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Connect to Protect Partnerships for Youth Prevention Interventions: Phase II

27. februar 2017 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Detaljert 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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

16706

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

12 år til 24 år (Barn, Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
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)..

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of North Carolina, Chapel Hill

Samarbeidspartnere

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

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. september 2003

Primær fullføring (Faktiske)

1. oktober 2010

Studiet fullført (Faktiske)

1. oktober 2010

Datoer for studieregistrering

Først innsendt

15. februar 2005

Først innsendt som oppfylte QC-kriteriene

15. februar 2005

Først lagt ut (Anslag)

16. februar 2005

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. mars 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. februar 2017

Sist bekreftet

1. juli 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ATN 016b

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