Text Size

Reducing Risk and Trauma-Related Stress in Persons Living With HIV

This study has been terminated.
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00186030
First received: September 13, 2005
Last updated: October 5, 2006
Last verified: September 2005
History of Changes
  Purpose

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 intervention’s effects. For instance, gender, age, ethnicity, or psychological distress (e.g., 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 intervention’s effects on outcomes. This information addresses the theoretical question of why the intervention works.

Condition Intervention Phase
HIV
PTSD
 Behavioral: HIV Skills-based Prevention
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Reducing Risk and Trauma-Related Stress in Persons Living With HIV

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • To determine whether key variables moderate the intervention’s effects. For instance, gender, age, ethnicity, or psychological distress (e.g., depression, anxiety) may interact with the intervention to affect risky sexual or drug-related behavior.
  • 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 intervention’s effects on outcomes. This information will

Estimated Enrollment: 102
Study Start Date: April 2003
Estimated Study Completion Date: March 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • must be 18 years or older, must be HIV-positive
  • report engaging in behavior that could put them at risk for HIV transmission during the past 3 months
  • report experiencing one or more trauma-related symptoms (i.e., reexperiencing, hyperarousal, or avoidance) occurring within the past three months.

Exclusion Criteria:

  • experience psychological symptoms or substance use problems so severe that it would impair their ability or the ability of others to participate in a group intervention
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00186030

Locations
United States, Wisconsin
Center for AIDS Intervention Research (CAIR)
Milwaukee, Wisconsin, United States, 53202
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Cheryl Gore-Felton, PhD Stanford University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00186030     History of Changes
Other Study ID Numbers: 5R03MH063643-02
Study First Received: September 13, 2005
Last Updated: October 5, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
HIV
AIDS
PTSD
Prevention

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013