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NCT03348813 · ClinicalTrials.gov registry record · NA
HIV/STI Prevention Among Black Adolescents With Mental Illnesses (Project GOLD)
A NA study of HIV and Mental Disorder, sponsored by University of Pennsylvania.
- Completed
- Registry status
- NA
- Development phase
- 108
- Enrollment target
- 1
- Study location
NCT03348813 is a NA study of HIV and Mental Disorder that has completed, run by University of Pennsylvania. The registered enrollment target is 108 participants, below the 440-participant average among 303 other HIV trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03348813, a NA study of HIV and Mental Disorder, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- NA
- Development phase
- 108 participants
- Enrollment target
- 1
- Study location
Study Summary
Despite advances in HIV/sexually transmitted infection (STI) prevention, Black youth account for the largest number of new HIV infections among heterosexual youth. Having a mental illness contributes to HIV/STI risk among heterosexually active Black youth, as some use sex as a means to manage psychological distress, regulate emotions and receive validation or acceptance. Current intervention models focus on cognitive-behavioral strategies to reduce risk among adolescents; however, these approaches in isolation do not address the psychopathology that further potentiates risk behaviors among adolescents with mental illnesses. This randomized controlled trial evaluated the effects of "Project GOLD", a theoretically-driven, gender and culturally relevant, developmentally and psychologically appropriate HIV/STI risk reduction intervention on the sexual behaviors of Black male and female adolescents in Philadelphia (aged 14-17). In addition to evidence-based HIV/STI preventions strategies (e.g., role playing), Project GOLD includes unique emotion regulation content to address the relationship between psychological distress and HIV/STI risk behaviors. The research team approached and screened 704 adolescents. Eighty-two participated in the elicitation research activities (e.g., focus groups, intervention dress rehearsal). Another 173 underwent a structured demographic and mental health diagnostic interview to determine RCT eligibility. Project GOLD was then tested with 108 Black youth in comparison to a general health promotion control condition (intervention n = 52; control n = 56). Youth who were not in psychiatric treatment were also included, as the investigators hypothesized that they would also benefit from the targeted psychoeducational content; post-hoc analyses examined differences in the intervention effects based on whether or not youth were in psychiatric treatment. The intervention had high feasibility and acceptability. These findings underscore the need to
Conditions Studied
Interventions
- BEHAVIORAL HIV/STI Prevention Intervention
- BEHAVIORAL General Health Control Intervention
Study Locations (1)
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2014-08-01 |
| Est. Completion | 2016-12-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03348813
The ClinicalTrials.gov registry entry for NCT03348813 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 108 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 440-participant average among 303 other HIV trials with a reported enrollment target (75% lower). The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with HIV appearing as the primary indexed condition, and to 2 interventions - of which HIV/STI Prevention Intervention is the first listed.
NCT03348813 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03348813 about?
NCT03348813 is a clinical study titled "HIV/STI Prevention Among Black Adolescents With Mental Illnesses (Project GOLD)". Despite advances in HIV/sexually transmitted infection (STI) prevention, Black youth account for the largest number of new HIV infections among heterosexual youth. Having a mental illness contributes to HIV/STI risk among heterosexually active Black youth, as some use sex as a means to manage psycho...
What is the current status of trial NCT03348813?
This trial is currently completed. It is a NA study. The enrollment target is 108 participants. The study started on 2014-08-01. Estimated completion is 2016-12-31.
What conditions does trial NCT03348813 study?
This clinical trial studies the following conditions: HIV, Mental Disorder, STI, Emotional Disturbances.
What interventions are being tested in trial NCT03348813?
The interventions under investigation include: HIV/STI Prevention Intervention (BEHAVIORAL), General Health Control Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT03348813?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03348813 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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