NCT02624193

Health Improvement for Baltimore Youth

Improving Treatment Adherence in HIV-Positive Youth Through Mindfulness Training

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 13 Years – 24 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV
• Adolescent Development
• Adolescent Behavior
• Medication Adherence

Interventions

Type	Name	Description
BEHAVIORAL	MBSR Program	Mindfulness-based stress reduction, as described previously.
BEHAVIORAL	HT Program	Health education curriculum, as described previously

Timeline

• Start date: 2013-04-01
• Primary completion: 2018-06-25
• Completion: 2018-06-25
• First posted: 2015-12-08
• Last updated: 2018-10-31

Locations

2 sites across 1 country: United States