Intervention Targeting Substance Using Older Adults With HIV
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01305629 |
Recruitment Status
:
Completed
First Posted
: March 1, 2011
Last Update Posted
: October 10, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Medication Adherence Substance Dependence | Behavioral: Spiritual Self-Schema Therapy | Not Applicable |
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 |

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.
|
- 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).
- 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).
- 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).
- 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.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 50 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

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
United States, New York | |
Center for HIV/AIDS Educational Studies and Training of Hunter College, CUNY | |
New York, New York, United States, 10018 |
Principal Investigator: | Jeffrey T. Parsons, Ph.D. | Hunter College, CUNY |
Additional Information:
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 |