PTSD and Risk Behavior - Article
Clinical Trial: PTSD and Risk Behavior
This study is not yet open for patient recruitment.
Verified by National Institute of Child Health and Human Development (NICHD) December 2005
|Phase IV |
MedlinePlus related topics: AIDS; Post-Traumatic Stress Disorder
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
Expected Total Enrollment: 60
Study start: January 2006
Last follow-up: January 2007
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.
- 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 as described in Section 5.1.) 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
- 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.
Location and Contact Information
University of Miami, Miami, Florida, 33101, United States
Montefiore Medical Center, Bronx, New York, 10467-2490, United States
The Children’s Hosp. of Philadelphia, Philadelphia, Pennsylvania, 19104, United States
Gretchen Clum, Ph.D, Study Chair, Tulane School of Public Health and Tropical Medicine
Website for the Adolescent Trials Network for HIV/AIDS Interventions
Last Updated: January 3, 2006
Record first received: December 30, 2005
ClinicalTrials.gov Identifier: NCT00271882
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-01-10