Behavioral Activation and HIV Risk Reduction for Men Who Have Sex With Men With Crystal Meth Abuse
Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Crystal Methamphetamine Abuse; Crystal Methamphetamine Dependence
Intervention: Behavioral Activation Therapy and Risk Reduction Counseling (BAT-RR) (Behavioral); Information, Motivation, Behavioral skills change approach to sexual risk reduction (Behavioral)
Phase: Phase 1
Status: Recruiting
Sponsored by: Massachusetts General Hospital Official(s) and/or principal investigator(s): Matthew Mimiaga, ScD, Principal Investigator, Affiliation: Fenway Community Health and Massachusetts General Hospital/Harvard Medical School
Overall contact: Matthew Mimiaga, ScD, MPH, Phone: 617-927-6084, Email: MMimiaga@fenwayhealth.org
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.
Clinical Details
Official title: Behavioral Activation and HIV Risk Reduction for MSM With Crystal Methamphetamine Abuse
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change in sexual risk
Secondary outcome: Change in crystal methamphetamine use
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
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)
Locations and Contacts
Matthew Mimiaga, ScD, MPH, Phone: 617-927-6084, Email: MMimiaga@fenwayhealth.org
Fenway Community Health, Boston, Massachusetts 02215, United States; Recruiting Jaclyn White, MPH, Phone: 617-927-6101, Email: jwhite@fenwayhealth.org
Additional Information
Related publications: Rajasingham R, Mimiaga MJ, White JM, Pinkston MM, Baden RP, Mitty JA. A systematic review of behavioral and treatment outcome studies among HIV-infected men who have sex with men who abuse crystal methamphetamine. AIDS Patient Care STDS. 2012 Jan;26(1):36-52. doi: 10.1089/apc.2011.0153. Epub 2011 Nov 9. Review.
Starting date: January 2011
Last updated: May 31, 2012
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