Health Improvement for Baltimore Youth

Johns Hopkins University97 enrolled

Overview

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.

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.

Eligibility

Sex: ALLMin age: 13 YearsMax age: 24 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 13-24 years of age * English speaking * Receiving care at the adolescent outpatient clinics at Johns Hopkins Children's Center (JHCC/University of Maryland Medical Center (UMMC)/Moore Clinic * Positive for HIV and aware of his/ her status * Prescribed anti-retroviral therapy (ART) * Able to attend and participate in the 9 week program sessions Exclusion Criteria: * patient currently exhibits significant psychological, developmental, or behavioral issues as assessed by the site clinical staff * participated in a previous MBSR program or studies Exclusion Criteria for supplement study: • patient is transgender

Outcomes

Primary Outcomes

Change in Treatment Adherence

Assessment of impact of MBSR versus HT on treatment adherence as measured by the Adolescent Medicine Trials Network (ATN) HIV Medication Adherence self-report measure, as well as CD4 and viral load counts pulled from the participant's medical record. The measure and medical record data collection takes place at baseline, post-program (3-month follow-up), 6-month follow-up, and 12-month follow-up.