Health Improvement for Baltimore Youth

Johns Hopkins University

Status: Completed

Conditions: Adolescent Development; Medication Adherence; HIV; Adolescent Behavior

Treatments: Behavioral: HT Program; Behavioral: MBSR Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02624193

1R01AT007888 (U.S. NIH Grant/Contract)

NA_00093335

Details and patient eligibility

About

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.

Full 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.

Enrollment: 97 patients

Sex: All

Ages: 13 to 24 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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97 participants in 2 patient groups, including a placebo group

MBSR Program

Experimental group

Description:

MBSR Program: The MBSR intervention is a nine-week program designed to cultivate mindfulness, a focused non-judgmental awareness of the present moment. It consists of eight 2-hour weekly sessions and one 3-hour retreat and the content includes three main components: 1) material related to mindfulness, meditation, yoga, and the mind-body connection; 2) experiential practice of mindful meditation (sitting, lying down, walking), gentle mindful yoga, and "body scan" during group meetings and encouragement of home practice; and 3) group discussion focused on problem-solving related to barriers to effective practice. HIV disease will not be discussed as a group topic, unless it is brought up by participants.

Treatment:

Behavioral: MBSR Program

HT Program

Placebo Comparator group

Description:

Healthy Topics Program: The health education program "Healthy Topics" (HT) will serve as an attention control group. The HT program is focused on providing age-appropriate health information and education. There is minimal content overlap in the MBSR and HT programs regarding self-care and healthy eating; however, the style, structure, and content of the MBSR and HT programs are distinct. HT participants will receive no training in MBSR or meditation. Topics covered include physical activity, nutrition, managing weight, building health, personal care, understanding adolescence, tobacco, alcohol, and other drugs. HIV disease will not be discussed as a group topic, unless it is brought up by participants.

Treatment:

Behavioral: HT Program