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Connect to Protect Partnerships for Youth Prevention Interventions: Phase II

27 februari 2017 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Gedetailleerde beschrijving

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

Observationeel

Inschrijving (Werkelijk)

16706

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

12 jaar tot 24 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
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)..

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of North Carolina, Chapel Hill

Medewerkers

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

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 september 2003

Primaire voltooiing (Werkelijk)

1 oktober 2010

Studie voltooiing (Werkelijk)

1 oktober 2010

Studieregistratiedata

Eerst ingediend

15 februari 2005

Eerst ingediend dat voldeed aan de QC-criteria

15 februari 2005

Eerst geplaatst (Schatting)

16 februari 2005

Updates van studierecords

Laatste update geplaatst (Werkelijk)

1 maart 2017

Laatste update ingediend die voldeed aan QC-criteria

27 februari 2017

Laatst geverifieerd

1 juli 2016

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • ATN 016b

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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