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

May 31, 2012 updated by: Matthew James Mimiaga, Massachusetts General Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Fenway Community Health
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
Behavioral: Information, Motivation, Behavioral skills change approach to sexual risk reduction
The comparison condition will only receive the two IMB risk reduction sessions.
Experimental: 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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and three months post-treatment; baseline and six months post-treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in crystal methamphetamine use
Time Frame: Baseline and three months post-treatment; baseline and six months post-treatment
For the present study, we will administer relevant sections of the Drug and Alcohol sections of the NIDA-CTN Addictions Severity Index Lite (ASI-Lite). We will use this methodology to determine the number of days of drug use, specifically crystal meth, and the number of distinct crystal meth episodes between study assessment visits (i.e., separate crystal meth binges).In addition to the ASI-Lite, we will also collect participant self-report measures of substance use via the ACASI. We have adapted and will also use the CDC's National HIV Behavioral Surveillance Survey, MSM cycle.
Baseline and three months post-treatment; baseline and six months post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fenway Community Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Matthew Mimiaga, ScD, Fenway Community Health and Massachusetts General Hospital/Harvard Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2011

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2013

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 3, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 7, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 3293841

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