Clinical Trial on HIV Infections, PTSD, Sexual Abuse - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Florida
  - Miami, Florida, United States, 33101
    - University of Miami
- New York
  - Bronx, New York, United States, 10467-2490
    - Montefiore Medical Center
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19104
    - The Children's Hosp. of Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 24 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Explore the interrelationship between abuse and sexual risk behavior Time Frame: 12 Months	To explore the interrelationship between abuse and sexual risk behavior in behaviorally-acquired HIV-positive female adolescents who report abuse histories	12 Months
Explore the interrelationship between abuse, substance use and sexual risk behavior Time Frame: 12 Months	To explore the interrelationship between abuse, substance use and sexual risk behavior in those participants who meet substance use criteria	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess preferred intervention delivery strategies for an abuse-related intervention Time Frame: 12 Months	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
Identify strengths/protective factors Time Frame: 12 Months	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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Institute on Drug Abuse (NIDA)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute of Mental Health (NIMH)

Investigators

Study Chair: Gretchen Clum, Ph.D, Tulane School of Public Health and Tropical Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Website for the Adolescent Trials Network for HIV/AIDS Interventions

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

December 30, 2005

First Submitted That Met QC Criteria