STD Risk Reduction for Heterosexual Methamphetamine Users

HIV Infections Clinical Trial

Official title: Reducing HIV/STD Risk, Methamphetamine Use, and Depression Among Heterosexuals

Status Completed

Clinical Trial Summary

This study will evaluate the effectiveness of a sexual risk reduction intervention in reducing sexual risk behavior in HIV uninfected, heterosexual people who use methamphetamine.

Clinical Trial Description

Methamphetamine is an addictive stimulant drug that strongly activates certain systems in the brain and can cause strong feelings of euphoria. Methamphetamine use has been associated with high risk sexual practices, such as unprotected anal and vaginal sex, multiple sex partners, and sex with partners who inject drugs. These behaviors and others have led to higher rates of STD- and HIV-infections among methamphetamine users. Despite the connection between methamphetamine use and high risk sexual behaviors, few efforts have been made to develop and implement sexual risk reduction programs for this population. Studies of risk reduction programs for "at risk" populations have shown that longer programs are more effective in maintaining improvements in sexual risk behaviors. This study will evaluate the effectiveness of a long-term sexual risk reduction intervention in reducing sexual risk behavior among heterosexual, HIV uninfected people who use methamphetamine.

Participants in this 12-month, open-label study will be randomly assigned to one of the following two conditions: 1) "Tri-focal Cognitive Behavioral Therapy - Social Skills Training (CBTSS) Counseling Program." This condition represents the active experimental condition. Consistent with the theoretical framework, this condition will involve nine 90-minute face-to-face counseling sessions that use cognitive behavioral therapy and strategies associated with social cognitive theory and the theory or reasoned action to address three treatment domains—mood regulation, reduction/cessation of meth use, and reduction of high risk sexual practices. 2) "Standard Care Comparison Condition." Subjects who are assigned to this condition will participate in nine weekly, face-to-face individual counseling sessions that provide standard care in relation to sexual risk, methamphetamine use, and depression. The sexual risk component is a modified version of Project RESPECT (CDC, Atlanta)1 that focuses on educational materials and personal risk appraisal. The meth component is a modified version of the 12-step drug abstinence program developed by the National Institute of Alcohol Abuse and Alcoholism (NIAAA)(Project MATCH). The depression component is an educational approach based primarily on materials provided by the National Alliance on Mental Illness (NAMI) and the National Institute of Mental Health (NIMH). All three programs are widely available and used in community practice. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections
• Sexually Transmitted Diseases
• Substance-Related Disorders

• NCT number: NCT00344214
• Study type: Interventional
• Source: University of California, San Diego
• Status: Completed
• Phase: N/A
• Start date: October 2006
• Completion date: August 2012