Clinical Trials Directory

Trials / Completed

CompletedNCT00271882

PTSD and Risk Behavior in HIV Positive Female Adolescents

Status
Completed
Phase
Study type
Observational
Enrollment
40 (actual)
Sponsor
University of North Carolina, Chapel Hill · Academic / Other
Sex
Female
Age
18 Years – 24 Years
Healthy volunteers
Not accepted

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.

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 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.

Conditions

Timeline

Start date
2006-03-01
Primary completion
2006-09-01
Completion
2006-09-01
First posted
2006-01-04
Last updated
2017-02-28

Locations

3 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00271882. Inclusion in this directory is not an endorsement.