HIV InfectionsNCT00683488
Integrated Treatment of Marijuana Abuse for HIV+ Youth
A study testing Focus Group, First Intervention Trial and Intervention Trial 2 in people with HIV Infections, run by University of North Carolina, Chapel Hill at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 16 to 24 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Focus Group, First Intervention Trial and Intervention Trial 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2008to Apr 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
United States3 sites
Childrens Hospital of Los Angeles
Los Angeles, California, 90027
Mount Sinai Medical Center
New York, New York, 10128
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Integrated Treatment of Alcohol and/or Marijuana Abuse for HIV-Infected Youth - Phase I
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.
- Conditions
- HIV Infections
- Being tested
- Focus Group, First Intervention Trial, Intervention Trial 2
- Keywords
- Substance Abuse, Adolescent community reinforcement approach, Adolescent Risk Behavior Assessment, Child and Adolescent Services Assessment, Cognitive behavioral therapy, Cognitive Therapy Rating Scale, Individual behavior therapy, Individual cognitive problem solving, Motivational enhancement therapy, HIV-Positive Youth With Substance Abuse, Complementary Therapies
- Medical subject headings
- HIV Infections, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus GroupBehavioural
Focus group using and collecting feedback on the CBT/CM intervention.
First Intervention TrialBehavioural
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 2Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 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. Receives: Behavioral: Focus Group |
| 2 | Experimental | 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. Receives: Behavioral: First Intervention Trial |
| 3 | Experimental | 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. Receives: Behavioral: Intervention Trial 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 years
Secondary outcomes (1)
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2008 (estimated)
- Study startApr 2008
- Primary completionAug 2010
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Larry K. Brown, M.D., Study chair, Adolescent Trials Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00683488
- Sponsor's protocol ID
- ATN 069
- Status last verified
- Feb 2016
- First submitted
- 21 May 2008
- Last updated
- 6 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Treatment of Alcohol and/or Marijuana Abuse for HIV-Infected Youth - Phase I
- ClinicalTrials.gov ID
- NCT00683488
- Acronym / sponsor ID
- ATN 069
- Conditions
- HIV Infections
- Keywords
- Substance Abuse, Adolescent community reinforcement approach, Adolescent Risk Behavior Assessment, Child and Adolescent Services Assessment, Cognitive behavioral therapy, Cognitive Therapy Rating Scale, Individual behavior therapy, Individual cognitive problem solving
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- Study start
- Apr 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 23 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Focus GroupFocus 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. |
| 2 | Experimental | Behavioral: First Intervention TrialThe 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. |
| 3 | Experimental | Behavioral: Intervention Trial 2The 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. |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focus GroupFocus group using and collecting feedback on the CBT/CM intervention. | Behavioural | 1 |
| First Intervention TrialIntervention 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. | Behavioural | 2 |
| Intervention Trial 2Evaluations/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. | Behavioural | 3 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2017.
- Website for the Adolescent Trials Network for HIV/AIDS InterventionsLink provided by the sponsor.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Larry K. Brown, M.D. study chair
Adolescent Trials Network
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focus Group, First Intervention Trial and Intervention Trial 2 in people with HIV Infections, run by University of North Carolina, Chapel Hill at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2017.