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
  Purpose

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.


Condition Intervention
Substance-Related Disorders
HIV Infections
Sexually Transmitted Diseases
Behavioral: Tri-focal cognitive behavioral therapy - social skills training (CBTSS) counseling program
Behavioral: Standard care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Reducing HIV/STD Risk, Methamphetamine Use, and Depression Among Heterosexuals

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Frequency of unprotected oral, anal, or vaginal sex [ Time Frame: Measured at Months 4, 8, and 12 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 432
Study Start Date: October 2006
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00344214

Locations
United States, California
HIV Neurobehavioral Research Center
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Thomas L. Patterson, PhD University of California, San Diego
  More Information

No publications provided

Responsible Party: Thomas L. Patterson, Professor in Residence, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00344214     History of Changes
Other Study ID Numbers: R01 MH061146, R01MH061146, DAHBR 9A-ASPQ
Study First Received: June 23, 2006
Last Updated: September 27, 2012
Health Authority: United States: Federal Government

Keywords provided by University of California, San Diego:
HIV
STDs
Methamphetamine

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Sexually Transmitted Diseases
Substance-Related Disorders
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female
Chemically-Induced Disorders
Mental Disorders
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents

ClinicalTrials.gov processed this record on August 19, 2014