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Intervention Targeting Substance Using Older Adults With HIV

Intervention Targeting Substance Using Older Adults With HIV

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01305629
Enrollment
120
Registered
2011-03-01
Start date
2011-06-30
Completion date
2016-06-30
Last updated
2016-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV, Medication Adherence, Substance Dependence

Keywords

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

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.

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.

Sponsors

Fordham University
CollaboratorOTHER
Hunter College of City University of New York
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
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

* 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)

Design outcomes

Primary

MeasureTime frameDescription
Adherence to HIV medicationevery four months over the course of a yearParticipants 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 useevery four months over the course of a yearParticipants 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

MeasureTime frameDescription
Mental Health/Quality of Lifeevery four months over the course of a yearParticipants 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 Riskevery four months over the course of a yearParticipants in the intervention condition will report greater reductions in high-risk sexual behavior compared to participants in the educational comparison condition.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026