STD Risk Reduction for Heterosexual Methamphetamine Users

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Thomas L. Patterson, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00344214
First received: June 23, 2006
Last updated: September 27, 2012
Last verified: September 2012

June 23, 2006
September 27, 2012
October 2006
August 2012   (final data collection date for primary outcome measure)
Frequency of unprotected oral, anal, or vaginal sex [ Time Frame: Measured at Months 4, 8, and 12 ] [ Designated as safety issue: Yes ]
  • Measured at Months 6, 12, and 18: Frequency of unprotected oral, anal, or vaginal sex
  • Protected sex ratio
  • Number and type of sexual partners
  • Number of sexual partners who inject drugs
  • Number of times traded sex for money or drugs, or vice versa
  • HIV serostatus
  • STD infections
Complete list of historical versions of study NCT00344214 on ClinicalTrials.gov Archive Site
  • Depressive symptoms [ Time Frame: Measured at Months 4, 8, and 12 ] [ Designated as safety issue: No ]
  • Methamphetamine use [ Time Frame: Measured at Months 4, 8, and 12 ] [ Designated as safety issue: No ]
  • STI incidence (gonorrhea, Chlamydia) [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
  • HIV serostatus [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: Yes ]
  • Measured at Months 6, 12, and 18: Process variables
  • Mechanisms of change variables
  • Psychosocial risk factors
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Substance-Related Disorders
  • HIV Infections
  • Sexually Transmitted Diseases
  • 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.
  • 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).
  • Experimental: 1
    Participants will receive the tri-focal cognitive behavioral therapy - social skills training counseling program
    Intervention: Behavioral: Tri-focal cognitive behavioral therapy - social skills training (CBTSS) counseling program
  • Active Comparator: 2
    Participants will receive the standard care comparison condition
    Intervention: Behavioral: Standard care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
432
August 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00344214
R01 MH061146, R01MH061146, DAHBR 9A-ASPQ
Not Provided
Thomas L. Patterson, University of California, San Diego
University of California, San Diego
National Institute of Mental Health (NIMH)
Principal Investigator: Thomas L. Patterson, PhD University of California, San Diego
University of California, San Diego
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP