HIV/STI Prevention Among Black Adolescents With Mental Illnesses (Project GOLD)
Condition: HIV; STI; Emotional Disturbances; Mental Disorder
MeSH terms: Mental Disorders; Affective Symptoms
Study type: Interventional

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.
    

Detailed description: 
      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.

      Assent versus Consent. In the state of Pennsylvania, adolescents between the ages of 14 to 17
      can autonomously make decisions about their sexual and mental health assessment and
      treatment. "…[I]f a minor is able to consent to medical, dental and health services under
      state law, the minor is also able to consent to take part in medical research" (pg. 9).
      Therefore, youth aged 14 to 17 provided consent to participate in the research without
      parental permission. Initial disagreements among the approving IRBs, however, lead to
      substantial protocol delays. The investigators agreed to exclude (or withdraw from
      participation) any adolescent whose parent/guardian is aware of/finds out about the study and
      indicates that they do not want their son or daughter to participate in the research. This
      was honored if a participant shared that his or her parent/guardian expressed to them that
      they did not want them in the study, or if the parent/guardian directly contacted a member of
      the research team to state they did not want their son or daughter to be involved.

      Procedures for Consent/Assent & Diagnostic Assessment. Adolescents who were preliminarily
      eligible were scheduled for their first study visit to undergo a 30-minute diagnostic
      assessment using the MINI to ascertain psychiatric diagnosis and rule out exclusionary
      disorders. Trained study personnel conducted all of the diagnostic assessments. Based on the
      diagnostic assessment, adolescents were excluded if they: 1) had a psychotic disorder, or
      disorder with psychosis, 2) were cognitively impaired, or 3) their current treatment required
      hospitalization. Eligible participants immediately participated in a brief, 10-minute
      structured demographic interview. The interview was used to obtain locator information to
      follow participants over the course of the study, as well as to elicit information regarding
      referral source, demographics, and clinical data (i.e. psychiatric and medical history). The
      structured diagnostic and demographic interviews took approximately 40 minutes. At the end of
      the structured interviews, participants were scheduled for their second study visit which
      included the baseline assessment and first intervention session.

      Procedures for Enrollment, Randomization & Intervention Trial. At the second study visit,
      participants completed the electronic baseline assessments (Intervention Baseline
      Questionnaire which includes the Background Information Questionnaire and PHQ-9) and provided
      urine specimens for STI testing. When the urine specimens were obtained, all participants
      signed a medical release form so that the study's Nurse Practitioner could receive the STI
      test results and confirm treatment for positive results with the health centers or chosen
      providers. They then immediately attended the first intervention session following these
      procedures. Randomization to either the targeted intervention or treatment control group
      occurred at the diagnostic visit. Where feasible, intervention and control group sessions ran
      concurrently at the same site; if the sessions could not be run on the same day, intervention
      and control group sessions were delivered within the same week at each site, or as close as
      possible thereafter. Participants attended the second intervention session (their third study
      visit) two weeks after the first intervention session. Immediately following the second/final
      intervention session they completed post-intervention measures, had their mouths swabbed for
      a rapid HIV test, and received their HIV/STI results. In accordance with the CDC's Revised
      Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health Care
      Settings, HIV screening was provided for all participants unless a participant expressly
      refused to take an HIV test (59.3% consented to HIV testing). Thus, study participants were
      offered HIV testing but not required to consent to testing to participate in the study.
      Participants also returned for post-intervention follow-up visits 3-, 6-, and 12-months after
      the date of their final intervention session. At each study visit, participants registered
      with the study coordinator, were screened with the electronic PHQ-9 and had all appropriate
      labs collected. They were then seated in a quiet room and provided with the electronic,
      self-administered Background Information Questionnaire.

      No adolescents tested positive for HIV over the course of the study. Those who tested
      positive for another STI were permitted to stay in the study. The study Nurse Practitioner
      notified participants of their baseline STI results at the end of the final intervention
      session, and participants received subsequent notifications by phone within 2-weeks after
      each of the 3 follow-up time points. Individuals who tested positive for an STI were referred
      to receive free treatment through the Philadelphia Health Department at the designated STI
      control health centers (Health Centers #1 [500 S. Broad St.] and #5 [1900 N. 20th St.]).
      Individuals who tested positive for an STI and fail to be located, did not comply with
      returning to the study site, or who failed to seek clinical treatment through an alternative
      provider, were reported to the City of Philadelphia Department of Public Health, as required
      by the City of Philadelphia.
    

Intervention name(s): HIV/STI Prevention Intervention; General Health Control Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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."
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Enrolled participants were randomized to either the targeted intervention group or the attention control group at the diagnostic visit. The permuted-block randomization technique was used with a block size of 4 and a 1:1 allocation ratio. Dr. Alex Hanlon (biostatistics consultant) generated the randomization list using a pseudo-randomizer computer program. The Research Coordinator maintained the spreadsheet for tracking and allocation concealment. To reduce the risk of encountering a floor or ceiling effect with intervention responsiveness, participants were stratified based on their PHQ-9 total scores (none/moderate depression versus moderately severe/severe depression) and gender.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Black; Adolescents; Community-based research; Randomized controlled trial; Intervention; Behavioral science