Health Improvement for Baltimore Youth
Condition: HIV; Adolescent Development; Adolescent Behavior; Medication Adherence
Study type: Interventional

Summary: 
      Preliminary data from the investigators' National Center for Complementary and Alternative
      Medicine (NCCAM)-funded R21 on mindfulness-based stress reduction (MBSR) in HIV-infected
      youth suggest an association between mindfulness and improved self-regulation and medication
      adherence. This randomized, controlled trial will help the investigators to better understand
      the specific impact of MBSR on HIV medication and treatment adherence in HIV-infected youth,
      and the efficacy of MBSR in the amelioration of stress and improved self-regulation.
    

Detailed description: 
      Despite remarkable advances in HIV medication effectiveness, adherence to HIV treatment
      recommendations is alarmingly poor, resulting in preventable morbidity and mortality. It is
      estimated that 26-72% of HIV-infected adolescents are non-adherent to their HIV medications
      and 22-33% are non-adherent with scheduled health care visits. HIV treatment non-adherence
      puts individuals at markedly increased risk for illness related to HIV itself and a variety
      of opportunistic infections, as well as at increased risk of spreading HIV.

      Preliminary data from the investigators' NCCAM-funded R21 on mindfulness-based stress
      reduction (MBSR) in HIV-infected youth suggest an association between mindfulness and
      improved medication adherence, as well as enhanced self-regulatory processes (coping,
      psychological function, and cognitive function). This two-armed randomized, controlled trial
      will help the investigators to better understand the specific impact of MBSR on HIV
      medication and treatment adherence in HIV-infected youth, and the efficacy of MBSR in the
      amelioration of stress and improved self-regulation.

      The aims of the study are as follows:

      Primary Objective

      Investigators hypothesize that MBSR vs. active control program (HT) participation will be
      associated with:

      • (H1) Improved HIV medication adherence (self-report validated by HIV viral load) at 3
      months, 6 months, and 12 months

      Secondary Objectives

      Investigators also hypothesize that MBSR vs. active control program (HT) participation will
      be associated with:

        -  (H2) Improved coping at 3, 6, and 12 months

        -  (H3) Improved psychological functioning at 3, 6, and 12 months

        -  (H4) Improved cognitive functioning at 3, 6, and 12 months

      Investigators will also explore:

        -  associations (and potential mediation) among mindfulness, self-regulation, and HIV
           medication adherence and

        -  using qualitative methods, experience with MBSR, HIV treatment adherence, as well as
           reasons for non-participation in the study and non-attendance of program sessions to
           inform future implementation planning.

        -  gender differences in the effects of MBSR versus HT on emotion regulation and
           physiological responses to stressful stimuli.
    

Intervention name(s): MBSR Program; HT Program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Mindfulness-based stress reduction, as described previously.; Health education curriculum, as described previously
Other intervention name(s): Mindfulness Program; Healthy Topics Program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Treatment Adherence; Mental Health; Well-being; Emerging Adults; Youth