An interventional study of Focus Group and First Intervention Trial in HIV Infections, sponsored by University of North Carolina, Chapel Hill. Completed at 3 sites in United States. Open to participants aged 16 Years to 24 Years. Per ClinicalTrials.gov, last updated 2017-03-06.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Treatment
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.
517 studies on the registry are indexed under Marijuana Abuse; 114 are open to participants now.
This study's enrollment of 46 is below the median of 60 across 421 interventional studies indexed under Marijuana Abuse.
Browse Marijuana Abuse studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.
Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
Focus group using and collecting feedback on the CBT/CM intervention.
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.
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.
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
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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University of North Carolina, Chapel Hill