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Sponsor study identifier
Secondary identifiers
NIH
NIH
interventional
108
1 country
1
Study Start
August 1, 2014
Actual (reported)Primary Completion
December 22, 2016
Actual (reported)Study Completion
December 31, 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 1, 2014
Actual (reported)December 22, 2016
Actual (reported)December 31, 2016
Actual (reported)November 1, 2017
Actual (reported)November 21, 2017
Actual (reported)Change from baseline consistent condom use at 12 months
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 coded as not practicing consistent condom use.
12 months
Change from baseline number of sexual partners at 12 months
12 months
Change from baseline laboratory confirmed STIs at 12 months
Two-session, small group HIV/STI prevention intervention.
Two-session, small group general health promotion 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.
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Brawner BM, Jemmott LS, Wingood G, Reason J, Mack N. HIV/STI Prevention Among Heterosexually Active Black Adolescents With Mental Illnesses: Focus Group Findings for Intervention Development. J Assoc Nurses AIDS Care. 2018 Jan-Feb;29(1):30-44. doi: 10.1016/j.jana.2017.09.008. Epub 2017 Sep 28.
Bridgette M Brawner, PhD
University of Pennsylvania
108 participants (actual enrollment reported by the registry).
First Submitted
November 1, 2017
12 months
Change from baseline HIV Diagnosis at 12 months
12 months
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."
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
First Posted
November 21, 2017
Study Start
August 1, 2014
Actual (reported)Primary Completion
December 22, 2016
Actual (reported)Study Completion
December 31, 2016
Actual (reported)Last Updated
November 29, 2017
Record last verified: 2017-11
For other investigators interested in using the data for secondary data analysis purposes (e.g., students, faculty), we will develop a data use agreement with specific guidelines associated with the parent study. This will include information related to confidentiality of the data and human subjects' protection, as well as the acknowledgement of our study in all publications and presentations.
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Source: ClinicalTrials.gov.
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