PTSD and Risk Behavior in HIV Positive Female Adolescents

HIV Infections Clinical Trial

Official title:

PTSD and Risk Behavior in HIV Positive Female Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00271882
• Other study ID #: ATN 053
• Status: Completed
• Phase: N/A
• First received: December 30, 2005
• Last updated: February 27, 2017
• Start date: March 2006
• Est. completion date: September 2006

Study information

• Verified date: February 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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, occurring over one to two sessions, will be conducted with each participant.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 24 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections
• HIV Seropositivity
• PTSD
• Sexual Abuse

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York
United States	University of Miami	Miami	Florida
United States	The Children's Hosp. of Philadelphia	Philadelphia	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Explore the interrelationship between abuse and sexual risk behavior	To explore the interrelationship between abuse and sexual risk behavior in behaviorally-acquired HIV-positive female adolescents who report abuse histories	12 Months
Primary	Explore the interrelationship between abuse, substance use and sexual risk behavior	To explore the interrelationship between abuse, substance use and sexual risk behavior in those participants who meet substance use criteria	12 Months
Secondary	Assess preferred intervention delivery strategies for an abuse-related intervention	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.	12 Months
Secondary	Identify strengths/protective factors	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.	12 Months

External Links

•   Website for the Adolescent Trials Network for HIV/AIDS Interventions