iTRAC-HERO for Risky Sexual Behavior

(iTRAC-HERO Trial)

Overseen By Julia Berteletti

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Klein Buendel, Inc.

Disqualifiers: Reading level, Sibling, Development disorder

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

120 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is the iTRAC-HERO treatment safe for humans?

The safety of testosterone gels, similar to iTRAC-HERO, has been evaluated in studies with hypogonadal men, showing that they are generally safe and well-tolerated. No significant adverse side effects were observed in these studies, indicating that such treatments are generally safe for human use. ^{1 2 3 4 5}

How does the iTRAC-HERO treatment differ from other treatments for risky sexual behavior?

The iTRAC-HERO treatment is unique because it likely incorporates a novel approach to addressing risky sexual behavior by focusing on psychological and personality traits, such as impulsivity and anxiety, which are linked to hypersexual behavior. This treatment may differ from others by targeting these underlying factors rather than just the behavior itself. ^{6 7 8 9 10}

What is the purpose of this trial?

Using the efficacious iTRAC intervention to enhance emotion regulation competencies as a foundation, this study will create and test iTRAC-HERO to teach emotion regulation skills in the context of sexual health education.

Research Team

Christopher Houck, PhD

Principal Investigator

Rhode Island Hospital

Eligibility Criteria

This trial is for adolescents who may engage in risky sexual behavior and need to improve their emotion regulation skills. Specific eligibility criteria are not provided, so it's best to contact the study team for details.

Inclusion Criteria

Attending 7th grade

I am between 12 and 14 years old.

Attending participating school

Exclusion Criteria

Have a sibling who has participated in the study

Have a developmental disorder

Unable to read at a 4th grade level

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Development

Development and testing of the iTRAC-HERO web app, including acceptability testing and modifications based on participant feedback

Not specified

Treatment

Participants complete the 8-module iTRAC-HERO web-based intervention targeting emotion regulation and sexual self-efficacy

8 weeks

Follow-up

Participants are monitored for changes in emotion regulation behaviors, self-efficacy, and sexual risk behaviors

6 months

Treatment Details

Interventions

• iTRAC-HERO

Trial Overview The iTRAC-HERO program is being tested. It's an internet-based intervention that builds on the existing iTRAC system, aiming to teach adolescents how to manage their emotions better in situations related to sexual health.

Participant Groups

Group I: iTRAC-HERO Experimental Treatment 1 Intervention

iTRAC-HERO is an 8-module, web-based intervention for middle school boys and girls to complete. Its goal is primary prevention of adolescent sexual risk behaviors by targeting emotion regulation and sexual self-efficacy. (e.g., to refuse sexual advances).

Group II: Waitlist Control Active Control 1 Intervention

Control participants will be assessed on the same schedule as the treatment condition and offered the intervention after 6-month follow-up.

Who Is Running the Clinical Trial?

Klein Buendel, Inc.

Lead Sponsor

Trials

41

Recruited

20,000+

University of Oregon

Collaborator

Trials

91

Recruited

46,700+

Rhode Island Hospital

Collaborator

Trials

275

Recruited

71,400+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Findings from Research

In a study involving 26 healthy male volunteers, applying 5.0 g of a 2.5% testosterone gel daily for 10 days successfully restored physiological testosterone levels, while 2.5 g was insufficient for this purpose.

Washing the gel off 10 minutes after application did not affect testosterone absorption, which helps minimize the risk of contamination for female partners or infants, enhancing the safety of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of a new transdermal testosterone gel in gonadotrophin-suppressed normal men. Rolf, C., Kemper, S., Lemmnitz, G., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of a new transdermal testosterone gel in gonadotrophin-suppressed normal men. [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

The efficacy, bioavailability and safety of a novel hydroalcoholic testosterone gel 2% in hypogonadal men: results from phase II open-label studies. [2017]

3. England pubmed.ncbi.nlm.nih.gov

A dose-escalation study to assess the efficacy and safety of sildenafil citrate in men with erectile dysfunction. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Testosterone buciclate (20 Aet-1) in hypogonadal men: pharmacokinetics and pharmacodynamics of the new long-acting androgen ester. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

The efficacy and safety of tadalafil in United States and Puerto Rican men with erectile dysfunction. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

An Online Assessment of Personality, Psychological, and Sexuality Trait Variables Associated with Self-Reported Hypersexual Behavior. [2019]

7. Denmark pubmed.ncbi.nlm.nih.gov

[Sexual behavior in HIV antibody positive homosexual and bisexual men]. [2006]

8. United States pubmed.ncbi.nlm.nih.gov

A model of sexual risk behaviors among young gay and bisexual men: longitudinal associations of mental health, substance abuse, sexual abuse, and the coming-out process. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Pornography consumption, sexual experiences, lifestyles, and self-rated health among male adolescents in Sweden. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Sexual Excitation and Sexual Inhibition in the Context of Sexual Risk-Taking. [2021]