Health Improvement for Baltimore Youth



Status:Completed
Conditions:HIV / AIDS, Psychiatric
Therapuetic Areas:Immunology / Infectious Diseases, Psychiatry / Psychology
Healthy:No
Age Range:13 - 24
Updated:11/2/2018
Start Date:April 2013
End Date:June 25, 2018

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Improving Treatment Adherence in HIV-Positive Youth Through Mindfulness Training

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.

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
We found this trial at
2
sites
Baltimore, Maryland 21287
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22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
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