Integrated Treatment of Marijuana Abuse for HIV+ Youth

NCT ID: NCT00683488

Last Updated: 2017-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2011-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Focus Group

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

First Intervention Trial

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Intervention Trial 2

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Focus Group

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

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

16 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Larry K. Brown, M.D.

Role: STUDY_CHAIR

Adolescent Trials Network

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Childrens Hospital of Los Angeles

Los Angeles, California, United States

Site Status

Mount Sinai Medical Center

New York, New York, United States

Site Status

Childrens Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

https://www.atnonline.org

Website for the Adolescent Trials Network for HIV/AIDS Interventions

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ATN 069

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Rewards for Cannabis Abstinence-study
NCT05836207 RECRUITING NA
Marijuana Treatment Project - 3
NCT00107588 COMPLETED NA