NCT00271882

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2006

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 30, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 4, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

February 28, 2017

Status Verified

February 1, 2016

Enrollment Period

6 months

First QC Date

December 30, 2005

Last Update Submit

February 27, 2017

Conditions

PTSDSexual AbuseHIV Infections

Keywords

Adolescent FemalesHIV positivePTSDSexual Abuse

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    12 Months

Secondary Outcomes (2)

  • Assess preferred intervention delivery strategies for an abuse-related intervention

    12 Months

  • Identify strengths/protective factors

    12 Months

Eligibility Criteria

Age18 Years - 24 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Miami

Miami, Florida, 33101, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467-2490, United States

Location

The Children's Hosp. of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Links

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticHIV InfectionsHIV Seropositivity

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Gretchen Clum, Ph.D

    Tulane School of Public Health and Tropical Medicine

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2005

First Posted

January 4, 2006

Study Start

March 1, 2006

Primary Completion

September 1, 2006

Study Completion

September 1, 2006

Last Updated

February 28, 2017

Record last verified: 2016-02

Locations

US(3)