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Behavioral Activation and HIV Risk Reduction for Men Who Have Sex With Men With Crystal Meth Abuse

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ClinicalTrials.gov Identifier: NCT01255280
Recruitment Status : Unknown
Verified May 2012 by Matthew James Mimiaga, Massachusetts General Hospital.
Recruitment status was:  Recruiting
First Posted : December 7, 2010
Last Update Posted : June 1, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to research a new behavioral treatment to reduce sexual risk-taking in men who have sex with men (MSM) who abuse crystal methamphetamine (crystal meth), and are at risk for HIV acquisition. This study proposes using a treatment based on our original pilot study that incorporates risk reduction and behavioral activation therapy. In order to help learn what types of treatment programs best help individuals who abuse crystal meth and engage in sexual risk-taking, we will compare our treatment to a control group. The treatment group will receive therapy incorporating behavioral risk reduction counseling with behavioral activation therapy to treat depression, helping individuals reengage in their life. The control group will receive the risk reduction counseling without the behavioral activation therapy. The current study hopes to explore the efficacy of this previous developed treatment in a two-arm pilot randomized controlled trial.

Condition or disease Intervention/treatment Phase
Crystal Methamphetamine Abuse Crystal Methamphetamine Dependence Behavioral: Behavioral Activation Therapy and Risk Reduction Counseling (BAT-RR) Behavioral: Information, Motivation, Behavioral skills change approach to sexual risk reduction Phase 1

Detailed Description:
  1. To estimate, in a two-arm pilot randomized controlled trial (RCT), the effect size of the proposed intervention on reductions in sexual risk taking and crystal meth use. The primary outcome is the number of unprotected anal sex acts and a secondary outcome is reduction in crystal meth use episodes over the follow up period.
  2. To explore the degree to which improvements in sexual risk taking are associated with the conceptual mediators of the effects of the intervention: reductions in crystal meth use and increases in pleasurable (but safe) activities, BAT skills, use of risk reduction skills, and reductions in depressed mood.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Behavioral Activation and HIV Risk Reduction for MSM With Crystal Methamphetamine Abuse
Study Start Date : January 2011
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Information, Motivation, Behavioral skills
The comparison condition will only receive the two IMB risk reduction sessions. The intervention will begin with modules that focus directly with sexual risk reduction practices. It will begin with a discussion of one's sexual history, sexual risk limits, and barriers (e.g., motivation or skills) to staying in their sexual risk limits. This session will also involve a Q&A discussion and the use of a fact sheet regarding HIV acquisition risk behaviors (information). The next session will involve motivational interviewing and the formulation of an individualized behavioral skills plan as needed.
Behavioral: Information, Motivation, Behavioral skills change approach to sexual risk reduction
The comparison condition will only receive the two IMB risk reduction sessions.
Experimental: Behavioral Activation Therapy and Risk Reduction Counseling
This intervention is given to patients in the experimental condition only and is comprised of 10 sessions—1 baseline session focused on orienting and rationale, 2 focused on risk reduction (consistent with the IMB model: information, motivation, and behavioral skills), 6 incorporating behavioral activation therapy/risk reduction counseling, and 1 final session on relapse prevention. Each session will last approximately fifty minutes in length; and will also involve a review of the previous materials,and hence the behavioral activation approach will be woven back into the risk reduction content.
Behavioral: Behavioral Activation Therapy and Risk Reduction Counseling (BAT-RR)
This intervention is given to patients in the experimental condition only and is comprised of 10 sessions.


Outcome Measures

Primary Outcome Measures :
  1. Change in sexual risk [ Time Frame: Baseline and three months post-treatment; baseline and six months post-treatment ]
    We will ask about number of unprotected and protected insertive and receptive anal, vaginal and oral sex acts with male and female sex partners separately for HIV seropositive, seronegative, and partners of unknown HIV status with questions from measures used in previous studies. We will use this to calculate the ratio of protected to unprotected acts, by serostatus partner, and by whether or not crystal meth was being used before or during sex. Baseline and three and six-month follow-up assessments will assess sexual risk taking in the previous 3-months to the assessment being completed.


Secondary Outcome Measures :
  1. Change in crystal methamphetamine use [ Time Frame: Baseline and three months post-treatment; baseline and six months post-treatment ]
    For the present study, we will administer relevant sections of the Drug and Alcohol sections of the NIDA-CTN Addictions Severity Index Lite (ASI-Lite). We will use this methodology to determine the number of days of drug use, specifically crystal meth, and the number of distinct crystal meth episodes between study assessment visits (i.e., separate crystal meth binges).In addition to the ASI-Lite, we will also collect participant self-report measures of substance use via the ACASI. We have adapted and will also use the CDC's National HIV Behavioral Surveillance Survey, MSM cycle.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 18 years or older
  • Self-reports as a man who has sex with men
  • HIV-uninfected and verifies serostatus at baseline (HIV antibody testing and positive tests will be confirmed by Western Blots; see Human Subjects for operational aspects)
  • Meets DSM-IV diagnostic criteria for crystal meth abuse/dependence
  • Self reported unprotected anal intercourse—receptive or insertive—with a non-monogamous male sexual partner, while concurrently using crystal meth (use of meth must be a few hours prior to, or during, sex) in the prior three months

Exclusion Criteria:

  • Unable to provide informed consent due to severe mental or physical illness, or substance intoxication at the time of interview
  • Has lived in the greater Boston area for three months or less (as a means to enhance participant retention)
  • Discovery of active suicidal ideation at the time of interview (these patients will be referred immediately for treatment, but may join the study when this is resolved)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01255280


Contacts
Contact: Matthew Mimiaga, ScD, MPH 617-927-6084 MMimiaga@fenwayhealth.org
Contact: Janna Gordon 617-643-1168 jrgordon@partners.org

Locations
United States, Massachusetts
Fenway Community Health Recruiting
Boston, Massachusetts, United States, 02215
Contact: Jaclyn White, MPH    617-927-6101    jwhite@fenwayhealth.org   
Sponsors and Collaborators
Massachusetts General Hospital
Fenway Community Health
Investigators
Principal Investigator: Matthew Mimiaga, ScD Fenway Community Health and Massachusetts General Hospital/Harvard Medical School
More Information

Publications:
Responsible Party: Matthew James Mimiaga, Assistant Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01255280     History of Changes
Other Study ID Numbers: 3293841
First Posted: December 7, 2010    Key Record Dates
Last Update Posted: June 1, 2012
Last Verified: May 2012

Keywords provided by Matthew James Mimiaga, Massachusetts General Hospital:
Crystal methamphetamine abuse
Crystal methamphetamine dependence
Sexual risk behavior
Men who have sex with men (MSM)
Behavioral activation

Additional relevant MeSH terms:
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors