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Completed

NCT Number: NCT00611338

Efficacy of Group Intervention to Reduce Stress Symptoms

This research study will examine the usefulness of groups in reducing stress and helping individuals with HIV to stay healthy and avoid problems associated with sexually transmitted diseases. We hope to discover whether being in a group is effective in reducing stress-related symptoms and promoting healthy behaviors.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

This is a risk reduction intervention for adults who are living with HIV, are experiencing trauma-related stress symptoms, and are at risk for HIV transmission. By first treating trauma symptoms, the effects of a skills-building HIV risk reduction intervention for adults experiencing trauma-related symptoms such as hyperarousal, dissociation, and avoidance will be enhanced. This is based on a model the proposes trauma-related symptoms have direct effects on HIV risk behavior. Therefore, the successful treatment of trauma-related symptoms will facilitate HIV risk behavior change.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 in the past three months, report experiencing one or more trauma-related symptoms within the past three months.

Exclusion criteria

Exclusion criteria include the presence of gross cognitive impairment, dementia, acute psychosis, or severe physical impairment that would preclude adequate comprehension of assessment material and participation in small group intervention.

Treatment and study plan

HIV Skills-based Prevention

Behavioral

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 3, 6, and 12 months after the group intervention sessions.

    Time frame: immediate post intervention, 3 months, 6 months, and 12 months

    unprotected insertive and receptive sexual intercourse

  2. To determine if decreasing trauma-related stress symptoms improves HIV risk reduction behavior above a standard HIV risk reduction intervention alone

    Time frame: immediate post intervention, 3 months, 6 months, and 12 months

    Mediation effect on trauma symptoms on HIV-related risk behavior

Secondary outcomes

  1. To determine whether key variables moderate the intervention's effects.

    Time frame: immediate post intervention, 3 months, 6 months and 12 months

    Gender, age, ethnicity, or psychological distress (e.g. , depression, anxiety) may interact with the intervention to affect risky sexual or drug-related behavior.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2006
Primary completion
2012
Study completion
2012
First posted
Feb 8, 2008
Registry last updated
Mar 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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