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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: Completed NA study of HIV and Mental Disorder, sponsored by University of Pennsylvania.

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. According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

This dichotomous variable was defined by the comparison of the number of protected intercourse acts and the number of intercourse acts. Participants who report at least one intercourse act and whose number of reported protected acts equals their number of acts use condoms during 100% of intercourse acts and will be defined as practicing consistent condom use. Participants who report at least one intercourse act and whose reported number of protected acts is less than their number of acts will be

Interventions

  • BEHAVIORAL HIV/STI Prevention Intervention
  • BEHAVIORAL General Health Control Intervention

Study Locations (1)

Pennsylvania

  • University of Pennsylvania - Philadelphia

Trial Details

FieldValue
Enrollment Target 108 participants
Start Date 2014-08-01
Est. Completion 2016-12-31
Phase NA
University of Pennsylvania

1,423 total trials

What the finished NCT03348813 record still lists

NCT03348813 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 440-participant average among 303 other HIV trials with a reported enrollment target (75% lower).

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 a single indexed study location in 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.

Similar trials for HIV

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03348813's enrollment target sits among peer trials

108 147th of 303 higher than 157 of 303 other HIV trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other HIV trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03348813, the US trial registry maintained by the National Library of Medicine. NCT03348813 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.