Back to resultsIntervention Targeting Substance Using Older Adults With HIV
Primary Purpose
HIV, Medication Adherence, Substance Dependence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spiritual Self-Schema Therapy
Sponsored by
About this trial
This is an interventional treatment trial for HIV focused on measuring HIV, Medication Adherence, Substance Use, Older adults, Treatment
Eligibility 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)
Sites / Locations
- Center for HIV/AIDS Educational Studies and Training of Hunter College, CUNY
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention Condition
Education Condition
Arm Description
Twelve sessions of spiritual self schema counseling, adapted to target target medication adherence and substance use.
Eight sessions of education with content designed to mirror the information covered in the intervention condition.
Outcomes
Primary Outcome Measures
Adherence to HIV medication
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
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
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
Participants in the intervention condition will report greater reductions in high-risk sexual behavior compared to participants in the educational comparison condition.
Full Information
NCT ID
NCT01305629
First Posted
February 28, 2011
Last Updated
October 7, 2016
Sponsor
Hunter College of City University of New York
Collaborators
Fordham University
1. Study Identification
Unique Protocol Identification Number
NCT01305629
Brief Title
Intervention Targeting Substance Using Older Adults With HIV
Official Title
Intervention Targeting Substance Using Older Adults With HIV
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hunter College of City University of New York
Collaborators
Fordham University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Medication Adherence, Substance Dependence
Keywords
HIV, Medication Adherence, Substance Use, Older adults, Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Condition
Arm Type
Experimental
Arm Description
Twelve sessions of spiritual self schema counseling, adapted to target target medication adherence and substance use.
Arm Title
Education Condition
Arm Type
Active Comparator
Arm Description
Eight sessions of education with content designed to mirror the information covered in the intervention condition.
Intervention Type
Behavioral
Intervention Name(s)
Spiritual Self-Schema Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adherence to HIV medication
Description
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).
Time Frame
every four months over the course of a year
Title
Substance use
Description
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).
Time Frame
every four months over the course of a year
Secondary Outcome Measure Information:
Title
Mental Health/Quality of Life
Description
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).
Time Frame
every four months over the course of a year
Title
Sexual Risk
Description
Participants in the intervention condition will report greater reductions in high-risk sexual behavior compared to participants in the educational comparison condition.
Time Frame
every four months over the course of a year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey T. Parsons, Ph.D.
Organizational Affiliation
Hunter College, CUNY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for HIV/AIDS Educational Studies and Training of Hunter College, CUNY
City
New York
State/Province
New York
ZIP/Postal Code
10018
Country
United States
12. IPD Sharing Statement
Links:
URL
http://chestnyc.org
Description
Related Info
Learn more about this trial
Intervention Targeting Substance Using Older Adults With HIV
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