- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00103896
Connect to Protect Partnerships for Youth Prevention Interventions: Phase II
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
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
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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San Juan, Puerto Rico, 00936
- University Pediatric Hospital
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California
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Los Angeles, California, Vereinigte Staaten, 90054
- Childrens Hospital of Los Angeles
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San Diego, California, Vereinigte Staaten, 92103
- UCSD Mother, Child & Adolescent HIV Program
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San Francisco, California, Vereinigte Staaten, 94143
- Univ of Califormia at San Francisco
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District of Columbia
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Washington, District of Columbia, Vereinigte Staaten, 20010
- Children's Hospital National Medical Center
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Florida
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Ft. Lauderdale, Florida, Vereinigte Staaten, 33301
- Children's Diag. and Treatment Center
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Miami, Florida, Vereinigte Staaten, 33101
- University of Miami
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Tampa, Florida, Vereinigte Staaten, 33606
- USF Peds Div. of Infectious Disease
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Illinois
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Chicago, Illinois, Vereinigte Staaten, 60612
- Stroger Hospital of Cook County
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Louisiana
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New Orleans, Louisiana, Vereinigte Staaten, 70112
- Tulane Medical Center
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Maryland
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Baltimore, Maryland, Vereinigte Staaten, 21201
- University of Maryland
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Massachusetts
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Boston, Massachusetts, Vereinigte Staaten, 02115
- Childrens' Hospital of Boston
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New York
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Bronx, New York, Vereinigte Staaten, 10467
- Montefiore Medical Center, Adolescent AIDS Program
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New York, New York, Vereinigte Staaten, 10128
- Mount Sinai Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, Vereinigte Staaten, 19104
- Children's Hopsital of Philadelphia
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
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
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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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).
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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).
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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)..
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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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
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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.
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One time assessment at 10 months
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Describe HIV risk behaviors of adolescents and young adults recruited from targeted venues
Zeitfenster: One time assessment at 10 months
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The outcome measure will be assessed by conducting HIV serosurveys at each venue identified with youth whose HIV status is unknown.
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One time assessment at 10 months
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Describe social networks of adolescents and young adults recruited from targeted venues
Zeitfenster: One time assessment at 10 months
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The outcome measure will be assessed by conducting HIV serosurveys at each venue identified with youth whose HIV status is unknown.
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One time assessment at 10 months
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Describe HIV seroprevalence of adolescents and young adults recruited from targeted venues
Zeitfenster: One time assessment at 10 months
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The outcome measure will be assessed by conducting HIV serosurveys at each venue identified with youth whose HIV status is unknown.
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One time assessment at 10 months
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Assess the characteristics of the community-researcher partnerships
Zeitfenster: One time assessment at 10 months
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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.
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One time assessment at 10 months
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Assess quality of the community-researcher partnerships
Zeitfenster: One time assessment at 10 months
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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.
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One time assessment at 10 months
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Assess outcomes of the community-researcher partnerships
Zeitfenster: One time assessment at 10 months
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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.
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One time assessment at 10 months
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Mitarbeiter und Ermittler
Mitarbeiter
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
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- RNA-Virusinfektionen
- Viruserkrankungen
- Infektionen
- Durch Blut übertragene Infektionen
- Übertragbare Krankheiten
- Sexuell übertragbare Krankheiten, viral
- Sexuell übertragbare Krankheiten
- Lentivirus-Infektionen
- Retroviridae-Infektionen
- Immunologische Mangelsyndrome
- Erkrankungen des Immunsystems
- HIV-Infektionen
Andere Studien-ID-Nummern
- ATN 016b
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