MedPath

Integrated Treatment of Marijuana Abuse for HIV+ Youth

Not Applicable
Completed
Conditions
HIV Infections
Interventions
Behavioral: First Intervention Trial
Behavioral: Focus Group
Behavioral: Intervention Trial 2
Registration Number
NCT00683488
Lead Sponsor
University of North Carolina, Chapel Hill
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
46
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
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
2First Intervention TrialThe first intervention trial will enroll 9 participants (3 participants per site). Exit interviews of participants will assess acceptability, feasibility, and relevance of the intervention. Quantitative assessments pre and post intervention using audio computer-assisted self-interviewing (ACASI) will document immediate changes in substance use, sexual risk, and adherence to medical care. Additional qualitative feedback from interviews with mental health providers and study coordinators will address feasibility, acceptability, and relevance of the intervention and its methods.
1Focus GroupFocus groups with adolescents with SA (Substance Abuse) will be conducted at each site (one group with 5 to 6 adolescents per site) to provide information on the areas of the intervention in need of adaptation in order to reflect the context of HIV infection.
3Intervention Trial 2The revised intervention will be implemented with 20 participants (6 to 8 at each site). Exit interviews with subjects and feedback from mental health providers and study coordinators will provide the same qualitative information as in the first intervention trial. Quantitative data on participant outcomes such as substance use, sexual risk, and adherence to medical care will be collected pre, post and 3 month post intervention through ACASI.
Primary Outcome Measures
NameTimeMethod
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.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.2 years
Secondary Outcome Measures
NameTimeMethod
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

Trial Locations

Locations (3)

Childrens Hospital of Los Angeles

🇺🇸

Los Angeles, California, United States

Childrens Hospital of Philadelphia

🇺🇸

Philadelphia, Pennsylvania, United States

Mount Sinai Medical Center

🇺🇸

New York, New York, United States

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