Status:
COMPLETED
PTSD and Risk Behavior in HIV Positive Female Adolescents
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
Conditions:
PTSD
Sexual Abuse
Eligibility:
FEMALE
18-24 years
Brief Summary
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, oc...
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 dur...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00271882
Start Date
March 1 2006
End Date
September 1 2006
Last Update
February 28 2017
Active Locations (3)
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1
University of Miami
Miami, Florida, United States, 33101
2
Montefiore Medical Center
The Bronx, New York, United States, 10467-2490
3
The Children's Hosp. of Philadelphia
Philadelphia, Pennsylvania, United States, 19104