Skip to main content
Clinical Trials/NCT00344214
NCT00344214
Completed
N/A

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

University of California, San Diego1 site in 1 country432 target enrollmentOctober 2006

Overview

Phase
N/A
Intervention
Not specified
Conditions
Substance-Related Disorders
Sponsor
University of California, San Diego
Enrollment
432
Locations
1
Primary Endpoint
Frequency of unprotected oral, anal, or vaginal sex
Status
Completed
Last Updated
13 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
October 2006
End Date
August 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Thomas L. Patterson

Professor in Residence

University of California, San Diego

Eligibility Criteria

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

Outcomes

Primary Outcomes

Frequency of unprotected oral, anal, or vaginal sex

Time Frame: Measured at Months 4, 8, and 12

Secondary Outcomes

  • HIV serostatus(Measured at Month 12)
  • 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)

Study Sites (1)

Loading locations...

Similar Trials