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Connect to Protect Partnerships for Youth Prevention Interventions: Phase II

27. februar 2017 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

16706

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

12 år til 24 år (Barn, Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

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)..

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of North Carolina, Chapel Hill

Samarbejdspartnere

National Institute on Drug Abuse (NIDA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Mental Health (NIMH)

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2003

Primær færdiggørelse (Faktiske)

1. oktober 2010

Studieafslutning (Faktiske)

1. oktober 2010

Datoer for studieregistrering

Først indsendt

15. februar 2005

Først indsendt, der opfyldte QC-kriterier

15. februar 2005

Først opslået (Skøn)

16. februar 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. marts 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. februar 2017

Sidst verificeret

1. juli 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ATN 016b

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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