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PTSD and Risk Behavior in HIV Positive Female Adolescents

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00271882
First received: December 30, 2005
Last updated: May 15, 2014
Last verified: April 2014
  Purpose

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: Observational Model: Cohort
Time Perspective: Prospective
Official Title: PTSD and Risk Behavior in HIV Positive Female Adolescents

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 40
Study Start Date: March 2006
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 24 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

English speaking women, 18-24 years old with behaviorally- acquired HIV through heterosexual intercourse or injection drug use after the age of 9 years, who report a history of sexual and/or physical abuse prior to age 18, and who have engaged in vaginal or anal intercourse in the 4 months prior to screening.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00271882

Locations
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
Sponsors and Collaborators
Investigators
Study Chair: Gretchen Clum, Ph.D Tulane School of Public Health and Tropical Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00271882     History of Changes
Other Study ID Numbers: ATN 053
Study First Received: December 30, 2005
Last Updated: May 15, 2014
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Adolescent Females
HIV positive
PTSD
Sexual Abuse

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
HIV Seropositivity
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 23, 2014