Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00432926
Status:
COMPLETED
Last Update Posted:
2012-09-28
First Post:
2007-02-06
Brief Title:
Behavior Change and Maintenance Intervention for HIV MSM Methamphetamine Users
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Behavior Change and Maintenance Intervention for HIV MSM Methamphetamine Users
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 tests the effectiveness of a behavioral intervention to reduce sexual risk behavior in HIV-positive methamphetamine-using men who have sex with men MSM It builds on the findings of a previous study R01 DA012116 Promoting safer sex in HIV homosexual and bisexual men who use methamphetamine That study achieved significant short-term results that eroded over time Accordingly this study hypothesizes that the addition of a maintenance component to the already proven counseling and educational components of the treatment model will result in longer-lasting positive effects
Detailed Description:
Methamphetamine use by MSM has been consistently associated with increased HIV transmission In the previous funding period we demonstrated reductions in transmission risk behavior associated with participation in our behavioral intervention however these improvements eroded over time underscoring the need to develop and test interventions designed to enhance longer-term behavior change The objective of this study is to evaluate the efficacy of an intervention designed to maintain reductions in high-risk sexual practices achieved by methamphetamine-using HIV MSM Three major questions addressed are 1 Can methamphetamine-using HIV MSM modify their high-risk sexual practices over an extended 16-month period 2 Do group maintenance sessions result in less erosion of behavioral improvements 3 Are the underlying mechanisms the same for acquisition and maintenance of behavior change We will assign 450 sexually active HIV MSM who regularly use methamphetamine and who have had unprotected sex with an HIV-negative or unknown-status partner to one of three conditions 1 an eight-session intervention combining client-centered motivational interviewing and structured behavioral counseling to address five intervention domains context of unsafe sexdrug use condom use safer sex negotiation disclosure and enhancement of social supports 2 the same eight counseling sessions ie identical to condition 1 above plus eight group-format safer sex maintenance sessions which utilize clinical strategies from relapse prevention to identify high-risk situations and develop effective coping strategies or 3 an attention-control condition that is time-equivalent to condition 2 above and addresses diet exercise and HIV Thus we will determine whether longer-term maintenance of safer sex behaviors is possible among HIV methamphetamine-using MSM a population that remains at very high risk of HIV transmission and for which substitution therapies to promote cessation and risk reduction are not yet available
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 |
|---|---|---|---|
| R01DA021115 | NIH | None | httpsreporternihgovquickSearchR01DA021115 |