NCT02492893

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 9, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

April 18, 2017

Status Verified

April 1, 2017

Enrollment Period

1.2 years

First QC Date

June 19, 2015

Last Update Submit

April 14, 2017

Conditions

Substance Related DisordersHIV

Outcome Measures

Primary Outcomes (2)

  • Stress: Perceived Stress Scale (self-report)

    3 months

  • Substance use: Time Line Follow Back (self-report)

    3 months

Secondary Outcomes (4)

  • 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

Study Arms (2)

Hatha Yoga

EXPERIMENTAL

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

Other: Hatha yoga

Treatment as Usual

NO INTERVENTION

Interventions

Hatha yogaOTHER
Hatha Yoga

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2015

First Posted

July 9, 2015

Study Start

December 1, 2014

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

April 18, 2017

Record last verified: 2017-04

Locations

US(1)