Clinical trial NCT00271882: PTSD and Risk Behavior in HIV Positive Female Adolescents
Official title: PTSD and Risk Behavior in HIV Positive Female Adolescents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PTSD
Sexual Abuse
HIV Infections
Keywords: Adolescent Females
HIV positive
PTSD
Sexual Abuse
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: National Institute of Mental Health (NIMH)
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2006-01-04
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Explore the interrelationship between abuse and sexual risk behavior
timeFrame: 12 Months
measure: Explore the interrelationship between abuse, substance use and sexual risk behavior
timeFrame: 12 Months
Secondary outcomes:
measure: Assess preferred intervention delivery strategies for an abuse-related intervention
timeFrame: 12 Months
measure: Identify strengths/protective factors
timeFrame: 12 Months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Philadelphia
country: United States
facility: The Children's Hosp. of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Tulane School of Public Health and Tropical Medicine
name: Gretchen Clum, Ph.D
role: STUDY_CHAIR
References: