Integrated Treatment of Marijuana Abuse for HIV+ Youth

Sponsor

University of North Carolina, Chapel Hill (Other)

Overall Status

Completed

CT.gov ID

NCT00683488

Collaborator

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

Enrollment

Locations

Arms

Duration (Months)

15.3

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Behavioral: Focus Group Behavioral: First Intervention Trial Behavioral: Intervention Trial 2	N/A

Study Design

Study Type:

Interventional

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 :

Apr 1, 2008

Actual Primary Completion Date :

Aug 1, 2010

Actual Study Completion Date :

Apr 1, 2011

Arms and Interventions

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

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.

Behavioral: Focus Group

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

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.

Behavioral: 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.

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.

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.

Outcome Measures

Primary Outcome Measures

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]
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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 24 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Childrens Hospital of Los Angeles	Los Angeles	California	United States	90027
2	Mount Sinai Medical Center	New York	New York	United States	10128
3	Childrens Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104