Integrated Treatment of Alcohol and/or Marijuana Abuse for HIV-Infected Youth - Phase I

University of North Carolina, Chapel Hill3 sites in 1 country46 target enrollmentApril 2008

ConditionsHIV Infections

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: HIV Infections
Sponsor: University of North Carolina, Chapel Hill
Enrollment: 46
Locations: 3
Primary Endpoint: To evaluate the acceptability, feasibility, and effectiveness of the CBT/CM intervention for alcohol and/or marijuana abuse, adherence to medical care, emotion regulation, and safer sexual behavior.
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is an exploratory study that will adapt and test a combined cognitive behavioral treatment and contingency management intervention for alcohol and/or marijuana abuse for use in HIV-infected adolescents.

Registry

clinicaltrials.gov

Start Date

April 2008

End Date

April 2011

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of North Carolina, Chapel Hill

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adolescents between the ages of 16-24 years (inclusive) at the time of informed consent/assent as determined by medical record review or verbal verification from referring professional
•HIV-infected and aware of their status as documented by medical record review or verbal verification from referring professional
•Receives services at one of the three participating ATN clinic site or their community partners
•A score of 2 or greater on the CRAFFT indicating possible alcohol or marijuana use problem or abuse
•Alcohol and/or Marijuana Use or Abuse Disorder as indicated by the SSPQ-X
•Appropriate for an outpatient or intensive outpatient level of care in accordance with the American Academy of Child and Adolescent Psychiatry practice parameters as decided by site mental health provider in consultation with Drs. Brown and Esposito-Smythers
•English-speaking
•Ability and willingness to provide informed consent/assent for study participation
•Satisfactorily understands the nature of the study and the informed consent process as documented by the Consent Form Comprehension Assessment Questionnaire

Exclusion Criteria

•Presence of serious psychiatric symptoms (e.g., active hallucinations, thought disorder)
•Visibly distraught (e.g., suicidal, homicidal, exhibiting violent behavior)
•Intoxicated or under the influence of alcohol or other substances at the time of study entry

Outcomes

Primary Outcomes

To evaluate the acceptability, feasibility, and effectiveness of the CBT/CM intervention for alcohol and/or marijuana abuse, adherence to medical care, emotion regulation, and safer sexual behavior.

Time Frame: 2 years

To adapt a developmentally appropriate CBT/CM intervention for alcohol and/or marijuana abuse for HIV+ youth, relevant to the context of chronic medical care, emotion dysregulation due to frequent co-morbid psychiatric disorders and sexual risk behavior.

Time Frame: 2 years

Secondary Outcomes

To revise the CBT/CM intervention based on information obtained in Phase 1 (this protocol), prepare for Phase 2 (to be supported by NIH), and disseminate the treatment manual to the ATN sites.(2 years)