NCT07145749

Brief 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

Trial Health

75
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at below P25 for not_applicable hiv-infections

Timeline
2mo left

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Dec 2024Jul 2026

First Submitted

Initial submission to the registry

August 13, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

December 7, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
27 days until next milestone

First Posted

Study publicly available on registry

August 28, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

August 28, 2025

Status Verified

August 1, 2025

Enrollment Period

8 months

First QC Date

August 13, 2024

Last Update Submit

August 26, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    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.

Study Arms (2)

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).

Behavioral: Transtheoretical theory-based educationOther: Pre-test-after-test-re-test

Control group

OTHER

No additional intervention will be applied.

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

Interventions

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).

Experimental group

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

Control groupExperimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya Sağlik Bilimleri Enstitüsü

Sakarya, Serdi̇van, 54440, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

HIV InfectionsSexual Behavior

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Since the training will be given to the experimental group in our study, it was not possible to provide double-blind researcher blindness in terms of blinding and masking. However, masking was applied wherever possible from the delivery of evaluations to the scoring and the initial assignment of individuals. The researcher who conducted the survey, made the random assignment, the researcher who made the statistical evaluation and the AMATEM personnel who drew the envelopes were blinded to the study. At the same time, the coded answer sheets will only be entered into the analysis program after the study is completed. Single-blind randomization will be provided by ensuring that the person who does the analysis does not know which individual the survey forms belong to. It was planned in a way that the experimental group would not meet the control group before and after the training program. In this way, cross-contamination of the experimental and control groups was prevented.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

August 13, 2024

First Posted

August 28, 2025

Study Start

December 7, 2024

Primary Completion

August 1, 2025

Study Completion (Estimated)

July 1, 2026

Last Updated

August 28, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations