Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2026-02-25 @ 5:54 PM
Study NCT ID:
NCT02492893
Status:
COMPLETED
Last Update Posted:
2017-04-18
First Post:
2015-06-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Yoga Intervention for Substance Use and ART Adherence in Community Reentry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-14', 'studyFirstSubmitDate': '2015-06-19', 'studyFirstSubmitQcDate': '2015-07-06', 'lastUpdatePostDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stress: Perceived Stress Scale (self-report)', 'timeFrame': '3 months'}, {'measure': 'Substance use: Time Line Follow Back (self-report)', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Antiretroviral therapy adherence: prescription refill (pharmacy data)', 'timeFrame': '3 months'}, {'measure': 'Heart rate: sphygmomanometer', 'timeFrame': '3 months'}, {'measure': 'Blood pressure: sphygmomanometer', 'timeFrame': '3 months'}, {'measure': 'Viral load: blood test', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Substance Related Disorders', 'HIV']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* have HIV\n* experience substance use challenges, within one year of reentry from prison or jail'}, 'identificationModule': {'nctId': 'NCT02492893', 'briefTitle': 'Yoga Intervention for Substance Use and ART Adherence in Community Reentry', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Yoga Intervention for Substance Use and Antiretroviral Therapy Adherence in Community', 'orgStudyIdInfo': {'id': '820294'}, 'secondaryIdInfos': [{'id': '1F31DA038429-01', 'link': 'https://reporter.nih.gov/quickSearch/1F31DA038429-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hatha Yoga', 'description': 'A 12-session 90-minute weekly hatha yoga intervention, that includes asanas (physical postures), pranayama (breathing exercises) and dhyana (meditation.', 'interventionNames': ['Other: Hatha yoga']}, {'type': 'NO_INTERVENTION', 'label': 'Treatment as Usual'}], 'interventions': [{'name': 'Hatha yoga', 'type': 'OTHER', 'armGroupLabels': ['Hatha Yoga']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, {'name': 'Peter McManus Charitable Trust', 'class': 'OTHER'}, {'name': 'National Coalition of Independent Scholars', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}