HIV InfectionsSEXUALRISKNCT07145749
Examining the Effects of Theory-based Education on Individuals' Sexual Behavior.
A study testing Transtheoretical theory-based education and Pre-test-after-test-re-test in people with HIV Infections and Sexual Behavior, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Sexual Behavior
- What is being tested?
- Transtheoretical theory-based education and Pre-test-after-test-re-test
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Dec 2024to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Presence of visual, hearing, or communication disorders
- Refusing to participate voluntarily in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sakarya Sağlik Bilimleri Enstitüsü
Sakarya, Serdi̇van, 54440
About this study
Official 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.
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.
- Conditions
- HIV Infections, Sexual Behavior
- Being tested
- Transtheoretical theory-based education, Pre-test-after-test-re-test
- Medical subject headings
- HIV Infections, Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transtheoretical theory-based educationBehavioural
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-testOther
Information Form, Sexual Risk Taking Scale, AIDS Knowledge Scale and AIDS Prevention Self-Efficacy Scale
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 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). Receives: Behavioral: Transtheoretical theory-based education; Other: Pre-test-after-test-re-test |
| Control group | Other | No additional intervention will be applied. Receives: Other: Pre-test-after-test-re-test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start7 Dec 2024
- Primary completionAug 2025 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The experimental group will receive 8 weeks of transtheoretical theory-based training and will be given a training booklet at the end of the training.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hülya İncirkuş Küçük, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145749
- Sponsor's protocol ID
- E-71522473-050.04-372987-197
- Acronym
- SEXUALRISK
- Status last verified
- Aug 2025
- First submitted
- 13 Aug 2024
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 36857056Leandro 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 32049218Evers 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 35523571Efrati 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 35010552Chun 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07145749
- Acronym / sponsor ID
- SEXUALRISK / E-71522473-050.04-372987-197
- Conditions
- HIV Infections, Sexual Behavior
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 7 Dec 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The experimental group will receive 8 weeks of transtheoretical theory-based training and will be given a training booklet at the end of the training.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Transtheoretical theory-based education, Other: Pre-test-after-test-re-testTranstheoretical 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). |
| Control group | Other | Other: Pre-test-after-test-re-testNo additional intervention will be applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- Presence of visual, hearing, or communication disorders
- Refusing to participate voluntarily in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transtheoretical theory-based educationTranstheoretical 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). | Behavioural | Experimental group |
| Pre-test-after-test-re-testInformation Form, Sexual Risk Taking Scale, AIDS Knowledge Scale and AIDS Prevention Self-Efficacy Scale | Other | Control group, Experimental group |
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Results publication: PubMed 36857056Lin 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.
- Results publication: PubMed 32049218Leandro 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.
- Results publication: PubMed 35523571Evers 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.
- Results publication: PubMed 35010552Efrati 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.
- Results publication: PubMed 31967534Chun 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transtheoretical theory-based education and Pre-test-after-test-re-test in people with HIV Infections and Sexual Behavior, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07145749, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.