STD Risk Reduction for Heterosexual Methamphetamine Users
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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 |
- Frequency of unprotected oral, anal, or vaginal sex [ Time Frame: Measured at Months 4, 8, and 12 ] [ Designated as safety issue: Yes ]
- 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 |
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| United States, California | |
| HIV Neurobehavioral Research Center | |
| San Diego, California, United States, 92103 | |
| 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 |
Mental Disorders Methamphetamine Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses Adrenergic Agents Adrenergic Uptake Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013