HIV/STI Prevention for Adolescents With Substance Use Disorders in Treatment
Condition: HIV; Sexually Transmitted Diseases
MeSH terms: Sexually Transmitted Diseases; Substance-Related Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Adolescents with substance use disorders (SUD) are at substantial risk for contracting
      HIV/STIs compared to their counterparts without SUD, yet few HIV/STI sexual risk reduction
      interventions have been developed to meet their unique needs, and none use a family-based
      intervention approach, which the literature recommends as the focus for intervention for
      youth. Current state policies neither require providers in clinics delivering substance use
      treatment to offer HIV/STI sexual risk reduction nor offer providers tools or training for
      HIV/STI prevention. There is clear public health need to develop innovative methods of
      service delivery and effective strategies of HIV/STI sexual risk reduction that address
      multiple contexts of risk (i.e. family) for this high risk population. The current proposal
      addresses this need by developing a provider-delivered HIV sexual risk reduction intervention
      to be implemented in outpatient SUD treatment that: 1) builds the clinics' capacity to help
      families under their care to more comfortably address the adolescent's sexuality; 2) promotes
      youth's safer sex practices; and 3) reduces HIV/STI sexual risk behaviors among adolescents
      with SUD in care.
    

Detailed description: 
      The incidence of HIV and (sexually transmitted infections) STI continues to rise in the US
      among youth, and rates of HIV/STI sexual risk behaviors among adolescents with substance use
      disorders (SUD) are significantly higher compared with their counterparts without SUD. Yet
      HIV/STI sexual risk reduction is not regularly implemented within adolescent SUD treatment
      programs. To address this urgent public health priority, the investigators propose first to
      develop a manualized sexual risk reduction intervention that 1) builds community clinics'
      capacity to help families in their care to address systematically adolescents' sexuality; 2)
      promotes the youths' safer sex practices; and 3) reduces HIV/STI sexual risk behaviors among
      adolescents with SUD in treatment. Second, the investigators propose to pilot test the
      manualized intervention to examine feasibility and acceptability of implementation in
      real-world settings and determine optimal research parameters for such settings in
      preparation for a randomized clinical trial (RCT). The intervention development process will
      use a Community Based Participatory Research model of adaptation and development that has
      been successfully implemented by the PI in other settings. The investigators will conduct
      formative work to guide adaptation of a multi-family group HIV/STI sexual risk reduction
      intervention that has demonstrated efficacy with youth, ages 13-18, who have non-SUD
      psychiatric disorders (Project STYLE: Strengthening Today's Youth Life Experience; R01
      MH63008; PI: Brown). This formative work (Phase 1 - protocol 6183) will leverage the research
      sample of CASALEAP, an ongoing NIDA-funded, large-scale naturalistic study of the
      effectiveness of outpatient SUD treatment for adolescent (R01 DA019607; PI: Hogue). The
      resulting new manualized intervention (STYLEnS: STYLE and Substance) then will be
      pilot-tested (Phase 2 - protocol 6622) with a sample of male and female adolescents with SUD
      (n=60) in treatment in three well-established New York City mental health outpatient
      treatment programs which are typical of those for adolescents with SUD and in which the
      investigators have active partnerships. Pilot participants will be randomly assigned to
      either STYLEnS or an attention control intervention (Health Promotion). Participants will
      receive a full-day group intervention on the day of randomization (multi-family, caregivers
      alone and adolescents alone), return in two weeks for an individual adolescent/caregiver dyad
      session, and participate in a half-day booster group session three months later. The pilot
      test will evaluate the feasibility and acceptability of conducting an intervention in
      outpatient clinics treating adolescents with SUD, examine optimal factors influencing
      research methods, and estimate intervention parameters for a RCT. Acceptability and
      feasibility will be assessed using process measures following each session as well as after
      the intervention is completed. The investigators will assess change in sexual risk behavior
      outcomes from baseline to 3 months post-intervention. This study will lay the groundwork for
      refining the design of a RCT of the new intervention. Implementing a HIV/STI sexual risk
      reduction intervention in clinics providing SUD treatment represents an innovative and
      potentially cost-effective approach to enable typically overburdened SUD treatment providers
      to address the heightened HIV/STI risk in SUD youth. This proposal responds to the need to
      develop HIV/STI sexual risk reduction intervention services for adolescents with SUD that can
      be applied in and easily disseminated to clinical settings.
    

Intervention name(s): STYLEnS; Health Promotion
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Multifamily group HIV/STI Prevention Intervention or Single Family Dyad (youth and a parent); Health Promotion Intervention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HIV/STI; Prevention; Adolescents; Substance Use Disorders; Family-based intervention