Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00186030
Status:
TERMINATED
Last Update Posted:
2006-10-06
First Post:
2005-09-13
Brief Title:
Reducing Risk and Trauma-Related Stress in Persons Living With HIV
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Reducing Risk and Trauma-Related Stress in Persons Living With HIV
Status:
TERMINATED
Status Verified Date:
2005-09
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 two-year study tested the concept that an intervention which reduces trauma-related symptoms among adults who are living with human immunodeficiency virus HIV are experiencing trauma-related stress symptoms and engaging in behavior that facilitates HIV transmission can reduce the transmission risk of HIV Our central premise was that by first treating trauma symptoms we would enhance the effects of a skills-building HIV risk reduction intervention for adults experiencing trauma-related symptoms such as hyperarousal dissociation and avoidance
The study aims were to
1 To determine if decreasing trauma-related stress symptoms improves HIV risk reduction behavior above a standard HIV risk reduction intervention alone post-intervention and 3 months after the small group intervention sessions
2 To determine whether key variables moderate the interventions effects For instance gender age ethnicity or psychological distress eg depression anxiety may interact with the intervention to affect risky sexual or drug-related behavior and
3 To determine whether there is evidence that the theoretical mediator variables which include trauma-related stress symptoms self-efficacy communication skills and social support mediate the interventions effects on outcomes This information addresses the theoretical question of why the intervention works
The study aims were to
1 To determine if decreasing trauma-related stress symptoms improves HIV risk reduction behavior above a standard HIV risk reduction intervention alone post-intervention and 3 months after the small group intervention sessions
2 To determine whether key variables moderate the interventions effects For instance gender age ethnicity or psychological distress eg depression anxiety may interact with the intervention to affect risky sexual or drug-related behavior and
3 To determine whether there is evidence that the theoretical mediator variables which include trauma-related stress symptoms self-efficacy communication skills and social support mediate the interventions effects on outcomes This information addresses the theoretical question of why the intervention works
Detailed Description:
There are no published longitudinal studies examining the impact of traumatic events on risk behavior among HIV-positive men and women As a result we know very little about how stress particularly trauma-related stress influences HIV risk behavior This study will be one of the first randomized studies to examine the efficacy of reducing HIV risk behavior by combining a trauma-focused stress reduction intervention with a standard HIV prevention skills intervention This study is specifically targeting a low-income urban population a group that experiences a disproportionate rate of crime as well as HIV infection Findings of the research will likely provide information on the relationship between trauma and risk behavior Furthermore this research can identify key issues related to stress psychosocial factors and overall health that will be relevant to investigate in future larger-scale studies of HIV-positive as well as HIV-negative populations
Individuals who reported living with HIV engaging in HIV risk behavior in the past 3 months experiencing a traumatic stressor and trauma-related symptoms in the past 3 months were assigned to one of three conditions 1 standard HIV prevention skills 2 standard HIV prevention skills trauma-focused stress reduction skills training or 3 trauma-focused stress reduction skills training
Individuals who reported living with HIV engaging in HIV risk behavior in the past 3 months experiencing a traumatic stressor and trauma-related symptoms in the past 3 months were assigned to one of three conditions 1 standard HIV prevention skills 2 standard HIV prevention skills trauma-focused stress reduction skills training or 3 trauma-focused stress reduction skills training
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