Intervention Targeting Substance Using Older Adults With HIV

NCT01305629 | Completed DMC

• 1 other identifier: R01DA029567-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV; Medication Adherence; Substance Dependence

Keywords

HIV; Medication Adherence; Substance Use; Older adults; Treatment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Mental Health/Quality of Life

  every four months over the course of a year

• Sexual Risk

  every four months over the course of a year

Study Arms (2)

Intervention Condition

EXPERIMENTAL

Twelve sessions of spiritual self schema counseling, adapted to target target medication adherence and substance use.

Behavioral: Spiritual Self-Schema Therapy

Education Condition

ACTIVE COMPARATOR

Eight sessions of education with content designed to mirror the information covered in the intervention condition.

Behavioral: Spiritual Self-Schema Therapy

Interventions

Spiritual Self-Schema Therapy BEHAVIORAL

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.

Education Condition; Intervention Condition

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hunter College of City University of New York: lead
• Fordham University: collaborator

Study Sites (1)

Center for HIV/AIDS Educational Studies and Training of Hunter College, CUNY

New York, New York, 10018, United States

Location

MeSH Terms

Conditions

Medication Adherence; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Jeffrey T. Parsons, Ph.D.

  Hunter College, CUNY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 28, 2011
• First Posted: March 1, 2011
• Study Start: June 1, 2011
• Primary Completion: August 1, 2015
• Study Completion: June 1, 2016
• Last Updated: October 10, 2016

Record last verified: 2016-10

Locations

US (1)