Intervention Targeting Substance Using Older Adults With HIV

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Hunter College
Sponsor:
Collaborator:
Fordham University
Information provided by (Responsible Party):
Jeffrey T. Parsons, Hunter College
ClinicalTrials.gov Identifier:
NCT01305629
First received: February 28, 2011
Last updated: May 30, 2013
Last verified: May 2013
  Purpose

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 Intervention
HIV
Medication Adherence
Substance Dependence
Behavioral: Spiritual Self-Schema Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intervention Targeting Substance Using Older Adults With HIV

Resource links provided by NLM:


Further study details as provided by Hunter College:

Primary Outcome Measures:
  • Adherence to HIV medication [ Time Frame: every four months over the course of a year ] [ Designated as safety issue: No ]
    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).

  • Substance use [ Time Frame: every four months over the course of a year ] [ Designated as safety issue: No ]
    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:
  • Mental Health/Quality of Life [ Time Frame: every four months over the course of a year ] [ Designated as safety issue: No ]
    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).

  • Sexual Risk [ Time Frame: every four months over the course of a year ] [ Designated as safety issue: No ]
    Participants in the intervention condition will report greater reductions in high-risk sexual behavior compared to participants in the educational comparison condition.


Estimated Enrollment: 212
Study Start Date: June 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01305629

Contacts
Contact: Ethan Fusaris 212-206-7919 ext 933 efusaris@chestnyc.org
Contact: Ruben Jimenez 212-206-7919 ext 913 rjiminez@chestnyc.org

Locations
United States, New York
Center for HIV/AIDS Educational Studies and Training of Hunter College, CUNY Recruiting
New York, New York, United States, 10018
Principal Investigator: Jeffrey T Parsons, PhD         
Sponsors and Collaborators
Hunter College
Fordham University
  More Information

Additional Information:
No publications provided

Responsible Party: Jeffrey T. Parsons, Professor, Hunter College
ClinicalTrials.gov Identifier: NCT01305629     History of Changes
Other Study ID Numbers: R01 DA029567-01
Study First Received: February 28, 2011
Last Updated: May 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Hunter College:
HIV
Medication Adherence
Substance Use
Older adults
Treatment

Additional relevant MeSH terms:
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 28, 2014