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HIV/STI Prevention Among Black Adolescents With Mental Illnesses (Project GOLD)
NCT03348813 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 108 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,457 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03348813 reports 1 study location spanning 1 distinct geographic area — top geographies include Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03348813?
The interventions under investigation include: HIV/STI Prevention Intervention (BEHAVIORAL), General Health Control Intervention (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03348813?
This trial is sponsored by University of Pennsylvania, which has 1,457 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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