NCT03348813

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

Completed NA Last updated 29 November 2017

What this trial tests

NA trial testing HIV/STI Prevention Intervention in HIV in 108 participants. Completed in 31 December 2016.

Timeline

1 August 2014

Primary endpoint
22 December 2016

31 December 2016

Quick facts

Lead sponsor	University of Pennsylvania
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	108
Start date	1 August 2014
Primary completion	22 December 2016
Estimated completion	31 December 2016
Sites	1 location across United States

Drugs / interventions tested

• HIV/STI Prevention Intervention
• General Health Control Intervention

Conditions studied

• HIV — all drugs for HIV →
• STI — all drugs for STI →
• Emotional Disturbances — all drugs for Emotional Disturbances →
• Mental Disorder — all drugs for Mental Disorder →

Sponsor

University of Pennsylvania

Who can join

Adults 14 to 17, any sex, with HIV or STI. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Vital Voices: HIV Prevention and Care Interventions Developed for Disproportionately Affected Communities by Historically Underrepresented, Early-Career Scientists.
   Sutton MY, Martinez O, Brawner BM, Prado G, et al · · 2021 · cited 13× · PMID 33128188 · DOI 10.1007/s40615-020-00908-2
2. Project GOLD: A pilot randomized controlled trial of a novel psychoeducational HIV/STI prevention intervention for heterosexually-active black youth.
   Brawner BM, Jemmott LS, Wingood G, Lozano AJ, et al · · 2019 · cited 5× · PMID 30730043 · DOI 10.1002/nur.21930
3. Results from Project GOLD: A pilot randomized controlled trial of a psychoeducational HIV/STI prevention intervention for black youth.
   Brawner BM, Jemmott LS, Hanlon AL, Lozano AJ, et al · · 2021 · cited 3× · PMID 33550841 · DOI 10.1080/09540121.2021.1874273