Behavioral Activation and HIV Risk Reduction for Men Who Have Sex With Men With Crystal Meth Abuse
|ClinicalTrials.gov Identifier: NCT01255280|
Recruitment Status : Unknown
Verified May 2012 by Matthew James Mimiaga, Massachusetts General Hospital.
Recruitment status was: Recruiting
First Posted : December 7, 2010
Last Update Posted : June 1, 2012
|Condition or disease||Intervention/treatment||Phase|
|Crystal Methamphetamine Abuse Crystal Methamphetamine Dependence||Behavioral: Behavioral Activation Therapy and Risk Reduction Counseling (BAT-RR) Behavioral: Information, Motivation, Behavioral skills change approach to sexual risk reduction||Phase 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.
- 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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Behavioral Activation and HIV Risk Reduction for MSM With Crystal Methamphetamine Abuse|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||December 2013|
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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01255280
|Contact: Matthew Mimiaga, ScD, MPH||617-927-6084||MMimiaga@fenwayhealth.org|
|Contact: Janna Gordonfirstname.lastname@example.org|
|United States, Massachusetts|
|Fenway Community Health||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Jaclyn White, MPH 617-927-6101 email@example.com|
|Principal Investigator:||Matthew Mimiaga, ScD||Fenway Community Health and Massachusetts General Hospital/Harvard Medical School|