Integrated Treatment of Marijuana Abuse for HIV+ Youth
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ClinicalTrials.gov Identifier: NCT00683488 |
Recruitment Status
:
Completed
First Posted
: May 23, 2008
Last Update Posted
: March 6, 2017
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Condition or disease | Intervention/treatment | Phase |
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HIV Infections | Behavioral: Focus Group Behavioral: First Intervention Trial Behavioral: Intervention Trial 2 | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 46 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Integrated Treatment of Alcohol and/or Marijuana Abuse for HIV-Infected Youth - Phase I |
Study Start Date : | April 2008 |
Actual Primary Completion Date : | August 2010 |
Actual Study Completion Date : | April 2011 |
Arm | Intervention/treatment |
---|---|
Experimental: 1
Focus 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.
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Behavioral: Focus Group
Focus group using and collecting feedback on the CBT/CM intervention.
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Experimental: 2
The 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.
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Behavioral: First Intervention Trial
Intervention will comprise of approximately 15 weekly sessions.
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Experimental: 3
The 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.
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Behavioral: Intervention Trial 2
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.
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- 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 ]
- 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 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 ]

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Ages Eligible for Study: | 16 Years to 24 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00683488
United States, California | |
Childrens Hospital of Los Angeles | |
Los Angeles, California, United States, 90027 | |
United States, New York | |
Mount Sinai Medical Center | |
New York, New York, United States, 10128 | |
United States, Pennsylvania | |
Childrens Hospital of Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104 |
Study Chair: | Larry K. Brown, M.D. | Adolescent Trials Network |
Additional Information:
Responsible Party: | University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT00683488 History of Changes |
Other Study ID Numbers: |
ATN 069 |
First Posted: | May 23, 2008 Key Record Dates |
Last Update Posted: | March 6, 2017 |
Last Verified: | February 2016 |
Keywords provided by University of North Carolina, Chapel Hill:
Substance Abuse Adolescent community reinforcement approach Adolescent Risk Behavior Assessment Child and Adolescent Services Assessment Cognitive behavioral therapy Cognitive Therapy Rating Scale |
Individual behavior therapy Individual cognitive problem solving Motivational enhancement therapy HIV-Positive Youth With Substance Abuse Complementary Therapies |
Additional relevant MeSH terms:
HIV Infections Marijuana Abuse Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Substance-Related Disorders Chemically-Induced Disorders Mental Disorders |