Intervention Targeting Substance Using Older Adults With HIV

Not Applicable

Completed

• Conditions: HIV; Substance Dependence; Medication Adherence
• Interventions: Behavioral: Spiritual Self-Schema Therapy

• Registration Number: NCT01305629
• Lead Sponsor: Hunter College of City University of New York

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-02-28
• Study First Submitted QC: 2011-02-28
• Study First Posted: 2011-03-01
• Study Start: 2011-06
• Primary Completion: 2015-08
• Study Completion: 2016-06
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-07
• Last Update Posted: 2016-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Education Condition	Spiritual Self-Schema Therapy	Eight sessions of education with content designed to mirror the information covered in the intervention condition.
Intervention Condition	Spiritual Self-Schema Therapy	Twelve sessions of spiritual self schema counseling, adapted to target target medication adherence and substance use.

Primary Outcome Measures

Name	Time	Method
Adherence to HIV medication	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	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).

Secondary Outcome Measures

Name	Time	Method
Mental Health/Quality of Life	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	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.

Trial Locations

Locations (1)

Center for HIV/AIDS Educational Studies and Training of Hunter College, CUNY; 🇺🇸 New York, New York, United States