Integrated Treatment of Marijuana Abuse for HIV+ Youth

University of North Carolina (UNC)

Status: Completed

Conditions: HIV Infections

Treatments: Behavioral: Intervention Trial 2; Behavioral: Focus Group; Behavioral: First Intervention Trial

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00683488

ATN 069

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 16 to 24 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 3 patient groups

1

Experimental group

Description:

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.

Treatment:

Behavioral: Focus Group

2

Experimental group

Description:

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.

Treatment:

Behavioral: First Intervention Trial

3

Experimental group

Description:

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.

Treatment:

Behavioral: Intervention Trial 2