Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute on Drug Abuse (NIDA) National Institute of Mental Health (NIMH) National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
---|---|
Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00271882 |
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.
Condition |
---|
PTSD Sexual Abuse HIV Infections |
Study Type: | Observational |
Study Design: | Psychosocial, Longitudinal, Defined Population, Retrospective/Prospective Study |
Official Title: | Posttraumatic Stress Disorder and Risk Behavior in HIV Positive Female Adolescents |
Estimated Enrollment: | 60 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | October 2006 |
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.
Ages Eligible for Study: | 18 Years to 24 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study ID Numbers: | ATN 053 |
Study First Received: | December 30, 2005 |
Last Updated: | April 24, 2007 |
ClinicalTrials.gov Identifier: | NCT00271882 |
Health Authority: | United States: Federal Government |
Adolescent Females HIV positive PTSD Sexual Abuse |
Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome Stress Stress Disorders, Traumatic Immunologic Deficiency Syndromes Virus Diseases HIV Seropositivity |
Anxiety Disorders HIV Infections Mental Disorders Sexually Transmitted Diseases Stress Disorders, Post-Traumatic Retroviridae Infections |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |