PTSD and Risk Behavior in HIV Positive Female Adolescents
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||PTSD and Risk Behavior in HIV Positive Female Adolescents|
- Explore the interrelationship between abuse and sexual risk behavior [ Time Frame: 12 Months ] [ Designated as safety issue: No ]To explore the interrelationship between abuse and sexual risk behavior in behaviorally-acquired HIV-positive female adolescents who report abuse histories
- Explore the interrelationship between abuse, substance use and sexual risk behavior [ Time Frame: 12 Months ] [ Designated as safety issue: No ]To explore the interrelationship between abuse, substance use and sexual risk behavior in those participants who meet substance use criteria
- Assess preferred intervention delivery strategies for an abuse-related intervention [ Time Frame: 12 Months ] [ Designated as safety issue: No ]To assess preferred intervention delivery strategies for an abuse-related intervention such as length of treatment, incorporation of support/guardian figure, incorporation of issues related to HIV, and incorporation of specific sexual risk behavior modules.
- Identify strengths/protective factors [ Time Frame: 12 Months ] [ Designated as safety issue: No ]To identify strengths/protective factors (coping strategies, parent or network support) in girls who have experienced abuse that may be utilized to enhance the intervention.
|Study Start Date:||March 2006|
|Study Completion Date:||September 2006|
|Primary Completion Date:||September 2006 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00271882
|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|
|Study Chair:||Gretchen Clum, Ph.D||Tulane School of Public Health and Tropical Medicine|