Intervention Targeting Substance Using Older Adults With HIV

Study Overview
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Brief Summary
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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.

Official Title
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Intervention Targeting Substance Using Older Adults With HIV

Conditions
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HIV, Medication Adherence, Substance Dependence

Intervention / Treatment
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* Behavioral: Spiritual Self-Schema Therapy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Condition<br>Twelve sessions of spiritual self schema counseling, adapted to target target medication adherence and substance use. | Behavioral: Spiritual Self-Schema Therapy<br>* 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.<br>|
| Active Comparator: Education Condition<br>Eight sessions of education with content designed to mirror the information covered in the intervention condition. | Behavioral: Spiritual Self-Schema Therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | every four months over the course of a year | 
| 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). | every four months over the course of a year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | every four months over the course of a year | 
| Sexual Risk | Participants in the intervention condition will report greater reductions in high-risk sexual behavior compared to participants in the educational comparison condition. | every four months over the course of a year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Medication Adherence, Substance Use, Older adults, Treatment