Integrated Stepped Care for Unhealthy Alcohol Use in HIV
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ClinicalTrials.gov Identifier: NCT01410123 |
Recruitment Status
:
Active, not recruiting
First Posted
: August 4, 2011
Last Update Posted
: January 10, 2018
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Sponsor:
Yale University
Collaborators:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
VA Office of Research and Development
Information provided by (Responsible Party):
Yale University
Tracking Information | |||||||
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First Submitted Date ICMJE | July 28, 2011 | ||||||
First Posted Date ICMJE | August 4, 2011 | ||||||
Last Update Posted Date | January 10, 2018 | ||||||
Study Start Date ICMJE | January 2013 | ||||||
Estimated Primary Completion Date | July 2018 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | Complete list of historical versions of study NCT01410123 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Change in biological markers as measured by the VACS index. [ Time Frame: 6 months ] | ||||||
Current Other Outcome Measures ICMJE | Not Provided | ||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Integrated Stepped Care for Unhealthy Alcohol Use in HIV | ||||||
Official Title ICMJE | Integrated Stepped Care for Unhealthy Alcohol Use in HIV | ||||||
Brief Summary | The study is a series of 3 linked randomized clinical trials of 6 month duration, with a total of 12 month follow-up, to evaluate the effect of Integrated Stepped Care on drinking outcomes and HIV biologic markers (including VACS index) in HIV-infected patients with unhealthy alcohol use. | ||||||
Detailed Description | Unhealthy alcohol use threatens the health benefits seen with antiretroviral therapy (ART) for HIV-infected (HIV+) patients. Although research has demonstrated the efficacy of brief interventions, motivational counseling, and medications to treat unhealthy alcohol use in HIV uninfected patients, there is limited research or use of these treatments in HIV+ patients. We have demonstrated that integrated treatment of addiction in HIV clinics is feasible. Stepped care algorithms can facilitate the evaluation of varying intensities of treatments for unhealthy alcohol use. The proposed study will compare onsite Integrated Stepped Care treatment (ISC) to treatment as usual (TAU) in three, linked, 6-month randomized clinical trials in 642 HIV+ patients with unhealthy alcohol use. Screened patients are randomized to ISC or TAU after determining that they meet criteria for either 1) at-risk drinking, 2) alcohol abuse or dependence or 3) moderate alcohol consumption in the presence of liver disease. ISC and TAU are tailored to the drinking category. ISC for at-risk drinkers and those with Moderate Alcohol use and Liver Disease begins with a brief intervention and is stepped up to Motivational Enhancement Therapy (MET) in those who meet predefined failure criteria. ISC for abuse or dependence begins with addiction physician management (APM) including alcohol pharmacotherapy if not contraindicated. APM is stepped up to include MET if predefined failure criteria are met. The study will test the hypothesis that ISC leads to decreased alcohol consumption and improved HIV biomarkers. Data analyses will be conducted on the intention to treat sample. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase | Not Applicable | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||
Actual Enrollment ICMJE |
319 | ||||||
Original Estimated Enrollment ICMJE |
642 | ||||||
Estimated Study Completion Date | July 2018 | ||||||
Estimated Primary Completion Date | July 2018 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 21 Years and older (Adult, Senior) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01410123 | ||||||
Other Study ID Numbers ICMJE | 1105008544 U01AA020795 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement | Not Provided | ||||||
Responsible Party | Yale University | ||||||
Study Sponsor ICMJE | Yale University | ||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Yale University | ||||||
Verification Date | January 2018 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |