Clinical trial NCT00344214: STD Risk Reduction for Heterosexual Methamphetamine Users
Official title: Reducing HIV/STD Risk, Methamphetamine Use, and Depression Among Heterosexuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance-Related Disorders
HIV Infections
Sexually Transmitted Diseases
Keywords: HIV
STDs
Methamphetamine
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2006-06-26
Enrollment: 432
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Frequency of unprotected oral, anal, or vaginal sex
timeFrame: Measured at Months 4, 8, and 12
Secondary outcomes:
measure: Depressive symptoms
timeFrame: Measured at Months 4, 8, and 12
measure: Methamphetamine use
timeFrame: Measured at Months 4, 8, and 12
measure: STI incidence (gonorrhea, Chlamydia)
timeFrame: Measured at Month 12
measure: HIV serostatus
timeFrame: Measured at Month 12
Other outcomes:
Locations:
city: San Diego
country: United States
facility: HIV Neurobehavioral Research Center
state: California
Study officials:
affiliation: University of California, San Diego
name: Thomas L. Patterson, PhD
role: PRINCIPAL_INVESTIGATOR
References: