Health Improvement for Baltimore Youth

HIV Clinical Trial

Official title: Improving Treatment Adherence in HIV-Positive Youth Through Mindfulness Training

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Adolescent Behavior
• Adolescent Development
• HIV
• Medication Adherence

• NCT number: NCT02624193
• Study type: Interventional
• Source: Johns Hopkins University
• Status: Completed
• Phase: N/A
• Start date: April 2013
• Completion date: June 25, 2018