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STD Risk Reduction for Heterosexual Methamphetamine Users

Primary Purpose

Substance-Related Disorders, HIV Infections, Sexually Transmitted Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tri-focal cognitive behavioral therapy - social skills training (CBTSS) counseling program
Standard care
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Substance-Related Disorders focused on measuring HIV, STDs, Methamphetamine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • HIV Neurobehavioral Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Participants will receive the tri-focal cognitive behavioral therapy - social skills training counseling program

Participants will receive the standard care comparison condition

Outcomes

Primary Outcome Measures

Frequency of unprotected oral, anal, or vaginal sex

Secondary Outcome Measures

Depressive symptoms
Methamphetamine use
STI incidence (gonorrhea, Chlamydia)
HIV serostatus

Full Information

First Posted
June 23, 2006
Last Updated
September 27, 2012
Sponsor
University of California, San Diego
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00344214
Brief Title
STD Risk Reduction for Heterosexual Methamphetamine Users
Official Title
Reducing HIV/STD Risk, Methamphetamine Use, and Depression Among Heterosexuals
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance-Related Disorders, HIV Infections, Sexually Transmitted Diseases
Keywords
HIV, STDs, Methamphetamine

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
432 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive the tri-focal cognitive behavioral therapy - social skills training counseling program
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants will receive the standard care comparison condition
Intervention Type
Behavioral
Intervention Name(s)
Tri-focal cognitive behavioral therapy - social skills training (CBTSS) counseling program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard care
Intervention Description
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).
Primary Outcome Measure Information:
Title
Frequency of unprotected oral, anal, or vaginal sex
Time Frame
Measured at Months 4, 8, and 12
Secondary Outcome Measure Information:
Title
Depressive symptoms
Time Frame
Measured at Months 4, 8, and 12
Title
Methamphetamine use
Time Frame
Measured at Months 4, 8, and 12
Title
STI incidence (gonorrhea, Chlamydia)
Time Frame
Measured at Month 12
Title
HIV serostatus
Time Frame
Measured at Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas L. Patterson, PhD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
HIV Neurobehavioral Research Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States

12. IPD Sharing Statement

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STD Risk Reduction for Heterosexual Methamphetamine Users

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