Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2026-02-19 @ 11:42 PM
Study NCT ID:
NCT02624193
Status:
COMPLETED
Last Update Posted:
2018-10-31
First Post:
2015-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Health Improvement for Baltimore Youth
Sponsor:
Johns Hopkins University
Organization:
Study Overview
Official Title:
Improving Treatment Adherence in HIV-Positive Youth Through Mindfulness Training
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R01AT007888 | NIH | None | https://reporter.nih.gov/quic… | View |