PTSDNCT00271882
PTSD and Risk Behavior in HIV Positive Female Adolescents
An observational study of PTSD and Sexual Abuse, run by University of North Carolina, Chapel Hill at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 24 years, women only
- Conditions the study is for
- PTSD, Sexual Abuse, HIV Infections
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2006to Sep 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Miami
Miami, Florida, 33101
The Children's Hosp. of Philadelphia
Philadelphia, Pennsylvania, 19104
Montefiore Medical Center
The Bronx, New York, 10467-2490
About this study
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.
Read the 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
- PTSD, Sexual Abuse, HIV Infections
- Keywords
- Adolescent Females, HIV positive, PTSD, Sexual Abuse
- Medical subject headings
- Stress Disorders, Post-Traumatic, HIV Infections, HIV Seropositivity
What is being measured
The primary outcome is the main question the study is designed to answer.
Explore the interrelationship between abuse and sexual risk behavior
To explore the interrelationship between abuse and sexual risk behavior in behaviorally-acquired HIV-positive female adolescents who report abuse histories
Measured: 12 Months
Explore the interrelationship between abuse, substance use and sexual risk behavior
To explore the interrelationship between abuse, substance use and sexual risk behavior in those participants who meet substance use criteria
Measured: 12 Months
Secondary outcomes (2)
Assess preferred intervention delivery strategies for an abuse-related intervention
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.
Measured: 12 Months
Identify strengths/protective factors
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.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2006 (estimated)
- Study startMar 2006
- Primary completionSep 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Gretchen Clum, Ph.D, Study chair, Tulane School of Public Health and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00271882
- Sponsor's protocol ID
- ATN 053
- Status last verified
- Feb 2016
- First submitted
- 30 Dec 2005
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PTSD and Risk Behavior in HIV Positive Female Adolescents
- ClinicalTrials.gov ID
- NCT00271882
- Acronym / sponsor ID
- ATN 053
- Conditions
- PTSD, Sexual Abuse, HIV Infections
- Keywords
- Adolescent Females, HIV positive, PTSD, Sexual Abuse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Mar 2006
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 4 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
2 secondary outcomes
Assess preferred intervention delivery strategies for an abuse-related intervention
Time frame: 12 Months
Identify strengths/protective factors
Time frame: 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
- Website for the Adolescent Trials Network for HIV/AIDS InterventionsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gretchen Clum, Ph.D study chair
Tulane School of Public Health and Tropical Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PTSD and Sexual Abuse, run by University of North Carolina, Chapel Hill at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Explore the interrelationship between abuse and sexual risk behavior (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2017.