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

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.

Study Overview

• Status: Terminated
• Conditions: PTSD; HIV
• Intervention / Treatment: Behavioral: HIV Skills-based Prevention

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.

• Study Type: Interventional
• Enrollment: 102
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53202
      • Center for AIDS Intervention Research (CAIR)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Cheryl Gore-Felton, PhD, Stanford University

Study record dates

Study Major Dates

• Study Start: April 1, 2003
• Study Completion: March 1, 2004

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 16, 2005

Study Record Updates

• Last Update Posted (Estimate): October 6, 2006
• Last Update Submitted That Met QC Criteria: October 5, 2006
• Last Verified: September 1, 2005

More Information

Terms related to this study

• Keywords: PTSD; HIV; Prevention; AIDS
• Other Study ID Numbers: 5R03MH063643-02 (U.S. NIH Grant/Contract)