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Completed

NCT Number: NCT00683488

Integrated Treatment of Marijuana Abuse for HIV+ Youth

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mental Disorders RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Substance-Related Disorders Urogenital Diseases Virus Diseases

Age range

16 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Childrens Hospital of Los Angeles, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Focus Group

Behavioral

Focus group using and collecting feedback on the CBT/CM intervention.

First Intervention Trial

Behavioral

Intervention will comprise of approximately 15 weekly sessions.

  • Exit interviews at the end of each session will assess acceptability, feasibility, and relevance of the intervention.
  • Quantitative assessment (ACASI) pre and post intervention will document immediate changes in substance use, sexual risk, and adherence to medical care.
  • Qualitative feedback from interviews with mental health providers and study coordinators will address acceptability and feasibility.

Intervention Trial 2

Behavioral

Evaluations/assessments will be similar to those involved for the first intervention trial. Study participants will return for a follow-up visit 3 months after the last intervention session to complete the ACASI.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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.

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
May 23, 2008
Registry last updated
Mar 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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