HIV/STI Prevention Among Black Adolescents With Mental Illnesses

This project was approved by the University of Pennsylvania, the Philadelphia Department of Public Health, and the School District of Philadelphia. The primary study site was the University of Pennsylvania. Recruitment took place at public locations in the city of Philadelphia (e.g., recreational centers, community events), Community Behavioral Health (CBH) provider sites, and schools in the School District of Philadelphia.

Phase 1: Team-Building and Elicitation Research (Study aim #1; N = 53). Team building and community engagement were an ongoing process throughout the course of the study. The investigators initially focused on team-building and strengthening ties with collaborators, securing buy-in from key community stakeholders and providers, recruiting 8 members for a youth CAB, and hiring and training project staff. The investigators were committed to the development of an acceptable, practical intervention which could easily be implemented and sustained in the targeted community setting. Therefore, continual feedback from Black adolescents with mental illnesses, CBH providers and research staff was pivotal. Further, Black adolescents in the target demographic and young adults from the community were hired as members of the study team in a capacity building approach to create a pipeline for future HIV/AIDS research investigators and community workers. The investigators also built upon their existent elicitation research with members of the study population. Four mixed gender focus groups were conducted with concurrent open-ended questionnaire administration with Black adolescent males (n= 18) and females (n= 15). The team held meetings with CBH providers and the youth CAB to determine factors associated with HIV/STI risk related sexual behaviors in the population, and the role of psychiatric symptoms, the social determinants of health, gender and culture in sexual risk taking among Black adolescents with mental illnesses. The baseline intervention questionnaire was also piloted with Black adolescent males (n= 10) and females (n= 10) for accuracy; revisions were made based on participant suggestions. Psychometrics of the revised instrument were assessed and results compared to the original version. The qualitative and quantitative data were examined concurrently to explore participants' behavioral, normative and control beliefs, as well as contextual factors, as they relate to HIV/STI risk. Subsequently, this knowledge was used in the design of the targeted intervention.

Phase 2: Intervention Development and Pre-Pilot Testing (Study aim #2; N = 29). The investigators used an iterative process to develop the targeted intervention. They sought feedback from their elicitation participants, youth CAB, and CBH providers at each stage of intervention development. This input was used to ensure accurate interpretation of the study findings, as well as to refine the intervention for relevance and sustainability. The primary outcome of these processes was the development of "Project GOLD", a theoretically-driven, gender and culturally relevant, developmentally and psychologically appropriate behavioral intervention to reduce HIV/STI risk among heterosexually-active Black adolescents receiving outpatient mental health treatment. The intervention name was created by the youth CAB, along with the project logo. The intent in this branding was to foster gender and cultural pride through visually and verbally reinforcing the intervention's tagline: "We are Kings and Queens who make confident and royal decisions". The first pre-pilot testing, or dress rehearsal, of the interventions and all study materials and instruments was conducted with a sample of Black adolescent males (n= 4) and females (n= 4). Participants completed pre- and post-intervention assessments, and the team debriefed with them to solicit their feedback on ways to improve the project. Revisions were made and a new, independent sample of Black adolescent males (n= 3) and females (n= 4) completed the second pre-intervention pilot. The investigators completed the same process for the general health intervention (N = 14). The goals of the intervention pilots were to evaluate whether the interventions were likely to affect the conceptual variables, to evaluate whether the participants viewed the interventions as valuable and engaging, and to ensure the study protocols were relevant to achieve the aims.

Phase 3: Intervention Pilot (Study aims #3 & 4; N = 108). Based on the Phase 2 findings, the final versions of the intervention protocols, materials and instruments were developed and sent for printing. The intervention was piloted with 108 youth; 109 enrolled but one participant was terminated at the baseline visit for eminent suicide risk. Participants were randomized to either Project GOLD (n = 52) or the general health promotion control arm (n = 56). There were five RCT visits: baseline, immediate post, and 3-, 6-, and 12-month follow-up.

RCT Sample, Recruitment and Enrollment. Provider referrals, waiting room encounters, flyers, social media, and teen-focused community events and locations (e.g., talent showcases and game nights; recreational centers) were used to inform potential participants about the study. As part of the investigators' community engagement mission, the research team hosted programs and/or partnered with local community-based organizations to promote HIV/STI awareness and encourage testing among youth. In an effort to increase study enrollment, staff members also screened interested youth for eligibility at these events. The programs took place in reserved campus space at the University of Pennsylvania, or a public community space as approved (e.g., local YMCA or recreation center). Eligibility was determined using a structured screening script either in person or by telephone. All study visits took place at one of the sites where participants were recruited, at the University of Pennsylvania in a private conference room, or in a private conference room at a community-based organization near where participants are recruited (e.g., recreation center). No data collection occurred at any School District schools or property as a condition of their IRB approval. For the RCT, participants registered with the study coordinator, were assessed by a research team member using an electronic version of the Patient Health Questionnaire-9 (PHQ-9), provided a urine specimen, had their mouths swabbed for the rapid HIV test, and completed the self-administered sexual risk behavior questionnaire in a private, quiet room.