STD Risk Reduction for Heterosexual Methamphetamine Users

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00344214
• Other study ID #: R01MH061146
• Secondary ID: R01MH061146DAHBR
• Status: Completed
• Phase: N/A
• First received: June 23, 2006
• Last updated: September 27, 2012
• Start date: October 2006
• Est. completion date: August 2012

Study information

• Verified date: September 2012
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 432
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections
• Sexually Transmitted Diseases
• Substance-Related Disorders

Intervention

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.
• 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).

Locations

Country	Name	City	State
United States	HIV Neurobehavioral Research Center	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of unprotected oral, anal, or vaginal sex		Measured at Months 4, 8, and 12	Yes
Secondary	Depressive symptoms		Measured at Months 4, 8, and 12	No
Secondary	Methamphetamine use		Measured at Months 4, 8, and 12	No
Secondary	STI incidence (gonorrhea, Chlamydia)		Measured at Month 12	No
Secondary	HIV serostatus		Measured at Month 12	Yes