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Intervention Targeting Substance Using Older Adults With HIV

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ClinicalTrials.gov Identifier: NCT01305629
Recruitment Status : Completed
First Posted : March 1, 2011
Last Update Posted : October 10, 2016
Sponsor:
Collaborator:
Fordham University
Information provided by (Responsible Party):
Jeffrey T. Parsons, Hunter College

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The proposed study uses a randomized controlled experimental design to evaluate the efficacy of a brief intervention using spiritual self schema (3S+) counseling to simultaneously target HIV health outcomes, and substance use among alcohol and/or drug dependent HIV positive older adults (age 50+), relative to an attention control condition. Participants will be randomly assigned to receive either: (1) 12 sessions of 3S+ counseling, adapted for the present study to target both non-injection drug use, drinking, and HIV health; or (2) 12 sessions of education about HIV health and the associated with alcohol and drug use that will serve as an attention-control.

Condition or disease Intervention/treatment Phase
HIV Medication Adherence Substance Dependence Behavioral: Spiritual Self-Schema Therapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intervention Targeting Substance Using Older Adults With HIV
Study Start Date : June 2011
Actual Primary Completion Date : August 2015
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention Condition
Twelve sessions of spiritual self schema counseling, adapted to target target medication adherence and substance use.
 Behavioral: Spiritual Self-Schema Therapy
The Spiritual Self Schema therapy (3S+) intervention will consist of a series of 12 one hour-long sessions delivered individually to participants over a four-month period. The 3S+ approach combines cognitive and behavioral therapy techniques with elements of non-theistic Buddhist philosophy to increase motivation for treatment adherence, alcohol and/or substance use reduction or abstinence and the prevention or reduction of HIV risk behaviors. 3S+ draws from self-regulation theory, self-schema theory, and self-discrepancy theory to assist participants in defining and perceiving their addict self, when their addict self is active, and its resulting negative affect state. 3S+ remediates the "addict" schema by proposing the construction of an alternate and competing schema: the "spiritual self." This spiritual self schema is compatible with HIV self-care, alcohol and drug use reduction or abstinence, adherence to treatment, and a compassionate life.
Active Comparator: Education Condition
Eight sessions of education with content designed to mirror the information covered in the intervention condition.
 Behavioral: Spiritual Self-Schema Therapy
The Spiritual Self Schema therapy (3S+) intervention will consist of a series of 12 one hour-long sessions delivered individually to participants over a four-month period. The 3S+ approach combines cognitive and behavioral therapy techniques with elements of non-theistic Buddhist philosophy to increase motivation for treatment adherence, alcohol and/or substance use reduction or abstinence and the prevention or reduction of HIV risk behaviors. 3S+ draws from self-regulation theory, self-schema theory, and self-discrepancy theory to assist participants in defining and perceiving their addict self, when their addict self is active, and its resulting negative affect state. 3S+ remediates the "addict" schema by proposing the construction of an alternate and competing schema: the "spiritual self." This spiritual self schema is compatible with HIV self-care, alcohol and drug use reduction or abstinence, adherence to treatment, and a compassionate life.


Outcome Measures
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Primary Outcome Measures :
  1. Adherence to HIV medication [ Time Frame: every four months over the course of a year ]
    Participants in the intervention condition will report greater reductions in viral load, and greater increases in CD4 counts and self-reported adherence than those in the education comparison at the end of the intervention period (4 months). Those in the intervention condition will also maintain greater reductions in viral load, and greater increases in CD4 counts and self-reported adherence than those in the education comparison condition at the three follow-up assessments (4, 8, and 12 months).

  2. Substance use [ Time Frame: every four months over the course of a year ]
    Participants in the intervention condition will report greater reductions in self-reported days of substance use and severity of dependence than those in the education comparison at at the end of the intervention period (4 months). Those in the intervention condition will also maintain greater reductions in self-reported days of substance use than those in the education comparison condition at the three follow-up assessments (4, 8, and 12 months).


Secondary Outcome Measures :
  1. Mental Health/Quality of Life [ Time Frame: every four months over the course of a year ]
    Participants in the intervention condition will report greater increases in mental health measures (e.g, depression, anxiety) and quality of life measures (e.g., life satisfaction, loneliness, perceived stress).

  2. Sexual Risk [ Time Frame: every four months over the course of a year ]
    Participants in the intervention condition will report greater reductions in high-risk sexual behavior compared to participants in the educational comparison condition.


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV+ (provide HIV medication bottle with name on it)
  • Age 50 or older (provide picture ID with DOB at baseline)
  • Report current alcohol/drug dependence (AUDIT score of 8 or DAST-10 score of 4 on screener; C-DIS at baseline)
  • On a prescribed HAART medication regimen and reports sub-optimal adherence (self-report missed at least 3 days in last 30 at 1 pill/day that is 90%)
  • Communicate with staff and complete a survey in English or Spanish (English only for the pilot)

Exclusion Criteria:

  • Current intravenous drug use (self-report at screener and baseline)
  • Currently in a methadone drug treatment program (screener self-report)
  • Unstable, serious psychiatric symptoms (SCID-Psych at baseline)
  • Currently suicidal/homicidal (SCID-Psych at baseline)
  • Gross cognitive impairment (Mini-Mental at baseline)
  • Current enrollment in alcohol/drug treatment or HIV study (screener self-report)
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01305629


Locations
United States, New York
Center for HIV/AIDS Educational Studies and Training of Hunter College, CUNY
New York, New York, United States, 10018
Sponsors and Collaborators
Hunter College of City University of New York
Fordham University
Investigators
Principal Investigator: Jeffrey T. Parsons, Ph.D. Hunter College, CUNY
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: Jeffrey T. Parsons, Professor, Hunter College
ClinicalTrials.gov Identifier: NCT01305629     History of Changes
Other Study ID Numbers: R01DA029567-01 ( U.S. NIH Grant/Contract )
First Posted: March 1, 2011    Key Record Dates
Last Update Posted: October 10, 2016
Last Verified: October 2016

Keywords provided by Jeffrey T. Parsons, Hunter College:
HIV
Medication Adherence
Substance Use
Older adults
Treatment

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders