals.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Willing to participate voluntarily in the study
  • Age 18 years or older
  • Under probation and receiving treatment at AMATEM
  • Able to read and write (literate)

Exclusion criteria

  • Presence of visual, hearing, or communication disorders
  • Refusing to participate voluntarily in the study

Treatment and study plan

Transtheoretical theory-based education

Behavioral

Transtheoretical theory-based education will be provided to individuals with substance use disorders face-to-face in 8 modes and each lesson will last 45 minutes. Weekly education stages of transtheoretical theory-based education: Week 1; Stage 1 (not thinking); Weeks 2 and 3, Stage 2 (Thinking/Intention); Weeks 4 and 5, Stage 3 (Preparation); Weeks 6 and 7, Stage 4 (taking action); Week 8, Stage 5 (Maintenance/Continuing).

Pre-test-after-test-re-test

Other

Information Form, Sexual Risk Taking Scale, AIDS Knowledge Scale and AIDS Prevention Self-Efficacy Scale

Primary outcomes

  1. Sexual Risk Taking Scale (SCRAS)

    Time frame: At the end of the planned training program (8 weeks); It will be applied as the final test. In order to measure the permanence of behavioral change after the training, the final test was planned to be repeated after an average of 2 months.

    It consists of a total of 10 items aimed at collecting information about risky sexual behaviors experienced by the person in the last 12 months and throughout his/her life. Five items of the scale are answered as yes-no, two items are answered as fill-in-the-blank, two items are answered as triple Likert type, and one item is answered as quadruple Likert type. The possible score from the scale is between 0 and 10, with higher scores indicating more sexual risk taking.The alpha internal consistency coefficient of the scale was found to be 0.71.

  2. AIDS Knowledge Scale (AIS)

    Time frame: At the end of the planned training program (8 weeks); It will be applied as the final test. In order to measure the permanence of behavioral change after the training, the final test was planned to be repeated after an average of 2 months.

    The scale has 18 items. The total score varies between 0-18, with higher scores indicating more AIDS knowledge. The content validity index of the scale was found to be 0.98. The internal consistency of the scale was found to be 0.85 and the test-retest reliability was found to be 0.80.

  3. AIDS Prevention Self-Efficacy Scale (AIPS)

    Time frame: At the end of the planned training program (8 weeks); It will be applied as the final test. In order to measure the permanence of behavioral change after the training, the final test was planned to be repeated after an average of 2 months.

    It is a five-point Likert-type scale with a total of 27 items. Scores on the scale range from 27 to 135, with higher scores indicating higher self-efficacy. The internal consistency coefficient of the total scale was found to be 0.93, and the test-retest reliability was found to be 0.85.

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study title

Investigation of the Effects of Transtheoretical Theory-based Education Given to Individuals Followed in Amatem on Their Sexual Risk Taking, AIDS Knowledge Levels and Protection Self-efficacy: a Randomized Controlled Trial.

Acronym: SEXUALRISK

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 28, 2025
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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