Yoga Intervention for Substance Use and ART Adherence in Community Reentry

Sponsor

University of Pennsylvania (Other)

Overall Status

Completed

CT.gov ID

NCT02492893

Collaborator

National Institute on Drug Abuse (NIDA) (NIH), Peter F. McManus Charitable Trust (Other), National Coalition of Independent Scholars (Other)

Enrollment

Location

Arms

Duration (Months)

5.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Substance Related Disorders HIV	Other: Hatha yoga	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Yoga Intervention for Substance Use and Antiretroviral Therapy Adherence in Community

Study Start Date :

Dec 1, 2014

Actual Primary Completion Date :

Feb 1, 2016

Actual Study Completion Date :

Feb 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hatha Yoga A 12-session 90-minute weekly hatha yoga intervention, that includes asanas (physical postures), pranayama (breathing exercises) and dhyana (meditation.	Other: Hatha yoga
No Intervention: Treatment as Usual

Arm

Intervention/Treatment

Experimental: Hatha Yoga

A 12-session 90-minute weekly hatha yoga intervention, that includes asanas (physical postures), pranayama (breathing exercises) and dhyana (meditation.

Other: Hatha yoga

No Intervention: Treatment as Usual

Outcome Measures

Primary Outcome Measures

Stress: Perceived Stress Scale (self-report) [3 months]
Substance use: Time Line Follow Back (self-report) [3 months]

Secondary Outcome Measures

Antiretroviral therapy adherence: prescription refill (pharmacy data) [3 months]
Heart rate: sphygmomanometer [3 months]
Blood pressure: sphygmomanometer [3 months]
Viral load: blood test [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

have HIV
experience substance use challenges, within one year of reentry from prison or jail

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

University of Pennsylvania
National Institute on Drug Abuse (NIDA)
Peter F. McManus Charitable Trust
National Coalition of Independent Scholars

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Pennsylvania

ClinicalTrials.gov Identifier:

NCT02492893

Other Study ID Numbers:

820294
1F31DA038429-01

First Posted:

Jul 9, 2015

Last Update Posted:

Apr 18, 2017

Last Verified:

Apr 1, 2017

Additional relevant MeSH terms:

Substance-Related Disorders

Study Results

No Results Posted as of Apr 18, 2017