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Intervention Targeting Medication Adherence and Methamphetamine Use in HIV Positive Men (ACE) (ACE)

Primary Purpose

HIV Medication Adherence, Methamphetamine Use, Sexual Risk

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational Interviewing + Cognitive Behavioral Skills Training
Education Attention Control
Sponsored by
Hunter College of City University of New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Medication Adherence focused on measuring Medication Adherence, Methamphetamine Use, Sexual Risk, Poly-substance Use, HIV, Treatment, Motivational Interviewing, Cognitive Behavioral Skills Training, Men Who Have Sex With Men

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Center for HIV/AIDS Educational Studies and Training of Hunter College, CUNY

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Condition

Education Condition

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Adherence to HIV medication
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).
Methamphetamine use.
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).

Secondary Outcome Measures

Sexual Risk
Participants in the intervention condition will report greater reductions in high-risk sexual behavior compared to participants in the educational comparison condition.
Polysubstance use
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.

Full Information

First Posted
May 11, 2010
Last Updated
May 30, 2013
Sponsor
Hunter College of City University of New York
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1. Study Identification

Unique Protocol Identification Number
NCT01122186
Brief Title
Intervention Targeting Medication Adherence and Methamphetamine Use in HIV Positive Men (ACE)
Acronym
ACE
Official Title
Intervention Targeting Medication Adherence and Methamphetamine Use in HIV Positive Men
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hunter College of City University of New York

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Medication Adherence, Methamphetamine Use, Sexual Risk, Poly-substance Use, HIV Infections
Keywords
Medication Adherence, Methamphetamine Use, Sexual Risk, Poly-substance Use, HIV, Treatment, Motivational Interviewing, Cognitive Behavioral Skills Training, Men Who Have Sex With Men

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Condition
Arm Type
Experimental
Arm Description
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.
Arm Title
Education Condition
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing + Cognitive Behavioral Skills Training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Education Attention Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adherence to HIV medication
Description
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).
Time Frame
every three months over the course of a year
Title
Methamphetamine use.
Description
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).
Time Frame
every three months over the course of a year
Secondary Outcome Measure Information:
Title
Sexual Risk
Description
Participants in the intervention condition will report greater reductions in high-risk sexual behavior compared to participants in the educational comparison condition.
Time Frame
every three months over the course of a year
Title
Polysubstance use
Description
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.
Time Frame
every three months over the course of a year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Center for HIV/AIDS Educational Studies and Training of Hunter College, CUNY
City
New York
State/Province
New York
ZIP/Postal Code
10018
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.hunter.cuny.edu/chest/
Description
Center for HIV/AIDS Educational Studies and Training website

Learn more about this trial

Intervention Targeting Medication Adherence and Methamphetamine Use in HIV Positive Men (ACE)

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