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

NCT00186030 | Terminated Phase 1

• 1 other identifier: 5R03MH063643-02
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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. 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. 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. 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.

Conditions

HIV; PTSD

Keywords

HIV; AIDS; PTSD; Prevention

Outcome Measures

Primary Outcomes (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

Secondary Outcomes (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.

• 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

Interventions

HIV Skills-based Prevention BEHAVIORAL

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Center for AIDS Intervention Research (CAIR)

Milwaukee, Wisconsin, 53202, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Cheryl Gore-Felton, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: April 1, 2003
• Study Completion: March 1, 2004
• Last Updated: October 6, 2006

Record last verified: 2005-09

Locations

US (1)