- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01122186
Intervention Targeting Medication Adherence and Methamphetamine Use in HIV Positive Men (ACE) (ACE)
May 30, 2013 updated by: Jeffrey T. Parsons, Hunter College of City University of New York
Intervention Targeting Medication Adherence and Methamphetamine Use in HIV Positive Men
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
210
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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New York, New York, United States, 10018
- Center for HIV/AIDS Educational Studies and Training of Hunter College, CUNY
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- HIV+ (confirmed at baseline through documentation)
- Biologically male
- report sex with another man at least once
- report methamphetamine use at least three times in the past three months
- report less than 90% HAART medication adherence, as measured by the total number of days a participant missed an HIV medication in the last 30
- able to communicate with staff and complete a survey that is in English.
Exclusion Criteria:
- Unstable, serious psychiatric symptoms
- Currently suicidal/homicidal
- Evidence of gross cognitive impairment
- Self-reported current enrollment in a drug or HIV-related intervention or research study.
- Methadone use
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Condition
Eight sessions of Motivational Interviewing and Cognitive Behavioral Skills Training, adapted to target both MA use and medication adherence, as well as sexual risk behaviors and polydrug use.
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The first two sessions will be primarily Motivational Interviewing and begin with an introduction to the nature of treatment, emphasizing the client's autonomy, and explain that the purpose of the sessions is to explore feelings about their medication adherence, meth use, and any other issues, with the eventual goal of working towards any changes the client may wish to make.
During the third session, the client will complete an individualized functional analysis of recent occasions when the client missed medication, used MA and/or other substances, and engaged in risky sex (not necessarily all at the same time).
Sessions four through seven will focus on Cognitive Behavioral Skills Training for adherence, reducing or stopping meth use, reducing or stopping the combination of meth and other drug use, and avoiding risky sexual behavior.
The final session emphasizes maintenance of behavior change and relapse prevention.
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Active Comparator: Education Condition
Eight sessions of education with content designed to mirror the information covered in the intervention condition.
The content will be as follows: 3 sessions focusing on medication adherence; 3 sessions focusing on the dangers of methamphetamine use; 1 session addressing sexual risk; and 1 session addressing poly-substance use.
|
During the first two sessions participants watch the documentary "Rock bottom" to receive information on Crystal Methamphetamine, and the possible interactions between HIV medications and recreational substances.
Sessions 3 and 4 focus on the importance of medication adherence, viral replication and mutation, and resistance.
Session 5 focuses on the negative effects of several recreational substances as well as the negative effects of mixing substances.
Session six discusses HIV stigma, transmission risk sexual behavior, and HIV disclosure.
Session 7 revisits medication adherence, focusing on dealing with medication side effects and communicating with health care providers.
The final session uses part of the documentary "Meth" which highlights issues of methamphetamine use through interviews with men in various stages of recovery.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence to HIV medication
Time Frame: every three months over the course of a year
|
Participants in the intervention condition will report greater reductions in viral load, and greater increases in CD4 counts and self-reported adherence than those in the education comparison at at the end of the intervention period (3 months).
Those in the intervention condition will also maintain greater reductions in viral load, and greater increases in CD4 counts and self-reported adherence than those in the education comparison condition at the three follow-up assessments (6, 9, and 12 months).
|
every three months over the course of a year
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Methamphetamine use.
Time Frame: every three months over the course of a year
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Participants in the intervention condition will report greater reductions in self-reported days of methamphetamine use than those in the education comparison at at the end of the intervention period (3 months).
Those in the intervention condition will also maintain greater reductions in self-reported days of methamphetamine use than those in the education comparison condition at the three follow-up assessments (6, 9, and 12 months).
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every three months over the course of a year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sexual Risk
Time Frame: every three months over the course of a year
|
Participants in the intervention condition will report greater reductions in high-risk sexual behavior compared to participants in the educational comparison condition.
|
every three months over the course of a year
|
Polysubstance use
Time Frame: every three months over the course of a year
|
Participants in the intervention condition will report greater reductions in the use of substances other than methamphetamine, compared to participants in the educational comparison condition.
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every three months over the course of a year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
May 11, 2010
First Submitted That Met QC Criteria
May 12, 2010
First Posted (Estimate)
May 13, 2010
Study Record Updates
Last Update Posted (Estimate)
June 3, 2013
Last Update Submitted That Met QC Criteria
May 30, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R01DA023395 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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