Integrated Treatment of Marijuana Abuse for HIV+ Youth

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00683488
• Other study ID #: ATN 069
• Status: Completed
• Phase: N/A
• First received: May 21, 2008
• Last updated: March 2, 2017
• Start date: April 2008
• Est. completion date: April 2011

Study information

• Verified date: February 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: April 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections
• Marijuana Abuse

Intervention

Behavioral:
• Focus Group
Focus group using and collecting feedback on the CBT/CM intervention.
• First Intervention Trial
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
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.

Locations

Country	Name	City	State
United States	Childrens Hospital of Los Angeles	Los Angeles	California
United States	Mount Sinai Medical Center	New York	New York
United States	Childrens Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Mental Health (NIMH), National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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

External Links

•   Website for the Adolescent Trials Network for HIV/AIDS Interventions