Intervention Targeting Medication Adherence and Methamphetamine Use in HIV Positive Men (ACE)
This study is currently recruiting participants.
Verified June 2011 by Hunter College
Sponsor:
Hunter College
Information provided by:
Hunter College
ClinicalTrials.gov Identifier:
NCT01122186
First received: May 11, 2010
Last updated: June 21, 2011
Last verified: June 2011
| Tracking Information | |||||
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| First Received Date ICMJE | May 11, 2010 | ||||
| Last Updated Date | June 21, 2011 | ||||
| Start Date ICMJE | September 2007 | ||||
| Estimated Primary Completion Date | January 2012 (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 NCT01122186 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Intervention Targeting Medication Adherence and Methamphetamine Use in HIV Positive Men (ACE) | ||||
| Official Title ICMJE | Intervention Targeting Medication Adherence and Methamphetamine Use in HIV Positive Men | ||||
| Brief Summary | The primary aim is to test an innovative 8-session intervention, based on Motivational Interviewing and Cognitive Behavioral Skills-Training for the co-occurrence of methamphetamine use and highly active antiretroviral therapy (HAART) non-adherence among methamphetamine using HIV+ MSM in NYC, compared to an 8-session educational (ED) condition. Participants in the intervention condition will report greater reductions in the number of days of methamphetamine use and viral load, and greater increases in CD4 counts and self-reported and objectively measured adherence than those in the education condition. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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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 | Recruiting | ||||
| Estimated Enrollment ICMJE | 240 | ||||
| Estimated Completion Date | January 2012 | ||||
| Estimated Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01122186 | ||||
| Other Study ID Numbers ICMJE | 1R01DA023395 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Jeffrey T. Parsons, Hunter College of the City University of New York and Center for HIV/AIDS Educational Studies and Training | ||||
| Study Sponsor ICMJE | Hunter College | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Hunter College | ||||
| Verification Date | June 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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