Intervention Targeting Substance Using Older Adults With HIV

HIV Clinical Trial

Official title:

Intervention Targeting Substance Using Older Adults With HIV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01305629
• Other study ID #: R01DA029567-01
• Status: Completed
• Phase: N/A
• First received: February 28, 2011
• Last updated: October 7, 2016
• Start date: June 2011
• Est. completion date: June 2016

Study information

• Verified date: October 2016
• Source: Hunter College
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV
• Medication Adherence
• Substance Dependence
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Center for HIV/AIDS Educational Studies and Training of Hunter College, CUNY	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Hunter College	Fordham University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No

External Links

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