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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jeffrey T. Parsons, Hunter College
ClinicalTrials.gov Identifier:
NCT01122186
First received: May 11, 2010
Last updated: May 30, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
HIV Medication Adherence
Methamphetamine Use
Sexual Risk
Poly-substance Use
HIV Infections
Behavioral: Motivational Interviewing + Cognitive Behavioral Skills Training
Behavioral: Education Attention Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intervention Targeting Medication Adherence and Methamphetamine Use in HIV Positive Men

Resource links provided by NLM:


Further study details as provided by Hunter College:

Primary Outcome Measures:
  • Adherence to HIV medication [ Time Frame: every three months over the course of a year ] [ Designated as safety issue: No ]
    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. [ Time Frame: every three months over the course of a year ] [ Designated as safety issue: No ]
    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 [ Time Frame: every three months over the course of a year ] [ Designated as safety issue: No ]
    Participants in the intervention condition will report greater reductions in high-risk sexual behavior compared to participants in the educational comparison condition.

  • Polysubstance use [ Time Frame: every three months over the course of a year ] [ Designated as safety issue: No ]
    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.


Enrollment: 210
Study Start Date: September 2007
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Motivational Interviewing + Cognitive Behavioral Skills Training
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.
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.
Behavioral: Education Attention Control
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01122186

Locations
United States, New York
Center for HIV/AIDS Educational Studies and Training of Hunter College, CUNY
New York, New York, United States, 10018
Sponsors and Collaborators
Hunter College
  More Information

Additional Information:
No publications provided

Responsible Party: Jeffrey T. Parsons, Professor, Hunter College
ClinicalTrials.gov Identifier: NCT01122186     History of Changes
Other Study ID Numbers: 1R01DA023395
Study First Received: May 11, 2010
Last Updated: May 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Hunter College:
Medication Adherence
Methamphetamine Use
Sexual Risk
Poly-substance Use
HIV
Treatment
Motivational Interviewing
Cognitive Behavioral Skills Training
Men Who Have Sex With Men

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
HIV Seropositivity
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Methamphetamine
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors

ClinicalTrials.gov processed this record on April 23, 2014