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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

Page last updated: August 20, 2015

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