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Posttraumatic Stress Disorder (PTSD) and Risk Behavior
This study has been completed.
Sponsors and Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00271882
  Purpose

This is a qualitative study using a purposive sampling methodology to interview HIV-positive female adolescents who have experienced physical and/or sexual abuse. An open-ended, in-depth interview, occurring over one to two sessions, will be conducted with each participant.


Condition
PTSD
Sexual Abuse
HIV Infections

MedlinePlus related topics: AIDS Post-Traumatic Stress Disorder
U.S. FDA Resources
Study Type: Observational
Study Design: Psychosocial, Longitudinal, Defined Population, Retrospective/Prospective Study
Official Title: Posttraumatic Stress Disorder and Risk Behavior in HIV Positive Female Adolescents

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Estimated Enrollment: 60
Study Start Date: March 2006
Estimated Study Completion Date: October 2006
Detailed Description:

This study is expected to take approximately 12 months to accrue participants and complete all the interviews. The interview will be conducted in one or two sessions and will be up to two hours in duration per session.

The study will initially be conducted at three ATN clinical sites with approximately 20 females recruited per site for a total of 60 participants. Other ATN clinical sites may be allowed to participate in the future if the study is slow to accrue.

The participants consist of English speaking women, ages 18-24 years, who acquired HIV through heterosexual intercourse or injection drug use after the age of 9 years, reported a history of sexual and/or physical abuse prior to age 18, and engaged in vaginal or anal intercourse in the 4 months prior to screening.

Approximately half of the participants will report a recent history of substance use as defined by study criteria and approximately half of the participants will report no such history.

Eligible patients will be identified and screened by the ATN research staff at the participating sites. The Protocol Chair and trained Research Assistant will conduct the open-ended qualitative interviews using an open-ended script. The interview will be audio-taped and transcribed. Prior to the open-ended script interview, participants will be asked about Posttraumatic Stress Disorder symptoms, abuse history, substance use, sexual behavior, and demographics. Responses to these questions will not be audio-taped and will be entered into the ATN 053 database by the ATN site staff.

  Eligibility

Ages Eligible for Study:   18 Years to 24 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 through 24 years old, inclusive, at the time of administration of the Screening Questionnaire.
  • Female birth gender
  • Verbal confirmation of acquisition of behaviorally-acquired HIV infection including from injection drug use (IDU) or heterosexual intercourse (vaginal, oral and/or anal) after the age of 9 years
  • HIV-1 infection as documented by a positive result on any of the following licensed tests at any time: any antibody test confirmed by Western blot, HIV culture, plasma HIV-1 RNA PCR > 1,000 copies/mL or a HIV DNA PCR
  • History of physical and/or sexual abuse prior to age 18 years old documented by a Screening Questionnaire
  • Voluntary vaginal and/or anal intercourse with a male within the 4 months prior to screening.
  • Ability to understand and communicate in spoken English sufficient to provide informed consent and to be interviewed
  • Availability of enrollment slots for the participant’s assigned substance-use category at the time of the Screening Questionnaire. (Approximately half of the participants will report substance use) This will be monitored throughout the study enrollment period.
  • Willingness to have the qualitative study interview audio-taped
  • Willingness and ability to provide informed consent

Exclusion Criteria:

  • Currently suicidal or homicidal by clinician judgment
  • Visibly distraught and/or visibly emotionally unstable (e.g., depressive mood, exhibiting manic, suicidal, or violent behavior);
  • Visibly intoxicated or under the influence of psychoactive agents; or
  • Presents as acutely ill.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00271882

Locations
United States, Florida
University of Miami
Miami, Florida, United States, 33101
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467-2490
United States, Pennsylvania
The Children’s Hosp. of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Investigators
Study Chair: Gretchen Clum, Ph.D Tulane School of Public Health and Tropical Medicine
  More Information

Website for the Adolescent Trials Network for HIV/AIDS Interventions  This link exits the ClinicalTrials.gov site

Study ID Numbers: ATN 053
Study First Received: December 30, 2005
Last Updated: April 24, 2007
ClinicalTrials.gov Identifier: NCT00271882  
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Adolescent Females
HIV positive
PTSD
Sexual Abuse

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Acquired Immunodeficiency Syndrome
Stress
Stress Disorders, Traumatic
Immunologic Deficiency Syndromes
Virus Diseases
HIV Seropositivity
Anxiety Disorders
HIV Infections
Mental Disorders
Sexually Transmitted Diseases
Stress Disorders, Post-Traumatic
Retroviridae Infections

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009