Back to resultsYoga Intervention for Substance Use and ART Adherence in Community Reentry
Primary Purpose
Substance Related Disorders, HIV
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hatha yoga
Sponsored by
About this trial
This is an interventional supportive care trial for Substance Related Disorders
Eligibility Criteria
Inclusion Criteria:
- have HIV
- experience substance use challenges, within one year of reentry from prison or jail
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Hatha Yoga
Treatment as Usual
Arm Description
A 12-session 90-minute weekly hatha yoga intervention, that includes asanas (physical postures), pranayama (breathing exercises) and dhyana (meditation.
Outcomes
Primary Outcome Measures
Stress: Perceived Stress Scale (self-report)
Substance use: Time Line Follow Back (self-report)
Secondary Outcome Measures
Antiretroviral therapy adherence: prescription refill (pharmacy data)
Heart rate: sphygmomanometer
Blood pressure: sphygmomanometer
Viral load: blood test
Full Information
NCT ID
NCT02492893
First Posted
June 19, 2015
Last Updated
April 14, 2017
Sponsor
University of Pennsylvania
Collaborators
National Institute on Drug Abuse (NIDA), Peter F. McManus Charitable Trust, National Coalition of Independent Scholars
1. Study Identification
Unique Protocol Identification Number
NCT02492893
Brief Title
Yoga Intervention for Substance Use and ART Adherence in Community Reentry
Official Title
Yoga Intervention for Substance Use and Antiretroviral Therapy Adherence in Community
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
National Institute on Drug Abuse (NIDA), Peter F. McManus Charitable Trust, National Coalition of Independent Scholars
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
People with HIV and a substance use disorder who are reentering the community from prison or jail face the dual risks of relapse and interruptions in adherence to antiretroviral therapy (ART) medication. This mixed-methods randomized controlled trial will compare the stress, substance use and ART adherence outcomes of participants in a 12-session, 90-minute weekly yoga group intervention with participants in a treatment as usual control group. All participants are re-entering the community, have HIV and experience substance use challenges.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Related Disorders, HIV
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hatha Yoga
Arm Type
Experimental
Arm Description
A 12-session 90-minute weekly hatha yoga intervention, that includes asanas (physical postures), pranayama (breathing exercises) and dhyana (meditation.
Arm Title
Treatment as Usual
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Hatha yoga
Primary Outcome Measure Information:
Title
Stress: Perceived Stress Scale (self-report)
Time Frame
3 months
Title
Substance use: Time Line Follow Back (self-report)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Antiretroviral therapy adherence: prescription refill (pharmacy data)
Time Frame
3 months
Title
Heart rate: sphygmomanometer
Time Frame
3 months
Title
Blood pressure: sphygmomanometer
Time Frame
3 months
Title
Viral load: blood test
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
have HIV
experience substance use challenges, within one year of reentry from prison or jail
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
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Yoga Intervention for Substance Use and ART Adherence in Community Reentry
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