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Connect to Protect Partnerships for Youth Prevention Interventions: Phase II

27. Februar 2017 aktualisiert von: University of North Carolina, Chapel Hill

Connect to Protect (C2P) Partnerships for Youth Prevention Interventions: Phase II

This is Phase II of a three stage project whose overall goals are to develop viable community-based HIV prevention interventions and to form and maintain the necessary community collaborations to support such Adolescent Trials Network (ATN) research activities.

This phase will describe specific locations within high-risk areas where youth, ages 12-24, spend time. HIV risk behaviors, social networking patterns and HIV prevalence among youth at these venues will be assessed by administering anonymous computerized interviews to eligible and willing youth. This information will be shared with community partners during scheduled working group meetings.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Detaillierte Beschreibung

This is Phase II of a three stage project whose overall goals are to develop viable community-based HIV prevention interventions and to form and maintain the necessary community collaborations to support such ATN research activities.

During this phase, each ATN site will gather additional information within high-risk areas and solicit community partner input to ultimately pinpoint the specific locations where at-risk youths, ages 12-24, may be recruited for interventions. This will be done by the following methods:

Venues will be identified by HIV+ youth at the ATN site by participation in an anonymous computerized interview. Site staff will then perform brief venue interviews (BVIs) at selected venues to assess the potential yield of youths 12-24 years old. Community partners will also provide the site staff with information on known high-risk venues. High-risk venues will further be identified by the results of anonymous computerized interviews and HIV assays obtained from eligible and willing youth participants at the venues. The interviews will gather information on HIV risk behaviors, social networking patterns and HIV prevalence among youths at these venues. This information will be shared with community partners during scheduled working group meetings.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

16706

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

      • San Juan, Puerto Rico, 00936
        • University Pediatric Hospital
    • California
      • Los Angeles, California, Vereinigte Staaten, 90054
        • Childrens Hospital of Los Angeles
      • San Diego, California, Vereinigte Staaten, 92103
        • UCSD Mother, Child & Adolescent HIV Program
      • San Francisco, California, Vereinigte Staaten, 94143
        • Univ of Califormia at San Francisco
    • District of Columbia
      • Washington, District of Columbia, Vereinigte Staaten, 20010
        • Children's Hospital National Medical Center
    • Florida
      • Ft. Lauderdale, Florida, Vereinigte Staaten, 33301
        • Children's Diag. and Treatment Center
      • Miami, Florida, Vereinigte Staaten, 33101
        • University of Miami
      • Tampa, Florida, Vereinigte Staaten, 33606
        • USF Peds Div. of Infectious Disease
    • Illinois
      • Chicago, Illinois, Vereinigte Staaten, 60612
        • Stroger Hospital of Cook County
    • Louisiana
      • New Orleans, Louisiana, Vereinigte Staaten, 70112
        • Tulane Medical Center
    • Maryland
      • Baltimore, Maryland, Vereinigte Staaten, 21201
        • University of Maryland
    • Massachusetts
      • Boston, Massachusetts, Vereinigte Staaten, 02115
        • Childrens' Hospital of Boston
    • New York
      • Bronx, New York, Vereinigte Staaten, 10467
        • Montefiore Medical Center, Adolescent AIDS Program
      • New York, New York, Vereinigte Staaten, 10128
        • Mount Sinai Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, Vereinigte Staaten, 19104
        • Children's Hopsital of Philadelphia

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

12 Jahre bis 24 Jahre (Kind, Erwachsene)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

HIV infected youth, ages 12 through 24 years old, in treatment/care at each of the 15 ATN sites will be interviewed using ACASI technology to reveal possible venues where youth at high risk for acquiring the HIV may be found. Individuals approached at 3-5 of these identified venues who appear to be 12 through 24 years will be offered a brief venue interview. Anonymous HIV serosurvey (ACASI and HIV-Ab assay) will be administered to 20-30 young women at 2-3 identified high-risk venues, and 20-30 young men at 2-3 identified high-risk venues, who provide verbal confirmation of being 12 through 24 years old, and whose HIV status is unknown to the site staff.

Beschreibung

Inclusion Criteria:

Index Subjects:

  • Documented HIV-infection
  • Acquisition of HIV after age 9 years
  • Verbal confirmation of 12-24 years of age
  • Verbal report of having engaged in sexual activity (vaginal, anal and/or oral sex) within the past 12 months
  • Ability to understand and willingness to provide informed consent/assent

BVI subjects:

  • Youths who appear to be 12-24 years old

HIV Serosurvey subjects at the venues:

  • Verbal confirmation of 12-24 years of age
  • Verbal report of having engaged in sexual activity (vaginal, anal and/or oral sex) within the past 12 months
  • Ability to understand and willingness to provide informed consent/assent

Exclusion Criteria:

  • Visibly distraught and/or emotionally unstable (i.e. depressive mood, exhibiting manic, suicidal or violent behavior, etc.)
  • Visibly intoxicated or under the influence of psychoactive agents
  • Clinically presents as acutely ill

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
HIV Infected Youth in Treatment/Care
HIV infected youth in treatment/care will be interviewed using Audio Computer-Assisted Self-Administered Interview ACASI technology to reveal possible venues where youth at high risk for acquiring the disease may be found (N = 20-30 individuals per ATN site).
BVI Individuals
Additional data will be gathered on potential recruitment venues by administering a brief venue interview (BVI) to individuals who appear to be between 12 and 24 years old (N = unlimited individuals during 3-5 assessment periods per venue each lasting 5 hours).
HIV Serosurvey Individuals
HIV Serosurvey Individuals Anonymous structured interview using ACASI technology and an anonymous HIV antibody assay will be administered to 20-30 young women at 2-3 targeted locations and 20-30 young men at 2-3 targeted locations whose HIV status is unknown (N = 160-360 individuals per ATN site)..

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Ascertain specific community venues where at-risk youth can be recruited for interventions within the high-risk areas identified in the first Phase of the study
Zeitfenster: One time assessment at 10 months
The outcome measure will be assessed using results from: (a) Phase I mapping; (b) Phase II interviews with HIV-infected youth; and (c) Phase II Brief Venue Interviews (BVIs). Input from community partners and ethnographic procedures will add critical information.
One time assessment at 10 months
Describe HIV risk behaviors of adolescents and young adults recruited from targeted venues
Zeitfenster: One time assessment at 10 months
The outcome measure will be assessed by conducting HIV serosurveys at each venue identified with youth whose HIV status is unknown.
One time assessment at 10 months
Describe social networks of adolescents and young adults recruited from targeted venues
Zeitfenster: One time assessment at 10 months
The outcome measure will be assessed by conducting HIV serosurveys at each venue identified with youth whose HIV status is unknown.
One time assessment at 10 months
Describe HIV seroprevalence of adolescents and young adults recruited from targeted venues
Zeitfenster: One time assessment at 10 months
The outcome measure will be assessed by conducting HIV serosurveys at each venue identified with youth whose HIV status is unknown.
One time assessment at 10 months
Assess the characteristics of the community-researcher partnerships
Zeitfenster: One time assessment at 10 months
The outcome measure will be assessed by conducting interviews with C2P staff and their community partners. Questionnaires will be completed by both parties and detailed documentation kept.
One time assessment at 10 months
Assess quality of the community-researcher partnerships
Zeitfenster: One time assessment at 10 months
The outcome measure will be assessed by conducting interviews with C2P staff and their community partners. Questionnaires will be completed by both parties and detailed documentation kept.
One time assessment at 10 months
Assess outcomes of the community-researcher partnerships
Zeitfenster: One time assessment at 10 months
The outcome measure will be assessed by conducting interviews with C2P staff and their community partners. Questionnaires will be completed by both parties and detailed documentation kept.
One time assessment at 10 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Donna Futterman, MD, Montefiore Medical Center
  • Hauptermittler: Sue Ellen Abdalian, MD, Tulane Medical Center
  • Studienstuhl: Jonathan Ellen, MD, Johns Hopkins Medical Center
  • Hauptermittler: Ligia Peralta, MD, Division of Adolescent & Young Adult Medicine University of MD, Medical School
  • Hauptermittler: Marvin Belzer, MD, Childrens Hosp of Los Angeles, Division of Adolescent Medicine
  • Hauptermittler: Bret Rudy, MD, Children's Hospital of Philadelphia
  • Hauptermittler: Larry D'Angelo, MD, Children's National Research Institute
  • Hauptermittler: Cathryn Samples, MD, Boston Children's Hospital
  • Hauptermittler: Lisa Henry-Reid, MD, John H. Stroger Jr. Hospital and the CORE Center
  • Hauptermittler: Ana Puga, MD, Children's Diag. and Treatment Ctr of Ft. Lauderdale, FL
  • Hauptermittler: Lawrence Friedman, MD, University of Miami, School of Medicine, Div of Adolescent Medicine
  • Hauptermittler: Patricia Emmanuel, MD, University of South Florida, Peds Div of Infectious Disease
  • Hauptermittler: Linda Levin, MD, Mount Sinai Adolescent Health Center
  • Hauptermittler: Irma Febo, MD, University of Puerto Rico Medical Sciences Campus
  • Hauptermittler: Stephen A Spector, MD, UCSD Mother, Child, & Adolescent HIV Program
  • Hauptermittler: Rolando M Viani, MD, UCSD Mother, Child, & Adolescent HIV Program
  • Hauptermittler: Barbara Moscicki, MD, UCSF, Division of Adoles. Med
  • Hauptermittler: Coco Auerswald, MD, UCSF, Division of Adoles. Med

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. September 2003

Primärer Abschluss (Tatsächlich)

1. Oktober 2010

Studienabschluss (Tatsächlich)

1. Oktober 2010

Studienanmeldedaten

Zuerst eingereicht

15. Februar 2005

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

15. Februar 2005

Zuerst gepostet (Schätzen)

16. Februar 2005

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

1. März 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

27. Februar 2017

Zuletzt verifiziert

1. Juli 2016

Mehr Informationen

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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