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CompletedNCT01305629Updated Oct 10, 2016

Intervention Targeting Substance Using Older Adults With HIV

An interventional study of Spiritual Self-Schema Therapy in HIV, Medication Adherence and Substance Dependence, sponsored by Hunter College of City University of New York. Completed at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2016-10-10.

Sponsored by Hunter College of City University of New York · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
50 Years and older
Sex
All
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Study 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.

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Conditions studied

  • HIV
  • Medication Adherence
  • Substance Dependence

Keywords

  • HIV
  • Medication Adherence
  • Substance Use
  • Older adults
  • Treatment
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In context

Substance-Related Disorders

2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.

This study's enrollment of 120 is above the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.

Browse Substance-Related Disorders studies →

Lead sponsor

Hunter College of City University of New York is the lead sponsor of 36 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years and older
Sexes eligible
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

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)
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    Intervention Condition

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

    Behavioral: Spiritual Self-Schema Therapy

  • 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

Interventions

  • BehavioralSpiritual 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.

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What researchers measure

Primary outcomes

  1. 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).

    Time frame: every four months over the course of a year

  2. 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).

    Time frame: every four months over the course of a year

Secondary outcomes

  1. 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).

    Time frame: every four months over the course of a year

  2. Sexual Risk

    Participants in the intervention condition will report greater reductions in high-risk sexual behavior compared to participants in the educational comparison condition.

    Time frame: every four months over the course of a year

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Study locations

1 site
  • Center for HIV/AIDS Educational Studies and Training of Hunter College, CUNY
    New York, New York 10018, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 10, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01305629
Lead sponsor
Hunter College of City University of New York
Collaborators
Fordham University
Responsible party
Jeffrey T. Parsons (Professor, Hunter College of City University of New York) — Principal investigator
First posted
Mar 1, 2011
Start date
Jun 2011
Primary completion
Aug 2015
Completion
Jun 2016
Last update
Oct 10, 2016

Study contacts

Jeffrey T. Parsons, Ph.D.
principal investigator · Hunter College, CUNY

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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