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Clinical Trials/NCT01255280
NCT01255280
Unknown
Phase 1

Behavioral Activation and HIV Risk Reduction for MSM With Crystal Methamphetamine Abuse

Massachusetts General Hospital1 site in 1 country50 target enrollmentJanuary 2011

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Crystal Methamphetamine Abuse
Sponsor
Massachusetts General Hospital
Enrollment
50
Locations
1
Primary Endpoint
Change in sexual risk
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2011
End Date
December 2013
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Matthew James Mimiaga

Assistant Professor

Massachusetts General Hospital

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)

Outcomes

Primary Outcomes

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 Outcomes

  • Change in crystal methamphetamine use(Baseline and three months post-treatment; baseline and six months post-treatment)

Study Sites (1)

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