HIV/STI Prevention Among Black Adolescents With Mental Illnesses (Project GOLD)
NCT03348813 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108
Last updated 2017-11-29
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 encourage HIV/STI testing and risk reduction efforts among Black youth, including those with mental illnesses.
Conditions
- HIV
- STI
- Emotional Disturbances
- Mental Disorder
Interventions
- BEHAVIORAL
-
HIV/STI Prevention Intervention
The targeted HIV/STI risk reduction intervention was delivered with groups of up to 8 participants through 8, 45-minute modules equally divided over 2 days (4 modules per session). It was designed to enhance participants' knowledge and ability to reduce their risk of HIV/STIs. Grounded in both social/behavioral and cognitive theories, the intervention includes psychoeducation, and was intended to enhance participants' HIV/STI prevention knowledge, attitudes, beliefs and skills in a manner relevant to Black adolescents.
- BEHAVIORAL
-
General Health Control Intervention
The original Promoting Health among Teens (PHAT) Project was designed to increase knowledge and motivation regarding healthful dietary practices, aerobic exercise, and breast and testicular self-examination, and to discourage cigarette smoking. The 8-hour, 2-session PHAT intervention was shortened to mirror the Project GOLD HIV/STI risk reduction curriculum. This was done to control for the Hawthorne effect and reduce the likelihood that effects of the HIV/STI risk reduction intervention can be attributed to its nonspecific features, including special attention. From an ethical standpoint, adolescents in both conditions received a valuable and engaging health-risk-reduction intervention as opposed to "usual care."
Sponsors & Collaborators
-
Centers for Disease Control and Prevention
collaborator FED -
National Institute of Mental Health (NIMH)
collaborator NIH - lead OTHER
Principal Investigators
-
Bridgette M Brawner, PhD · University of Pennsylvania
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 14 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-08-01
- Primary Completion
- 2016-12-22
- Completion
- 2016-12-31
Countries
- United States
Study Locations
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