Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00344214
Status:
COMPLETED
Last Update Posted:
2012-09-28
First Post:
2006-06-23
Brief Title:
STD Risk Reduction for Heterosexual Methamphetamine Users
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Reducing HIVSTD Risk Methamphetamine Use and Depression Among Heterosexuals
Status:
COMPLETED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 reductioncessation 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 Atlanta1 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 NIAAAProject 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
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 reductioncessation 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 Atlanta1 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 NIAAAProject 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DAHBR 9A-ASPQ | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH061146 |
| R01MH061146 | NIH | None | None |