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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Crystal Methamphetamine Abuse Crystal Methamphetamine Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Information, Motivation, Behavioral skills change approach to sexual risk reduction

Intervention Type BEHAVIORAL

The comparison condition will only receive the two IMB risk reduction sessions.

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.

Group Type EXPERIMENTAL

Behavioral Activation Therapy and Risk Reduction Counseling (BAT-RR)

Intervention Type BEHAVIORAL

This intervention is given to patients in the experimental condition only and is comprised of 10 sessions.

Interventions

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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.

Intervention Type BEHAVIORAL

Information, Motivation, Behavioral skills change approach to sexual risk reduction

The comparison condition will only receive the two IMB risk reduction sessions.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No