ClinicalTrials.gg
Active, not recruitingNCT07145749SEXUALRISKUpdated Aug 28, 2025

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

An interventional study of Transtheoretical theory-based education and Pre-test-after-test-re-test in HIV Infections and Sexual Behavior, sponsored by Saglik Bilimleri Universitesi. Active, not recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-28.

Sponsored by Saglik Bilimleri Universitesi · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 3 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • HIV Infections
  • Sexual Behavior
03

In context

HIV Infections

4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.

This study's enrollment of 48 is below the median of 80 across 3,489 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

Saglik Bilimleri Universitesi is the lead sponsor of 453 studies on the registry; 140 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Presence of visual, hearing, or communication disorders
  • Refusing to participate voluntarily in the study
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    Experimental group

    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).

    Behavioral: Transtheoretical theory-based education · Other: Pre-test-after-test-re-test

  • Other
    Control group

    No additional intervention will be applied.

    Other: Pre-test-after-test-re-test

Interventions

  • BehavioralTranstheoretical theory-based education

    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).

  • OtherPre-test-after-test-re-test

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

06

What researchers measure

Primary outcomes

  1. Sexual Risk Taking Scale (SCRAS)

    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.

    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.

  2. AIDS Knowledge Scale (AIS)

    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.

    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.

  3. AIDS Prevention Self-Efficacy Scale (AIPS)

    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.

    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.

07

Study locations

1 site
  • Sakarya Sağlik Bilimleri Enstitüsü
    Sakarya, Serdi̇van 54440, Turkey (Türkiye)
08

References and documents

Publications

  • Lin H, Liu Y, Zhang H, Zhu Z, Zhang X, Chang C. Assessment of a Text Message-Based Smoking Cessation Intervention for Adult Smokers in China: A Randomized Clinical Trial. JAMA Netw Open. 2023 Mar 1;6(3):e230301. doi: 10.1001/jamanetworkopen.2023.0301. PubMed 36857056 ↗
  • Leandro TA, Nunes MM, Teixeira IX, Lopes MVO, Araujo TL, Lima FET, Silva VMD. Development of middle-range theories in nursing. Rev Bras Enferm. 2020 Feb 10;73(1):e20170893. doi: 10.1590/0034-7167-2017-0893. eCollection 2020. English, Portuguese. PubMed 32049218 ↗
  • Evers YJ, Op den Camp KPL, Lenaers M, Dukers-Muijrers NHTM, Hoebe CJPA. Alcohol and drug use during sex and its association with sexually transmitted infections: a retrospective cohort study among young people aged under 25 years visiting Dutch STI clinics. Sex Transm Infect. 2023 Mar;99(2):97-103. doi: 10.1136/sextrans-2021-055355. Epub 2022 May 6. PubMed 35523571 ↗
  • Efrati Y, Kraus SW, Kaplan G. Common Features in Compulsive Sexual Behavior, Substance Use Disorders, Personality, Temperament, and Attachment-A Narrative Review. Int J Environ Res Public Health. 2021 Dec 28;19(1):296. doi: 10.3390/ijerph19010296. PubMed 35010552 ↗
  • Chun J. Public Health Threat of Tobacco and Substance Use in Asia: An Introduction to the Theme Issue. J Psychoactive Drugs. 2020 Jan-Mar;52(1):1-4. doi: 10.1080/02791072.2020.1717686. Epub 2020 Jan 22. PubMed 31967534 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07145749
Responsible party
Hülya İncirkuş Küçük (PhD Student, Saglik Bilimleri Universitesi) — Principal investigator
First posted
Aug 28, 2025
Start date
Dec 7, 2024
Primary completion
Aug 2025 (estimated)
Completion
Jul 2026 (estimated)
Last update
Aug 28, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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