Clinical trial NCT01255280: Behavioral Activation and HIV Risk Reduction for Men Who Have Sex With Men With Crystal Meth Abuse
Official title: Behavioral Activation and HIV Risk Reduction for MSM With Crystal Methamphetamine Abuse
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Crystal Methamphetamine Abuse
Crystal Methamphetamine Dependence
Keywords: Crystal methamphetamine abuse
Crystal methamphetamine dependence
Sexual risk behavior
Men who have sex with men (MSM)
Behavioral activation
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Fenway Community Health
First posted: 2010-12-07
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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)

Primary outcomes:
measure: Change in sexual risk
timeFrame: Baseline and three months post-treatment; baseline and six months post-treatment
Secondary outcomes:
measure: Change in crystal methamphetamine use
timeFrame: Baseline and three months post-treatment; baseline and six months post-treatment
Other outcomes:
Locations:
city: Boston
country: United States
facility: Fenway Community Health
state: Massachusetts
Study officials:
affiliation: Fenway Community Health and Massachusetts General Hospital/Harvard Medical School
name: Matthew Mimiaga, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.