HIV/STI Prevention Among Black Adolescents With Mental Illnesses (Project GOLD)

Completed · Not applicable

Conditions studied: HIV, STI, Emotional Disturbances, Mental Disorder

In brief

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 encourage HIV/STI testing and risk reduction efforts among Black youth, including those with mental illnesses.

Key facts

Study ID

NCT03348813

Run by

University of Pennsylvania

People needed

108

Starts

2014-08-01

Expected to finish

2016-12-31

Last updated by the study team

2017-11-29

Who can join

Age: 14 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 14 to 17 years old
• Self-identify as Black (inclusive of African American, Caribbean-American, etc.)
• Have ever had vaginal sex
• Able to speak, read and write in the English language
• Able to provide signed informed consent/assent
• Plan to be in the Philadelphia area for the next 12 months.

You may not qualify if…

• Diagnosis of a psychotic disorder (i.e. Schizophrenia) or a disorder with psychotic features (ascertained by the MINI)
• Cognitive deficit that would impair ability to complete study procedures
• Actively suicidal (ascertained through the Columbia-Suicide Severity Rating Scale [C-SSRS]) or requiring hospitalization
• Unstable contact information (i.e. homeless or no permanent address, or no land line or mobile phone)
• Participants were not excluded for concurrent use of herbal remedies, mineral supplements, or psychopharmacologic therapies, however these factors will be controlled for in the data analyses.

Where it is running

• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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