STD Risk Reduction for Heterosexual Methamphetamine Users

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

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.

Study Overview

• Status: Completed
• Conditions: Substance-Related Disorders; HIV Infections; Sexually Transmitted Diseases
• Intervention / Treatment: Behavioral: Tri-focal cognitive behavioral therapy - social skills training (CBTSS) counseling program; Behavioral: Standard care

Detailed 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 Type: Interventional
• Enrollment (Actual): 432
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92103
      • HIV Neurobehavioral Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• HIV uninfected
• Use of methamphetamine via snorting or smoking at least once a month for the 2 months prior to study entry
• Heterosexual
• History of unprotected sex within 2 months prior to study entry

Exclusion Criteria:

• Current diagnosis of a major psychiatric disorder with psychotic or suicidal symptoms
• History of consistent use of condoms or dental dams for oral, vaginal, or anal sex with all partners within 2 months prior to study entry
• Currently trying to get pregnant or get a partner pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1; Participants will receive the tri-focal cognitive behavioral therapy - social skills training counseling program	Behavioral: Tri-focal cognitive behavioral therapy - social skills training (CBTSS) counseling program; This condition is a Theory-Based Counseling Program. The program will involve nine 90-minute face-to-face counseling sessions that use CBT and strategies associated with social cognitive theory. The theory addresses three treatment domains, including mood regulation, reduction/cessation of meth use, and reduction of high risk sexual practices.
ACTIVE_COMPARATOR: 2; Participants will receive the standard care comparison condition	Behavioral: Standard care; Standard care involves 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 1 (CDC, Atlanta) 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Frequency of unprotected oral, anal, or vaginal sex	Measured at Months 4, 8, and 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Depressive symptoms	Measured at Months 4, 8, and 12
Methamphetamine use	Measured at Months 4, 8, and 12
STI incidence (gonorrhea, Chlamydia)	Measured at Month 12
HIV serostatus	Measured at Month 12

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Thomas L. Patterson, PhD, University of California, San Diego

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (ACTUAL): August 1, 2012
• Study Completion (ACTUAL): August 1, 2012

Study Registration Dates

• First Submitted: June 23, 2006
• First Submitted That Met QC Criteria: June 23, 2006
• First Posted (ESTIMATE): June 26, 2006

Study Record Updates

• Last Update Posted (ESTIMATE): September 28, 2012
• Last Update Submitted That Met QC Criteria: September 27, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: HIV; STDs; Methamphetamine
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Infections; Communicable Diseases; Disease Attributes; Substance-Related Disorders; Sexually Transmitted Diseases
• Other Study ID Numbers: R01MH061146 (NIH); DAHBR 9A-ASPQ (NIMH)