PTSD and Risk Behavior in HIV Positive Female Adolescents



Status:Completed
Conditions:HIV / AIDS, Psychiatric
Therapuetic Areas:Immunology / Infectious Diseases, Psychiatry / Psychology
Healthy:No
Age Range:18 - 24
Updated:3/1/2017
Start Date:March 2006
End Date:September 2006

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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.

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.

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.
We found this trial at
3
sites
Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Philadelphia, PA
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