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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02492893
Other study ID # 820294
Secondary ID 1F31DA038429-01
Status Completed
Phase N/A
First received June 19, 2015
Last updated April 14, 2017
Start date December 2014
Est. completion date February 2016

Study information

Verified date April 2017
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date February 2016
Est. primary completion date February 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- have HIV

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

Study Design


Intervention

Other:
Hatha yoga


Locations

Country Name City State
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (4)

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

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Stress: Perceived Stress Scale (self-report) 3 months
Primary Substance use: Time Line Follow Back (self-report) 3 months
Secondary Antiretroviral therapy adherence: prescription refill (pharmacy data) 3 months
Secondary Heart rate: sphygmomanometer 3 months
Secondary Blood pressure: sphygmomanometer 3 months
Secondary Viral load: blood test 3 months
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